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<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - Dental Pain; BRIEF: To evaluate the efficacy of a single dose NTC-510 or NTC-510A for dental pain following third molar extraction. ; DRUG USED: NanoBUP; DRUG CLASS: Non-NME; INDICATION: Postsurgical Pain; TARGET: Opioid receptors; THERAPY: Monotherapy; LEAD SPONSOR: NanoSHIFT LLC; CRITERIA: Inclusion Criteria: - Subject is able to read, understand, and sign the approved informed consent form. - Subject is an adult between 18 and 45 years of age, inclusive, who has been evaluated and scheduled for an elective third molar surgical extraction (targeting 1 or 2 third molars, at least 1 of which is mandibular and fully or partially impacted by bone). Supernumerary or affected adjacent teeth may be removed at the surgeons discretion. - Subject has body mass index of 18.0 to 30.0 kg/m2, inclusive. - Female subjects of childbearing potential must be using a medically acceptable form of birth control for at least 1 month prior to screening (3 months on oral contraceptives), e.g., oral or patch contraceptives, intrauterine device (copper/hormonal), NuvaRing®, Depo-Provera®, or double-barrier method, and have a negative pregnancy test prior to surgery. Female subjects of nonchildbearing potential must be amenorrheic for at least 2 years or have had a hysterectomy and/or bilateral oophorectomy. - Subject must experience moderate to severe pain (i.e., rating of 2 or 3 on a 4-point categorical PI scale [0 = none, 1 = mild, 2 = moderate, and 3 = severe] and a score of ≥ 50 mm on a 100 mm VAS) within 5 hours after the dental extraction. - Subject has been administered only 2% topical benzocaine, lidocaine with epinephrine, and/or nitrous oxide as preoperative medication. - Subject is determined by the investigator to be otherwise in good health and unlikely to be at risk from participation in this study. Exclusion Criteria: - Female subject who is pregnant or lactating. - Subject has a history of human immunodeficiency virus, hepatitis B, or hepatitis C infection. - Subject has participated in any clinical research study within the previous 8 weeks. - Subject has a history of seizures and/or significant head trauma. - Subject has an abnormal cardiac condition including any of the following: - Medically significant disorders of cardiac rate and/or rhythm - QTc interval > 450 msec (calculated using Fridericias correction) or uncorrected QT interval > 500 msec, PR interval > 240 msec or ≤ 110 msec, evidence of second or third degree atrioventricular block, pathological Q-waves (defined as Q-wave > 40 msec or depth > 0.5 mV), evidence of ventricular pre-excitation, complete left bundle branch block, and/or resting heart rate outside the range of 40 to 120 beats per minute - Subject has evidence of clinically significant abnormal laboratory values including the following: - Impaired kidney function (i.e., serum creatinine ≥ 1.5 mg/dL) - Impaired liver function (laboratory test values ≥ 3 times the upper limit of normal [ULN] for aspartate aminotransferase or alanine aminotransferase, or values > 2 times the ULN for alkaline phosphatase), or total bilirubin level > 1.5 times the ULN or, in the opinion of the investigator, liver function impairment to the extent that the subject should not participate in this study - Presence of Gilberts Syndrome or any known hepatobiliary abnormalities - Any other laboratory values judged as clinically significant by the investigator - Subject has a history of chronic or sustained intake of opioid drugs in the preceding 12 months, or has taken any medication containing opioid compounds in the month preceding entry to this trial. - Subject has a history of alcohol or substance abuse or addiction within 2 years before screening and/or routine consumption of 3 or more alcohol-containing beverages per day. Subject has consumed alcohol within 3 days before administration of study drug or cannot abstain for the duration of confinement to the clinical unit. - Subject has a prior history of intolerance to opioid drugs, their excipients, or related compounds. - Subject has positive urine test for alcohol, cotinine, or drugs of abuse at screening or check-in. If a subject is excluded for a positive drug screen due to prescribed medication for pain from an infected molar, the subject may be rescreened after the appropriate washout period. - Subject has used any medication (with the exception of vitamins and contraceptives), including over-the-counter medications, herbal and/or mineral supplements, dietary supplements, or has ingested grapefruit-containing foods or beverages within 3 days before administration of study drug, or cannot abstain for the duration of confinement to the clinical unit. - Subject has ingested caffeine-containing foods or beverages (e.g., coffee, tea, chocolate, and colas) within 24 hours before administration of study drug or cannot abstain for the duration of confinement to the clinical unit. - Subject has smoked or used other nicotine products within 3 days before study drug administration or cannot abstain for the duration of confinement to the clinical unit. - Subject has the presence of any conditions possibly affecting drug absorption (e.g., gastrectomy or malabsorption) or has taken oral medications that affect gastric acid availability (including H2 antagonists, proton-pump inhibitors, and antacids) within 3 days before administration of study drug. - Subject has any current dental or medical condition that could prevent safe participation in this study. - Subject has significant medical or psychiatric symptoms, cognitive impairment, or other factors which, in the opinion of the investigator, would preclude compliance with the protocol, adequate cooperation in the study, or obtaining informed consent. ; PRIMARY OUTCOME: Decrease in dental pain when taking a single doses of NTC-510 or NTC-510A at 2.0, 1.0, or 0.5 mg following third molar extraction.; SECONDARY OUTCOME 1: Evaluate the number of subjects with adverse events following a single oral dose of 2.0, 1.0, or 0.5 mg for acute pain relief (PR) following third molar extraction[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - PEDFIC2 (OLE); BRIEF: Open Label Extension Study to evaluate long term safety and persistence of effect of A4250 in children with PFIC. ; DRUG USED: Bylvay; DRUG CLASS: New Molecular Entity (NME); INDICATION: Progressive Familial Intrahepatic Cholestasis (PFIC); TARGET: Ileal Bile Acid Transporter (IBAT)/Apical Sodium-dependent Bile Acid Transporter (ASBT); THERAPY: Monotherapy; LEAD SPONSOR: Albireo; CRITERIA: Inclusion Criteria Cohort 1: 1. Completion of the 24-week Treatment Period of Study A4250-005 or withdrawn from Study A4250-005 due to patient/caregiver judgment of intolerable symptoms after completing at least 12 weeks of treatment 2. Signed informed consent and assent as appropriate 3. Patients expected to have a consistent caregiver for the duration of the study 4. Caregivers (and age appropriate patients) must be willing and able to use an eDiary device as required by the study Inclusion Criteria Cohort 2: 1. A male or female patient of any age, with a clinical diagnosis of PFIC, including episodic forms (i.e., BRIC), and with a body weight ≥5 kg at Visit S-1. 2. Patient must have clinical genetic confirmation of PFIC 3. Patients with PFIC, excluding BRIC, must have elevated serum bile acid concentration,specifically measured to be ≥100 μmol/L, taken as the average of 2 samples at least 7 days apart (Visits S-1 and S-2) prior to the Screening/Inclusion Visit (Visit 1). 4. Patients with PFIC, excluding BRIC, must have history of significant pruritus and a caregiver-reported observed scratching or patient-reported itching (for patients >18 with no caregiver-reported observed scratching) in the eDiary average of ≥2 (on 0 to 4 scale) in the 2 weeks prior to the Screening/Inclusion Visit (Visit 1). 5. Patients with episodic forms of PFIC (i.e., BRIC) must have an emerging flare characterized by clinically significant pruritus and elevated serum bile acid levels/cholestasis as judged by the investigator. 6. Patient and/or legal guardian must sign informed consent (and assent) as appropriate. Patients who turn 18 years of age (or legal age per country) during the study will be required to re-consent in order to remain in the study. 7. Age appropriate patients are expected to have a consistent caregiver for the duration of the study 8. Caregivers and age-appropriate patients (≥8 years of age) must be willing and able to use an eDiary device as required by the study Exclusion Criteria Cohort 1: 1. Decompensated liver disease: coagulopathy, history, or presence of clinically significant ascites, variceal hemorrhage, and/or encephalopathy 2. Sexually active males and females who are not using a reliable contraceptive method with ≤1% failure rate (such as hormonal contraception, intra-uterine device, or complete abstinence) throughout the duration of the study and 90 days thereafter 3. Patients not compliant with treatment in study A4250-005 4. Any other conditions or abnormalities which, in the opinion of the investigator or Medical Monitor, may compromise the safety of the patient, or interfere with the patient participating in or completing the study Exclusion Criteria Cohort 2: 1. Known pathologic variations of the ABCB11 gene that have been demonstrated to result in complete absence of the BSEP protein 2. Patient with past medical history or ongoing presence of other types of liver disease including, but not limited to, the following: 1. Biliary atresia of any kind 2. Suspected or proven liver cancer or metastasis to the liver on imaging studies 3. Histopathology on liver biopsy is suggestive of alternate non-PFIC related etiology of cholestasis Note: Patients with clinically significant portal hypertension are allowed. 3. Patient with a past medical history or ongoing presence of any other disease or condition known to interfere with the absorption, distribution, metabolism (specifically bile acid metabolism), or excretion of drugs in the intestine, including but not limited to,inflammatory bowel disease. 4. Patient with past medical history or ongoing chronic (i.e., >3 months) diarrhea requiring intravenous fluid or nutritional intervention for treatment of the diarrhea and/or its sequelae. 5. Patient has a confirmed past diagnosis of infection with human immunodeficiency virus or other present and active, clinically significant, acute, or chronic infection, or past medical history of any major episode of infection requiring hospitalization or treatment with parenteral anti-infective treatment within 4 weeks of treatment start (Study Day 1) or completion of oral anti-infective treatment within 2 weeks prior to start of Screening Period. 6. Any patient with suspected or confirmed cancers except for basal cell carcinoma, and non-liver cancers treated at least 5 years prior to Screening with no evidence of recurrence. 7. Patient has had a liver transplant, or a liver transplant is planned within 6 months of the Screening/Inclusion Visit. 8. Decompensated liver disease, coagulopathy, history, or presence of clinically significant ascites, variceal hemorrhage, and/or encephalopathy 9. INR >1.4 (the patient may be treated with Vitamin K intravenously, and if INR is ≤1.4 at resampling the patient may be included). 10. Serum ALT >10 × upper limit of normal (ULN) at Screening. 11. Serum ALT >15 × ULN at any time point during the last 6 months unless an alternate etiology was confirmed for the elevation. 12. Total bilirubin >10 × ULN at Screening. 13. Patient suffers from uncontrolled, recalcitrant pruritic condition other than PFIC. Examples include, but not limited to, refractory atopic dermatitis or other primary pruritic skin diseases. 14. Any patient who is pregnant or lactating or who is planning to become pregnant within 72 weeks of the Screening/Inclusion Visit. 15. Sexually active males and females who are not using a reliable contraceptive method with ≤1% failure rate (such as hormonal contraception, intrauterine device, or complete abstinence) throughout the duration of the study and 90 days thereafter (from signed informed consent through 90 days after last dose of study drug). 16. Patient with a past medical history of alcohol or substance abuse will be excluded. Patient must agree to refrain from illicit drug and alcohol use during the study. 17. Administration of bile acid or lipid binding resins and medications that slow GI motility. 18. Patient has had investigational exposure to a drug, biologic agent, or medical device within 30 days prior to Screening, or 5 half-lives of the study agent, whichever is longer. 19. Any other conditions or abnormalities which, in the opinion of the investigator or Medical Monitor, may compromise the safety of the patient, or interfere with the patient participating in or completing the study. ; PRIMARY OUTCOME: Change in Pruritus; SECONDARY OUTCOME 1: All-cause mortality[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - pCAD-Positive Tumors; BRIEF: A first-in-human sttudy using PCA062 in patients with p-CAD positive solid tumors. ; DRUG USED: PCA-062; DRUG CLASS: Biologic; INDICATION: Solid Tumors; TARGET: Antibody-drug Conjugate (ADC), Cadherins; THERAPY: Monotherapy; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Inclusion criteria: 1. Male or female ≥ 18 years of age 2. Documented pCAD expressing tumor cells with the exception of HNSCC and ESCC. An archived tumor sample collected within 36 months prior to baseline if available, or a new tumor biopsy sample must be available for molecular pre-screening. 3. Consent for a tumor biopsy at screening 4. Progressive disease and no effective therapy exists 5. Measurable disease as per RECIST v1.1 criteria 6. ECOG Performance status of ≤ 2 Exclusion criteria: 1. CNS metastatic involvement 2. Clinically significant cardiac, respiratory, gastrointestinal, renal, hepatic or neurological conditions. 3. A history of serious allergic reactions, which in the opinion of the investigator pose an increased risk of serious infusion reactions. 4. Monocular vision or has media opacities or any other condition that precludes monitoring of the retina or the fundus, or has a history of ophthalmology exam with retina or cornea abnormalities 5. Previously treated with anti-pCAD biologic therapies. 6. Received anti-cancer therapies within the following time frames prior to the first dose of study treatment: - Conventional cytotoxic chemotherapy: ≤4 weeks - Biologic therapy (eg, antibodies), other than ADCs: ≤4 weeks - Non-cytotoxic small molecule therapeutics: ≤5 T1/2 or ≤2 weeks (whichever is longer) - Other investigational agents: ≤4 weeks - Radiation therapy (palliative setting is allowed.): ≤4 weeks - Major surgery: ≤2 weeks 7. Patient has out of range laboratory values defined as: - Hematological values: - Absolute neutrophil count (ANC) <1.5 x 109/L - Hemoglobin (Hgb) <9 g/dL - Platelets <100 x 109/L - Hepatic and renal function - Total bilirubin >1.5 x upper limit of normal (ULN). For patients with Gilberts syndrome, total bilirubin >2.5 x ULN. - Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >3 x ULN for patients without tumor involvement of the liver or >5 x ULN for patients with tumor involvement of the liver. - Serum creatinine >1.5 x ULN and/or measured creatinine clearance < 40 ml/min ; PRIMARY OUTCOME: Incidence rate of dose limiting toxicities; SECONDARY OUTCOME 1: Incidence and severity of serious/adverse events[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - LUN06-113; BRIEF: At this point in the treatment of extensive stage SCLC, we have reached a plateau in survival with conventional chemotherapy and newer regimens are greatly needed. It has been noted that patients with increased VEGF levels have a poorer prognosis. Anti-angiogenic agents hold significant promise in the treatment of patients with extensive stage SCLC. ZD6474, a new inhibitor of the VEGFR-2, has shown favorable action in NSCLC. ; DRUG USED: Caprelsa; DRUG CLASS: New Molecular Entity (NME); INDICATION: Small Cell Lung Cancer (SCLC); TARGET: EGFR (Epidermal Growth Factor Receptor), RET, VEGF (Vascular endothelial growth factor); THERAPY: Monotherapy; LEAD SPONSOR: Hoosier Cancer Research Network; CRITERIA: Inclusion Criteria: - Histological or cytological proof of chemotherapy-naïve, extensive, small cell lung cancer. - Measurable disease according to RECIST and obtained by imaging within 28 days prior to being registered for protocol therapy. - Written informed consent and HIPAA authorization for release of personal health information. - Age 18 years or older at the time of consent. - Potassium ≥4.0 mmol/L and <5.5mmol/L (supplementation is allowed). - Calcium within normal range (supplementation is allowed). - Magnesium within normal range (supplementation is allowed). Exclusion Criteria: - No prior EGFR inhibitor or antiangiogenic agent allowed. - No prior hormonal therapy. - No symptomatic brain metastasis. - No clinically significant infections as judged by the treating investigator. - No evidence of severe or uncontrolled other systemic disease or any concurrent condition which in the Investigators opinion makes it undesirable for the subject to participate in the trial or which would jeopardize compliance with the protocol. - No previous history of QTc prolongation as a result of medication that required discontinuation of that medication. - No congenital long QT syndrome or known 1st degree relative with unexplained sudden death under 40 years of age. - No presence of left bundle branch block (LBBB.) - No QTc with Bazetts correction that is unmeasurable, or ≥480 msec on screening ECG obtained within 7 days prior to registration for protocol therapy. If a subject has QTc ≥480 msec on screening ECG, the screen ECG may be repeated twice (at least 24 hours apart). The average QTc from the three screening ECGs must be <480 msec in order for the subject to be eligible for the study. - No concomitant (within 14 days prior to registration for and during protocol therapy) medication associated with Torsades de Pointes or cause QTc prolongation, is allowed. Medications that prolong QT, but are not strictly associated with Torsades, are allowed if medically necessary and will require increased ECG and electrolyte monitoring. - No uncontrolled hypertension (systolic blood pressure greater than 160 mm Hg or diastolic blood pressure greater than 100 mm Hg). - No currently active diarrhea that may affect the ability to absorb ZD6474. - No prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, Gleason < grade 7 prostate cancers, or other cancer for which the subject has been disease-free for at least 5 years. - Major surgery must be completed greater than 28 days prior to registration for protocol therapy and healed surgical incision is required. - No concomitant (within 14 days prior to registration for and during protocol therapy) medications that are potent inducers (rifampicin, rifabutin, phenytoin, carbamazepine, phenobarbital and St. Johns Wort) of CYP3A4 function. - Females of childbearing potential and males must be willing to use an effective method of contraception (hormonal or barrier method of birth control; abstinence) from the time consent is signed until 8 weeks after treatment discontinuation. - Females of childbearing potential must have a negative pregnancy test within 7 days prior to being registered for protocol therapy. - Females must not be breastfeeding. ; PRIMARY OUTCOME: Time to Disease Progression - Median Time to Progression and Log-Rank Test; SECONDARY OUTCOME 1: Percentage of Participants With Grade 3/4 Hematologic and Non-Hematologic Toxicities[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - Female Stress Urinary Incontinence (Canada); BRIEF: The Autologous Cell Therapy for Female SUI study is a clinical trial to determine the safety and potential effectiveness of a single dose of 200 million Cook MyoSite Autologous Muscle Derived Cells for treatment of Stress Urinary Incontinence. ; DRUG USED: Autologous Muscle Derived Cells; DRUG CLASS: Biologic; INDICATION: Urinary Incontinence; TARGET: Stem Cells/Other Cell Therapies; THERAPY: Monotherapy; LEAD SPONSOR: Cook MyoSite; CRITERIA: Inclusion Criteria: - SUI with normal detrusor activity confirmed with urodynamics - Bladder capacity >200 ml - Incontinence has not shown any improvement for at least -6 months - Failed prior treatments (e.g., behavior modification, bladder exercises, biofeedback, electrical stimulation, bulking injections, urethral suspensions and/or drug therapy) Exclusion Criteria: - Known vesicoureteral reflux, vaginal prolapse beyond the introitus, or other significant pelvic floor abnormalities with high pressure instability - Neuromuscular disorder (e.g., muscular dystrophy, multiple sclerosis) - Uncontrolled diabetes - Pregnant, lactating, or plans to become pregnant during course of the study - Morbid obesity (defined as 100 pounds over their ideal body weight, or BMI ≥40) and not expected to benefit from treatment - Current or acute conditions involving cystitis or urethritis - Scheduled to receive radiation treatment to the vicinity, or history of radiation treatment to the urethra or adjacent structures ; PRIMARY OUTCOME: Number of Participants That Experienced Biopsy Procedure-related Adverse Events; SECONDARY OUTCOME 1: [/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - REDDSTAR; BRIEF: examine safety of topical application of single dose allogeneic bone marrow derived mesenchymal stromal cells to non-healing diabetic foot ulcers ; DRUG USED: Orbcel; DRUG CLASS: Biologic; INDICATION: Diabetic Foot and Other Ulcers; TARGET: Stem Cells/Other Cell Therapies; THERAPY: Monotherapy; LEAD SPONSOR: Steno Diabetes Center Copenhagen; CRITERIA: Inclusion Criteria: 1. Age 18-80 years. 2. Type 1 or Type 2 diabetes mellitus (with any kind or combination of pharmacological treatment for disease and/or complications to disease). 3. HbA1c ≤ 97 mmol/mol (≤ 11%). 4. Males or non-pregnant females. 5. Understand trial information document. 6. Provide written informed consent. 7. Duration of (diabetic foot) wound > 4 but < 52 weeks. 8. Reduction of < 50% area over 4 weeks despite standard care (standard care; off-loading, weekly debridement, dressings, orthotic). 9. Wound area with sharp debridement of ≥ 0.5 but ≤ 4.0 cm2. 10. Clinically non-infected wound. 11. Texas wound stage 1a, 1c or 2a. 12. Location of wound below malleolus. 13. Affected limb toe pressure ≥ 40 mmHg. 14. An ankle-brachial systolic pressure index between 0.7 and 1.3. 15. Diagnosis of peripheral neuropathy using American Diabetes Association guidelines (monofilament/vibration sensation/biothesiometer). 16. Able to adhere to study visit protocol. 17. Adhere to offloading devices/orthotic. Exclusion Criteria: 1. Life expectancy of less than 12 months. 2. Patients with a definite diagnosis of any immunodeficiency disorder. 3. Viral hepatitis [patient must have negative hepatitis B surface-antigen (HBsAg) and hepatitis C antibody (HepCAb) test results obtained within 2 weeks prior to the Treatment Day (Day 1)]. 4. Active, uncontrolled connective tissue disease. 5. Renal failure as defined by serum creatinine > 220 µmol/L. 6. Liver function tests that are > 2.0 times Upper Limit Normal. 7. Poor nutritional status as measured by serum albumin < 30 g/L. 8. Active cancer or a history of cancer in the 5 years prior to signing the informed consent form (history of basal cell carcinoma is allowed). 9. Active wound infection (i.e. recent onset of erythema, oedema, and increased temperature of the foot with normal radiographs). 10. Diabetic Charcot neuroarthropathy or other structural deformity that would prevent adequate off-loading of the study foot. 11. Treatment with any systemic corticosteroid immunosuppressive chemotherapeutic agent, antiviral, or previous/current radiation therapy to lower extremity to be treated within 30 days prior to signing the informed consent form. 12. Having received another investigational drug or biologic within 30 days prior to signing the informed consent form or currently participating in an investigational drug or biologic study. 13. A psychiatric condition or chronic alcohol or drug abuse problem, determined from the patients medical history, which in the Investigators opinion may pose a threat to patient compliance. 14. History of non-compliance with treatment or clinical visit attendance (i.e. this study requires that patients will comply with the protocol and ulcer care regimen). 15. Any unstable medical condition judged by the Principal Investigator that would cause the study to be detrimental to the patient. 16. Wounds caused primarily by untreated vascular insufficiency, or where patients are primarily eligible for vascular intervention to promote wound healing. 17. Wounds with an aetiology not related to diabetes. 18. More than three wounds on the target lower extremity. 19. The wound to be studied not anatomically distinct from another wound(s) (separated by < 1 cm from another wound or would interfere with standard of care treatment of another wound. Only one single wound per one study subject can be treated in this study. 20. Wounds which decrease in area by > 50% during the screening 4-week run-in period. 21. Ulcers with underlying osteomyelitis on the leg with the wound to be treated. 22. Patients presenting with the clinical characteristics of cellulitis at the wound site (suppurative inflammation involving particularly the subcutaneous tissue, often mild erythema, tenderness, malaise, chills and fever). 23. Revascularization surgery on the leg with the wound to be treated ≤8 weeks prior to signing the informed consent form. 24. Surgery to lengthen Achilles tendon on the leg with the wound to be treated ≤8 weeks prior to signing the informed consent form. 25. Necrosis, purulence, or sinus tracts that cannot be removed by debridement on foot to be treated. 26. Received dermal substitute or living skin equivalent within 30 days prior to signing the informed consent form. 27. Received prior (Regranex®/becaplermin) therapy within 30 days prior to signing the informed consent form. 28. Has known history of clinical sensitivity reactions to products of bovine origin or to the primary or secondary dressings used in the trial. ; PRIMARY OUTCOME: serious adverse events attributable to intervention; SECONDARY OUTCOME 1: healing[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - LIBERTY ASTHMA TRAVERSE (Long-Term Follow-Up); BRIEF: Primary Objective: To describe the long-term safety of dupilumab in treatment of participants with moderate to severe asthma who completed the previous asthma clinical trial (TRAVERSE-LTS12551). ; DRUG USED: Dupixent; DRUG CLASS: Biologic; INDICATION: Asthma; TARGET: IL-13 (Interleukin-13), IL-4 Receptor (IL-4R); THERAPY: Monotherapy; LEAD SPONSOR: Sanofi; CRITERIA: Inclusion criteria: - Participants with asthma who completed the treatment period in the previous dupilumab asthma clinical study LTS12551. - Signed written informed consent. Exclusion criteria: - Participants who experienced any systemic hypersensitivity reactions to the investigational medicinal product in the previous dupilumab asthma study LTS12551, which, in the opinion of the Investigator, could indicate that continued treatment with dupilumab might present an unreasonable risk for the participant. - Clinically significant comorbidity/lung disease other than asthma. - Participants with active autoimmune disease or participants who, as per Investigators medical judgment, were suspected of having high risk for developing autoimmune disease. - History of malignancy within 5 years before enrollment except completely treated in situ carcinoma of the cervix, completely treated and resolved non-metastatic squamous or basal cell carcinoma of the skin. The above information was not intended to contain all considerations relevant to a participants potential participation in a clinical trial. ; PRIMARY OUTCOME: Percentage of Participants With Treatment-emergent Adverse Events (TEAEs); SECONDARY OUTCOME 1: Adverse Events of Special Interest (AESIs) Event Rate (Event Per100 Participant-years)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - ACT12505 (Part II); BRIEF: Study objectives: - Part 1 TDU11685 To assess in patients with knee Osteoarthritis (OA), the safety, tolerability and pharmacokinetics (PK) of single intra-articular doses of SAR113945. - Part 2 ACT12505 To assess in patients with knee OA, the efficacy, safety and tolerability of a single intra-articular dose of SAR113945. ; DRUG USED: SAR113945; DRUG CLASS: New Molecular Entity (NME); INDICATION: Osteoarthritis and Osteoarthritis Pain; TARGET: IkappaB kinase (IKK); THERAPY: Monotherapy; LEAD SPONSOR: Sanofi; CRITERIA: Inclusion criteria : Diagnosis of primary knee osteoarthritis, based upon the following: - X-ray or Magnetic Resonance Imaging (MRI) evidence within the last 6 months for joint space narrowing and osteophyte formation - Patients will be Kellgren and Lawrence classification II/III, and total Western Ontario McMaster (WOMAC) score 24 -72. - Patients fulfilling the American College of Rheumatology Clinical and Radiographic criteria for Osteoarthritis. Exclusion criteria: - Patients younger than 40 years - Women of child bearing potential. - Women either sterilized for more than 3 months, or post-menopausal for more than 12 months. Menopause is defined as over age of 60 years or being amenorrheic for at least 2 years with plasma FSH level >30 IU/L. - Secondary osteoarthritis: e.g., autoimmune disease, joint dysplasia, aseptic osteonecrosis, acromegaly, Pagets disease, Ehlers-Danlos Syndrome, Gauchers disease, Sticklers syndrome, joint infection, haemophilia, haemochromatosis, calcium pyrophosphate deposition disease, or neuropathic arthropathy. - Presence of local skin abnormality at the affected knee joint. - Intra-articular injection within 3 months. The above information is not intended to contain all considerations relevant to a patients potential participation in a clinical trial. ; PRIMARY OUTCOME: Womac Pain Score (5 items); SECONDARY OUTCOME 1: Womac Pain Score (5 items)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIa - T2D + Albuminuria; BRIEF: Primary objective: - To characterize the effects of 12 weeks treatment with study drug on albumin-creatinine ratio (ACR) in patients with type 2 diabetes and albuminuria Secondary objectives: - To characterize the effect of study drug on glycosylated hemoglobin fraction (HbA1c) - To evaluate the effect of study drug on markers of glycemic disorders, systemic inflammation, renal and liver disease and cardiovascular function - To assess the safety and tolerability of study drug - To determine the population pharmacokinetics (PK) of study drug ; DRUG USED: NOX-E36; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetic Nephropathy; TARGET: Chemokine (C-C motif) Ligand 2 (CCL2)/MCP-1, Immune System; THERAPY: Monotherapy; LEAD SPONSOR: TME Pharma AG; CRITERIA: Inclusion Criteria: 1. Type 2 diabetes mellitus according to American Diabetes Association (ADA) definition 2. Age ≥ 18 3. HbA1c between 6.0% and 10.5%, inclusive 4. ACR > 100 mg/g calculated 3 times in first morning void urine, at least 2 of the measurements > 100 mg/g 5. Patients on stable (unchanged medication for at least 3 months) treatment to control hypertension, hyperglycemia and (if applicable) dyslipidemia 6. Stable treatment with angiotensin-converting enzyme inhibitors (ACEi) and/or Angiotensin II receptor blockers (ARBs) (renin-angiotensin system [RAS] blockade) 7. Willing and able to understand and sign an approved Informed Consent form 8. Men must agree to follow accepted birth control methods during treatment and for 3 months after completion of treatment. Women must be of non-childbearing potential. Exclusion Criteria: 1. Type 1 diabetes mellitus 2. Estimated Glomerular Filtration Rate (eGFR) ≤25 mL/min/1.73m2 (calculated by the Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] formula) 3. Recent cardiovascular events (3 months) 4. Uncontrolled hypertension (upper limits 180/110 mmHg) 5. Dialysis and/or acute kidney injury within 3 months before screening 6. Significant edema, infectious diseases, leg ulcers 7. Severe concurrent disease which, in the judgment of the investigator, would interfere significantly with the assessments of safety and efficacy during this study 8. Treatment with any other investigational agent, or participation in another clinical study within 90 days prior to baseline visit 9. Patient with known infection with human immunodeficiency virus (HIV), Hepatitis B or Hepatitis C 10. In the judgment of the clinical investigator, clinically significant abnormal laboratory values at the screening visit 11. Use of thiazolidinedione class drugs, immune suppressants, steroid therapy (except for topical use or inhalation), chronic use of non-steroidal anti-inflammatory drug (NSAIDs), cyclooxygenase type 2 (COX-2) inhibitors, two or more diuretic drugs and/or aliskiren 12. In the judgment of the clinical investigator, patients who are likely to be non-compliant or uncooperative during the study. 13. Previous participation in this study. ; PRIMARY OUTCOME: Effect of NOX-E36 on albuminuria as measured by ACR (albumin to creatinine ratio; mg/g); SECONDARY OUTCOME 1: Effect of NOX-E36 on hsCRP[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - E-04 (Moderate to Severe, Germany); BRIEF: This study will investigate the steroid sparing potential of DS107E to vehicle in patients with moderate to severe atopic dermatitis. DS107E or vehicle will be topically administered with a steroid twice a day for the first 7 days. For the following 28 days DS107E or vehicle will be topically administered twice a day. This study will enrol approximately 40 adult patients. ; DRUG USED: DS107; DRUG CLASS: New Molecular Entity (NME); INDICATION: Atopic Dermatitis (Eczema); TARGET: Eicosanoids; THERAPY: Monotherapy; LEAD SPONSOR: DS Biopharma; CRITERIA: Inclusion Criteria: - Female and male volunteers aged 18-65 who are willing to give written informed consent. - Diagnosis of atopic dermatitis (> 6 months) according to the Hanifin and Raika Criteria; - Presence of at least 2 moderate to severe (target lesion score</=8) inflammatory lesions of comparable severity, erythema >/= 2 - Patients with moderate to severe atopic dermatitis (IGA=3-4) - A body surface area score of less than 20% Exclusion Criteria: - Clinically significant impairment of renal or hepatic function. - Other skin conditions that might interfere with atopic dermatitis diagnosis and/or evaluation (such as psoriasis or current viral, bacterial and fungal skin infections). - History of intolerance to any ingredient in DS107E DGLA cream or Vehicle or intolerance to any ingredient in Ecural®(Mometasone furoate 0.1%). Of note, any intolerance to PHB ester (benzoate, parabens) or soy or its cross-allergen peanut, as these are ingredients of DS107E. - Use of biologics 3 months prior to start of treatment/ Day 0 visit (baseline), or 5 half-lives (whichever is longer). - Use of systemic treatments (other than biologics) that could affect atopic dermatitis less than 4 weeks prior to baseline visit (Day 0), e.g. retinoids, calcineurin inhibitors, methotrexate, cyclosporine, hydroxycarbamide (hydroxyurea), azathioprine and oral/injectable corticosteroids; Intranasal corticosteroids and inhaled corticosteroids for stable medical conditions are allowed. - Treatment with any experimental drug within 30 days prior to Day 0 visit (baseline), or 5 half lives (whichever is longer). - Excessive sun exposure, use of tanning booths or other ultraviolet (UV) light sources 4 weeks prior to Day 0 visit (baseline) and/or is planning a trip to sunny climate or to use tanning booths or other UV sources between screening and follow-up visits. - Use of any topical medicated treatment for atopic dermatitis 2 weeks prior to start of treatment/Day 0 visit (baseline), including but not limited to, topical corticosteroids, calcineurin inhibitors, tars, bleach, antimicrobials and bleach baths. - Use of topical products containing ceramides 2 weeks prior to Day 0. Topical products that do not contain ceramides are allowed. - Use of anti-histamines for atopic dermatitis within 2 weeks of baseline. - Medical history of chronic infectious disease (e.g., hepatitis B, hepatitis C or infection with human immunodeficiency virus). - History of clinically significant drug or alcohol abuse in the last year prior to Day 0 (baseline). ; PRIMARY OUTCOME: Eczema Area and Severity Index (EASI); SECONDARY OUTCOME 1: Eczema Area and Severity Index (EASI)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - ELATIVE; BRIEF: The participants of this study will have confirmed Primary Biliary Cholangitis (PBC) with inadequate response or intolerance to ursodeoxycholic acid (which is a medication used in the management and treatment of cholestatic liver disease). PBC is a slowly progressive disease characterized by damage of the bile ducts in the liver, leading to a buildup of bile acids which causes further damage. The liver damage in PBC may lead to scarring (cirrhosis). PBC may also be associated with multiple symptoms. Many patients with PBC may require liver transplant or may die if the disease progresses and a liver transplant is not done. This study has two main parts; the first part will compare a daily dose of elafibranor (the study drug) to a daily dose of placebo (a dummy treatment), and will last between a minimum of one year and a maximum of two years. In the second part, all participants will receive elafibranor, for a period between 4-5 years. The main aim of this study is to determine if elafibranor is better than placebo at decreasing the levels of a specific blood test (alkaline phosphatase) that provides information about participants disease. This study will also study the safety of long-term treatment with elafibranor, as well as the impact on symptoms such as pruritus and fatigue. ; DRUG USED: Elafibranor; DRUG CLASS: New Molecular Entity (NME); INDICATION: Primary Biliary Cholangitis (PBC) and Hepatic Fibrosis; TARGET: PPAR alpha, PPAR delta; THERAPY: Monotherapy; LEAD SPONSOR: Ipsen; CRITERIA: Inclusion Criteria - Males or females age of 18 to 75 years (inclusive) - Definite or probable PBC diagnosis - ALP ≥ 1.67x upper limit of normal (ULN) - Total bilirubin (TB) ≤ 2x ULN - UDCA for at least 12 months (stable dose ≥ 3 months) prior to screening, or unable to tolerate UDCA treatment (no UDCA for ≥ 3 months) prior to screening (per country standard-of-care dosing) - Must have PBC Worst Itch NRS collected prior to randomization - Females participating in this study must be of non-child bearing potential or must be using highly efficient contraception for the full duration of the study and for 1 month after the last drug intake Exclusion Criteria: - History or presence of other concomitant liver disease - Clinically significant hepatic decompensation, including patients with complications of cirrhosis/portal hypertension - Medical conditions that may cause non-hepatic increases in ALP (e.g., Pagets disease) or which may diminish life expectancy to < 2 years, including known cancers - Patient has a positive test for HIV Type 1 or 2 at screening, or patient is known to have tested positive for HIV - Evidence of any other unstable or untreated clinically significant disease - History of alcohol abuse - For female patients: known pregnancy or lactating - Use of fibrates and glitazones within 2 months prior to screening - Use of OCA, azathioprine, cyclosporine, methotrexate, mycophenolate, pentoxifylline, budesonide and other systemic corticosteroids (parenteral and oral chronic administration only); potentially hepatotoxic drugs - (including α-methyl-dopa, sodium valproic acid isoniazid, or nitrofurantoin) within 3 months prior to screening - Use of antibodies or immunotherapy directed against interleukins (ILs) or other cytokines or chemokines within 12 months prior to screening - For patients with previous exposure to obeticholic acid (OCA), OCA should be discontinued 3 months prior to screening - Patients who are currently participating in, plan to participate in, or have participated in an investigational drug study or medical device study containing active substance within 30 days or five half-lives, whichever is longer, prior to screening; for patients with previous exposure to seladelpar, seladelpar should be discontinued 3 months prior to screening - ALT and/or AST values > 5 x ULN - For patients with AT or TB>ULN at SV1, variability of AT or TB > 40% (see section 3.5.1) - Albumin<3.0 g/dl - Severely advanced patients according to Rotterdam criteria (TB > ULN and albumin <LLN) - INR > 1.3 due to altered hepatic function - CPK > 2 x ULN - Screening serum creatinine > 1.5 mg/dl - Significant renal disease, including nephritic syndrome, chronic kidney disease (defined as patients with markers of kidney failure damage or eGFR < 60 mL/min/1,73 m2) calculated by MDRD - Platelet count < 150 x 103/μL - AFP > 20 ng/mL with 4-phase liver CT or MRI imaging suggesting presence of liver cancer - Known hypersensitivity to the investigational product or to any of the formulation excipients of the elafibranor or placebo tablet Mental instability or incompetence, such that the validity of informed consent or ability to be compliant with the study is uncertain ; PRIMARY OUTCOME: Percentage of participants with response to treatment measured by the combination levels of Alkaline Phosphate Levels (ALP) and Total Bilirubin (TB); SECONDARY OUTCOME 1: Percentage of participants who normalised ALP levels[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - AM2 (Asia Pacific); BRIEF: This study will investigate if treatment with vernakalant hydrochloride (MK-6621) results in a greater proportion of patients with treatment-induced conversion of Atrial Fibrillation to sinus rhythm compared to placebo. ; DRUG USED: Brinavess; DRUG CLASS: New Molecular Entity (NME); INDICATION: Atrial Fibrillation/Flutter; TARGET: Potassium channels, Sodium Channels; THERAPY: Monotherapy; LEAD SPONSOR: Advanz Pharma; CRITERIA: Inclusion Criteria: - Abstinent or willing to use 2 acceptable methods of birth control - Patient has an atrial arrhythmia with dysrhythmic symptoms - Patient is receiving adequate anticoagulant therapy - Patient has stable blood pressure - Patient weighs between 45 and 136 kg (99 and 300 lbs) - Patient is adequately hydrated Exclusion Criteria: - Patient is pregnant, breast-feeding, or expecting to become pregnant during the study - Patient routinely consumes more than 2 alcoholic drinks per day - Patient has known or suspected prolonged QT, familial long QT syndrome, previous Torsades de Pointes, Brugada syndrome - Patient has known bradycardia, advanced AV block, or sick-sinus syndrome, unless controlled by a pacemaker - Patient has severe aortic stenosis - Patient has atrial flutter - Patient has Class IV congestive heart failure (CHF) - Patient has had a myocardial infarction (MI) or acute coronary syndrome (ACS) - Patient has had cardiac surgery within 30 days - Patient has known atrial thrombus - Patient has reversible causes of Atrial Fibrillation - Patient has failed electrical cardioversion during current episode of Atrial Fibrillation - Patient has uncorrected electrolyte imbalance - Patient has clinical evidence of digoxin toxicity - Patient has received certain antiarrhythmic drugs or intravenous amiodarone within 7 days - Patient is known to be HIV positive - Patient has a history of cancer within the past 5 years, except for certain skin or cervical cancers ; PRIMARY OUTCOME: Proportion of Patients With Treatment-induced Conversion of Atrial Fibrillation to Sinus Rhythm; SECONDARY OUTCOME 1: [/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - w/Rosuvastatin; BRIEF: The purpose of this study is to evaluate the effect of lanabecestat on rosuvastatin. The amount of rosuvastatin in the blood will be compared, when taken alone, and then when taken with lanabecestat. The amount of lanabecestat that gets into the bloodstream will be measured. Information about any side effects that may occur will also be collected. Participants will be on study for 21 days with a follow-up at least 7 days afterwards. Screening will be undertaken within 45 days prior to enrollment. ; DRUG USED: Lanabecestat; DRUG CLASS: New Molecular Entity (NME); INDICATION: Alzheimers Disease (AD); TARGET: Beta-secretase (BACE); THERAPY: Combination; LEAD SPONSOR: AstraZeneca; CRITERIA: Inclusion Criteria: - Women not of childbearing potential may participate and include those who are: - Infertile due to surgical sterilization (hysterectomy, bilateral oophorectomy, or tubal ligation), congenital anomaly such as mullerian agenesis; or - Postmenopausal - defined as women over 50 years of age with an intact uterus who have not taken hormones or oral contraceptives within 1 year, who have had either Spontaneous cessation of menses for at least 12 consecutive months, or 6 to 12 months of spontaneous amenorrhea with follicle-stimulating hormone level greater than (>)40 milli-international units per millilitre (mIU/mL) consistent with menopause - Caucasian and may be of Hispanic ethnicity - Body mass index (BMI) of 19 to 32 kilogram per meter square (kg/m²), inclusive, at the time of screening Exclusion Criteria: - Have a clinically significant abnormal blood pressure or heart rate (supine) as determined by the investigator ; PRIMARY OUTCOME: Pharmacokinetics (PK): Area Under The Drug Concentration Time Curve From Zero to Infinity (AUC-∞) of Rosuvastatin; SECONDARY OUTCOME 1: Pharmacokinetics (PK): Area Under the Drug Concentration Time Curve During a 24-hour Dosing Interval (AUCτ) of Lanabecestat (LY3314814)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIa - w/Faldaprevir/BI207127 (U.S.); BRIEF: This study is designed to provide a preliminary assessment of the safety and effectiveness of the combination of PPI-668, BI 207127 and faldaprevir, with or without ribavirin, in the treatment of chronic hepatitis C virus infection. ; DRUG USED: Asclevir; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hepatitis C (HCV) (Antiviral); TARGET: Non-structural 5A protein (NS5A); THERAPY: Combination; LEAD SPONSOR: Presidio Pharmaceuticals, Inc.; CRITERIA: Inclusion Criteria: 1. Male or female, 18 to 65 years of age; if females are of childbearing potential, then they must be willing to use two non-hormonal methods of birth control 2. Body weight greater than 40 kg and less than 125 kg 3. Clinical diagnosis of chronic hepatitis C 4. Treatment-naïve for hepatitis C: no previous treatment with interferon, pegylated interferon, ribavirin, telaprevir, boceprevir, or any investigational therapies for hepatitis C 5. No symptoms or signs of intercurrent illness at Screen (other than those attributable to hepatitis C) 6. No clinically significant abnormalities in the 12-lead electrocardiogram at Screen 7. Signed informed consent prior to trial participation. Exclusion Criteria: 1. Seropositive for HIV antibody or Hepatitis B Surface Antigen at Screen 2. Liver disease due to causes other than chronic HCV infection 3. Symptoms or signs of decompensated liver disease, or evidence of cirrhosis 4. Any medical condition that may interfere with the absorption, distribution or elimination of study drugs 5. Poorly controlled or unstable hypertension at Screen. 6. Clinically significant, unstable cardiovascular or pulmonary disease, including cardiovascular or pulmonary disease requiring pharmacologic intervention other than anti-hypertensive medications, statins, and/or prophylactic aspirin (or similar anticoagulant). 7. Red blood cell disorder, including (but not limited to): thalassemia major or minor, sickle cell anemia. 8. Diabetes Mellitus treated with insulin or hypoglycemic agents 9. History of asthma requiring hospital admission within the preceding 12 months 10. History of alcohol abuse or illicit drug use which could interfere with a patients compliance with the protocol requirements, or with the safety or efficacy assessments in this study 11. Patients requiring treatment, during this study, with any of the medications on the restricted medications list (provided in the investigator site file), are not eligible for this study due to considerations of possible drug interactions with the study drug regimen. ; PRIMARY OUTCOME: the proportion of patients achieving sustained viral response (SVR); SECONDARY OUTCOME 1: Proportion of patients with virologic relapse post-treatment, defined as confirmed and quantifiable (>LLOQ) serum HCV RNA in a patient who achieved non-detectable serum HCV RNA by the end of treatment[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - INN-CB-024; BRIEF: This is a multicenter, randomized, double-blind, placebo-controlled efficacy and safety study of the INL-001 (bupivacaine HCl) implant, at 300 mg, in patients following abdominoplasty to evaluate postoperative analgesia. ; DRUG USED: XaraColl; DRUG CLASS: Non-NME; INDICATION: Postsurgical Pain; TARGET: Sodium Channels; THERAPY: Monotherapy; LEAD SPONSOR: Innocoll; CRITERIA: Inclusion Criteria - Has a body mass index of 18-35 kg/m2. - Must qualify for a planned (nonemergency) abdominoplasty with rectus sheath plication, with an incision that does not extend beyond the umbilicus, to be performed using standard surgical technique under general anesthesia. - Has the ability and willingness to comply with all study procedures including being domiciled for at least 72 hours after surgery. - Is willing to use opioid analgesia, if needed. Exclusion Criteria - Has a known hypersensitivity to amide-type local anesthetics, fentanyl, morphine, oxycodone, acetaminophen, NSAIDs, or bovine products. - Is scheduled for other significant concurrent surgical procedures (eg, gastrointestinal resection or additional cosmetic procedures concurrent with abdominoplasty). - Has used an opioid analgesic on an extended daily basis (≥5 mg oral morphine equivalents per day for 3 or more days a week) within 4 weeks before surgery and/or chronically uses pain medication. - Has any chronic painful condition (eg, fibromyalgia), as determined by the investigator, that may confound the assessment of pain associated with the abdominoplasty procedure ; PRIMARY OUTCOME: SPI24; SECONDARY OUTCOME 1: The secondary objective is to assess the safety and tolerability of INL 001 implants after placement[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - TWINSS; BRIEF: This study will evaluate safety, efficacy, pharmacokinetics (PK) and pharmacodynamics (PD) of multiple doses of CFZ533 (iscalimab) in patients with Sjögrens Syndrome. ; DRUG USED: Iscalimab; DRUG CLASS: Biologic; INDICATION: Sjogrens Syndrome; TARGET: Cluster of Differentiation 40 (CD40); THERAPY: Monotherapy; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Inclusion Criteria: - Signed informed consent - Male or female patient ≥ 18 years of age - Classification of Sjögrens Syndrome according to ACR/EULAR 2016 criteria (Shiboski et al 2017) - Seropositive for anti-Ro/SSA antibodies - Stimulated whole salivary flow rate of ≥ 0.1 mL/min Inclusion criteria specific for Cohort 1: - ESSDAI ≥ 5 within the 8 predefined organ domains - ESSPRI score of ≥5 Inclusion criteria specific for Cohort 2: - ESSDAI < 5 within 8 domains scored for inclusion criterion for Cohort 1 - ESSPRI fatigue subscore ≥ 5 or ESSPRI dryness subscore ≥ 5 Exclusion Criteria: - Sjögrens Syndrome overlap syndromes where another autoimmune rheumatic disease constitutes the principle illness - Use of other investigational drugs - Prior use of B cell depleting therapies, abatacept or any other immunosuppressants unless specifically allowed be the protocol. - Use of steroids at dose >10 mg/day. - Uncontrolled ocular rosacea (affecting the eye adnexa), posterior blepharitis or Meibomian gland disease (this criterion applies only to patients considered for Cohort 2) - Active viral, bacterial or other infections requiring systemic treatment - Receipt of live/attenuated vaccine within a 2-month period prior to randomization. - Chronic infection with hepatitis B (HBV) or hepatitis C (HCV). - Evidence of active tuberculosis (TB) infection. ; PRIMARY OUTCOME: Change in EULAR Sjögren Syndrome Disease Activity Index (ESSDAI) score from baseline at 24 weeks as compared to placebo; SECONDARY OUTCOME 1: Change from baseline in ESSPRI at Week 24[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - DA9801-DN-001 (US Safety Study); BRIEF: To evaluate the effectiveness of DA-9801 at 300mg, 600mg, 900mg and placebo, in reducing pain in subjects with diabetic neuropathic pain compared to their baseline values. ; DRUG USED: NB-01; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetic Peripheral Neuropathy (DPN); TARGET: Nerve growth factor (NGF)/receptor; THERAPY: Monotherapy; LEAD SPONSOR: NeuroBo Pharmaceuticals Inc.; CRITERIA: Inclusion Criteria: - Must be 18 to 75 years of age - Diagnosed with Type I or Type II diabetes - HbA1c ≤ 12% at the time of screening - Has diabetic neuropathic pain (numbness, soreness, shooting or poking pain) in the lower extremities for more than 3 months prior to screening and with no adequate relief from other treatments - Has an average pain score of ≥ 4 for 24 hours at least 4 days out of the week prior to randomization as assessed by the 11-point Likert NRS. - If female of childbearing potential, subject must have a negative serum pregnancy test at screening - Understands and is willing to participate in the clinical study and can comply with study procedures and visits. - Normal cognitive and communicative ability as judged by clinical assessment and ability to complete self-reported questionnaires - Subject is willing and able to give informed consent Exclusion Criteria: - Evidence of another type of neuropathic pain caused by a condition other than diabetes - Pain from another source as severe or greater than the pain under study - BMI (Body Mass Index) > 37 kg/m2 - Clinical signs of infection related to sores of any type on the legs - Subjects on any investigational drug(s) or therapeutic device(s) within 30 days preceding screening; or subject or physician anticipates use of any of these therapies by the subject during the course of the study - Previous participation in the Treatment Phase of this Protocol - History of drug or alcohol abuse, within the past 6 months - Malignant disease not in remission for 5 years or more that has been medically or surgically treated without evidence of metastases - Presence of one or more medical conditions, as determined by medical history, which seriously compromises the subjects ability to complete the study, including history of poor adherence with medical treatment, renal, hepatic, hematologic, active auto-immune or immune diseases that, in the opinion of the Investigator, would make the subject an inappropriate candidate for this study: c) One or more abnormal blood biochemistry analyte result that is ≥ 3 times that of the upper limit of the normal range; d) For laboratory results that are significantly lower than the normal range, specific criteria will be used to judge subject eligibility for randomization for Total protein, Albumin, and Hemoglobin or Platelets. - Known history of having Acquired Immunodeficiency Syndrome (AIDS) or with a history known to be infected with Human Immunodeficiency Virus (HIV) - New York Heart Association (NYHA) Class III and IV congestive heart failure (CHF), as defined by the following criteria: a)Class III: Symptoms with moderate exertion b)Class IV: Symptoms at rest - Pregnant or breast feeding - Women of child-bearing potential not using an effective birth control method. Women of child-bearing potential are defined as women physiologically capable of becoming pregnant, UNLESS they meet the following criteria: d) Post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum Follicle Stimulating Hormone (FSH) levels > 40mIU/m, OR; e) 6 weeks post surgical bilateral oophorectomy with or without hysterectomy, OR; f) Are using one or more of the following acceptable methods of contraception: surgical sterilization, hormonal contraception, and double-barrier methods. Reliable contraception should be maintained throughout the study and for 7 days after study discontinuation. - Subjects with a diagnosis of psychiatric disorders such as major depressive disorder, bipolar disorder, obsessive compulsive disorder, generalized anxiety, dysthymia or suicidality/suicide ideation - Administration of local anesthetic shot or systemic steroids within two months of screening - Subjects not willing to undergo a two-week washout period for pharmacologic and non-pharmacologic pain management techniques ; PRIMARY OUTCOME: Change in Clinic Visit Pain Score at the 12 Week Visit Compared to Baseline as Assessed by the 11-point Likert Numerical Rating Scale (NRS); SECONDARY OUTCOME 1: Percentage Change in Clinic Visit Pain Score at the 12-week Visit Compared to Baseline as Assessed by the 11-point Likert Numerical Rating Scale (NRS)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - AIHA; BRIEF: The purpose of this study is to evaluate the safety and efficacy of parsaclisib administered orally to participants with autoimmune hemolytic anemia (AIHA) who have decreased hemoglobin and evidence of ongoing hemolysis that requires treatment intervention. ; DRUG USED: Parsaclisib; DRUG CLASS: New Molecular Entity (NME); INDICATION: Autoimmune Hemolytic Anemia (AIHA); TARGET: p110 delta/PIK3CD; THERAPY: Monotherapy; LEAD SPONSOR: Incyte Corporation; CRITERIA: Inclusion Criteria: - Diagnosis of AIHA based on the presence of hemolytic anemia and serological evidence of anti-erythrocyte antibodies, detectable by the direct antiglobulin test. - Participants who have disease progression after treatment with standard therapies that are known to confer clinical benefit, or who are intolerant to treatment, or who refuse standard treatment. There is no limit to the number of prior treatment regimens. - Hemoglobin 7 to 10 g/dL. - No evidence of a lymphoproliferative malignancy or other autoimmune-related underlying conditions. - Eastern Cooperative Oncology Group performance status of 0 to 2. - Willingness to avoid pregnancy or fathering children. Exclusion Criteria: - Pregnant or breastfeeding women. - Concurrent conditions and history of other protocol-specified diseases. - ANC < 1.5 × 10^9/L. - Platelet count < 100 × 10^9/L. - Severely impaired liver function. - Impaired renal function with estimated creatinine clearance less than 45 mL/min. - Anti-phospholipid antibodies positive or elevated anti-streptolysin antibodies. - Positive serology test results for hepatitis B surface antigen or core antibody, or hepatitis C virus antibody with detectable RNA at screening, consistent with active or chronic infection. - Known HIV infection or positivity on immunoassay. - History or presence of an abnormal ECG that, in the investigators opinion, is clinically meaningful. - Known hypersensitivity or severe reaction to parsaclisib or its excipients. ; PRIMARY OUTCOME: Percentage of Participants Attaining a Complete Response at Any Visit From Week 6 to Week 12; SECONDARY OUTCOME 1: Number of Participants With Any TEAE in the Extension Period[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - Single Dose SC or IV; BRIEF: The purpose of this study is to assess the safety and tolerability of AMG 139 following single subcutaneous (SC) or intravenous (IV) dose administration in healthy subjects and subjects with moderate to severe psoriasis (PsO). ; DRUG USED: Brazikumab; DRUG CLASS: Biologic; INDICATION: Psoriasis; TARGET: IL-23 (Interleukin-23) ; THERAPY: Monotherapy; LEAD SPONSOR: AstraZeneca; CRITERIA: Inclusion Criteria: Part A - Healthy Volunteers: - Healthy male or female of non-reproductive potential subjects between 18 to 45 years-of-age - Body mass index (BMI) between 18 and 32 kg/m2 - Normal or clinically acceptable physical examination, clinical laboratory values, and ECG - Additional inclusion criteria apply Part B - Psoriasis Subjects: - Male or female of non-reproductive potential subjects with PsO between 18 to 55 years-of-age - Body mass index (BMI) between 18 and 32 kg/m2 - Normal or clinically acceptable physical examination (PE), clinical laboratory values, and ECG; clinically acceptable PE includes evidence of moderate to severe plaque PsO - Diagnosis of plaque PsO for at least 6 months - Moderate to severe plaque PsO defined by: - A minimum PASI score of ≥ 10 - Psoriasis involving ≥ 10% of the Body Surface Area (BSA) - Additional inclusion criteria apply Exclusion Criteria: Parts A - Healthy Volunteers: - History or evidence of a clinically significant disorder (including psychiatric), condition or disease that would pose a risk to subject safety or interfere with the study evaluation, procedures or completion; - Recent or on-going infection(s) - Underlying condition(s) that predisposes the subject to infections - History of malignancy of any type, other than in situ cervical cancer or surgically excised non-melanomatous skin cancers in past 5 years - Additional exclusion criteria apply Part B - Psoriasis Subjects: - History or evidence of a clinically significant disorder (including psychiatric), condition or disease that would pose a risk to subject safety or interfere with the study evaluation, procedures or completion; - Recent or on-going infection(s) - Underlying condition(s) that predisposes the subject to infections - Guttate, pustular, or other non-plaque forms of PsO - Evidence of skin conditions other than PsO (eg, eczema) that would interfere with evaluations of the effect of investigational product on psoriasis - History of malignancy of any type, other than in situ cervical cancer or surgically excised non-melanomatous skin cancers in past 5 years - Additional exclusion criteria apply ; PRIMARY OUTCOME: Safety & tolerability: treatment-emergent AEs including clinically significant changes in physical examinations, safety lab tests, ECG, vital signs, or immunogenicity to AMG 139; SECONDARY OUTCOME 1: Characterization of the pharmacokinetics (PK) of AMG 139[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - MAD (Study 200); BRIEF: To assess the safety, tolerability, and immunogenicity of ACC-001, an investigational active immunization, in patients with mild to moderate Alzheimers disease. ; DRUG USED: ACC-001; DRUG CLASS: Biologic; INDICATION: Alzheimers Disease (AD); TARGET: Amyloid Beta/Amyloid Plaques, Immune System; THERAPY: Monotherapy; LEAD SPONSOR: Pfizer; CRITERIA: Inclusion Criteria: - Diagnosis of probable Alzheimers Disease with Mini-Mental State Examination (MMSE) score of 16-26 (except Germany: 21-26) - Brain MRI consistent with Alzheimer Disease - Concurent use of Chloniesterase inhibitor or memantine allowed if stable - Other inclusion criteria apply Exclusion Criteria: - Significant Neurological Disease other than Alzheimers disease - Major psychiatric disorder - Contraindication to undergo brain MRI - Clinically significant systemic illness - Other exclusion criteria apply ; PRIMARY OUTCOME: Percentage of Participants With Treatment-emergent AEs or Serious Adverse Events (SAEs); SECONDARY OUTCOME 1: Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - NSABP B-41 (HER2+); BRIEF: The primary purpose of this study is to determine whether breast cancer tumors respond (as measured by pathologic complete response: the absence of microscopic evidence of invasive tumor cells in the breast) to combined chemotherapy of AC(doxorubicin and cyclophosphamide) followed by paclitaxel plus trastuzumab or lapatinib or both given before surgery to patients with HER2-positive breast cancer. Trastuzumab will also be given to all patients after surgery. The study will also evaluate the toxic effects of the chemotherapy combination, including effects on the heart, and will determine survival and progression-free survival 5 years after treatment. Also, the study will look at whether there are gene expression profiles in the tumor tissue that can predict pathologic complete response. ; DRUG USED: Tykerb; DRUG CLASS: New Molecular Entity (NME); INDICATION: Breast Cancer; TARGET: EGFR (Epidermal Growth Factor Receptor), HER2/neu or ErbB-2; THERAPY: Combination; LEAD SPONSOR: NSABP Foundation Inc; CRITERIA: Inclusion criteria: - Female - 18 years or older - ECOG performance status of 0 or 1 - Primary breast tumor palpable and measures greater than or equal to 2.0 cm by physical exam - Diagnosis of invasive adenocarcinoma made by core needle biopsy - Breast cancer determined to be HER2-positive - LVEF assessment by MUGA scan or ECG within 3 months prior to randomization - Blood counts must meet the following criteria: - ANC greater than or equal to 1200/mm3 - Platelet count greater than or equal to 100,000/mm3 - Hemoglobin greater than or equal to 10 g/dL - Serum creatinine less than or equal to ULN for the lab - Adequate hepatic function by these criteria: - Total bilirubin less than or equal to the ULN for the lab unless the patient has a bilirubin elevation greater than ULN to 1.5 x ULN resulting from Gilberts disease or similar syndrome due to slow conjugation of bilirubin; and - Alkaline phosphatase less than or equal to 2.5 x ULN; and - AST less than or equal to 1.5 x ULN for the lab. - If skeletal pain present or alkaline phosphatase greater than ULN (but less than or equal to 2.5 x ULN), bone scan or PET scan must not demonstrate metastatic disease - If AST or alkaline phosphatase greater than ULN , liver imaging (CT, MRI or PET scan) must not demonstrate definitive metastatic disease and the requirements in criterion for hepatic function must be met - Able to swallow oral medications Exclusion criteria: - FNA alone to diagnose the primary tumor - Excisional biopsy or lumpectomy was performed prior to randomization - Surgical axillary staging procedure prior to randomization. Exceptions: 1) FNA or core biopsy of an axillary node for any patient, and 2) although not recommended, a pre-neoadjuvant therapy SN biopsy for patients with clinically negative axillary nodes. - Tumors clinically staged as T4 - Ipsilateral cN2b or cN3 disease (Patients with cN1 or cN2a disease are eligible) - Definitive clinical or radiologic evidence of metastatic disease - Synchronous bilateral invasive breast cancer - Requirement for chronic use of any of the medications or substances specified in the protocol - Treatment including RT, chemotherapy, and/or targeted therapy for the currently diagnosed breast cancer prior to randomization - Any sex hormonal therapy, e.g., birth control pills, ovarian hormone replacement therapy, etc. (These patients are eligible if therapy is discontinued prior to randomization) - Continued therapy with any hormonal agent such as raloxifene, tamoxifen, or other SERM. (Patients are eligible only if these medications are discontinued prior to randomization) - Prior history of breast cancer, including DCIS (Patients with a history of LCIS are eligible) - Prior therapy with anthracyclines, taxanes, trastuzumab, or lapatinib for any malignancy - Other malignancies unless the patient is considered to be disease-free for 5 or more years prior to randomization and is deemed by her physician to be at low risk for recurrence. Patients with the following cancers are eligible if diagnosed and treated within the past 5 years: carcinoma in situ of the cervix, carcinoma in situ of the colon, melanoma in situ, and basal cell and squamous cell carcinoma of the skin. - Cardiac disease that would preclude the use of the drugs included in the B-41 treatment regimens. This includes but is not confined to: - Active cardiac disease: - angina pectoris requiring the use of anti-anginal medication; - ventricular arrhythmias except for benign premature ventricular contractions controlled by medication; - conduction abnormality requiring a pacemaker; - supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication; and - clinically significant valvular disease. - History of cardiac disease: - myocardial infarction; - congestive heart failure; or - cardiomyopathy. - Uncontrolled hypertension, defined as blood pressure greater than 150/90 mm/Hg on antihypertensive therapy - History of or current symptomatic interstitial pneumonitis or pulmonary fibrosis or definitive evidence of interstitial pneumonitis or pulmonary fibrosis described on CT or chest x-ray in asymptomatic patients - Sensory/motor neuropathy greater than or equal to grade 2, as defined by the NCIs CTCAE v3.0 - Malabsorption syndrome, ulcerative colitis, resection of the stomach or small bowel, or other disease significantly affecting gastrointestinal function - Other non-malignant systemic disease that would preclude treatment with any of the treatment regimens or would prevent required follow-up - Conditions that would prohibit administration of corticosteroids - Administration of any investigational agents within 30 days before randomization - Pregnancy or lactation ; PRIMARY OUTCOME: Determination of pathologic complete response (pCR), defined by the absence of microscopic evidence of invasive tumor cells in the post chemotherapy surgical breast specimen.; SECONDARY OUTCOME 1: The determination of pCR in the surgical breast and lymph node specimens following chemotherapy.[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIIb - KAMILLA; BRIEF: This two-cohort, open-label, multicenter study will assess the safety, efficacy and tolerability of trastuzumab emtansine in participants with HER2-positive locally advanced breast cancer (LABC) or metastatic breast cancer (mBC) who have received prior anti-HER2 and chemotherapy-based treatment. Participants in Cohort 1 will be drawn from the general participant population; Cohort 2 will include only Asian participants. ; DRUG USED: Kadcyla; DRUG CLASS: Biologic; INDICATION: Breast Cancer; TARGET: Antibody-drug Conjugate (ADC), HER2/neu or ErbB-2, Microtubules (Tubulin); THERAPY: Monotherapy; LEAD SPONSOR: Hoffmann-La Roche; CRITERIA: Inclusion Criteria: - HER2-positive disease determined locally - Histologically or cytologically confirmed invasive breast cancer - Prior treatment for breast cancer in the adjuvant, unresectable, locally advanced or metastatic setting must include both chemotherapy, alone or in combination with another agent, and an anti-HER2 agent, alone or in combination with another agent - Documented progression of incurable, unresectable, LABC, or mBC, defined by the investigator: progression must occur during or after most recent treatment for LABC/mBC or within 6 months of completing adjuvant therapy - Measurable and/or non-measurable disease - Left ventricular ejection fraction (LVEF) >/=50% by either echocardiogram (ECHO) or multiple-gated acquisition scan (MUGA) - Eastern Cooperative Oncology Group (ECOG) performance status of 0,1 or 2 - Adequate organ function - Use of highly effective contraception as defined by the protocol Exclusion Criteria: - History of treatment with trastuzumab emtansine - Prior enrollment into a clinical study containing trastuzumab emtansine regardless of having received trastuzumab emtansine or not - Peripheral neuropathy of Grade >/= 3 per National Cancer Institute (NCI) common terminology criteria for adverse events (CTCAE) v 4.0 - History of other malignancy within the previous 5 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage 1 uterine cancer, synchronous or previously diagnosed HER2-positive breast cancer - History of receiving any anti-cancer drug/biologic or investigational treatment within 21 days prior to first study treatment except hormone therapy, which can be given up to 7 days prior to first study treatment; recovery of treatment-related toxicity consistent with other eligibility criteria - History of exposure to cumulative doses of anthracyclines - History of radiation therapy within 14 days of first study treatment. The participant must have recovered from any resulting acute toxicity (to Grade </=1) prior to first study treatment. - Metastatic central nervous system (CNS) disease only - Brain metastases which are symptomatic - History of a decrease in LVEF to less than (<) 40% or symptomatic congestive heart failure (CHF) with previous trastuzumab treatment - History of symptomatic CHF (New York Heart Association [NYHA] Classes II-IV) or serious cardiac arrhythmia requiring treatment - History of myocardial infarction or unstable angina within 6 months of first study treatment - Current dyspnea at rest due to complications of advanced malignancy or requirement for continuous oxygen therapy - Current severe, uncontrolled systemic disease (clinically significant cardiovascular, pulmonary, or metabolic disease) - Pregnancy or lactation - Currently known active infection with human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C virus - History of intolerance (such as Grade 3-4 infusion reaction) or hypersensitivity to trastuzumab or murine proteins or any component of the product ; PRIMARY OUTCOME: Percentage of Participants With Adverse Events of Primary Interest (AEPIs); SECONDARY OUTCOME 1: Percentage of Participants With Specific AEPIs[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - w/Panitumumab; BRIEF: The purpose of this study is to characterize the safety and tolerability of AMG 706 plus panitumumab when administered with either FOLFIRI or FOLFOX4 chemotherapy regimens. This is a Phase 1b clinical study. ; DRUG USED: Motesanib; DRUG CLASS: New Molecular Entity (NME); INDICATION: Colorectal Cancer (CRC); TARGET: KIT/c-KIT, Platelet-derived growth factor (PDGF), VEGF (Vascular endothelial growth factor); THERAPY: Combination; LEAD SPONSOR: Amgen; CRITERIA: For complete inclusion and exclusion criteria, please refer to the investigator. Inclusion Criteria 1. Competent to comprehend, sign, and date an Institutional Review Board (IRB) approved informed consent form 2. Diagnosis of metastatic colorectal adenocarcinoma (may have received 1 prior chemotherapy regimen for metastatic CRC) 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 4. Adequate hematological function 5. Adequate renal function 6. Adequate hepatic function 7. Life expectancy of greater than or equal to 3 months as documented by the investigator Exclusion Criteria: 1. More than 1 prior chemotherapy regimen for metastatic CRC 2. Central nervous system (CNS) metastases 3. History of venous thrombosis 4. Myocardial infarction, cerebrovascular accident, transient ischemic attack, grade 2 or greater peripheral vascular disease, congestive heart failure, ongoing arrhythmias requiring medication, or unstable angina within 1 year before study enrollment 5. History of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial pneumonitis or pulmonary fibrosis on screening chest computed tomograph (CT) scan 6. Average systolic blood pressure > 150mm Hg or average diastolic blood pressure of > 90mm Hg 7. Radiotherapy within 28 days of study enrollment or within 14 days of study enrollment for peripheral lesions 8. Prior AMG 706, oral inhibitors of AMG706, panitumumab, or another anti-EGFr monoclonal antibody (mAb) (e.g., cetuximab [Erbitux®] or EMD 72000) 9. Systemic chemotherapy within 28 days before study enrollment 10. Major surgery within 28 days or minor surgery within 7days of study enrollment 11. History of life threatening ventricular arrhythmia (eg, sustained ventricular tachycardia) 12. Female and male subjects of childbearing potential not using adequate contraceptive precautions 13. Participation in therapeutic clinical trials within 30 days before study enrollment 14. Not recovered from all previous therapies 15. Clinically significant open would, ulcer or fracture 16. Any co-morbid medical condition that would increase the risk of toxicity ; PRIMARY OUTCOME: Part 1a - The incidence of adverse events and clinical laboratory abnormalities defined as dose-limiting toxicities; SECONDARY OUTCOME 1: Part 1a - The PK of irinotecan (and its active metabolite SN38) when administered as a part of the FOLFIRI regimen with panitumumab and AMG 706[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - vs. LASW1510 ; BRIEF: The aim of this study is to determine the efficacy, safety and tolerability of LAS41007 compared to a marketed reference product as well as to vehicle (topical application, twice daily, indication mild to moderate AK). ; DRUG USED: LAS41007; DRUG CLASS: New Molecular Entity (NME); INDICATION: Actinic Keratoses; TARGET: Unknown; THERAPY: Monotherapy; LEAD SPONSOR: Almirall, S.A.; CRITERIA: Inclusion Criteria: - Have at least 6 but not more than 16 clinically confirmed AK target lesions of mild to moderate (grade I to II, according to Olsen et al., 1991) intensity in the whole treatment area (TA) (and additionally one representative AK lesion for histological diagnosis of AK), which must be located in the face including the forehead (excluding eyelids, lips and mucosa) and/or bald scalp, - The AK target lesions must be discrete and quantifiable; the distance from one lesion to its neighbor lesion must be greater than 1.0 cm, - The diameter of each AK target lesion should be not less than 0.5 cm and not greater than 1.5 cm, - The target lesions must be located in up to 3 TAs with a size of 25 cm2 per TA (i.e. total area of TA is up to 75 cm2), - Diagnosis of AK histologically confirmed Exclusion Criteria: - Have known hypersensitivity, intolerance or allergies against ingredients of the IMPs and other non-steroidal anti-inflammatory agents, - Have a history of bronchospasm, asthma, urticaria, or rhinitis after the intake of non-steroidal anti-inflammatory drugs (NSAIDs), - Have a history of gastrointestinal bleeding or perforation associated with prior therapy with NSAIDs, - Have evidence of clinically significant or unstable medical conditions, - Have currently and within the past 3 months other malignant tumors of the skin in the TAs, - Suffer from paresthesia in the TAs, - Show cornu cutaneum of the skin and/or hypertrophic AK lesions in the TAs, - Are known to be pregnant or lactating (currently or within the past 3 months), - Any clinically relevant abnormal finding during Screening and/or Baseline, - Specific topical treatments in the target area within defined time periods. - Specific physical treatments in the TAs within defined time periods. - Specific systemic treatments within defined time periods. - Patients suffering from AK in locations other than the target areas, receiving any topical AK-therapy throughout the interventional phase of the study until termination of V6, - Patients who need a permanent therapy with any other NSAID. The use of NSAIDs as prn (pro re nata), i.e. to be taken as needed (≤ 3 days at a stretch) and the use of ASA as anticoagulative therapy will be allowed, - Patients taking methotrexate or sulfonylurea during the interventional phase of the study, - Anticoagulative therapy, e.g. with cumarines or heparines throughout the interventional phase of the study. Treatment with ASA at a dose not exceeding 100 mg/d and clopidogrel at a dose not exceeding 75 mg/d will be allowed, - Patients having any significant physical abnormalities in the potential TAs that may cause difficulty with examination or final evaluation, - Have any dermatological disease in the TAs or surrounding area that may be exacerbated by treatment with topical diclofenac or cause difficulty with examination, - Physical or mental inability and/or unwillingness to apply the study preparations correctly and to follow the study restrictions and visits, - Any suspicion of current drug and/or alcohol abuse as assessed by the investigator, - Anticipated non-availability for study visits / procedures, - Exposure to an investigational product within the last 3 months, - Any previous randomization into this trial, - Patient is institutionalized because of legal or regulatory order, - Employee of the study site or of the Sponsors company or the CRO. ; PRIMARY OUTCOME: superiority of LAS41007 compared to vehicle; SECONDARY OUTCOME 1: superiority of LAS41007 compared to vehicle[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase Ib/II - Study 1562 (w/Vincristine); BRIEF: The primary objective of this study is to evaluate the safety of ENTO with VCR in participants with relapsed or refractory B-cell NHL. ; DRUG USED: Entospletinib; DRUG CLASS: New Molecular Entity (NME); INDICATION: Non-Hodgkins Lymphoma (NHL); TARGET: Spleen Tyrosine Kinase (syk); THERAPY: Combination; LEAD SPONSOR: Gilead Sciences; CRITERIA: Key Inclusion Criteria: - Measurable disease by computed tomograph (CT)/ and/or positron-emission tomography CT (PET-CT) - A) Dose Escalation Stage: Confirmed diagnosis of relapsed or refractory B-Cell NHL treated with prior treatment for lymphoid malignancy comprising of at least 1 regimen containing a therapeutic anti-CD20 antibody (eg, rituximab, ofatumumab, GA-101) and at least 2 prior combination chemotherapy regimens (or autologous stem cell transplant) , or treated with 1 prior combination chemotherapy regimen in patients without an approved second-line therapy option, requiring treatment in the opinion of the treating physician - B) Dose Expansion Cohorts: - Expansion Cohort A: Diagnosis of relapsed or refractory DLBCL treated with prior treatment for lymphoid malignancy comprising of at least 1 regimen containing a therapeutic anti-CD20 antibody (eg, rituximab, ofatumumab, GA-101) and at least 2 prior combination chemotherapy regimens or autologous stem cell transplant, or treated with 1 prior combination chemotherapy regimen in patients without an approved second-line therapy option, requiring treatment in the opinion of the treating physician - Expansion Cohort B: Diagnosis of relapsed or refractory B-cell NHL (other than DLBCL) treated with prior treatment for lymphoid malignancy comprising of at least 1 regimen containing a therapeutic anti-CD20 antibody (eg, rituximab, ofatumumab, GA-101) and at least 2 prior combination chemotherapy regimens or autologous stem cell transplant, or treated with 1 prior combination chemotherapy regimen in patients without an approved second-line therapy option, requiring treatment in the opinion of the treating physician - Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 or Karnofsky performance status ≥ 70 - Required screening laboratory data (within 2 weeks prior to administration of study drug) as defined in study protocol. - Adequate organ function defined by the screening laboratory inclusion and Left Ventricular Ejection Fraction (LVEF) ≥ 45% confirmed by echocardiogram (ECHO) or multigated acquisition (MUGA) - Discontinuation of all therapy (including radiotherapy, chemotherapy, tyrosine kinase inhibitors (TKIs), immunotherapy, or investigational therapy for the treatment of cancer at least 2 weeks prior to the initiation of study therapy - All acute toxic effects of any prior antitumor therapy resolved to Grade ≤ 1 before enrollment, with the exception of alopecia (any grade permitted) - For female individuals of childbearing potential, willingness to use a protocol-recommended method of contraception from the Screening visit throughout the study and 30 days from the last dose of ENTO or VCR, whichever is later. - For male individuals having intercourse with females of childbearing potential, willingness to abstain from heterosexual intercourse or use a protocol-recommended method of contraception from the start of study drug throughout the study treatment period and for 90 days following the last dose of ENTO or VCR, whichever is later and to refrain from sperm donation from the start of the study drug throughout the study treatment period and for 90 days following the last dose of ENTO or VCR, whichever is later. - In the judgment of the investigator, participation in the protocol offers an acceptable benefit-to-risk ratio when considering current disease status, medical condition, and the potential benefits and risks of alternative treatments for the individuals NHL - Willingness to comply with scheduled visits, drug administration plan, imaging studies, laboratory tests, other study procedures, and study restrictions - Have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures Key Exclusion Criteria: - Diagnosis of Primary Mediastinal Large B-cell Lymphoma - A life threatening illness, medical condition or organ system dysfunction which, in the investigators opinion, could compromise the individuals safety or interfere with the absorption or metabolism of ENTO - Active or symptomatic central nervous system (CNS) disease or epidural involvement - Uncontrolled intercurrent illness including, but not limited to, unstable angina pectoris or psychiatric illness/social situations that would limit compliance with study requirements - Current/ongoing Neuropathy (sensory or motor) Grade > 1 or any history of Grade ≥ 3 neuropathy with prior VCR or chemotherapy exposure (documentation by history is adequate to exclude) - Contraindication to receive VCR or any planned protocol-specified chemotherapy - Eligible for autologous stem cell transplant - History of myelodysplastic syndrome, allogeneic stem cell or solid organ transplantation - History of any other prior lymphoid malignancy other than the registrational histology or any other non-lymphoid malignancy except for the following: adequately treated local basal cell or squamous cell carcinoma of the skin, cervical carcinoma in situ, superficial bladder cancer, asymptomatic prostate cancer without known metastatic disease and with no requirement for therapy or requiring only hormonal therapy and with normal prostate specific antigen for ≥ 1 year prior to the start of study drug, or any other cancer that has been in complete remission without treatment for ≥ 5 years prior to enrollment - Known hypersensitivity or intolerance to any of the active substances or excipients in the formulations for ENTO - Evidence of uncontrolled systemic bacterial, fungal, or viral infection at the start of study drug - Ongoing drug-induced liver injury, chronic active Hepatitis C Virus (HCV), chronic active Hepatitis B Virus (HBV), human immunodeficiency virus (HIV), alcoholic liver disease, non-alcoholic steatohepatitis, primary biliary cirrhosis, extrahepatic obstruction caused by cholelithiasis, cirrhosis of the liver, or portal hypertension - Current therapy with proton pump inhibitors - Pregnancy or breastfeeding - Ongoing active pneumonitis - Prior treatment with a spleen tyrosine kinase (SYK) inhibitor Note: Other protocol defined Inclusion/Exclusion criteria may apply. ; PRIMARY OUTCOME: Number of Participants With Adverse Events (AEs) and Laboratory (Lab) Abnormalities Defined as Dose Limiting Toxicities (DLTs) in Participants With Relapsed or Refractory B-cell NHL: Dose Escalation Stage; SECONDARY OUTCOME 1: Number of Participants With AEs and Lab Abnormalities Not Defined as DLTs in Participants With Relapsed or Refractory B-cell NHL: Dose Escalation Stage[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II; BRIEF: Myocardial Infarctions (MI) are commonly known as heart attacks. An ST-Segment Elevation Myocardial Infarction (STEMI) is a more severe type of heart attack. Myocardial Infarctions happen when a coronary artery is partially or fully blocked suddenly by a blood clot, causing damage to at least some of the heart muscle being supplied by that artery. In a STEMI, a blood clot completely blocks the coronary artery. This can result in damage to the heart muscle that is supplied by the affected artery. The purpose of the IK-1001 STEMI Study is to evaluate the safety and effectiveness of an investigational study drug (IK-1001). IK-1001 is being studied to determine if it is safe and if it can reduce the amount of damage caused to the heart from a STEMI. Potential subjects may be eligible if they have been diagnosed with a STEMI and undergo a primary percutaneous coronary intervention (PCI, a procedure where a blocked coronary artery is unblocked during a cardiac catheterization), as well as meet other entry criteria. Up to 446 men and women, aged 18-80, will participate in this study at about 50 medical sites around the world. Study participation will last for about six months. Subjects will receive the study drug through an intravenous catheter over three hours during their PCI procedure. Subjects will be monitored in the hospital for approximately three to four days after the PCI. There are three follow-up visits at one, three and six months after the PCI with the study investigator after discharge from the hospital. ; DRUG USED: IK-1001; DRUG CLASS: New Molecular Entity (NME); INDICATION: Acute Coronary Syndrome (ACS); TARGET: Potassium channels; THERAPY: Monotherapy; LEAD SPONSOR: Mallinckrodt; CRITERIA: Inclusion Criteria: 1. Presentation to study hospital or institution with diagnosis of STEMI based on clinical and ECG findings (subject presented with ≥ 30 minutes of ischemic chest pain, within 12 hours of symptom onset, and has persistent ST-segment elevation of ≥ 2 mm ST-segment elevation in at least 2 contiguous leads in the ECG. 2. Age between 18 and 80 years (inclusive) 3. Signed Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved informed consent form Exclusion Criteria: 1. Prior MI (as determined by subject history and/or ECG), cardiac surgery, or severe pericardial, congenital, cardiomyopathic, or valvular heart disease 2. Cardiac arrest within the past 28 days 3. Requirement for urgent cardiac surgery 4. Previous CABG surgery or PCI 5. Evidence of moderate or severe CHF (Killip Classes III and IV) 6. Any bradyarrhythmia that is expected to require a pacemaker through Day 4 (range 3 to 5 days), thus preventing the MRI 7. Unable to undergo a MRI (including disallowed metallic implants, unable to tolerate gadolinium contrast media, morbid obesity, or severe claustrophobia) 8. Subjects with past or current renal impairment requiring dialysis 9. Active or recent hemorrhage requiring an invasive procedure for evaluation or transfusion or hemorrhagic stroke within 6 weeks prior to presentation 10. Known or suspected aortic dissection 11. Subjects who have received treatment for asthma within the past 12 months 12. Prior history of pulmonary disease requiring chronic oxygen therapy 13. Females of childbearing potential 14. Body weight > 150 kg or Body Mass Index (BMI) > 40 kg/m2 15. Medical problem likely to preclude completion of the study 16. Use of investigational drugs or devices within 30 days prior to enrollment into the study 17. Any underlying medical or psychiatric condition that, in the opinion of the Investigator, makes the subject an unsuitable candidate for the study 18. Known food allergy to sulfite-containing foods and/or any drug allergies to drugs that contain sulfur ; PRIMARY OUTCOME: Creatine Kinase, Muscle and Brain (CK-MB) Troponin T; SECONDARY OUTCOME 1: 12-Lead ECG[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - PACIFIC-2; BRIEF: This is a Phase III, randomized, double-blind, placebo-controlled, multi-center, international study assessing the efficacy and safety of durvalumab given concurrently with platinum-based CRT (durvalumab + standard of care [SoC] CRT) in patients with locally advanced, unresectable NSCLC (Stage III). ; DRUG USED: Imfinzi; DRUG CLASS: Biologic; INDICATION: Non-Small Cell Lung Cancer (NSCLC); TARGET: Immune System, Programmed death-1 receptor (PD-1) / Programmed death ligands (PD-L1 and PD-L2); THERAPY: Monotherapy; LEAD SPONSOR: AstraZeneca; CRITERIA: Principal inclusion criteria : - Subjects with histologically- or cytologically-documented NSCLC - Locally advanced, unresectable (Stage III) NSCLC - World Health Organisation (WHO) performance status 0-1 - At least one measurable lesion, not previously irradiated - Must have a life expectancy of at least 12 weeks at randomization Principal exclusion criteria : - Receipt of prior or current cancer treatment, including but not limited to, radiation therapy, investigational agents, chemotherapy, Durvalumab and mAbs. - Prior exposure to immune-mediated therapy, including but not limited to, other anti CTLA-4, anti-PD-1, anti-PD-L1, and anti PD L2 antibodies, excluding therapeutic anticancer vaccines. - History of allogeneic organ transplantation - Active or prior documented autoimmune or inflammatory disorders - Uncontrolled intercurrent illness - History of another primary malignancy / leptomeningeal carcinomatosis / active primary immunodeficiency - Active infection including tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus - Mixed small cell and NSCLC histology - Any medical contraindication to treatment with platinum-based doublet chemotherapy as listed in the local labelling - Known allergy or hypersensitivity to any of the IPs or any of the IP excipients. - Patients whose radiation treatment plans are likely to encompass a volume of whole lung receiving ≥20 Gy in total (V20) of more than 35% of lung volume. ; PRIMARY OUTCOME: Progression-free survival (PFS); SECONDARY OUTCOME 1: Overall Survival (OS)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - w/Temozolomide; BRIEF: This is a Phase 2, open-label, multicenter study to assess the PFS-6m of E7016 at the selected dose of 320-mg once daily (QD) in combination with 150-mg/m2 of Temozolomide (TMZ) in subjects with wt BRAF Stage IV or unresectable Stage III melanoma with disease progression. Eligible subjects must have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST). ; DRUG USED: E7016; DRUG CLASS: New Molecular Entity (NME); INDICATION: Melanoma; TARGET: Poly ADP-Ribose Polymerase (PARP); THERAPY: Combination; LEAD SPONSOR: Eisai Inc.; CRITERIA: Inclusion Criteria: Subjects must meet all the following criteria to be included in this study: 1. Males and females greater than or equal to 18 years of age 2. Voluntary agreement to provide written informed consent and the willingness and ability to comply with all aspects of the protocol 3. Life expectancy greater than or equal to 3 months after starting E7016 4. Performance status of 0 - 2 on the Eastern Cooperative Oncology Group (ECOG) scale 5. Histopathologically confirmed diagnosis of melanoma with wt BRAF status (except melanoma of intraocular origin) with disease progression 6. American Joint Committee on Cancer (AJCC) Stage IV melanoma or unresectable Stage III melanoma 7. Measurable disease meeting the following criteria: - At least one lesion of greater than or equal to 1.0 cm in the longest diameter for a non-lymph node or greater than or equal to 1.5 cm in the short-axis diameter for a lymph node which is serially measurable according to RECIST 1.1 using computerized tomography/magnetic resonance imaging (CT/MRI). If there is only one target lesion and it is a non-lymph node, it should have a longest diameter of greater than or equal to 1.5 cm. - Lesions that have had external beam radiotherapy (EBRT) or loco-regional therapies such as radiofrequency (RF) ablation must show evidence of progressive disease based on RECIST 1.1 to be deemed a target lesion. 8. Subjects with brain metastases will be eligible under the following conditions: - have undergone complete surgical excision and are more than 1 month post-surgery with no radiographic evidence of disease recurrence in the brain or - have undergone stereotactic radio surgery (gamma knife procedure or radiotherapy ) and are more than 1 month post procedure and with no radiographic evidence of disease progression in the brain and - are asymptomatic and - discontinued corticosteroid treatment and/or anticonvulsive therapy at least 1 week prior to Cycle 1, Day 1 9. Adequate renal function indicated by serum creatinine less than 1.5 mg/dL or calculated creatinine clearance greter than 50 mL/minute per Cockroft Gault formula 10. Adequate bone marrow reserve: - Absolute neutrophil count (ANC) greater than or equal to 1500/mm^3 (greater than or equal to 1.5 x 10^3/mL) - Platelets greater than or equal to 100,000/mm^3 (without transfusion) - Hemoglobin greater than or equal to 10 g/dL (less than 10.0 g/dL acceptable if corrected by growth factor or transfusion) 11. Adequate liver function: - Bilirubin less than or equal to 1.5 x the upper limit of normal (ULN) except for unconjugated hyperbilirubinemia of Gilberts syndrome - Alkaline phosphatase, alanine aminotransferase (ALT), and aspartate aminotransferase (AST) less than or equal to 3 times ULN (less than or equal to 5 x ULN if subject has liver metastases) 12. Left ventricular ejection fraction (LVEF) greater than 50% on echocardiography or multiple-gated acquisition (MUGA) scanning 13. Females must not be lactating or pregnant at screening or baseline (as documented by a negative beta-human chorionic gonadotropin [B-hCG] test with a minimum sensitivity of 25 IU/L or equivalent units of B-hCG). A separate baseline assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the first dose of study drug. All females will be considered to be of childbearing potential unless they are postmenopausal (amenorrheic for at least 12 consecutive months, in the appropriate age group, and without other known or suspected cause) or have been sterilized surgically (i.e., bilateral tubal ligation, total hysterectomy, or bilateral oophorectomy, all with surgery at least 1 month before dosing). Females of childbearing potential must not have had unprotected sexual intercourse within 30 days prior to study entry and must agree to use a highly effective method of contraception (e.g., total abstinence, an intrauterine device, a double-barrier method [such as condom plus diaphragm with spermicide], a contraceptive implant, an oral contraceptive, or have a vasectomized partner with confirmed azoospermia) throughout the entire study period and for 30 days after study drug discontinuation. If currently abstinent, the subject must agree to use a double-barrier method as described above if she becomes sexually active during the study period or for 30 days after study drug discontinuation. Females who are using hormonal contraceptives must have been on a stable dose of the same hormonal contraceptive product for at least 4 weeks prior to dosing and must continue to use the same contraceptive during the study and for 30 days after study drug discontinuation. 14. Male subjects must have had a successful vasectomy (confirmed azoospermia) or they and their female partners must meet the criteria above (i.e., not of childbearing potential or practicing highly effective contraception throughout the study period and for 30 days after study drug discontinuation). Exclusion Criteria: Subjects with any one of the following will be excluded from this study: 1. Subjects with melanoma of intraocular origin 2. Leptomeningeal metastasis or brain metastasis except as for inclusion criteria number 8 3. Subjects taking medications which are either strong CYP inhibitors or inducers 4. Subjects with active malignancies except for wt BRAF Stage IV and unresectable Stage III melanoma, basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, adequately treated Stage I or II cancer from which the subject is currently in complete remission, or any other cancer from which the subject has been disease-free for 5 years 5. Prior treatment with a PARP inhibitor 6. Prior treatment with dacarbazine (DTIC) or TMZ containing regimens 7. Subjects with known allergy, hypersensitivity, or other contraindication to E7016, TMZ, or DTIC or any of the other components of the formulations 8. Subjects with known human immunodeficiency virus infection (HIV), active hepatitis B or C 9. Subjects with active infections requiring specific anti-infective therapy 10. Subjects who have had a major surgical procedure (including tumor resection) within 4 weeks prior to initiating E7016 treatment 11. Subjects scheduled for surgery during the projected course of the study 12. Chemotherapy, radiation therapy, or immunotherapy within 4 weeks prior to initiating E7016 treatment (6 weeks for mitomycin C or nitrosoureas) or any investigational agent within 30 days prior to the first dose of study drug or who have not recovered (Grade 0 or 1) from any acute toxicity related to previous anticancer treatment 13. Prolongation of QT corrected, the QT interval corrected for heart rate (QTc) interval (greater than 480 ms) 14. Significant cardiovascular impairment: history of congestive heart failure greater than New York Heart Association (NYHA) Class II ; unstable angina; uncontrolled hypertension despite optimal treatment, myocardial infarction or stroke within 6 months of the first dose of study drug; or cardiac arrhythmia requiring medical treatment 15. Subjects with malabsorption syndrome or any other condition that might affect bioavailability of study drug (E7016 or TMZ) 16. Other relevant disease or adverse clinical conditions such as: - History of significant neurological (no neuropathy greater than Grade 2) or psychiatric disorders - Significant non-neoplastic liver disease (e.g., cirrhosis, active chronic hepatitis) - Significant non-neoplastic renal disease - Uncontrolled endocrine disease (e.g., diabetes mellitis, hypothyroidism or hyperthyroidism, adrenal disorder) i.e., requiring relevant changes in medication within the last month or hospital admission within the last 3 months 17. Any other major illness that, in the investigators judgment, will substantially increase the risk associated with the subjects participation in this study 18. Female who are pregnant or breastfeeding ; PRIMARY OUTCOME: The Progression Free Survival-6m rate defined as the proportion of subjects that are alive and progression-free at 6-months from the date of first dosing based on RECIST 1.1.; SECONDARY OUTCOME 1: [/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIIb - w/ Ivacaftor; BRIEF: The purpose of this study is to evaluate the safety and tolerability of LUM/IVA combination therapy in subjects 12 years and older with CF and advanced lung disease and who are homozygous for the F508del CFTR mutation ; DRUG USED: Orkambi; DRUG CLASS: New Molecular Entity (NME); INDICATION: Cystic Fibrosis (CF); TARGET: CF transmembrane conductance regulator (CFTR); THERAPY: Monotherapy; LEAD SPONSOR: Vertex Pharmaceuticals Incorporated; CRITERIA: Inclusion Criteria: - Homozygous for the F508del-CFTR mutation; historical genotype must be documented in the participants source documents. - Percent predicted FEV1 <40 of adjusted for age, sex, and height at Screening Exclusion Criteria: - Participant currently receiving invasive mechanical ventilation. - History of any comorbidity that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the participant - Any clinically significant laboratory abnormalities at screening that would interfere with the study assessments or pose an undue risk for the subject - A 12-lead electrocardiograms (ECG) demonstrating QTcF >450 msec at Screening - History of solid organ or hematological transplantation - History of alcohol or drug abuse in the past year - Ongoing or prior participation in an investigational drug study (including studies investigating lumacaftor and/or ivacaftor) within 30 days of screening. - Use of strong inhibitors, moderate inducers, or strong inducers of CYP3A - Pregnant and nursing females: Females of childbearing potential must have a negative pregnancy test at Screening and Day 1. - Sexually active subjects of reproductive potential who are not willing to follow the contraception requirements - Use of beta blockers or the equivalent at Screening. ; PRIMARY OUTCOME: Number of Participants With Treatment Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs); SECONDARY OUTCOME 1: Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) Up to Week 24[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - RELIEF-DPN 1; BRIEF: Evaluation of the efficacy of a low and high dose of LX9211 compared to placebo in reducing pain related to diabetic peripheral neuropathy over an 11 week assessment period. ; DRUG USED: LX9211; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetic Peripheral Neuropathy (DPN); TARGET: Adaptor-Associated Kinase 1 (AAK1); THERAPY: Monotherapy; LEAD SPONSOR: Lexicon Pharmaceuticals; CRITERIA: Inclusion Criteria: - Patient has given written informed consent to participate in the study in accordance with local regulations - Adult male and female patients ≥18 years of age at the time of screening - Body mass index ≥18.0 to ≤40.0 kg/m2 at Screening - Diagnosis of DPNP at Screening - Pain from DPN present for at least 6 months - A1C ≤11% at screening - Stable regimen for the treatment of T1DM or T2DM for ≥1 month prior to Screening Exclusion Criteria: - Presence of other painful conditions that may confound assessment or self-evaluation of DPNP - History of major depressive episode, active, significant psychiatric disorders - History of clinically significant drug or alcohol use disorder - History of neurolytic or neurosurgical therapy for DPNP - Use of opioid medications for management of DPNP within the 2 months prior to Screening Visit - Use of NSAIDs less than 2 weeks prior to the Screening Visit ; PRIMARY OUTCOME: Change from Baseline in Average Daily Pain Score (ADPS); SECONDARY OUTCOME 1: ≥30% reduction in pain intensity[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - PCYC-0210; BRIEF: The purpose of this study is to evaluate the safety of adding the investigational drug Motexafin Gadolinium to the standard treatment of radiation therapy and chemotherapy with drugs called 5-FU and cisplatin in patients with advanced head and neck cancer. ; DRUG USED: Motexafin gadolinium; DRUG CLASS: New Molecular Entity (NME); INDICATION: Head and Neck Cancer; TARGET: Reactive Oxygen Species/Free Radicals; THERAPY: Monotherapy; LEAD SPONSOR: Pharmacyclics LLC.; CRITERIA: Inclusion Criteria: - At least 18 years of age - Each patient must sign a study-specific informed consent form - Newly diagnosed, locally advanced, non-metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN) arising from a primary site in the oropharynx, hypopharynx, or larynx confirmed by evaluation of fine needle aspiration or biopsy samples and MRI - Eligible for curative intent treatment with hyperfractionated radiation and concurrent 5-FU and cisplatin - Karnofsky Performance Status score of at least 60% - Primary tumor at least 4 cm in diameter Exclusion Criteria: Laboratory Values of: - Serum creatinine > 1.8 mg/dL; unless 24-hour urine creatinine clearance is ≥ 70 mL/min - Serum total bilirubin > 1.5 times the upper limit of normal - ALT (formerly SGPT) > 1.5 times the upper limit of normal - Alkaline phosphatase > 1.5 times the upper limit of normal - Absolute neutrophil count (ANC) < 1500/L - Platelet count < 100,000/L - 3+ or greater proteinuria on urinalysis and - Squamous Cell Carcinoma of the Head and Neck arising from a primary site in the oral cavity or nasopharynx - Distant metastases - Prior history of cancer at any site treated with radiotherapy and/or chemotherapy - History of SCCHN diagnosed within 5 years of current diagnosis ; PRIMARY OUTCOME: ; SECONDARY OUTCOME 1: [/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I/II - Taiwan; BRIEF: This trial is a multi-site, randomized, open-label, parallel, and single-dose administration study to investigate the safety and efficacy of TLC599 in subjects with osteoarthritis of the knee. ; DRUG USED: TLC599; DRUG CLASS: Non-NME; INDICATION: Osteoarthritis and Osteoarthritis Pain; TARGET: Cyclooxygenases (COX-1, COX-2, and COX-3); THERAPY: Monotherapy; LEAD SPONSOR: Taiwan Liposome Company; CRITERIA: Inclusion Criteria: 1. Male or female subjects, at least 20 years of age 2. Documented diagnosis of OA of the knee for at least 6 months 3. At least a grade 2 severity based on the Kellgren and Lawrence Grading Scale 4. VAS score of ≥ 4 at baseline Exclusion Criteria: 1. Subjects who received systemic corticosteroids for the last 30 days prior to baseline 2. Subjects who received non-steroidal anti-inflammatory drug (NSAID), analgesics, or rehabilitations therapy within 7 days prior to baseline 3. History of rheumatoid arthritis or other autoimmune disease 4. Clinical signs and symptoms of acute infection or infection related inflammation in the other knee before dosing 5. History of infective arthritis, suspected or concurrent infection, or suspected or confirmed crystal diseases (gout or pseudogout) of the study knee 6. Concurrent systemic active or uncontrolled infectious disease 7. A history of treated malignancy which is disease free for ≤ 5 years. (The malignancy does not include non-basal-cell carcinoma of skin or carcinoma-insitu of the uterine cervix) 8. History of acquired or congenital immunodeficiency diseases 9. Platelet count < 80,000/μl, or blood coagulation disorders, including subjects with hemophilia, decompensated liver cirrhosis or uremia 10. Stroke or myocardial infarction within 3 months prior to the screening visit 11. Use of intra-articular corticosteroid, hyaluronic acid, or other intra-articular injection in the study knee joint within 3 months prior to the screening visit 12. Unstable study knee joint, including anterior cruciate ligament, any surgery to the study knee within the 12 months prior to the screening visit, and any prior arthroscopic or open surgery of the study knee or any planned/anticipated surgery during the study period 13. Any skin lesion/breakdown at the anticipated injection site or any condition that impairs penetration of the study knee joint space 14. Female subjects who are pregnant, nursing, planning pregnancy, or who are of childbearing potential and not using reliable means of contraception 15.Known allergy or hypersensitivity to the study drug or its components ; PRIMARY OUTCOME: Number of Participants With Treatment-Emergent Adverse Events (TEAEs); SECONDARY OUTCOME 1: [/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II/III - GATSBY (vs. Taxane); BRIEF: This multicenter, randomized, adaptive Phase II/III study will evaluate the efficacy and safety of trastuzumab emtansine (T-DM1) compared to standard taxane (docetaxel or paclitaxel) treatment in participants with human epidermal growth factor receptor 2 (HER2)-positive advanced gastric cancer. At the start of the trial (stage 1), participants will be randomized with a ratio 2:2:1 to one of three treatment arms: Arm A: trastuzumab emtansine 3.6 milligram per kilogram (mg/kg) per intravenous injection (IV) every 3 weeks; Arm B: trastuzumab emtansine 2.4 mg/kg IV every week; Arm C: standard taxane therapy (docetaxel 75 milligram per meter square [mg/m^2] IV every 3 weeks or paclitaxel 80 mg/m^2 kg IV every week per investigator choice). At the end of the first stage of the study, the dose and schedule of trastuzumab emtansine that will be used in the second stage of the study will be selected by an Independent Data Monitoring Committee (IDMC). The regimen selection analysis will be made after approximately 100 participants across all three study arms have been treated for at least 12 weeks. Once a trastuzumab emtansine regimen has been selected, Stage I participants who were assigned to the treatment arm which was selected for Stage II of the study and participants who were in the standard taxane group will continue to receive their assigned treatment regimen. Stage I participants who were assigned to the regimen that was not selected for further evaluation will continue to receive their assigned regimen and will continue to be followed for efficacy and safety. In Stage II of the study, additional participants will be recruited and randomized with a ratio 2:1 to either the selected regimen of trastuzumab emtansine or to the standard taxane therapy. Participants will receive study treatment until disease progression, unacceptable toxicity, initiation of another cancer therapy or withdrawal. ; DRUG USED: Kadcyla; DRUG CLASS: Biologic; INDICATION: Gastric Cancer; TARGET: Antibody-drug Conjugate (ADC), HER2/neu or ErbB-2, Microtubules (Tubulin); THERAPY: Monotherapy; LEAD SPONSOR: Hoffmann-La Roche; CRITERIA: Inclusion Criteria: - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 - Life expectancy of at least 12 weeks from the first dose of study treatment - Measurable and/or evaluable disease based on Response Evaluation Criteria in Solid Tumors (RECIST version 1.1) - Adequate organ function as determined by the following laboratory results, within 28 days prior to randomization - Participants must have a history of advanced gastric cancer (AGC), defined as unresectable and locally advanced or metastatic gastric cancer, including adenocarcinoma of the gastroesophageal junction (GEJ), and must have experienced disease progression during or after first-line therapy for their disease - HER2-positive tumor (primary tumor or metastatic lesion) as confirmed by central laboratory HER2 testing (immunohistochemistry and/or in-situ hybridization) - Participants must have received at least one prior chemotherapy regimen for AGC; prior therapy does not need to have included HER2-directed therapy. - First-line therapy for AGC, including adenocarcinoma of the GEJ, must have included a combination of at least a platinum- and a fluoropyrimidine-based treatment given concurrently; prior therapy does not need to have included a HER2-directed therapy. - Adjuvant or neoadjuvant therapy for AGC is allowed. Exclusion Criteria: - An interval shorter than 21 days from the last dose of chemotherapy or HER2-directed therapy until the time of randomization - Prior treatment with trastuzumab emtansine, docetaxel, or paclitaxel either as single agents or as part of a treatment regimen. - Treatment with any investigational anticancer drug within 21 days of the first study treatment administration - More than one prior line of therapy for advanced gastric cancer - History of other malignancy within the previous 5 years except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage I uterine cancer, or other malignancies with an expected curative outcome - Brain metastases that are untreated or symptomatic or require any radiation, surgery, or steroid therapy to control symptoms from brain metastases within 1 month of randomization - Peripheral neuropathy Grade >/=2 - Uncontrolled cardiopulmonary dysfunction (e.g., high blood pressure, serious cardiac arrhythmia) - Other current, severe, uncontrolled systemic disease (e.g., clinically significant metabolic disease, wound healing disorders, ulcers) - Clinically significant bleeding within 30 days before enrollment - For female participants, current pregnancy or lactation - Major surgical procedure or significant traumatic injury within 28 days prior to randomization or anticipation of the need for major surgery during the course of study treatment - Infection with Human immunodeficiency virus (HIV) or hepatitis B virus, hepatitis C virus ; PRIMARY OUTCOME: Overall Survival (OS)- Phase 3; SECONDARY OUTCOME 1: Percentage of Participants With Disease Progression or Death According to Modified Response Evaluation Criteria in Solid Tumors (mRECIST v1.1) - Phase 3[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - B1731004; BRIEF: The primary purpose of this study is to evaluate the pharmacodynamics of single oral doses of PF-05175157 in healthy volunteers ; DRUG USED: PF-05175157; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type II; TARGET: Acetyl-CoA carboxylase (ACAC, ACC); THERAPY: Monotherapy; LEAD SPONSOR: Pfizer; CRITERIA: Inclusion Criteria: - Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive. - Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG and clinical laboratory tests. - In addition, subjects must have normal pulmonary function tests and normal ocular examination. - Body Mass Index of 20.0 35.0 kg/m2; and a total body weight >50 kg (110 lbs). Exclusion Criteria: - Evidence or history of clinically significant hematological, renal, endocrine, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing). - Evidence or history of any chronic ongoing or current pulmonary disease. - History of smoking in the past 5 years or history or evidence of habitual use of other (non smoked) tobacco or nicotine-containing products within 3 months of Screening or positive cotinine test at Screening or Day 0. - Active ocular disease including infection, glaucoma, seasonal allergies, dry eye symptoms or retinal/optic nerve disease. ; PRIMARY OUTCOME: Changes in carbohydrate and lipid metabolism; SECONDARY OUTCOME 1: Pharmacokinetics: 0.5, 1, 1.5, 2.5, 6.5, 10.5, 24 hrs after dosing, parameters: Cmax, Tmax and Area under the Curve (AUC)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I/II - SIGNAL-AD; BRIEF: To investigate safety, tolerability, the effects on cognition and brain metabolism of pepinemab in early AD dementia (early AD) subjects. ; DRUG USED: Pepinemab; DRUG CLASS: Biologic; INDICATION: Alzheimers Disease (AD); TARGET: Semaphorin 4D/CD100; THERAPY: Monotherapy; LEAD SPONSOR: Vaccinex Inc.; CRITERIA: Inclusion 1. Written informed consent from the participant and legally acceptable representative (trial partner). 2. Have a reliable and competent trial partner who must have a close relationship with the participant, who has face to face contact at least three days a week for a minimum of ten waking hours a week and is willing to accompany the participant to all trial visits. The trial partner should understand the nature of the trial and adhere to trial requirements (e.g., dose, visit schedules, receive phone calls, and evaluations). 3. Male and female participants between the ages of 55 to 85 (inclusive). 4. If female, not be of childbearing potential as indicated by one of the following: a. Has reached natural menopause defined as either: i. ≥ 12 months of spontaneous amenorrhea or ii. ≥ 6 months of spontaneous amenorrhea with serum follicle stimulating hormone (FSH) levels > 40 mIU/ml as determined by the central laboratory; b. Has had a hysterectomy; or c. Has had a bilateral tubal ligation; or d. Has had a bilateral oophorectomy (with or without a hysterectomy) and more than 6 weeks have passed since the surgery. 5. If male, must agree to use a reliable method of birth control (condoms with contraceptive forms or sexual abstinence) during the study and for 6 months after the last dose of study drug. 6. Must fulfill one of the following: 1. A documented amyloid PET scan (florbetaben F18, florbetapir F18, or flutametamol F18) determined as positive by the Investigator obtained at any time prior to the Screening visit; or 2. A documented positive amyloid CSF result obtained at any time prior to the Screening visit; or 3. Investigator has knowledge of positive amyloid PET scan or positive amyloid CSF result obtained previously; or 4. A positive amyloid CSF result at screening. The cut-off value for CSF Aβ1-42 or CSF Aβ1-42/Aβ1-40 ratio will be based on the value determined by Vaccinex 7. Evidence of cognitive impairment based on history and neuropsychological testing that meet the diagnostic criteria for probable Alzheimers dementia. 8. Global Clinical Dementia Rating (CDR) of 0.5 or 1.0 9. MMSE score of 17-26, inclusive. 10. Adequate vision, hearing, and motor function to comply with testing. 11. If receiving medications for AD (including but not limited to donepezil, rivastigmine, galantamine, tacrine, and memantine), be on a stable dose for at least 8 weeks prior to Screening Visit. 12. If on stable doses of centrally-acting medications, be on a stable dose for 8 weeks prior to Screening Visit. 13. In the opinion of the Investigator, is in reasonably good health over the last 6 months and any chronic disease is stable based on medical history and screening assessments. Exclusion 1. Inability to comply with visit schedule or other protocol requirements. 2. Have participated in an investigational drug or device study within 30 days of the Baseline Visit. If previous investigational drug was a monoclonal antibody, antibody-drug conjugate, or similar protein therapeutic, 180 days or 5 half-lives, whichever occurs first. 3. Have a known allergy to any ingredient in the study drug formulation. 4. Have a body weight greater than 125 kg. 5. Are a suicide risk, as determined by meeting any of the following criteria: 1. Suicide attempt within one year prior to the Baseline Visit. 2. Suicidal ideation as defined by a positive response to question 4 and 5 on the C-SSRS within 60 days of the Baseline Visit. 6. Have a history of substance abuse (based on DSMIV criteria) within the past 12 months prior to Screening. 7. Significant acute or chronic infection at Screening including, among others: Known history of human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome. Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection (defined as, HBV surface antigen positive or positive HCV antibody with reflex to positive HCV RNA) at Screening. 8. Have clinically significant laboratory or ECG abnormalities at Screening in the opinion of the Investigator. 9. Have clinically relevant hematologic, hepatic, cardiac, or renal disease. 10. Have a clinically significant medical, surgical, laboratory, or behavioral abnormality which in the judgment of the Investigator makes the participant unsuitable for the study, as well as anyone with a history of malignancy of any type within 2 years of Screening. Persons with a history of surgically excised non-melanoma skin cancers, superficial bladder or prostate cancer are permitted. 11. Participants who have a diagnosis of a neurological condition causing cognitive impairment other than sporadic mild dementia due to AD (e.g., Lewy body disease or frontotemporal dementia), a primary psychiatric diagnosis (e.g., Cognitive Impairment due to Schizophrenia, CIAS), history of frequent concussions or significant findings on brain MRI at screening inconsistent with AD (e.g., cerebrovascular disease or tumor). 12. Have any of the following conditions (which would exclude MRI or PET participation): 1. Participants deemed unable to cooperate due to claustrophobia, inability to lie on scanner bed for 45 minutes, or inability to achieve venous access sufficient for tracer or pepinemab administration. 2. An implant/device/condition that is contraindicated for MRI (e.g., pacemaker, severe claustrophobia, prosthetic heart valve, any metal fragments in the eyes or body--in some cases, an X-ray may be needed before an MRI scan, to ensure it is safe to enter the scanner). 3. Body habitus that would impede completion of imaging scans. 13. Has an MRI scan obtained at Screening that shows evidence of a neurological disorder other than early AD or > 4 cerebral microhemorrhages (regardless of their anatomical location or diagnostic characterization as possible or definite), a single area of superficial siderosis, 14. Any other clinically significant finding on MRI (e.g., any lesion that may account for their cognitive impairment, including but not limited to brain tumor, severe white matter disease arteriovenous malformation, cavernous hemangioma, or any infarct in a strategic cortical or subcortical location). 15. Are undergoing FDG-PET and have received research-related radiation exposure that exceeds institutional guidelines in the prior year if applicable. 16. Are undergoing a LP for CSF collection and have any of the following conditions: uncorrected bleeding or clotting disorders, skin infections near the site of the LP, suspicion of increased intracranial pressure, allergies to numbing medications (local anesthetics), acute spinal trauma. 17. Are undergoing a LP for CSF collection and taking any of the following types of anticoagulants: coumarins and indandiones, Factor Xa inhibitors, heparins, or thrombin inhibitors. 18. Has received treatment with any FDA accelerated approval therapy for treatment of Alzheimers Disease 19. Has a Screening MRI that shows Amyloid-related imaging abnormalities edema (ARIA-E) ; PRIMARY OUTCOME: Number of subjects with treatment emergent adverse events (TEAEs); SECONDARY OUTCOME 1: Effects on brain metabolism[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - vs. Strattera (317 Study); BRIEF: This study will evaluate how long it takes for ADHD symptoms to improve in subjects who are judged by the Investigator to have had an inadequate response to methylphenidate therapy. The study will also test the safety of Lisdexamfetamine Dimesylate and how well it works. ; DRUG USED: Vyvanse; DRUG CLASS: New Molecular Entity (NME); INDICATION: Attention Deficit Hyperactivity Disorder (ADHD); TARGET: Dopamine, Norepinephrine (Noradrenaline); THERAPY: Monotherapy; LEAD SPONSOR: Shire; CRITERIA: Inclusion Criteria: - Subject has had an historical or current inadequate response to methylphenidate (MPH) treatment. Inadequate response includes but is not limited to the presence of some residual symptoms, with associated impairment inadequate duration of action and/or variability of symptom control, and/or Investigator feels that the subject may derive benefit from an alternative drug treatment to MPH therapy. - Subject is a male or female aged 6-17 years inclusive at the time of consent - Subject must meet Diagnostic and Statistical Manual of Mental Disorders, fourth edition. - Text Revision (DSM IV TR) criteria for a primary diagnosis of ADHD based on a detailed psychiatric evaluation - Subject must have a baseline ADHD-RS-IV total score 28. Exclusion Criteria: - Subject has taken more than 1 MPH treatment (for example, 2 or more different MPH treatments). Examples include but are not limited to RITALIN immediate release (IR) and EQUASYM IR; MEDIKINET IR and CONCERTA; RITALIN long-acting LA and CONCERTA. Note: this does not include subjects who have taken IR MPH for dose titration on a short-term basis (for example, £4 weeks) with an adequate response - In the Investigators judgement, subject has failed to respond to more than 1 previous course(s) of MPH treatment. Failure to respond includes worsening of symptoms or no change/minimal improvement of symptoms. - Subject has previously been exposed to STRATTERA or to amphetamine therapy - Subject has previously demonstrated intolerable side effects to 1 MPH treatment which limited titration to acceptable efficacy or that required a decrease in dose resulting in unacceptable tolerability and/or efficacy - Subject has a current, controlled (requiring a restricted medication) or uncontrolled, comorbid psychiatric diagnosis with significant symptoms such as any severe comorbid Axis II disorder or severe Axis I disorder or other symptomatic manifestations, such as agitated states, marked anxiety, or tension that, in the opinion of the examining physician, will contraindicate treatment with SPD489 or STRATTERA or confound efficacy or safety assessments. - Subject has a conduct disorder. Oppositional Defiant Disorder is not exclusionary. ; PRIMARY OUTCOME: Time to First Response; SECONDARY OUTCOME 1: Percent of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores - Last Observation Carried Forward (LOCF)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I/II - 001; BRIEF: Dose escalation study to determine the maximum tolerated dose of NEOD001 in approximately 30 subjects with AL amyloidosis. Expansion phase to evaluate safety, efficacy and pharmacokinetics of NEOD001 in 25 additional subjects at the maximum tolerated dose. ; DRUG USED: Birtamimab; DRUG CLASS: Biologic; INDICATION: Amyloid light-chain (AL) Amyloidosis; TARGET: Amyloid - light chain; THERAPY: Monotherapy; LEAD SPONSOR: Prothena Biosciences Ltd.; CRITERIA: Inclusion Criteria: 1. Males and females aged ≥18 years; 2. ECOG performance status (PS) 0-2; 3. Diagnosis of systemic AL amyloidosis (subjects with non-AL amyloidosis are not eligible); 4. Received at least one prior systemic therapy, which may include stem cell transplant, for AL amyloidosis; 5. Have adequate organ function; 6. Ability to understand and willingness to sign informed consent prior to initiation of any study procedures. Exclusion Criteria: 1. Secondary or familial amyloidosis; 2. Life expectancy of < 3 months; 3. Symptomatic multiple myeloma; 4. Hypersensitivities to other monoclonal antibodies; 5. Known HIV infection; 6. Women who are lactating; 7. Any other condition or prior therapy, which in the opinion of the PI, would make the subject unsuitable for the study. ; PRIMARY OUTCOME: Safety and tolerability; SECONDARY OUTCOME 1: Pharmacokinetics[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIa - HEP012 (Canada); BRIEF: This is a neoadjuvant Phase 2a, open-label trial in patients with metastatic colorectal carcinoma who are undergoing a complete resection of the metastatic colorectal tumors in their liver. ; DRUG USED: Pexa-Vec; DRUG CLASS: Biologic; INDICATION: Colorectal Cancer (CRC); TARGET: Granulocyte Macrophage Colony-Stimulating Factor Receptor (GM-CSFR)/CD116, Immune System, Oncolytic Virus Therapy, Thymidine Kinase; THERAPY: Monotherapy; LEAD SPONSOR: Jennerex Biotherapeutics; CRITERIA: Inclusion Criteria: - The planned surgical resection must be margin negative with complete resection or resection plus radiofrequency ablation (RFA) of metastatic CRC as determined by principal investigator or surgeon - Diagnosis of histologically-confirmed metastatic colorectal tumor(s) within the liver eligible for surgical resection. Eligible patients must have: preoperative work-up that reveals potential resectability (CT scan or MRI of the abdomen and pelvis and CT scan of the chest within 6 weeks of enrollment) preoperative work-up to ensure operability with general medical clearance as indicated - At least one measurable tumor mass by MRI (i.e. lesion that can accurately be measured in at least one dimension with longest diameter ≥ 1 cm) - Plan for a maximum resection of six (6) liver segments - Child Pugh A (Refer to APPENDIX C: Child-Pugh Classification - Performance Score: KPS score of ≥ 70 - Age ≥18 years - For patients treated with IT injection only: at least 1 intra-hepatic tumor with longest diameter (LD) ≥ 1.5 cm and ≤ 12 cm and which is technically amenable to injection under radiographic guidance targeted for surgical resection. - In patients treated with IT injection, the injected tumor must be included in the surgical resection specimen (a planned RFA of the injected tumor would not be eligible) - Total bilirubin ≤ 3 x ULN - AST, ALT < 5.0 x ULN - WBC ≥ 3.5x 109/L and ≤ 50 x 109/L - ANC ≥1.5 x 109/L - CD4 ≥ 200 total cells/mm3 - Hemoglobin ≥ 80g/L - Platelet count ≥ 100 x 109/L - Acceptable coagulation status: INR ≤ 1.4 - Creatinine ≤ 2 x ULN - Serum Sodium, Potassium and Calcium levels ≤ Grade 1 - If patients are diabetic or have a screening random glucose > 8.9mmol/L, a fasting glucose must be done and results must be WNL or Grade 1 in order to be eligible for the study. - For patients who are sexually active: patient must be able and willing to abstain from sex during JX-594 treatment period (to prevent pregnancy) and willing to use barrier method for at least 6 weeks after the last JX-594 treatment (to protect partner against infection). - Able and willing to sign an Institutional Review Board (IRB)/Independent Ethics Committee (IEC)/Research Ethics Board (REB)-approved written consent form Able and willing to comply with study procedures and follow-up examinations, including compliance with the Infection Control Guidelines for Patients contained within the written consent form. Exclusion Criteria: - Prior local-regional treatment (including hepatic arterial infusion, hepatic embolization, radiofrequency ablation) for tumor downstaging. Prior adjuvant chemotherapy will be accepted as long as the duration between chemotherapy and the development of metastases has been >8 weeks. - Pregnant or nursing an infant - Known myeloproliferative disorders requiring systemic therapy - Significant immunodeficiency due to underlying illness (e.g. HIV/AIDS) and/or medication (e.g. high dose systemic corticosteroids taken for more than 4 weeks within the preceding 3 months) - History of severe exfoliative skin condition (e.g. eczema or atopic dermatitis requiring systemic therapy for more than 4 weeks) - Tumor(s) invading a major vascular structure (e.g. carotid artery) - Clinically significant and/or rapidly accumulating ascites, pericardial and/or pleural effusions - Clinically significant active infection, requiring systemic antibiotic therapy, or uncontrolled medical condition which would, in the opinion of the principle investigator, impair the ability of the subject to receive protocol therapy - Severe or unstable cardiac disease, including significant coronary artery disease requiring angioplasty or stenting within the preceding 12 months, unless well-controlled and on stable medical therapy for at least 3 months - Known viable CNS malignancy (history of completely resected or irradiated brain metastases allowed) - Chronic use of anti-platelet or anti-coagulation medication that cannot be temporarily discontinued for at least seven days prior to treatment with JX-594. (Note: the following are allowed: low dose aspirin ≤ 100 mg, low dose coumadin as long as INR ≤ 1.4 and low-dose heparin to maintain port access) - Use of the following anti-viral agents: ribavirin, adefovir, cidofovir (at least 7 days prior to the first treatment), and PEG-IFN (at least 14 days prior to the first treatment). - Absolute contraindication to undergoing MRI scanning (e.g. pacemaker, paramagnetic intracranial aneurysm clip, inner ear implants, fragments of metal within the body, etc.). - Pulse oximetry O2 saturation < 90% at rest - Experienced a severe systemic reaction or side-effect as a result of a previous smallpox vaccination - Inability or unwillingness to give informed consent or comply with the procedures required in this protocol. - Patients with household contacts who meet any of these criteria will be excluded unless alternate living arrangements can be made during the patients dosing period and for at least 7 days following the last dose of study medication - Pregnant or nursing an infant - Children < 1 year old - People with skin disease (eczema, atopic dermatitis and related diseases - Immunocompromised hosts (severe deficiencies in cell-mediated immunity, including AIDS, organ transplant recipients, hematologist malignancies) ; PRIMARY OUTCOME: Delivery to and replication within tumors; SECONDARY OUTCOME 1: JX-594 spread to, and replication within, non-injected tumors after IT JX-594 injection[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - 021 - w/Glyburide; BRIEF: A Phase 3, Randomized, Double-blind, Placebo Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of BMS-298585 in Combination with Glyburide Therapy in Subjects with Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Sulfonylurea Therapy Alone. ; DRUG USED: Pargluva; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type II; TARGET: PPAR alpha, PPAR gamma; THERAPY: Combination; LEAD SPONSOR: Bristol-Myers Squibb; CRITERIA: Inclusion Criteria: - Type 2 Diabetes, HbA1c > 7.0% and < 10.0%, mean serum triglyceride < 600 mg/dL, body mass index < 41 kg/m2, fasting c-peptide . 1.5 ng/mL. Exclusion Criteria: - History of MI (myocardial infarction), coronary angioplasty or bypass graft(s), valvular disease or repair, unstable angina pectoris, transient ischemic attack (TIA), cerebrovascular attack, or cerebrovascular accident (CVA) within 6 months, congestive heart failure (NYHA Class III and IV, uncontrolled hypertension, history or renal disease, peripheral vascular disease (PVD), pulmonary disease, gastrointestinal disease, active liver disease or endocrine disease. ; PRIMARY OUTCOME: Compare change from baseline in HbA1c after 24 weeks of treatment with muraglitazar + glyburide vs placebo + glyburide; SECONDARY OUTCOME 1: Change in FPG from basline to W24, proportion of subjects receiving therapeutic response at W24, percent change of fasting lipid levels from baseline to W11/12, change in hs-CRP from baseline to W24[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - CIRM/City of Hope; BRIEF: The purpose of the study is to evaluate the safety and feasibility of administering SB-728mR-HSPC after conditioning with busulfan. ; DRUG USED: SB-728-HSPC; DRUG CLASS: Biologic; INDICATION: HIV / AIDS; TARGET: Chemokine Receptor 5 (CCR5), Stem Cells/Other Cell Therapies; THERAPY: Combination; LEAD SPONSOR: City of Hope Medical Center; CRITERIA: Inclusion Criteria: - Maximum age 75 years for cohort 1 and 65 years for cohort 2. - HIV-1 R5 seropositive with no evidence of CXCR4-tropic virus. - On cART with undetectable HIV-1 (<20 gc/ml HIV-1 RNA) for at least 12 months prior to screening evaluations. - CD4+ T-cell counts ≥200 cells/µL and ≤750 cells/µL. - No psychosocial conditions that would hinder study compliance and follow-up. - Absence of clinically significant cardiomyopathy, congestive heart failure. Secondary Eligibility Criteria (for registration): - Complete G-CSF/Plerixafor mobilization of HSPC. - Collect ≥7.5 x 10^6 CD34+ cells/kg in two aphereses. - The SB-728mR-HSPC product passed all release testing Exclusion Criteria: - Use of AZT or maraviroc in the cART regimen. - History of significant hematologic diseases such as leukemia, myelodysplasia, coagulopathy, and thromboembolism. - Any AIDS-related opportunistic infection occurring within the past year such as tuberculosis, cryptococcosis and for which treatment has been unsuccessful as determined by the Principal Investigator. - AIDS-related syndromes, infectious or otherwise, if perceived to cause excessive risk for morbidity post-HSPC infusion, as determined by the Principal Investigator. - Patients with active HBV or HCV infection, i.e., HBV DNA and HCV RNA in blood, are excluded. Those with inactive, but past infection with HBV (positive HBV surface antigen or HBV surface antibody) or inactive HCV (positive HCV antibody), must have no cirrhosis, as determined by abdominal ultrasound with elastography. - Active CMV retinitis or other active CMV-related organ dysfunction. - CXCR4-tropic virus. - Pregnant or nursing women. - Any history of HIV-associated encephalopathy; dementia of any kind; seizures in the past 12 months; any perceived inability to directly provide informed consent. - Participants may not be receiving any other investigational agents, or concurrent biological, chemotherapy, or radiation therapy. Participation in prior investigational drug or medical device study within the previous 45 days. - Current or history of immunomodulatory agent or steroid use. - Prior therapy with HIV vaccine or gene therapy product. - History of alcohol or substance abuse for the previous 12 months. - Participants with active malignancies. However, participants with skin cancers, namely basal cell or squamous cell carcinoma, and malignancies treated with curative intent having no known active disease present for ≥2 years, may be eligible. ; PRIMARY OUTCOME: Toxicity in subjects who received SB-728mR-HSPC after each busulfan dose level; SECONDARY OUTCOME 1: Number of CD34+ HSPC collected, gene modified, and released throughout the manufacturing process[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - 391101 (Solids); BRIEF: The purpose of the study is to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of anti-MIF antibody in subjects with malignant solid tumors (Arm 1) and in subjects with metastatic adenocarcinoma of the colon or rectum (Arm 2). ; DRUG USED: Imalumab; DRUG CLASS: Biologic; INDICATION: Colorectal Cancer (CRC); TARGET: Macrophage Migration Inhibitory Factor (MIF); THERAPY: Monotherapy; LEAD SPONSOR: Baxalta now part of Shire; CRITERIA: Main Inclusion Criteria: - Males and females 18 years of age and older at the time of screening - Anticipated life expectancy > 3 months at the time of screening - Arm 1 only: Histologically confirmed malignant solid tumor which is refractory to or has failed standard treatments, or participant is not considered medically suitable to receive standard of care treatment or refuses standard of care treatment - Arm 2 only: Histologically or cytologically confirmed diagnosis of metastatic adenocarcinoma of the colon or rectum which is refractory to or has failed standard treatments, or participant is not considered medically suitable to receive standard of care treatment or refuses standard of care treatment - Measurable or evaluable disease (as defined in the study protocol) - Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1 - Adequate hematological function (as defined in the study protocol) - Adequate renal function (as defined in the study protocol) - Adequate liver function (as defined in the study protocol) - Adequate venous access - Arm 2 only: At least 1 tumor that is amenable to biopsy, as determined by the investigator, and participant must be willing to undergo a biopsy prior to and at least once following anti-macrophage migration inhibitory factor (anti-MIF) antibody treatment - For women of childbearing potential, the participant must have a negative pregnancy test at screening and must agree to employ 2 forms of adequate contraceptive measures - For males, participants must agree to use adequate contraceptive measures including at least 1 barrier method, and abstain from sperm donation throughout the course of the study and for at least 90 days after the last administration of investigational product. - Participant is willing and able to comply with the requirements of the protocol Main Exclusion Criteria: - Known brain tumors or Central nervous system (CNS) metastases - Myocardial infarction within 6 months of anti-MIF antibody administration, congestive heart failure (New York Heart Association Class III or Class IV), unstable angina, unstable cardiac arrhythmia requiring medication, or risk factors for polymorphic ventricular tachycardia - Uncontrolled hypertension - Left ventricular ejection fraction (LVEF) <40%, as determined by screening echocardiogram (echocardiogram results obtained within 90 days prior to screening are acceptable) - QT/QTc interval >450 msec, as determined by screening electrocardiogram (ECG) - Antitumor therapy (chemotherapy, radiotherapy, antibody therapy, molecular targeted therapy, retinoid therapy, or hormonal therapy) within 4 weeks prior to administration of the investigational product (IP) (6 weeks for nitrosoureas and mitomycin C). Any previous treatment-related toxicities must have recovered to Grade ≤ 1 (graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03). Prior and concurrent use of hormone deprivation therapies for hormone-refractory prostate cancer or breast cancer are permitted. - Major surgery within 4 weeks prior to IP administration - Active joint inflammation or history of inflammatory arthritis or other immune disorder involving the joints - Active infection requiring IV antibiotics within 2 weeks prior to screening - Known history of hepatitis B virus (HBV), hepatitis C virus (HCV), or active tuberculosis. Known history of human immunodeficiency virus (HIV) type 1/2 or other immunodeficiency disease. - Participant has received a live vaccine within 4 weeks prior to screening - Known hypersensitivity to any component of recombinant protein production by Chinese Hamster Ovary (CHO) cells - Participant has been exposed to an investigational product (IP) or investigational device in another clinical study within 4 weeks prior to IP administration, or is scheduled to participate in another clinical study involving an IP or investigational device during the course of this study - Participant is nursing or intends to begin nursing during the course of the study - Any disorder or disease, or clinically significant abnormality on laboratory or other clinical test(s), that in medical judgment may impede the participants participation in the study, pose increased risk to the participant, or confound the results of the study - Participant is a family member or employee of the investigator ; PRIMARY OUTCOME: Number of participants experiencing serious adverse events (SAEs) and/or adverse events (AEs) regardless of causality; SECONDARY OUTCOME 1: Plasma pharmacokinetic parameters[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - NEX-PED-001; BRIEF: The purpose of this study is to evaluate the efficacy and safety of Nexagon® in subjects with Persistent Epithelial Defects (PED) originally caused by chemical burns. ; DRUG USED: Nexagon; DRUG CLASS: New Molecular Entity (NME); INDICATION: Persistent Corneal Epithelial Defects (Ophthalmology); TARGET: Connexin / Connexon / Hemichannel; THERAPY: Monotherapy; LEAD SPONSOR: OcuNexus Therapeutics, Inc.; CRITERIA: Inclusion Criteria: 1. Male and female subjects aged 18 years and over. 2. Subjects who are able to attend all follow-up visits and who are able to comply with all study procedures. 3. Subjects who are willing and able to give written informed consent to take part in the study. 4. At the Day -7 visit subjects must have a corneal epithelial defect that has persisted for between 7 days and 14 days, which has a minimum diameter of 2 mm along the greatest axis, and which has not shown improvement despite conventional treatment such as tear supplements and bandage contact lenses. 5. The original defect to the cornea must have been caused by either alkaline or acidic agents. Exclusion Criteria: 1. Use of concomitant ocular medications in the screening period that are not specified in standardized PED treatment regime 2. Likely to require the use of concomitant ocular medications that are not specified in the standardized PED treatment regime during the study follow-up period 3. Decrease or increase in the PED by more than 30% during the screening period. 4. Have an active lid or ocular infectious process of any sort 5. Subjects with corneal perforation or impending corneal perforation 6. The circumference affected by limbal blood vessel ischemia is greater than 75% of the circumference 7. Subjects with severe lid abnormalities contributory to the persistence of the PED such as inability to close the lids. 8. Subjects with bilateral PED, if the smaller PED has a longest diameter of > 2 mm. 9. Female subjects who are pregnant or breastfeeding. F 10. Subjects who have a history of AIDS or HIV. 11. Subjects with any other condition which, in the Investigators opinion, would exclude the subject from participating. 12. Treatment with systemic corticosteroids (equivalent to > 10 mg/day of prednisone) or immunosuppressive or chemotherapeutic agents within 7 days prior to Day 0, or likely to receive one of these therapies during study participation 13. Subjects who have participated in a clinical trial within 30 days prior to Day 0. 14. Diabetics with an HbA1c greater than 6.5%. 15. Diabetics who are currently prescribed more than one oral medication for their diabetes. 16. Subjects who have more than one distinct PED in the study eye. ; PRIMARY OUTCOME: The primary objective of this study is to evaluate the efficacy and safety of Nexagon® as a treatment for PED from chemical burn injuries.; SECONDARY OUTCOME 1: [/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - Dose Escalation; BRIEF: Study to investigate the safety and activity of NEO-PTC-01 in patients with unresectable or metastatic melanoma. NEO-PTC-01 is an autologous personalized T cell (PTC) product for adoptive cell therapy that is manufactured ex vivo and targets neoantigens displayed on the patients tumor and the tumor microenvironment. The study will be conducted in two parts, Part 1 (Dose Finding) and Part 2 (Dose Expansion). The dose-finding part of the study will test two doses of NEO-PTC-01 and will be structured according to a 3+3 dose escalation design. After the highest tolerated NEO-PTC-01 dose is identified, 2 additional evaluations in Part 1 are planned, a cohort to investigate NEO-PTC-01 in combination with interleukin (IL)-2 and another cohort introducing α programmed cell death protein 1 (αPD-1) therapy. The dose expansion part of the study will test the dose deemed to be safe in the dose-finding part of the study in an expanded cohort of patients to further define the safety of NEO-PTC-01. ; DRUG USED: NEO-PTC-01; DRUG CLASS: Biologic; INDICATION: Melanoma; TARGET: Stem Cells/Other Cell Therapies, T-Cell Receptor (TCR); THERAPY: Monotherapy; LEAD SPONSOR: BioNTech US Inc.; CRITERIA: Inclusion Criteria: - Adult (age 18 to 75) men and women willing and able to give written informed consent. - Histologically confirmed unresectable or metastatic melanoma. - Part 1: - Have previously received a PD-1/PD-L1 inhibitor (either as single agent or in combination) and a cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) inhibitor-containing regimen (single agent or combination) prior to NEO-PTC-01, with disease progression following these therapies or otherwise lack of clinical benefit as determined by the study investigator. - Part 2: - Have received/are currently receiving a PD-1/PD-L1 inhibitor (as a single agent or in combination with CTLA-4) for at least 3 months. - Have documented SD by RECIST v1.1 or clinically asymptomatic progressive disease on the most recent imaging assessment, which must have occurred within 3 months of enrollment. - In the opinion of the investigator, are medically eligible and able to continue with PD-1/PD-L1 inhibitor therapy. - In the opinion of the investigator, would benefit from the addition of a T-cell based therapy. - For known serine-threonine kinase (BRAF) mutant patients: patients must have also received targeted therapy (B-raf inhibitor or B-raf/mitogen-activated protein kinase enzyme [MEK] combination therapy) prior to NEO-PTC-01, unless deemed not appropriate to receive these treatments by the investigator. - Have at least one site of measurable disease by RECIST v1.1. - At least one site of disease must be accessible to biopsy for tumor tissue for sequence and immunological analysis. The biopsy site may be the same as the measurable site so long as it remains measurable. Surgical resection of the measurable site may not be performed if that site is the only measurable lesion. An archival biopsy may be used in place if the biopsy was taken within 6 months of informed consent. - Have Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1. - Recovered from all toxicities associated with prior treatment to acceptable baseline status (for laboratory toxicities see below limits for inclusion) or an National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0, Grade of 0 or 1, except for toxicities not considered by the treating physician to be a safety risk (e.g., alopecia). - Screening laboratory values must meet the following criteria and should be obtained prior to any production phase assessments: 1. White blood cell (WBC) count ≥ 3 × 10^3/μL. 2. Absolute neutrophil count (ANC) ≥ 1.5 × 10^3/μL. 3. Platelet count ≥ 100 × 10^3/μL. 4. Hemoglobin > 9 g/dL or 6 mmol/L. 5. Serum creatinine ≤ 1.5 × upper limit of normal (ULN) or creatinine clearance (CrCl) ≥ 50 mL/min by Cockcroft-Gault. 6. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × ULN. 7. Total bilirubin ≤ 1.5 × ULN (except in patients with Gilbert Syndrome, who can have total bilirubin < 3.0 mg/dL). 8. International Normalized Ratio (INR), Prothrombin Time (PT), or Activated Partial Thromboplastin Time (aPTT) ≤ 1.5 × ULN unless the patient is receiving anticoagulant therapy, as long as PT or aPTT is within therapeutic range of intended use of anticoagulants. Exclusion Criteria: - Age greater than 75 years or less than 18 years. - Received more than three prior lines of therapy for metastatic disease. - Have an active or history of autoimmune disease (known or suspected). Exceptions are permitted for vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition requiring only hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger. - Have known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Patients with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging [using the identical imaging modality for each assessment, either MRI or CT scan] for at least 4 weeks prior to enrollment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to enrollment. This exception does not include carcinomatous meningitis, which is excluded regardless of clinical and/or radiographic stability. - Active systemic infections requiring intravenous antimicrobial therapy, coagulation disorders or other active major medical illnesses of the cardiovascular, respiratory or immune system, as evidenced by a positive stress thallium or comparable test, myocardial infarction, clinically significant cardiac arrhythmias such as uncontrolled atrial fibrillation, ventricular tachycardia, or second- or third-degree heart block, and obstructive or restrictive pulmonary disease. - Active major medical illnesses of the immune system including conditions requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days prior to NEO-PTC-01 infusion. Inhaled or topical steroids and adrenal replacement doses (≤ 10 mg daily prednisone equivalents) are permitted in the absence of active autoimmune disease. - Known human immunodeficiency virus (HIV) infection, active chronic hepatitis B or C, and/or life-threatening illnesses unrelated to cancer that could, in the investigators opinion, interfere with participation in this study. - Have any underlying medical condition, psychiatric condition, or social situation that, in the investigators opinion, would interfere with participation in the study. - Have a planned major surgery that is expected to interfere with study participation or confound the ability to analyze study data. - Are pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 150 days after the end of the trial (EOT) visit. Nursing women are excluded from this study because there is an unknown but potential risk of AEs in nursing infants secondary to treatment of the mother with treatments to be administered in this study. - Have a history of another invasive malignancy aside from melanoma, except for the following circumstances: 1. Patient has been disease-free for at least 2 years and is deemed by the investigator to be at low risk for recurrence of that malignancy. 2. Patient was not treated with systemic chemotherapy for carcinoma in situ of the breast, oral cavity, or cervix, basal cell, or squamous cell carcinoma of the skin. ; PRIMARY OUTCOME: Rate of adverse events (AEs), including serious adverse events (SAEs) and AEs leading to treatment discontinuation; SECONDARY OUTCOME 1: Progression-free survival (PFS), defined as the time from the date of first dosing of NEO-PTC-01 to the date of first documented progressive disease (PD) or death, whichever comes first[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - SIRROUND-LTE; BRIEF: The purpose of this study is to evaluate the long-term safety and efficacy of CNTO 136 (sirukumab) in participants with rheumatoid arthritis (RA) who are unresponsive to treatment with modifying antirheumatic drugs (DMARDs) or anti-TNF alpha agents. ; DRUG USED: Sirukumab; DRUG CLASS: Biologic; INDICATION: Rheumatoid Arthritis (RA); TARGET: IL-6 (Interleukin-6); THERAPY: Monotherapy; LEAD SPONSOR: Janssen Research & Development, LLC; CRITERIA: Inclusion Criteria: - Completed participation in Studies CNTO136ARA3002 or CNTO136ARA3003 - Signed an informed consent form (ICF) indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study - Signed an informed consent form (ICF) for pharmacogenetics research (how a persons genes may affect a drugs effects) in order to participate in the optional pharmacogenetics component of this study. Refusal to give consent for this component does not exclude a participant from participation in this clinical study Exclusion Criteria: - Withdraws consent and/or discontinues participation in study CNTO136ARA3002 or CNTO136ARA3003 - Is pregnant - Has active diverticulitis - Has any condition that, in the opinion of the investigator, would make participation not be in the best interest (eg, compromise the well-being) of the participant or that could prevent, limit, or confound the protocol-specified assessments ; PRIMARY OUTCOME: Percentage of Participants With Serious Adverse Events (SAEs); SECONDARY OUTCOME 1: Percentage of Participants With Toxicity Grade 4 Decrease in Neutrophils[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - REACH-3 (Chronic GVHD); BRIEF: The purpose of this study is to assess the efficacy of ruxolitinib against best available therapy in participants with steroid-refractory chronic graft-versus-host disease (SR cGvHD). ; DRUG USED: Jakafi; DRUG CLASS: New Molecular Entity (NME); INDICATION: Graft vs. Host Disease (GVHD) - Treatment; TARGET: JAK/STAT ; THERAPY: Monotherapy; LEAD SPONSOR: Incyte Corporation; CRITERIA: Inclusion Criteria: - Have undergone allogeneic stem cell transplantation (alloSCT) from any donor source (matched unrelated donor, sibling, haplo-identical) using bone marrow, peripheral blood stem cells, or cord blood. Recipients of non-myeloablative, myeloablative, and reduced intensity conditioning are eligible - Evident myeloid and platelet engraftment: Absolute neutrophil count (ANC) > 1000/mm^3 and platelet count > 25,000/ mm^3 - Participants with clinically diagnosed moderate to severe cGvHD according to NIH Consensus Criteria prior to randomization: - Moderate cGvHD: At least one organ (not lung) with a score of 2, 3 or more organs involved with a score of 1 in each organ, or lung score of 1 - Severe cGvHD: at least 1 organ with a score of 3, or lung score of 2 or 3 - Participants currently receiving systemic or topical corticosteroids for the treatment of cGvHD for a duration of < 12 months prior to Cycle 1 Day 1 (if applicable), and have a confirmed diagnosis of steroid-refractory cGvHD defined per 2014 NIH consensus criteria irrespective of the concomitant use of a calcineurin inhibitor (CNI), as follows: - A lack of response or disease progression after administration of minimum prednisone 1 mg/kg/day for at least 1 week, OR - Disease persistence without improvement despite continued treatment with prednisone at > 0.5 mg/kg/day or 1 mg/kg/every other day for at least 4 weeks, OR - Increase to prednisolone dose to > 0.25 mg/kg/day after 2 unsuccessful attempts to taper the dose - Participant must accept to be treated with only one of the following BAT options on Cycle 1 Day 1 (additions and changes are allowed during the course of the study, but only with BAT from the following BAT options): extracorporeal photopheresis (ECP), low-dose methotrexate (MTX), mycophenolate mofetil (MMF), mTOR inhibitors (everolimus or sirolimus), infliximab, rituximab, pentostatin, imatinib, ibrutinib Exclusion Criteria: - Participants who have received 2 or more systemic treatment for cGvHD in addition to corticosteroids ± CNI for cGvHD - Patients that transition from active aGvHD to cGvHD without tapering off corticosteroids ± CNI and any systemic treatment * Patients receiving up to 30 mg by mouth once a day of hydrocortisone (i.e., physiologic replacement dose) of corticosteroids are allowed. - Participants who were treated with prior JAK inhibitors for aGvHD; except when the participant achieved complete or partial response and has been off JAK inhibitor treatment for at least 8 weeks prior to Cycle 1 Day 1 - Failed prior alloSCT within the past 6 months from Cycle 1 Day 1 - Participants with relapsed primary malignancy, or who have been treated for relapse after the alloSCT was performed - Steroid refractory cGvHD occurring after a non-scheduled donor lymphocyte infusion (DLI) administered for preemptive treatment of malignancy recurrence. Participants who have received a scheduled DLI as part of their transplant procedure and not for management of malignancy relapse are eligible - Any corticosteroid therapy for indications other than cGvHD at doses > 1 mg/kg/day methylprednisolone or equivalent within 7 days of Cycle 1 Day 1 ; PRIMARY OUTCOME: Efficacy of Ruxolitinib Versus Investigators Choice Best Available Therapy (BAT) in Participants With Moderate or Severe Steroid Refractory Chronic Graft Versus Host Disease (SR-cGvHD) Assessed by Overall Response Rate (ORR) at the Cycle 7 Day 1 Visit; SECONDARY OUTCOME 1: Rate of Participants With Clinically Relevant Improvement of the Modified Lee cGvHD Symptom Scale Score[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - 001; BRIEF: This trial will be conducted in three parts. Part A is a dose escalation trial followed by a dose confirmation trial in folate receptor (FR) 100% endometrial cancer participants. The primary hypothesis of this trial is that administration of vintafolide in combination with carboplatin and paclitaxel is safe and tolerable. Part B is a single dose, dose escalation, pharmacokinetic (PK), and QTc interval trial. The primary objectives include determination of the maximum single tolerated dose of vintafolide and to evaluate the effect of this single maximum dose on the QTc interval. Part C is a weekly dose escalation trial of vintafolide followed by a dose confirmation. The primary hypothesis of this part is that weekly vintafolide has acceptable safety and tolerability in participants with advanced cancers. ; DRUG USED: Vintafolide; DRUG CLASS: New Molecular Entity (NME); INDICATION: Solid Tumors; TARGET: Folate Receptor (FOLR1), Microtubules (Tubulin); THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: Endocyte; CRITERIA: Inclusion criteria for all participants: - Histologically-confirmed metastatic or locally advanced solid tumor that has failed to respond to standard therapy, progressed despite standard therapy, or for which standard therapy does not exist or is unacceptable to the participant - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 - At least one measurable metastatic or recurrent lesion - No history of a previous malignancy with the exception of cervical intraepithelial neoplasia, basal cell carcinoma of the skin, or adequately treated localized prostate carcinoma; or has undergone potentially curative therapy with no evidence of disease for five years - Adequate organ function - Female participants of childbearing potential must be willing to use acceptable methods of birth control or abstain from heterosexual activity for the course of the study through 90 days after the last dose of study therapy - Male participants must agree to use an adequate method of contraception for heterosexual activity starting with the first dose of study therapy through 90 days after the last dose of study therapy Inclusion criteria for Part A: - Tumor lesions characterized as folate receptor (FR) 100% as determined by an etarfolide Sequential Single Photon Emission Computed Tomography (SPECT) and CT scan - Histologically-confirmed diagnosis of locally advanced or metastatic or recurrent endometrial cancer Inclusion criteria for Parts B & C: - Must have an etarfolatide SPECT/CT scan to determine FR status Exclusion criteria for all participants: - Part A & Part C if enrolled after completion of Part B: Chemotherapy, radiotherapy, or biological therapy (including monoclonal antibodies) within 4 weeks prior to drug administration, or not recovered from adverse events due to agents administered more than 4 weeks earlier - Part B: Chemotherapy, radiotherapy, or biological therapy (including monoclonal antibodies) within 3 weeks prior to drug administration, or not recovered from adverse events due to agents administered more than 4 weeks earlier - Currently participating or has participated in a study with an investigational compound or device within 28 days of initial dosing on this study - Part A, dose escalation, Parts B and C: More than 3 prior cytotoxic regimens for metastatic disease. - Part A, dose confirmation: Has received more than 2 prior cytotoxic regimens for metastatic disease. - Primary central nervous system (CNS) tumor - Active CNS metastases and/or carcinomatous meningitis. - Known hypersensitivity to the components of the study therapy or its analogs - Recent (i.e., ≤ 6 weeks) history of abdominal surgery or peritonitis - Bowel occlusion or sub-occlusion - Prior whole abdominal or whole pelvis radiation therapy or radiation therapy to >10% of the bone marrow at any time in the past or prior radiation therapy within the last 3 years to the breast / sternum, head, or neck - Requires anti-folate therapy for the management of co-morbid conditions - Known regular user (including recreational use) of any illicit drugs or had a recent history (within the last year) of drug or alcohol abuse - Pregnant or breastfeeding or expecting to conceive, or donate sperm within the span of the study - Human Immunodeficiency Virus (HIV)-positive - Active Hepatitis B or C - Symptomatic ascites or pleural effusion. - History of stem cell or bone marrow transplant Exclusion Criteria for Part B: - Permanent pacemaker - Unable to refrain from use of all concomitant medications on Day 1 - Structural heart disease, history of myocardial infarction (MI), or unstable angina - History of cardiac arrhythmia, congestive heart failure (CHF), sick sinus syndrome, second or third degree atrioventricular (AV) block - History of risk factors for Torsades de Pointes such as CHF, uncorrected hypokalemia, family history of long QT syndrome ; PRIMARY OUTCOME: Parts A and C: Number of participants with dose-limiting toxicities (DLTs); SECONDARY OUTCOME 1: Number of participants whose best response is partial response (PR) or complete response (CR)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - SPIO-101 (Oral); BRIEF: The purpose of this study is to assess the study medication blood levels after administration of a single oral capsule of Bendavia at one of three dose levels. The effects of Bendavia on the volunteers will also be assessed. ; DRUG USED: Elamipretide (Systemic Delivery); DRUG CLASS: New Molecular Entity (NME); INDICATION: Chronic Heart Failure - Reduced Ejection Fraction (Chronic HFrEF); TARGET: Mitochondria, Reactive Oxygen Species/Free Radicals; THERAPY: Monotherapy; LEAD SPONSOR: Stealth BioTherapeutics Inc.; CRITERIA: Inclusion Criteria: - Healthy adult males or females aged between 18 and 65 years of age with signed informed consent. - Women who are not post-menopausal (without menstrual bleed for >24 months) or surgically sterile must have a negative serum pregnancy test at screening and within 24 hours of treatment with understanding (through informed consent process) to not become pregnant over the duration of the study and must agree to employ an effective form of birth control for the duration of the study. - Acceptable forms of birth control are: double-barrier contraceptives (condom, diaphragm with spermicide) or intra-uterine device 1 week prior to and at least 30 days post treatment even if hormonal contraceptives are used. Exclusion Criteria: - Serum sodium level below the lower limit of the sites clinical laboratory normal range at the study qualification visit, - Clinically significant laboratory abnormalities as determined by the Principal Investigator at laboratory screening - Creatinine clearance calculated by the Cockcroft and Gault method calculated to be <90 mL/min for males and <80 mL/min for females - Clinically significant abnormalities on physical examination, - Body weight less than 60 or greater than 80 kg and a body mass index of less than 18 kg/m2 or greater than 32 kg/m2, - Any disease or condition that might compromise the cardiovascular, hematological, renal, hepatic, pulmonary (including chronic asthma), endocrine (e.g., diabetes), central nervous, or gastrointestinal (including an ulcer) systems, - History of seizures or history of epilepsy, - History of serious (Principal Investigator judgment) mental illness, - Participant in any research involving investigational product within 30 days before planned date of drug administration, - Positive serology for human immunodeficiency virus type 1 or 2, hepatitis B surface antigen, or hepatitis C, - Fever greater than 37.5°C at the time of planned dosing, - Suspicion, or recent history, of alcohol or substance abuse, - Donated blood or blood products within the past 30 days, - Women who are pregnant or breastfeeding, - Employee or family member of the investigational site, - Subjects who currently smoke cigarettes, cigars, pipes or chew tobacco products or who have used any tobacco product in the 30 days prior to screening, - Subjects who are either unwilling to agree to refrain from use or found to be using: - Alcohol, caffeine, xanthine-containing food or beverages, nicotine products and over-the-counter medications with the exception of Tylenol from 24 hours prior to dosing and throughout the confinement period - Prescription medications from 14 days prior to, and 7 days post, dose (excluding hormonal contraceptives) - Hormonal contraceptives without concomitant use of double-barrier contraceptives (condom, diaphragm with spermicide) for a period of 7 days prior to, and 30 days post, dose - Subjects having previous exposure to Bendavia ; PRIMARY OUTCOME: Mean peak plasma concentration (Cmax) of Bendavia (ng/ml) in each cohort.; SECONDARY OUTCOME 1: Mean Area Under the Curve (AUC) for Bendavia metabolite M1 (hr.ng/ml) in the time from dosing to final plasma sample in each cohort.[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - MODE (HoFH); BRIEF: The available medications used to treat HoFH are targeted at reducing circulating levels of total and LDL-cholesterol. These measures can retard the progression of cardiovascular disease, however, they are unlikely to regress existing disease due to years of cholesterol accumulation in the vessel walls and therefore cannot adequately reduce the existing risk for an ischemic event. HDL has multiple actions that could lead to plaque stabilization and regression, such as rapid removal of large quantities of cholesterol from the vasculature, improvement in endothelial function, protection against oxidative damage and reduction in inflammation. This study will assess the effects of CER-001, a recombinant human Apo-A-1 based HDL mimetic, on indices of atherosclerotic plaque progression and regression as assessed by 3Tesla MRI measurements in patients with HoFH. ; DRUG USED: CER-001; DRUG CLASS: Biologic; INDICATION: Dyslipidemia / Hypercholesterolemia; TARGET: Reverse Cholesterol Transport (RCT); THERAPY: Monotherapy; LEAD SPONSOR: Cerenis Therapeutics, SA; CRITERIA: Inclusion Criteria: - Male or female subject 12 years or older - Subject presents with Homozygous FH Exclusion Criteria: - Weight >100 kg - Subjects with significant health problems in the recent past including blood disorders, cancer, or digestive problems - Female subjects of child-bearing potential - Known major hematologic, renal , hepatic, metabolic, gastrointestinal or endocrine dysfunction - Contraindication to MRI scanning that would preclude the use of contrast-enhanced 3TMRI ; PRIMARY OUTCOME: Percent change from baseline to follow-up in carotid mean vessel wall area; SECONDARY OUTCOME 1: Change in carotid vessel wall volume[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIa - Safety Evaluation; BRIEF: Open-label, dose-escalating, Phase IIa trial of NanoPac® to treat subjects with locally advanced pancreatic adenocarcinoma via direct intratumoral injection. ; DRUG USED: NanoPac; DRUG CLASS: Non-NME; INDICATION: Pancreatic Cancer; TARGET: Microtubules (Tubulin); THERAPY: Monotherapy; LEAD SPONSOR: NanOlogy, LLC; CRITERIA: Inclusion Criteria: - Signed informed consent; - Age ≥18 years; - Histologically/cytologically confirmed locally advanced pancreatic adenocarcinoma; at least one lesion with a diameter of at least 1.5 cm but no more than 6 cm as documented via imaging (within 6 weeks of Screening); - Subject not a candidate for surgery; - Completion of at least one standard of care IV chemotherapy course for subjects in the dose escalation phase of the study. IV chemotherapy will be initiated prior to first NanoPac injection for subjects in the second and third phases. Hematologic recovery must be confirmed prior to study entry; - Performance Status (ECOG) 0-1 at study entry; - Life expectancy of at least 3 months; - Adequate marrow, liver, and renal function at study entry: - ANC ≥ 1.5 x 109/L - Hemoglobin ≥ 9.5 grams/dL - Platelets ≥ 75 x 109/L - Total bilirubin ≤ 1.5x institutional ULN - AST/ ALT ≤ 2.5x institutional ULN - Creatinine ≤ 1.5x institutional ULN - Effective contraception if the risk of conception exists. Exclusion Criteria: - Thrombotic or embolic events; - Acute or subacute intestinal occlusion; - History of inflammatory bowel disease; - Known hypersensitivity to study drugs; - Known drug or alcohol abuse; - Pregnant or breastfeeding women; - Previous or concurrent history of non-pancreatic malignancy except for non-melanoma skin cancer. ; PRIMARY OUTCOME: Incidence of Treatment Emergent Adverse Events (safety and tolerability); SECONDARY OUTCOME 1: Pharmacokinetics: Area under the plasma concentration versus time curve (AUC) of NanoPac®[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - OL006; BRIEF: The purpose of the study is to assess the overall survival and progression free survival of patients treated with Litx™ + chemotherapy versus chemotherapy alone in the treatment of Colorectal Cancer with recurrent liver metastases, and to demonstrate the safety of Litx™ therapy. Litx™ consists of a light-activated drug, talaporfin sodium (LS11, Light Sciences Oncology, Bellevue, Washington), and a light generating device, composed of light-emitting diodes (LEDs), that is energized by a power controller and percutaneously placed in the target tumor tissue inside the body. ; DRUG USED: Aptocine; DRUG CLASS: New Molecular Entity (NME); INDICATION: Colorectal Cancer (CRC); TARGET: Reactive Oxygen Species/Free Radicals; THERAPY: Combination; LEAD SPONSOR: Light Sciences Oncology; CRITERIA: Inclusion Criteria: - Patients with recurrent metastatic liver lesions from colorectal cancer who progressed on either FOLFOX or FOLFIRI - Biopsy proven evidence of colorectal cancer - At least one liver lesion that can be measured in one dimension at >10 mm with spiral CT scan (CT preferred but MRI allowed) - ECOG Performance Status 0-2 - Life expectancy of at least 16 weeks - At least 30 days must have elapsed since the completion of any prior antineoplastic therapy and the patient must have recovered from acute side effects before day 0 - Understanding and ability to sign written informed consent - 18 years of age or more - Adequate hematologic, liver and renal functions as evidenced by the following: WBC > 2.5 × 10^9/L ; Platelet Count > 100 × 10^9/L ; Hemoglobin > 90 g/L ; Neutrophils >1.5 × 10^9/L ; PT and PTT < 1.5 Control ; SGOT, SGPT < 5 × ULN ; GGT < 5 × ULN ; Alkaline phosphatase < 5 × ULN ; Bilirubin < 3 × ULN ; Creatinine < 1.5 × ULN Exclusion Criteria: - Patients who are candidates for complete surgical resection - Patients who received bevacizumab (Avastin®) or cetuximab (Erbitux®) within 30 days of randomization. Use of bevacizumab or cetuximab is prohibited while participating in this study - Patients who would require more than a total number of 12 light source applications over three Litx™ experimental treatments (no more than 4 light sources per treatment). - Patients who have a single measurable tumor greater than 7.5 cm in any organ - Target lesions irradiated within 3 months of randomization - Patients with tumor involvement in greater than 50% of parenchyma of the liver - Evidence of major vessel invasion of any organ - Patients with any non-colorectal cancers except for adequately treated basal or squamous cell skin cancer, or adequately treated stage I or II cancer from which the patient has been disease-free for ≥ 3 years, or other cancer from which the patient has been disease-free for ≥ 5 years - Known sensitivity to porphyrin-type drugs or known history of porphyria - Pregnancy or breast-feeding patients. A negative pregnancy test (urine or serum) from women of childbearing age is required prior to enrollment. A fertile patient must use effective contraception during participation in the study - Concurrent participation in another clinical trial involving experimental treatment - Any concurrent disease or condition that in the opinion of the investigator impairs the patients ability to complete the trial such as psychological, familial, sociological, geographical or medical conditions which in the Principal Investigators opinion could compromise compliance with the objectives and procedures of this protocol or obscure interpretation of the trials data. ; PRIMARY OUTCOME: Overall Survival; SECONDARY OUTCOME 1: [/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - Study 301 (w/tislelizumab); BRIEF: The purpose of this study is to evaluate the efficacy and safety of tislelizumab in combination with sitravatinib compared with docetaxel in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have disease progression following platinum-based chemotherapy and anti-programmed cell death protein-1 (PD-1)/programmed cell death ligand-1 (PD-L1) antibody, with the anti-PD-(L)1 antibody administered in combination with or sequentially before or after the platinum-based chemotherapy. ; DRUG USED: Sitravatinib; DRUG CLASS: New Molecular Entity (NME); INDICATION: Non-Small Cell Lung Cancer (NSCLC); TARGET: EPH receptor B4 (EPHB4), Hepatocyte growth factor receptor (c-Met, HGFR), RET, VEGF Receptor (VEGFR); THERAPY: Combination; LEAD SPONSOR: BeiGene; CRITERIA: Key Inclusion Criteria: 1. Metastatic or unresectable locally advanced histologicallyor cytologically confirmed Non-Small Cell Lung Cancer (NCSLC), not amenable to treatment with curative intent 2. Able to provide archival/fresh tumor tissues for biomarker analysis to assess PD-L1 expression and other biomarkers. 3. No known Epidermal Growth Factor Receptor (EGFR) or B-Raf proto-oncogene (BRAF) sensitizing mutation, or anaplastic lymphoma kinase (ALK) rearrangement or ROS proto oncogene 1 (ROS1) rearrangement 4. Radiographic progression per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 on or after anti-PD-(L)1 containing therapy for locally advanced and unresectable or metastatic NSCLC. 5. No prior anticancer therapy having the same mechanism of action as sitravatinib (eg, tyrosine kinase inhibitor with a similar target profile or Vascular endothelial growth factor (VEGF)- or VEGFR inhibitor) 6. At least 1 measurable lesion as defined based on RECIST v1.1 by investigator Key Exclusion Criteria: 1. Has received docetaxel as monotherapy or in combination with other therapies. 2. Squamous NSCLC with central cavitation, or NSCLC with hemoptysis (> 50 mL/day) 3. Participants with tumor shown by imaging to be located around important vascular structures or if the investigator determines that the tumor is likely to invade important blood vessels and may cause fatal bleeding. 4. Active leptomeningeal disease for metastatic NSCLC, or uncontrolled or untreated brain metastasis. 5. Active autoimmune diseases or history of autoimmune diseases that may relapse. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply. ; PRIMARY OUTCOME: Overall survival (OS); SECONDARY OUTCOME 1: Progression-free survival (PFS)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - 2-Year Study in Men; BRIEF: This study will investigate if the drug zoledronic acid given once yearly is safe and has beneficial effects in treating osteoporosis by reducing bone loss and fractures in men with osteoporosis. ; DRUG USED: Reclast; DRUG CLASS: Non-NME; INDICATION: Osteoporosis / Osteopenia; TARGET: Osteoclast; THERAPY: Monotherapy; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Inclusion Criteria: • Osteoporosis as defined by very low bone mineral density in the hip and spine or low bone mineral density in the hip combined with presence of 1-3 mild or moderate fractures of the vertebrae Exclusion Criteria: - Low Vitamin D - Renal insufficiency - Previous treatment with certain anti-osteoporotic therapies (except after certain washout periods): calcitonin, bisphosphonates, parathyroid hormone (PTH), sodium fluoride, strontium ranelate, - Previous treatment with testosterone, anabolic steroids or growth hormone - Chronic use of systemic corticosteroids (oral or i.v.) within the last year - History of any cancer or metastases within the last 5 years - History of brittle bone disease, multiple myeloma, or Pagets disease, or any other metabolic bone disease, except osteoporosis - Bilateral hip replacements Other protocol-defined inclusion/exclusion criteria may apply ; PRIMARY OUTCOME: Percentage of Participants With at Least One New Morphometric Vertebral Fracture Over 24 Months; SECONDARY OUTCOME 1: Percentage of Participants With at Least One New Morphometric Vertebral Fracture Over 12 Months[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - TOMMORROW; BRIEF: The purpose of this study is to qualify the biomarker risk algorithm for prognosis of the risk of developing Mild Cognitive Impairment due to Alzheimers Disease (MCI-AD), and also to evaluate the efficacy of pioglitazone compared with placebo to delay the onset of MCI-AD in cognitively-normal participants who are at high-risk for developing MCI within 5 years. ; DRUG USED: Actos; DRUG CLASS: New Molecular Entity (NME); INDICATION: Alzheimers Disease (AD); TARGET: PPAR gamma; THERAPY: Monotherapy; LEAD SPONSOR: Takeda; CRITERIA: Inclusion Criteria: 1. In the opinion of the investigator, participant is capable of understanding and complying with protocol requirements. 2. Signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures. 3. Is able to physically perform the cognitive tests in the opinion of the investigator and is fluent in the language that tests will be administered. 4. Is cognitively normal at baseline, scoring as indicated for the following tests: - Clinical Dementia Rating (CDR)=0. - At least one memory test above -1.5 standard deviation (SD) of the demographically corrected normative mean. 5. Must score ≥25 on the Mini-Mental State Examination (MMSE) at the screening visit after the education and age adjustment. 6. Is male or postmenopausal female between the ages of 65 and 83 years, inclusive, at time of the Screening visit. 7. Has the ability and intention to participate in regular study visits, in the opinion of the Investigator. 8. Has a project partner who can separately complete an Acknowledgement Form on his/her own behalf and take part in the study (with the intent to do so as long as the participant is enrolled) to provide information on the cognitive, functional, and behavioral status of the participant and to assist with monitoring of study medication, if needed. Exclusion Criteria: 1. Has a current diagnosis or history of any type of cognitive impairment or dementia or has a current diagnosis or history of neurological/psychiatric disorder or any other diagnosis that significantly affects cognitive performance (eg, mental retardation, organic mental disorder). 2. Has a current diagnosis of significant psychiatric illness, per Diagnostic & Statistical Manual of Mental Disorders, 4th Edition - Text Revision (DSM-IV-TR) (or DSM-V when published) (including but not limited to major depressive disorder, anxiety disorders) and is in an acute phase/episode, or the participant has a current diagnosis or history of schizophrenia or bipolar disorder. 3. Has a glycosylated hemoglobin (HbA1c) >8.0% at the time of baseline or requires treatment with insulin, triple oral antidiabetic therapy or a peroxisome proliferator-activated receptor-gamma (PPAR-γ) agonist. The participant should be on a stable antidiabetic regimen for at least 3 months prior to enrollment. 4. Has a clinically significant unstable illness, for example, hepatic impairment or renal insufficiency, or cardiovascular, pulmonary, gastrointestinal (including s/p gastric bypass), endocrine, neurological, rheumatologic, immunologic, infectious, skin and subcutaneous tissue disorders, or metabolic disturbance. History of HIV infection is considered exclusionary for this study. 5. Has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse/dependence within 2 years prior to the Screening Visit. 6. Is an immediate family member, testing center employee, or is in a dependent relationship with a testing center employee who is involved in conduct of this study (eg, spouse, parent, child, and sibling) or may consent under duress. 7. Has a history of hypersensitivity or allergies to pioglitazone or related compounds. 8. Is required to take excluded medications as specified in the Excluded Medications Section. 9. Had any of the following values at the Baseline Visit (Visit 2): 1. A serum total bilirubin value >1.5× upper limit of normal (ULN). 2. A serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) value >2xULN. 3. Unexplained microscopic/macroscopic hematuria on one repeat examinations within 2 weeks of the initial assessment. 10. Is positive for either Hepatitis B surface antigen (HBsAg) or anti-hepatitis C virus (HCV) antibodies at the Baseline Visit (Visit 2). 11. Has a condition or takes medication that, in the opinion of the Investigator, could interfere with the assessments of safety, tolerability, or efficacy, or prevent the participant from adequately participating in the study or continue for the anticipated duration of the study. 12. Has received any investigational compound within 30 days prior to screening or 5 half-lives prior to Screening or is currently participating in another study which entails the administration of an investigational or marketed drug, supplement or intervention including, but not limited to diet, exercise, lifestyle or invasive procedure. 13. Has a history of any cancer that has been in remission for less than 2 years from the Screening Visit. Participants with basal cell or stage I squamous cell carcinoma of the skin will be eligible. Participants with history of bladder cancer are not eligible irrespective of the remission status. 14. Has a history or current diagnosis of macular edema or macular degeneration. 15. If female, has a history of postmenopausal fractures with no or minimal trauma (eg, wrist, hip, lumbar or thoracic vertebral fracture). 16. Has a history or current diagnosis of congestive heart failure (CHF), New York Heart Association Class III-IV. 17. Has been exposed to the cognitive tests performed in this study within 6 months prior to the Screening Visit, with the exception of the MMSE. 18. Participants Translocase of the Outer Mitochondrial Membrane 40 homolog (TOMM40) rs10524523 or apolipoprotein E (APOE) genotypes or APOE phenotype are known by the participant or the study staff participating in this study. ; PRIMARY OUTCOME: Time to Diagnosis of Mild Cognitive Impairment Due to Alzheimers Disease (MCI-AD) for Placebo-treated, High-risk, Non-Hispanic/Latino Caucasian Participants Versus Placebo-treated, Low-risk, Non-Hispanic/Latino Caucasian Participants; SECONDARY OUTCOME 1: Change From Baseline for Cognitive Decline on Composite Score on the Cognitive Test Battery for Pioglitazone-treated Participants Versus Placebo-treated Participants in the High-risk Stratum[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - LEAD 2 (w/Metformin); BRIEF: This trial is conducted in Europe, Oceania, Africa, Asia and South America. This trial is designed to show the effect of treatment with liraglutide when adding to existing metformin therapy and to compare it with the effects of metformin monotherapy and combination therapy of metformin and glimepiride. Two trial periods: A 6 month (26 weeks) randomised, double-blinded period followed by an 18 months open-label extension, in total 2 years (104 weeks). ; DRUG USED: Victoza; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type II; TARGET: GLP-1 Receptor; THERAPY: Combination; LEAD SPONSOR: Novo Nordisk A/S; CRITERIA: Inclusion Criteria: - Subjects diagnosed with type 2 diabetes and treated with oral anti-diabetic drugs (OADs) for at least 3 months - HbA1c: 7.0-11.0 % (both incl.) in subjects on OAD monotherapy. 7.0-10.0 % (both incl.) in subjects on OAD combination therapy - Body Mass Index (BMI) less than or equal 40 kg/m2 Exclusion Criteria: - Subjects treated with insulin within the last three months - Subjects with any serious medical condition - Females of child bearing potential who are pregnant, breast-feeding or have the intention of becoming pregnant or not using adequate contraceptive methods - Subjects using any drug (except for OADs), which in the Investigators opinion could interfere with the glucose level (e.g. systemic corticosteroids) ; PRIMARY OUTCOME: Change in Glycosylated A1c (HbA1c) at Week 26; SECONDARY OUTCOME 1: Change in Body Weight at Week 26[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - w/Carboplatin or Docetaxel (IV or Oral); BRIEF: The purpose of this study is to determine the safety, pharmacokinetics and maximum tolerated dose of ABT-348 as monotherapy and when given in combination with carboplatin or docetaxel. ; DRUG USED: ABT-348; DRUG CLASS: New Molecular Entity (NME); INDICATION: Solid Tumors; TARGET: Aurora Kinase; THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: AbbVie (prior sponsor, Abbott); CRITERIA: Inclusion Criteria: 1. Histological confirmation of locally advanced or metastatic solid tumor. - That is either refractory after standard of care therapy for the disease for which standard of care therapy is not reliably effective or does not exists, or - For which carboplatin has been determined to be an appropriate therapy, per the investigator, or - For which docetaxel has been determined to be an appropriate therapy, per the investigator. 2. Eastern Cooperative Oncology Group Status of 0-2 3. Serum creatinine value of ≤ 1.5 times the upper limit of normal (ULN) and either an estimated creatinine clearance value as determined by the Cockcroft-Gault formula or based on a 24 hour urine collection creatinine clearance value of ≥ 50 mL/min 4. Adequate liver function as demonstrated by serum bilirubin < 2 x ULN and AST and ALT ≤ 2.5 x ULN 5. Adequate bone marrow as demonstrated by absolute neutrophil count (ANC) ≥ 1,500/mm2 (1.5 x 109/L); Platelets ≥ 100,000/mm2 (100 x 109/L); Hemoglobin ≥ 9.0 g/dL (1.4 mmol/L) 6. QTc interval < 500 msec 7. Left Ventricular Ejection Fraction > 50% 8. Women of child-bearing potential and men must agree to use adequate contraception (one of the following listed below) prior to the study entry, for the duration of study participation and up to 3 months following completion of therapy. 9. Capable of understanding and complying with parameters as outlined in the protocol and able to sign informed consent, approved by an Institutional Review Board (IRB) prior to the initiation of any screening or study-specific procedures. Exclusion Criteria: 1. Subject has known active CNS involvement. The subject has untreated brain or meningeal metastases. 2. Subject has received anti-cancer therapy within a period of 21 days or 5 half lives (whichever is shorter) prior to Study Day 1 3. Subject has unresolved toxicities from prior anti-cancer therapy, grade 2 or higher clinically significant toxicity (excluding alopecia) 4. Subject has had major surgery within 28 days prior to Study Day 1 5. Subject currently exhibits symptomatic or persistent, uncontrolled hypertension defined as diastolic blood pressure > 90 mmHg or systolic blood pressure > 140 mmHg 6. Subject has proteinuria grade > 1 7. Subject is receiving therapeutic anticoagulation therapy. Low dose anti coagulation (e.g., low dose heparin or warfarin) for catheter prophylaxis will be permitted. 8. Clinically significant uncontrolled condition(s) 9.Psychiatric illness/social situation that would limit compliance with study requirements 10. Subject has a known infection with HIV, Hepatitis B or Hepatitis C 11. Subject with poorly controlled diabetes mellitus 12. Subject enrolled in Arm A, B, C and D is unable to swallow or absorb oral tablets normally 13. Any medical condition which in the opinion of the study investigator places the subject at an unacceptably high risk for toxicities 14. Female subjects who are lactating or pregnant 15. Subject enrolled in Arm E has hypersensitivity to drugs formulated with polyethoxylated castor oli (Cremophor) ; PRIMARY OUTCOME: Determine the safety profile (Adverse events by toxicity grade and relationship to study drug, serious adverse events, adverse events leading to discontinuation and relevant clinical laboratory abnormalities) of ABT-348 as monotherapy or in combination; SECONDARY OUTCOME 1: Evaluate safety at the recommended Phase 2 dose (RPTD) and schedule of ABT-348 as monotherapy, when in combination with carboplatin or in combination with docetaxel.[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - ONC-14-OvaII-1-QUI-2 (Russia); BRIEF: This is a multicenter, open-label study of safety and efficacy of Quisinostat in combination with Paclitaxel + Carboplatin chemotherapy in patients with metastatic or locally advanced epithelial ovarian cancer, primarily peritoneal or fallopian tube carcinoma, resistant to first line platinum and Paclitaxel based chemotherapy. The study will be carried out in 5-8 Russian and Belarusian sites. A maximum of 32 patients with metastatic or locally advanced epithelial ovarian cancer, primarily peritoneal or fallopian tube carcinoma, resistant to first line platinum and Paclitaxel based chemotherapy, will be enrolled in the study. ; DRUG USED: Quisinostat; DRUG CLASS: New Molecular Entity (NME); INDICATION: Ovarian Cancer; TARGET: Histone Deacetylase (HDAC); THERAPY: Combination; LEAD SPONSOR: NewVac LLC; CRITERIA: Inclusion Criteria: 1. Signed patients information sheet and informed consent form to participate in the study. 2. Histological confirmed diagnosis of serous epithelial ovarian, primarily peritoneal or fallopian tube carcinoma. 3. Females aged ≥ 18 years. 4. Patients must have an ECOG status of 0 or 1. 5. Patients must have received only 1 prior line of platinum and Paclitaxel based chemotherapy. 6. Tumor progression observed not less than 1 month and no more than 6 months after completion of the planned number of cycles of first line platinum/Paclitaxel based chemotherapy (Carboplatin in the dose AUC5-6 or Cisplatin in the dose ≥ 75 mg/m2, in combination with paclitaxel for 6 q3-4 wk cycles) and indications for undergoing the second line chemotherapy. 7. The patients must have at least one measurable lesion according to RECIST 1.1 criteria. 8. Tissue block from archived material at diagnosis must be available and be submitted for predictive biomarker analysis. 9. Patients ability to carry out visits and study procedures and to comply with the protocol. 10. Requirements for laboratory parameters determined below: Hematology: Absolute neutrophil count: Platelets: Hemoglobin: ≥ 1,500/mm3 (1.5 x 109 cells/L) - 100,000/mm3 (100 x 109 cells/L) - 9.0 g/dl Liver function: Total bilirubin: ≤ 1.5x upper limit of normal (ULN) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT): Alkalinephosphatase: - 2.5x ULN, or ≤ 5.0 x ULN in the case of liver metastasis - 5.0 x ULN Renal function: Serum creatinine: ≤2 mg/dL Coagulation panel: Activated partial thromboplastin time (aPTT): ≤ 1.5 x ULN 11. The expected survival time not less than 6 months. 12. Women of childbearing potential (not sterile or in menopause less than 2 years) must be practicing an effective method of birth control during the whole period of the study and 6 months after the last administration of the investigational product. Effective methods include usage of a condom or diaphragm (barrier method) with spermicide. Exclusion Criteria: 1. Patients previously treated with an HDAC inhibitor. Patients, who have been treated with Valproate for convulsions can be included, however only if the treatment has taken place > 30 days before the screening. 2. Have received treatment for ovarian cancer with any other prior chemotherapy than platinum (Carboplatin (AUC 5-6) or Cisplatin (≥ 75 mg/m2)) and paclitaxel (175-200 mg/m2) q3-4 wk for 6 cycles. Additional first line chemotherapy or prior treatment with additional investigational anticancer therapy is also an exclusion criterion. 3. Presence of specific toxicities of ≥ I grade, according to the NCI-CTCAE v.4.3, related to any prior anti-cancer therapy (excluding alopecia) 4. Patients with subsequent debulking operation (after first line chemotherapy) or radiotherapy due to the disease recurrence. 5. Patients who have undergone lower pelvis radiotherapy. 6. Patients with active or uncontrolled infection. 7. Patients with antibodies to human immunodeficiency virus (HIV), or hepatitis C virus (HCV), active hepatitis B virus (HBsAg). 8. History of other malignancies with the exception of basal cell carcinoma of the skin or cervical cancer in situ, that had undergone surgical removal or treatment within ≥ 5 years before the screening. 9. Patients with known cerebral metastases or clinical signs of cerebral metastases. 10. Have a history of severe hypersensitivity reaction to carboplatin, paclitaxel or agents within the histone deacetylase inhibitor group. 11. History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess during the year prior to inclusion. 12. Clinically significant cardiovascular diseases including: - Myocardial infarction within 12 months before screening - Unstable angina within 12 months before screening - Congestive heart failure Class III or IV according to the New York Heart Association criteria (NYHA) - Clinically significant ventricular arrhythmia including ventricular tachycardia, ventricular fibrillation, history of cardiac arrest, atrioventricular block (Mobitz II or III), use of cardiostimulator - QTc interval > 470 ms (ECG) (calculated according to Fredericia formula), or a diagnosis of long QTc syndrome - Hypotension (systolic blood pressure < 86 mm Hg) or bradycardia with a heart rate of < 50 beats per minute (ECG) except when caused by medications (e.g. beta-blockers) - Uncontrolled arterial hypertension (systolic arterial pressure > 170 mm Hg or diastolic blood pressure > 105 mm Hg) 13. Pregnancy and lactation 14. Drug or alcohol abuse at the moment of screening or in the past which according to the opinion of the Investigator makes the patient unsuitable for participation in the study 15. Inability to read or write; inability to understand and comply with the procedures of the study protocol; failure to comply with the treatment, which, in opinion of the Investigator, may affect the results of the study or the patients safety and prevent the patient from further participation in the study; any other associated medical or serious mental conditions that make the patient unsuitable for participation in the clinical study, limit the validity of informed consent or may affect the patients ability to participate in the study ; PRIMARY OUTCOME: Objective response rate; SECONDARY OUTCOME 1: Progression-free survival (PFS)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I/II - w/Paclitaxel; BRIEF: This is a multi-center, randomized, open-label, phase 1/2 study of continuous weekly paclitaxel and escalating doses of intermittent or continuous OSI-906 in patients with recurrent/relapsed ovarian and other solid tumors. ; DRUG USED: Linsitinib; DRUG CLASS: New Molecular Entity (NME); INDICATION: Ovarian Cancer; TARGET: IGF-1R (Insulin-like Growth Factor-1 Receptor) ; THERAPY: Combination; LEAD SPONSOR: Astellas Pharma Inc; CRITERIA: Inclusion Criteria: - Histologically or cytologically confirmed epithelial ovarian carcinoma Patients with fallopian or peritoneal cancer will also be eligible - Patients with any solid tumor that may be treated with weekly paclitaxel will be eligible for the phase 1 portion - For the phase 2 portion, patients must have elevated CA125 levels evaluable/assessable according to Gynecological Cancer Intergroup (GCIG) criteria (ie, > 70 U/mL) documented by 2 measurements at least 1 week apart - Patients must have radiologically confirmed progressive disease by RECIST v1.1 criteria within 6 months prior to randomization. (patients must have measurable disease according to RECIST v1.1) - Eastern Cooperative Oncology Group (ECOG) performance status(PS) 0 -1 - Predicted life expectancy ≥ 12 weeks - Patients may have had prior therapy, providing the following conditions are met: - Chemotherapy: Prior chemotherapy must have been completed at least 3 weeks prior to study enrollment (6 weeks for mitomycin C, nitrosoureas or high-dose carboplatin [≥ 600 mg/m²]and 4 weeks for investigational drugs 1. Patient should have recovered from any drug-related toxicities (with the exception of grade 1 neuropathy and or alopecia) 2. Phase 1: While there is no limit on the number of prior regimens for patients entered into the phase 1 portion, any prior taxane therapy must have been administered on a 3 week schedule 3. Phase 2: Patients must have received prior chemotherapy, which must have contained a platinum and a taxanes at some point. Any prior taxanes therapy must have been administered on a 3 week schedule. A maximum of 2 prior chemotherapy regimens are permitted. Patients must be refractory radiologically confirmed by computerized tomography (CT) scan progressive disease (PD) during chemotherapy) or resistant (radiologically confirmed by CT scan PD within six months of completing chemotherapy) to their last platinum-containing chemotherapy regimen - Radiation: Patients may have had prior radiation therapy provided they have recovered from the acute, toxic effects of radiotherapy prior to registration/randomization. Radiated lesions cannot be chosen as the target lesions a. A minimum of 21 days must have elapsed between the end of radiotherapy and registration/randomization into the study unless the radiation affected less than 25% of bone marrow - Surgery: Previous surgery is permitted provided that adequate wound healing has occurred prior to registration/randomization - Fasting glucose ≤ 150 mg/dL (8.3 mmol/L) - Adequate hematopoietic, hepatic, and renal function defined as follows: - Neutrophil count ≥ 1.5 x 10 ^9 /L and platelet count > = 100 x 10^9/L; - Bilirubin ≤ 1.5 x Upper Limit of Normal (ULN); - AST and/or ALT ≤ 2.5 x ULN or < = 5 x ULN if patient has documented liver metastases; and - Serum creatinine ≤ 1.5 x ULN - Female patient must be either: - Of non childbearing potential: 1. post-menopausal (defined as at least 1 year without any menses) prior to Screening, or 2. documented surgically sterile or status post hysterectomy (at least 1 month prior to Screening) - Or, if of childbearing potential: 1. must have a negative urine pregnancy test at Screening, and 2. must use two forms of birth control (one of which must be a barrier method) starting at Screening and throughout the study period and for 28 days [or 5 half lives, whichever is longer] after final study drug administration - Female patient must not be breastfeeding at Screening or during the study period and for 28 days [or 5 half lives of the study drug whichever is longer] after final study drug administration - Female patient must not donate ova starting at Screening and throughout the study period and for 28 days [or 5 half lives of the study drug whichever is longer] after final study drug administration - Patients must provide verbal and written informed consent to participate in the study Exclusion Criteria: - Diabetes mellitus currently requiring medication (eg, insulin or oral hypoglycemics) - During the phase 2 portion, patients with histology of abdominal adenocarcinoma of unknown origin or a diagnosis of a borderline ovarian tumor - Previous or concurrent malignancies (excluding curatively treated basal or squamous cell carcinoma of the skin or cervical carcinoma in situ) unless the patient has been in remission for at least 3 years - History of significant cardiovascular disease unless the disease is well-controlled. Significant cardiac diseases includes second/third degree heart block; significant ischemic heart disease; poorly controlled hypertension; congestive heart failure of New York Heart Association (NYHA) Class II or worse (slight limitation of physical activity; comfortable at rest, but ordinary physical activity results in fatigue, palpitation, or dyspnea) - History of cerebrovascular accident (CVA) within 6 months prior to registration/randomization or that is not stable - Prior therapy with an insulin-like growth factor (IGF-1R) inhibitor - Use of drugs that have a risk of causing QT interval prolongation within 14 days prior to Day 1 dosing - Known or prior hypersensitivity to taxanes in spite of premedication or drugs containing Cremophor - Gastro-intestinal abnormalities, including bowel obstruction, inability to take oral medication, requirement for intravenous (IV) alimentation,active peptic ulcer or prior surgical procedures or bowel resection affecting absorption - Active infection or serious underlying medical condition (including any type of active seizure disorder within 12 months prior to registration/randomization) that would impair the ability of the patient to receive protocol treatment - History of any psychiatric condition that might impair the patients ability to understand or to comply with the requirements of the study or to provide informed consent - Pregnancy or breast-feeding - Symptomatic brain metastases that are not stable, require steroids, are potentially life threatening, or that have required radiation within 28 days prior to registration/randomization - History of allergic reactions attributed to compounds of similar chemical or biologic composition to the study drug - History of arrhythmia (multifocal premature ventricular contractions [PVCs], bigeminy, trigeminy, ventricular tachycardia, or uncontrolled atrial fibrillation) that is symptomatic or requires treatment (≥ grade 3), left bundle branch block (LBBB), or asymptomatic sustained ventricular tachycardia are not allowed. Patients with atrial fibrillation controlled by medication are not excluded. Patients with mean QTcF interval ≥ 450 msec at screening are excluded - Use of drugs that have a known risk of causing Torsade de Pointes (TdP) or that that have a risk of causing QT interval prolongation within 14 days prior to Day 1 dosing are prohibited - Use of the potent CYP1A2 inhibitors ciprofloxacin and fluvoxamine. Other less potent CYP1A2 inhibitors/inducers are not excluded - Participated in any interventional clinical study or has been treated with any investigational drugs within 30 days or 5 half lives whichever is longer, prior to the initiation of Screening or during the course of the study ; PRIMARY OUTCOME: Determine Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D); SECONDARY OUTCOME 1: Objective Response Rate (ORR)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase Ib/II TULiP - w/Palbociclib + Letrozole (University of Colorado); BRIEF: This is a multicenter run-in phase Ib / roll-over phase II study of triple targeted drug combination (HER2-targeted small molecule inhibitor tucatinib, CDK4/6 inhibitor palbociclib and aromatase inhibitor letrozole) as a first or second line of therapy in patients with metastatic hormone receptor positive and HER2-positive breast cancer. ; DRUG USED: Tukysa; DRUG CLASS: New Molecular Entity (NME); INDICATION: Breast Cancer; TARGET: HER2/neu or ErbB-2; THERAPY: Combination; LEAD SPONSOR: University of Colorado, Denver; CRITERIA: Inclusion Criteria: 1. Subjects must have a histologically confirmed diagnosis of HR+/HER2+ locally advanced unresectable or metastatic breast cancer. Estrogen or progesterone receptor positivity is defined by IHC according to the most recent ASCO/CAP guidelines. HER2 positivity is defined by standard of care fluorescence in situ hybridization (FISH) and/or 3+ staining by IHC according to the most recent ASCO/CAP guidelines. 2. Measurable and/or evaluable disease per RECIST 1.1 criteria and/or RANO-BM criteria . Bone only disease is allowed. 3. CNS inclusion criteria: - Subjects without CNS metastases are eligible. Note: brain imaging is not required for asymptomatic subjects without known brain metastatic disease prior to enrollment into the study - Subjects with untreated asymptomatic CNS metastases not needing immediate local therapy in the opinion of investigator are eligible. For subjects with untreated asymptomatic CNS lesions > 2.0 cm by contrast-enhanced MRI, discussion with and approval from the Lead PI is required prior to enrollment - Subjects with stable brain metastases previously treated with radiation therapy or surgery are allowed to enroll, provided that they are off corticosteroids or on stable/tapering dose of corticosteroids and stability of CNS metastatic disease for at least 4 weeks has been demonstrated, with the last MRI taken within 2 weeks prior to cycle 1 day 1 of the study. Relevant records of any CNS treatment must be available to allow for classification of target and non-target lesions 4. Age ≥ 18 years 5. ECOG performance status 0-1 6. Life expectancy of more than 6 months, in the opinion of the investigator 7. Study subjects should be post-menopausal women; premenopausal women are eligible if on ovarian suppression, or agreeable to mandatory ovarian suppression. Women of childbearing potential, defined as premenopausal women who are not permanently sterile (i.e., due to hysterectomy, bilateral oophorectomy, bilateral tubal ligation, or bilateral tubal occlusion) are required to have negative pregnancy tests prior to initiation of treatment. 8. Prior treatments: - Subjects should have received at least two approved HER2-targeted agents (trastuzumab, pertuzumab, or TDM-1) in the course of their disease - Subjects should have had at least 1 line of prior HER2-targeted therapy in the metastatic setting, with the exception of asymptomatic subjects with oligometastatic or bone / soft tissue only disease who, on investigator opinion, are appropriate for a single agent antiendocrine therapy per NCCN guidelines - Subjects who have had up to 2 lines of prior endocrine therapy in the metastatic setting are allowed. Prior adjuvant and/or neoadjuvant endocrine regimens are allowed and not counted towards this limit 9. Adequate organ and marrow function as defined below: - Absolute neutrophil count ≥ 1,500/mm3 - Platelets ≥ 75,000/mm3 - Hemoglobin ≥ 9.0 mg/dL without red blood cell transfusion ≤ 7 days prior to Cycle 1Day 1 of therapy - Total serum bilirubin ≤ 1.5 X upper limit of normal (ULN) except for subjects with known Gilberts disease, who may enroll if the conjugated bilirubin is ≤ 1.5 ULN - AST (SGOT)/ALT (SGPT) ≤2.5 X ULN; - Serum creatinine ≤ 1.5 mg/dL - International normalized ratio (INR) and activated partial thromboplastin time (aPTT) ≤1.5 X ULN unless on medication known to alter INR and aPTT - Left ventricular ejection fraction (LVEF) ≥ 50% (as assessed by ECHO or MUGA) documented within 4 weeks prior to first dose of study treatment - Serum or urine pregnancy test (for women of childbearing potential) negative ≤ 7 days of starting treatment 10. Ability to understand and the willingness to sign a written informed consent and comply with the study scheduled visits, treatment plans, laboratory tests and other procedures. 11. Subject or legally authorized representative of a subject must provide signed informed consent per a consent document that has been approved by an institutional review board or independent ethics committee (IRB/IEC) prior to initiation of any study-related tests or procedures that are not part of standard-of-care for the subjects disease. Exclusion criteria: 1. Subjects with previously treated progressing brain metastases are excluded from the study 2. Subjects with known brain metastases and contraindications to undergo contrast MRI imaging of the brain are excluded from the study 3. Pregnancy or breast feeding 4. Current active treatment with an investigational agent 5. Known history of hypersensitivity to aromatase-inhibitor drugs 6. Any toxicity related to prior cancer therapies that has not resolved to ≤ Grade 1, with the exception of peripheral neuropathy, which must have resolved to ≤ Grade 2, and alopecia 7. Previous treatment with lapatinib, neratinib, afatinib, or other investigational EGFR-family receptor tyrosine kinase inhibitor or HER2 tyrosine kinase inhibitor 8. Previous treatment with palbociclib, abemaciclib, ribociclib or other investigational CDK4/6 inhibitors 9. Any systemic anti-cancer therapy (including hormonal therapy), radiation, or experimental agent ≤ 2 weeks of first dose of study treatment 10. Active bacterial, fungal or viral infections requiring treatment with IV antibiotic, IV antifungal, or IV anti-viral drugs 11. Known hepatitis B (HBV), hepatitis C (HCV) or human immunodeficiency virus (HIV) infections. Note: pretesting is not required. 12. Inability to swallow pills or any significant gastrointestinal disease which would preclude the adequate oral absorption of medications 13. Use of prohibited medications within 3 elimination half-lives prior to first dose of the study treatment 14. Known myocardial infarction, severe/unstable angina, percutaneous transluminal coronary angioplasty/stenting (PTCA), or coronary artery bypass graft (CABG) within 6 month of the first dose of the study treatment 15. Clinically significant cardio-vascular disease, such as ventricular arrhythmia requiring therapy, uncontrolled hypertension (defined as persistent systolic blood pressure > 160 mm Hg and/or diastolic blood pressure > 100 mm Hg on antihypertensive medications), or any history of symptomatic congestive heart failure (CHF) 16. Other severe acute or chronic medical or psychiatric conditions or laboratory abnormalities that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, or in the judgment of the investigator would make the subject inappropriate for entry into the study. ; PRIMARY OUTCOME: Phase Ib Primary Outcome: Proportion of Patients Who Experienced DLTs Attributable to Palbociclib, Tucatinib, or Both; SECONDARY OUTCOME 1: Phase Ib Secondary Outcome: Tucatinib and Palbociclib AUC[0-6] Post Tucatinib and Palbociclib Dose[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I/II - Grade 4 Gliomas; BRIEF: TVI-Brain-1 is an experimental treatment that takes advantage of the fact that your body can produce immune cells, called killer white blood cells that have the ability to kill large numbers of the cancer cells that are present in your body. TVI-Brain-1 is designed to generate large numbers of those killer white blood cells and to deliver those cells into your body so that they can kill your cancer cells. ; DRUG USED: TVI-Brain-1; DRUG CLASS: Biologic; INDICATION: Brain Cancer (Malignant Glioma; AA and glioblastoma (GBM)); TARGET: Immune System, Stem Cells/Other Cell Therapies, T lymphocytes; THERAPY: Monotherapy; LEAD SPONSOR: TVAX Biomedical; CRITERIA: Inclusion Criteria: - Age > 18 - Informed consent - Diagnosis of grade IV glioma with progression following standard treatment. - Must be able to tolerate surgery to provide tumor tissue for vaccine. - Must be able to produce viable vaccine from tumor tissue. - Eastern Cooperative Oncology Group (ECOG) performance status must be < 2 or Karnofsky Performance Status must be 70 or greater. - Negative HIV test. - Negative for hepatitis B and C virus. - Respiratory reserve must be reasonable. - Sufficient renal function. - Satisfactory blood counts. - Negative pregnancy test for women of childbearing potential. Exclusion Criteria: - Surgically removed cancer reveals that it is not grade IV glioma. - Concomitant life-threatening disease. - Active autoimmune disease. - Currently receiving chemotherapy or biological therapy for the treatment of cancer. - Currently receiving immunosuppressive drugs for any reason. - Prior treatment with Avastin or other anti-angiogenesis treatment within 6 months. - Prior treatment with Gliadel wafers. - Corticosteroids beyond peri-operative period. - Psychological, familial, sociological or geographical conditions that do not permit adequate medical follow-up and compliance with the study protocol. ; PRIMARY OUTCOME: Number of Participants Experiencing the Incidence of Grade One or Higher Adverse Events; SECONDARY OUTCOME 1: Overall Survival[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - w/Minocycline; BRIEF: The purpose of this study is to assess whether the antidepressant effect from intravenous (IV) ketamine treatment can be maintained by minocycline compared to placebo after IV ketamine treatment is stopped. ; DRUG USED: Ketamine; DRUG CLASS: Non-NME; INDICATION: Major Depressive Disorder (MDD); TARGET: NMDA Glutamate Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Janssen Research & Development, LLC; CRITERIA: Inclusion Criteria: - Diagnostic criteria for moderate to severe major depressive disorder (MDD), without psychotic features, or Bipolar Disorder Type II - Patients should have an Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) total score ≥ 34 at Screening and at Day 1 (predose) - Patients with major depressive disorder should have failed at least two adequate treatment courses (dose and duration) with antidepressant therapy, one of which is in the current episode - Patients should not have received electroconvulsive therapy (ECT) in the current episode but could be those for whom ECT is considered - Patients with bipolar depression (BPD) Type II must have been taking a stable dose of a mood-stabilizing medication (e.g., lithium, valproate, carbamazepine, lamotrigine, antipsychotic agents) for at least 4 weeks, dosed clinically to target the therapeutic range - Patients currently taking an antidepressant(s) must have received at least 2 weeks of stable antidepressant therapy at the time of Screening - Doses of current antidepressant therapies should remain the same for the duration of the study - Women must be postmenopausal, surgically sterile, or if heterosexually active, practicing a highly effective method of birth control - Men who are heterosexually active with a woman of childbearing potential must agree to use a double barrier method of birth control and to not donate sperm during the study and for 3 months after receiving the last dose of study drug Exclusion Criteria: - Has a current DSM-IV axis I diagnosis other than MDD or BPD Type II at screening (except for co-morbid anxiety disorders) - Has a diagnosis of substance abuse or dependence within 6 months prior to screening evaluation (nicotine and caffeine dependence are not exclusionary) - Patient is currently taking more than 4 psychotropic medications at Day 1 (predose) - Has an autoimmune disorder such as Crohns disease, rheumatoid arthritis, psoriasis currently treated with/requiring treatment with immunomodulatory therapies - Has any significant cardiovascular, respiratory, neurologic, renal, hepatic, endocrine, or immunologic diseases based on screening examination - Has uncontrolled hypertension (diastolic blood pressure ≥ 90 mmHg), despite diet, exercise or a stable dose of an allowed antihypertensive treatment, at Screening or Day 1 (predose) - Has planned vaccination within 2 weeks prior to the first dose of study medication through 2 weeks after the last dose of study medication - Has an active infectious disease/current infection - Has known allergies, hypersensitivity, or intolerance to minocycline or ketamine or its excipients - Has contraindications to the use of minocycline or ketamine per local prescribing information ; PRIMARY OUTCOME: Proportion of patients (among responders) who survive relapse-free; SECONDARY OUTCOME 1: Change in MADRS total score among non-responders from pre-randomization to end-of-study[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - CS203 w/Latanoprost; BRIEF: This is a double-masked, randomized, multi-center, active-controlled, crossover comparison of the addition of AR-12286 or timolol to latanoprost in the treatment of elevated intraocular pressure (IOP). ; DRUG USED: AR-12286; DRUG CLASS: New Molecular Entity (NME); INDICATION: Glaucoma / Ocular Hypertension (Ophthalmology); TARGET: Rho GTPase/Rho Kinase; THERAPY: Combination; LEAD SPONSOR: Aerie Pharmaceuticals; CRITERIA: Inclusion Criteria: - 18 years of age or greater. - Diagnosis of open angle glaucoma (OAG) or ocular hypertension (OHT). - Currently using prostaglandin analogue (monotherapy or combination therapy) O.U. ≥ 1 month at time of study entry (first qualification visit) in study eye(s). - Qualification Visit 1 (Screening) IOP at 16:00 hrs: PG monotherapy patients: ≥ 18 mm Hg; Combination therapy patients: >= 16 mm Hg. Qualification Visit 2 (post latanoprost run-in) IOP ≥ 20 mm Hg at 08:00 hrs and 10:00 hrs, IOP ≥ 18 mm Hg at 16:00 hrs in study eye(s). (Note: combination therapy may include any combination of topical ocular hypotensive agents). - Corrected visual acuity in each eye +1.0 logMAR or better by ETDRS in each eye (equivalent to 20/200). - Able and willing to give signed informed consent and follow study instructions Exclusion Criteria: In either eye: - Previously randomized to treatment in a clinical study of AR-12286. - Intraocular pressure > 36 mm Hg. - History of acute angle-closure glaucoma, or closed or narrow angle upon gonioscopy - Known hypersensitivity or contraindication to timolol maleate ophthalmic solution, or any component of the formulation (benzalkonium chloride, etc.), or to topical anesthetics, including history of conjunctival hyperemia with topical latanoprost of severity greater than 1 on a 0-3 scale. - Ocular trauma within the past six months, or ocular surgery or laser treatment within the past three months. - Contact lens wear within 30 minutes of instillation of study medication. - PG monotherapy patients: Ocular hypotensive medication (other than prostaglandin) within 4 weeks of Visit 0 (Study entry, first qualification visit). Combination therapy patients: Ocular hypotensive medication (other than prostaglandin and current additional agent) within 4 weeks of Visit 0 (Study entry, first qualification visit). - Conjunctival hyperemia of grade 2+ or greater at Visit 1. - Any other ocular medication within 4 weeks of Visit 1 with the exception of lubricating drops for dry eye (which may be used throughout the study). - Clinically significant ocular disease (e.g. corneal edema, uveitis, severe keratoconjunctivitis sicca) which might interfere with the study, including glaucomatous damage so severe that treatment with only latanoprost for two periods of up to 4 weeks is not judged safe (e.g., advanced glaucomatous optic nerve head or visual field loss). - Any abnormality preventing reliable applanation tonometry of either eye. In study eye(s): - Glaucoma: pseudoexfoliation or pigment dispersion component, history of angle closure. Note: Previous laser peripheral iridotomy is acceptable. - Previous glaucoma intraocular surgery or laser procedures. - Refractive surgery (e.g., radial keratotomy, PRK, LASIK, etc.). - Central corneal thickness greater than 600 µ. Systemic: - Known bronchial asthma (history or current), severe chronic obstructive pulmonary disease, sinus bradycardia, second or third degree atrioventricular block or overt cardiac failure. - Clinically significant abnormalities in laboratory tests at screening, recognizing that subjects are not fasting at the time of drawing blood. - Clinically significant systemic disease (e.g., uncontrolled diabetes, myasthenia gravis, hepatic, renal, cardiovascular or endocrine disorders) which might interfere with the study. - Participation in any investigational study within the past 30 days. - Changes of systemic medication that could have a substantial effect on IOP 4 weeks prior to screening, or anticipated during the study. - Women of childbearing potential who are pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control. ; PRIMARY OUTCOME: Intraocular pressure; SECONDARY OUTCOME 1: Ocular safety[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase Ia - Health Volunteers; BRIEF: This study is being done to compare the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of an intravenous (IV) formulation of SYNT001. This is the first-in-human (FIH) study of SYNT001. ; DRUG USED: ALXN1830; DRUG CLASS: Biologic; INDICATION: Pemphigus Vulgaris; TARGET: Neonatal Fc Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Syntimmune, Inc.; CRITERIA: IInclusion Criteria: Subjects must meet the following criteria to be included: - Healthy as determined by comprehensive clinical assessment and clinical laboratory investigations - Body mass index 18.5 to 30.0 kg/m2 - Must use medically acceptable contraception - Willingness to complete all study measurements and assessments in compliance with the protocol Exclusion Criteria: Subjects meeting any of the following criteria are to be excluded: - Past or present disease that is judged by the investigator to have the potential to interfere with the study procedures, compromise safety or affect the PK evaluations - Subject unable or unwilling to comply with the protocol - Any exposure to an investigational drug within the 30 days prior to screening - Use of any tobacco or nicotine-containing products - Abuse of alcohol - Positive drug test or history of drug abuse ; PRIMARY OUTCOME: assessment of safety data (counts and percentages of adverse events); SECONDARY OUTCOME 1: Pharmacokinetics (serum concentration of SYNT001)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - w/Pembrolizumab; BRIEF: This study evaluates the combination of bavituximab and pembrolizumab in the treatment of gastric and gastroesphogeal cancer. All patients will receive both bavituximab, a drug that is not yet approved by the FDA, and pembrolizumab known as Keytruda. There is no expanded access program available for the investigational agents per this protocol. ; DRUG USED: Bavituximab; DRUG CLASS: Biologic; INDICATION: Gastric Cancer; TARGET: Phosphatidylserine; THERAPY: Combination; LEAD SPONSOR: OncXerna Theraputics, Inc.; CRITERIA: Inclusion Criteria: - Signed written informed consent - Men and women ≥ 18 years old; ≥ 20 years old in South Korea and Taiwan - Unresectable metastatic or locally advanced gastric or GEJ adenocarcinoma - Progressed on and/or after at least 1 prior regimen for metastatic disease or achieved stable disease or better in two consecutive scans to PD-1/PD-L1 inhibition alone or in combination with chemotherapy and relapsed - Willing and able to provide fresh formalin-fixed paraffin-embedded tissue tumor sample - Presence of at least one measurable lesion - ECOG of 0 or 1 - Has adequate organ functions - Women of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to start of study treatment. - Women must not be breastfeeding. - Women of childbearing potential , must agree to follow instructions for highly effective method(s) of contraception - Males who are sexually active with women of childbearing potential must agree to follow instructions for highly effective method(s) of contraception - Has adequate treatment washout period before start of study treatment Exclusion Criteria: - Received any form of anti-phosphatidylserine therapies - Prior treatment with any checkpoint inhibitor or other therapies targeting T-cell control - Known microsatellite instability-high (MSI-H) gastric or GEJ adenocarcinoma - Medical history of myocardial infarction within 6 months before registration, symptomatic congestive heart failure (CHF) , troponin levels consistent with myocardial infarction, unstable angina, or serious cardiac arrhythmia - Weight loss >10% over 2 months prior to first dose of study treatment - History of pneumonitis that required steroids or has current pneumonitis - Has known active CNS metastases/and or carcinomatous meningitis - Known additional malignancy that is progressing or has required active treatment in within the past 3 years - An active infection requiring systemic therapy - Known human immunodeficiency virus (HIV) infection or known acute hepatitis B or C infection - Unresolved toxicities from previous cancer treatments - History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participants participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator - Active autoimmune disease or history of chronic recurrent autoimmune disease - Severe hypersensitivity (≥ Grade 3) to pembrolizumab and/or any of its excipients. - History of infusion reactions to any component/excipient of bavituximab - History of severe hypersensitivity reactions to mAbs. - Systemic steroid therapy within 7 days prior to the first dose of study treatment - Has received a live vaccine within 30 days prior to first dose of study drug. - Prior organ transplantation including allogeneic or autologous stem-cell transplantation - Currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment - Receipt of treatment with immunotherapy, biological therapies, or therapeutic doses of hormonal therapies within 3 weeks of scheduled C1D1 dosing - Known psychiatric, substance abuse disorder, or geographical travel limitations that would interfere with participants ability to cooperate with the requirements of the study - Pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study ; PRIMARY OUTCOME: Number of Patients With Treatment Emergent Adverse Events (TEAE); SECONDARY OUTCOME 1: [/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - M.D. Anderson Cancer Center; BRIEF: The goal of this clinical research study is to find the highest tolerated dose of NC-4016 that can be given to patients with advanced solid tumors or lymphoma. The safety of the drug will also be studied. ; DRUG USED: NC-4016; DRUG CLASS: Non-NME; INDICATION: Solid Tumors; TARGET: DNA; THERAPY: Monotherapy; LEAD SPONSOR: NanoCarrier Co., Ltd.; CRITERIA: Inclusion Criteria: 1. Have signed written informed consent prior to the initiation of any study-specific procedures 2. Be a male or female 18 years or older 3. Have a histologically or cytologically confirmed diagnosis of advanced solid tumor or lymphoma, or primitive hepatocarcinoma with radiological diagnosis 4. Have advanced or metastatic disease refractory to standard curative or palliative therapy or contraindication to standard therapy 5. Have an ECOG performance status of 0-2 6. Have adequate bone marrow reserve: a. Absolute neutrophil count at least 1.5 x 10^9/L, b. Platelet count at least 100 x 10^9/L, and c. Hemoglobin at least 10 g/L (transfusion is allowed to achieve hemoglobin of 10 g/L) 7. Have adequate liver function: a. Total serum bilirubin no more than 1.5 x upper limit of normal (ULN), and b. Alanine aminotransferase and aspartate aminotransferase<= 2.5 x ULN or <= 5.0 x ULN in case of documented hepatic metastasis 8. Have adequate renal function: glomerular filtration rate >=50 mL/min (calculated according to the formula of Cockcroft and Gault) 9. Be reasonably recovered from preceding major surgery as judged by the investigator or no major surgery within 4 weeks prior to the start of Day 1 treatment 10. Have a negative pregnancy test for females at screening, preferably done within 1 week before Day 1 of treatment (not applicable to patients with bilateral oophorectomy and/or hysterectomy) 11. Be willing to abstain from heterosexual activity or practice physical barrier contraception from study entry to 6 months after the last day of treatment Exclusion Criteria: 1. Have peripheral neuropathy of Grade 3 or Grade 4 at screening, according to National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE)v4.03, 14 June 2010 scale; or TNSc score greater than 4 2. Have an interval from previous neurotoxic platinums of less than 6 months and/or from previous other neurotoxic drugs less than 3 months (eg, taxanes) unless reasonably recovered from all grades of neurotoxicity as judged by the investigator 3. Have a history of thrombocytopenia with complications including hemorrhage or bleeding >= Grade 2 using NCI CTCAE v4.03, 14 June 2010 that required medical intervention or any hemolytic condition or coagulation disorders that would make participation unsafe in the opinion of the investigator 4. Have unresolved toxicity from previous treatment or previous investigational agents; excluding alopecia. Clinical judgment by the investigator is allowed to determine if grade 1 fatigue at screening is residual toxicity from prior treatment or is a symptom of the patients general condition or disease. The investigator and medical monitor will discuss the eligibility of patients with baseline toxicity 5. Have known hypersensitivity to Pt compounds 6. Have received investigational agents or systemic anticancer agents (other than neurotoxic compounds) within 14 days of Day 1 of treatment, or 28 days for those agents with unknown elimination half-lives, or known elimination half-lives greater than 50 hours; or 6 weeks for mitomycin C or for nitrosourea agents 7. Is pregnant or breast-feeding 8. Have signs or symptoms of end organ failure, major chronic illnesses other than cancer, or any severe concomitant conditions which, in the opinion of the investigator, make it undesirable for the patient to participate in the study, or which could jeopardize compliance with the protocol 9. Have experienced any of the following within the 6-month period prior to screening: angina pectoris, coronary artery disease or cerebrovascular accident, transient ischemic attack, cardiac failure with known ejection fraction less than 40%, or cardiac arrhythmia requiring medical therapy 10. Have known hepatitis B or C, or human immunodeficiency virus infection 11. Is unwilling or unable to comply with study procedures, or is planning to take a vacation for 7 or more consecutive days during the treatment phase of the study ; PRIMARY OUTCOME: Maximum Tolerated Dose (MTD) of NC-4016; SECONDARY OUTCOME 1: Cmax[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - DIABGAD-1 (Linköping University); BRIEF: The objectives of this study is to - evaluate the safety and influence of treatment with GAD-Alum (Diamyd) combined with Vitamin D and Ibuprofen on preservation of residual insulin secretion in recently diagnosed Type 1 Diabetes - evaluate how the above mentioned treatments influence the immune system of the subjects and interact with any viral infections - evaluate the safety and influence of treatment with double dose of GAD-Alum (Diamyd) plus Vitamin D on the immune system, viral infections, and on preservation of residual insulin secretion in recently diagnosed Type 1 Diabetes ; DRUG USED: Diamyd; DRUG CLASS: Vaccine; INDICATION: Diabetes Mellitus, Type I; TARGET: Glutamic Acid Decarboxylase (GAD), Immune System; THERAPY: Combination; LEAD SPONSOR: Johnny Ludvigsson; CRITERIA: Main Inclusion Criteria: - Male and female patients between 10 and 18 years of age - Insulin dependent Type 1 Diabetes mellitus diagnosed within the previous 4 months at time of screening - Fasting C-peptide level at time of screening above or equal to 0.12 nmol/L - Elevated GAD65 antibodies (GADA) at time of screening Main Exclusion Criteria: - Treatment with immunosuppressants, continuous anti-inflammatory drug, Vitamin D or any anti-diabetic medications other than insulin - A history of certain diseases or conditions (e.g. anemia, HIV, epilepsy, head trauma, neurological diseases or cerebrovascular accident, alcohol or drug abuse etc) - Treatment with any vaccine within 4 months prior to first planned administration of GAD-Alum/placebo or planned treatment with vaccine up to 4 months after the last injections with GAD-Alum/Placebo, including influenza vaccines - Participation in other clinical trials with a new chemical entity within the previous 3 months - Pregnancy or planned pregnancy within 1 year after the last GAD-Alum/placebo dose - Presence of associated serious disease or condition which in the opinion of the investigator makes the patient non-eligible for the study ; PRIMARY OUTCOME: Change in C-peptide (90 minute value and AUC mean 0-120 min) during a Mixed Meal Tolerance Test from baseline to month 6, 15 and 30; SECONDARY OUTCOME 1: Proportion of patients with a stimulated maximum C-peptide level above 0.2 nmol/L[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - vs.Tolterodine ER (China, India, Korea, Taiwan); BRIEF: This study is to assess the efficacy and safety of YM178 in patients with symptoms of overactive bladder. ; DRUG USED: Myrbetriq; DRUG CLASS: New Molecular Entity (NME); INDICATION: Overactive Bladder (OAB); TARGET: Beta-3 adrenergic receptor (ß3 adrenoceptor); THERAPY: Monotherapy; LEAD SPONSOR: Astellas Pharma Inc; CRITERIA: Inclusion Criteria: - Subjects with symptoms of overactive bladder for at least 12 weeks before the study - Subjects capable of walking to the lavatory without assistance and measuring the urine volume by him/herself - Subject with an average frequency of micturition of 8 or more times per 24-hour period - Subject with an average episode of urgency or urge incontinence of one or more times per 24-hours period - Subject having provided written informed consent by him/herself Exclusion Criteria: - Subject having stress urinary incontinence as a predominant symptom - Subject with transient symptoms suspected for overactive bladder - Subject complicated with urinary tract infection, urinary stones, and/or interstitial cystitis or with a historical condition of recurrent urinary tract infection - Subject complicated with bladder tumor/prostatic tumor or with the historical condition - Subject confirmed to have a post-void residual volume of >=100ml or with a clinically significant lower urinary tract obstructive disease - Subject with indwelling catheter or practicing intermittent self-catheterization - Subject giving radiotherapy influencing urinary tract functions, or thermotherapy for benign prostatic hyperplasia - Subject giving surgical therapy which may influence urinary tract functions within 24 weeks before the study - Subject with uncontrolled hypertension (indicated by sitting SBP >=180mmHg or DPB >= 110mmHg) - Subject with a pulse rate >= 110bpm or <50 bpm ; PRIMARY OUTCOME: Change in mean number of micturitions per 24 hrs; SECONDARY OUTCOME 1: Change in mean number of urgency episodes per 24 hrs[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - w/C5 inhibitors; BRIEF: The main objective of this study is to evaluate the efficacy of danicopan as add-on therapy to a complement component 5 (C5) inhibitor (eculizumab or ravulizumab) in participants with PNH who have clinically evident EVH. ; DRUG USED: Danicopan; DRUG CLASS: New Molecular Entity (NME); INDICATION: Paroxysmal Nocturnal Hemoglobinuria (PNH); TARGET: Factor D (alternate complement pathway); THERAPY: Combination; LEAD SPONSOR: Alexion Pharmaceuticals, Inc.; CRITERIA: Inclusion Criteria: - Diagnosis of PNH - Clinically Evident EVH defined by: - Anemia (Hgb ≤9.5 gram/deciliter) with absolute reticulocyte count ≥120 x 10^9/liter - Receiving an approved C5 inhibitor for at least 6 months prior to Day 1 - Platelet count ≥30,000/microliters (µL) - Absolute neutrophil counts ≥500/μL - Documentation of/or willingness to receive vaccinations for N. meningiditis and prophylactic antibiotics as required Exclusion Criteria: - History of a major organ transplant or hematopoietic stem cell transplantation (HSCT) - Participants with known aplastic anemia or other bone marrow failure that requires HSCT or other therapies including anti-thymocyte globulin and/or immunosuppressants - Known or suspected complement deficiency - Laboratory abnormalities at screening, including: - Alanine aminotransferase >2 x ULN (>3 x ULN in case of patients with documented liver iron overload defined by serum ferratin values - 500 ng/ML) - Direct bilirubin >2 x ULN (unless due to EVH or documented Gilberts Syndrome) - Current evidence of biliary cholestasis - Estimated glomerular filtration rate of <30 milliliters/minute/1.73 meter squared and/or are on dialysis - Evidence of human immunodeficiency virus, hepatitis B, or active hepatitis C infection at screening ; PRIMARY OUTCOME: Change From Baseline in Hgb at Week 12; SECONDARY OUTCOME 1: Percentage of Participants With Hgb Increase of ≥2 g/dL (≥20 g/L) From Baseline in the Absence of Transfusion at Week 12[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - VLZ-MD-23 (Pediatric); BRIEF: The purpose of this study is to evaluate the long-term safety and tolerability of vilazodone for the treatment of MDD in pediatric outpatients (7-17 years). ; DRUG USED: Viibryd; DRUG CLASS: New Molecular Entity (NME); INDICATION: Major Depressive Disorder (MDD); TARGET: Serotonin 5-HT1 receptor, Serotonin Reuptake; THERAPY: Monotherapy; LEAD SPONSOR: Forest Laboratories; CRITERIA: Inclusion Criteria: - Male or Female outpatients betw een 7-17 years of age - Primary diagnosis of major depressive disorder (MDD) - Childrens Depression Rating Scale-Revised (CDRS-R) score of 40 or greater - Clinical Global Impressions-Severity (CGI-S) score of 4 or greater Exclusion Criteria: - Current (past 3 months) principal Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision based diagnosis of an Axis I disorder other than MDD that is the primary focus of treatment (de novo patients only) - History of suicidal behavior, or requires precaution against suicide - Not generally healthy medical condition - Seizure disorder ; PRIMARY OUTCOME: Number of Participants to Experience a Treatment Emergent Adverse Event (TEAE); SECONDARY OUTCOME 1: Change From Baseline in the CDRS-R Total Score[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I/II - Study 0001; BRIEF: The purpose of this research study is to determine the safety and tolerability of TL-895. There are 2 parts of this study. Part 1 tested increasing doses of TL-895 to identify the recommended safe dose for participants with relapsed/refractory (R/R) B cell malignancies who failed at least 1 but no more than 3 prior therapies. Part 1 of this study is no longer enrolling participants. Arms 1 & 2 of Part 2 of this study will test different doses of TL-895 in participants with R/R CLL or SLL who have failed at least 1 prior therapy. Arms 1 & 2 of Part 2 of this study is randomized (like the flip of a coin) to receive a specific treatment dose. If someone participates in arms 1 or 2 of Part 2, the dose they receive will be either 100mg twice a day or 150mg twice a day. Arms 3 and 4 of Part 2 of this study will test the 150mg and 100mg BID dose of TL-895, respectively in treatment naïve participants with CLL/SLL. Arms 5 and 6 of Part 2 will test 150mg TL-895 BID in combination with 240 mg navtemadlin QD in participants with relapsed/refractory and treatment naïve without 17p(del). Arm 7 will test 150mg TL-895 in combination with 240 mg navtemadlin QD in participants with relapsed/refractory CLL/SLL with 17p(del). Every participant in this study will receive TL-895. ; DRUG USED: M7583; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diffuse Large B-Cell Lymphoma (DLBCL) - NHL; TARGET: Brutons Tyrosine Kinase (BTK); THERAPY: Monotherapy; LEAD SPONSOR: Telios Pharma, Inc.; CRITERIA: Inclusion Criteria - Relapsed/refractory CLL or relapsed/refractory SLL (Arms 1, 2, 5, and 7) - Treatment naïve CLL or SLL (Arm 3, 4, and 6) - ECOG performance status of ≤ 2 - Adequate hematologic, hepatic, and renal functions Exclusion Criteria - Prior treatment with any BTK or PI3K inhibitors - History of major organ transplant - Women who are pregnant or breastfeeding ; PRIMARY OUTCOME: Part 1 (Dose Escalation): DLTs (Dose Limiting Toxicities) during Cycle 1; SECONDARY OUTCOME 1: Part 1 (Dose Escalation): Best Overall Response (BOR)/Progression Free Survival (PFS)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase Ia - SAD (Australia); BRIEF: A Dose Escalating Study of PRS-060 Administered by Oral Inhalation or IV Infusion in Healthy Subjects ; DRUG USED: PRS-060; DRUG CLASS: Biologic; INDICATION: Asthma; TARGET: IL-4 Receptor (IL-4R); THERAPY: Monotherapy; LEAD SPONSOR: Pieris Australia Pty Ltd; CRITERIA: Inclusion Criteria: - Healthy male and female of non-childbearing potential (post-menopausal or surgically sterilized) subjects of 18 to 55 years of age - Body mass index (BMI) of 18-35 - Subjects who are non-smokers or ex-smokers who have not smoked in the last 6 months (determined by urine cotinine < 500 ng/ml, at screening visit). Exclusion Criteria: - History or clinical manifestations of any clinically significant medical disorder that, in the opinion of the investigator, may put the subject at risk because of participation in the study, influence the results of the study or affect the subjects ability to participate in the study. - A history of drug or alcohol abuse. - History of, or known significant infection including hepatitis A, B, or C, Human immunodeficiency Virus (HIV), tuberculosis (i.e., positive result for Interferon (INF)-y release assay (IGRA), QuantiFERON TB-Gold), that may put the subject at risk during participation in the study. - Any clinically significant illness, infection, medical/surgical procedure, or trauma within 4 weeks of day 1 or planned inpatient surgery or hospitalization during the study period. - Subjects with any history of malignancy or neoplastic disease. - Any clinically significant abnormalities in clinical chemistry, hematology, or urinalysis results, as judged by the principal investigator. - Subjects who have received live or attenuated vaccine in the 4 weeks prior to day 1 subjects with a disease history suggesting abnormal immune function - Inability to communicate well with the Investigator (i.e. language problem, poor mental development or impaired cerebral function) - Participation in any clinical study for a New Chemical Entity within the previous 16 weeks or a marketed drug clinical study within the previous 12 weeks or within 5 half- lives, whichever is the longer, before the first dose of study drug. - Donation of 450 ml or more blood within the previous 12 weeks - Women who are pregnant - Males who are sexually active with a female partner of childbearing potential and who have not had a vasectomy and who do not agree to double methods of contraception with at least one barrier from day 1 for 90 days. ; PRIMARY OUTCOME: Number of participants with Adverse Events (AEs) after a single inhaled or IV infusion dose of PRS-060.; SECONDARY OUTCOME 1: PK assessment: Cmax (observed maximum serum concentration taken directly from the individual concentration-time curve)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - Pediatric; BRIEF: This study will evaluate A4250 (IBATinhibitor) as a treatment option in pediatric patients with chronic cholestasis with main emphasis on safety evaluation and on effects on pruritus ; DRUG USED: Bylvay; DRUG CLASS: New Molecular Entity (NME); INDICATION: Progressive Familial Intrahepatic Cholestasis (PFIC); TARGET: Ileal Bile Acid Transporter (IBAT)/Apical Sodium-dependent Bile Acid Transporter (ASBT); THERAPY: Monotherapy; LEAD SPONSOR: Albireo; CRITERIA: Inclusion Criteria: - Diagnosis of pruritus due to chronic cholestasis based on history and investigator judgment. This will include but will not be restricted to patients with Progressive familial intrahepatic cholestasis (PFIC), Alagille syndrome (ALGS), Biliary Atresia and Sclerosing Cholangitis Exclusion Criteria: - Any condition that in the opinion of the investigator constitutes a risk for the patient or a contraindication for participation and completion of the study, or could interfere with study objectives, conduct, or evaluations - Clinical or biochemical signs of decompensated liver disease - Liver transplantation ; PRIMARY OUTCOME: AE evaluation; SECONDARY OUTCOME 1: Bile acid changes[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II; BRIEF: The primary purpose of the study is to compare the efficacy of LY2452473 + tadalafil to tadalafil alone in improving the erectile function (EF) of men with erectile dysfunction (ED) who incompletely respond to tadalafil alone. ; DRUG USED: LY900010; DRUG CLASS: New Molecular Entity (NME); INDICATION: Erectile Dysfunction (ED); TARGET: Phosphodiesterase 5 (PDE5); THERAPY: Combination; LEAD SPONSOR: Eli Lilly and Company; CRITERIA: Inclusion Criteria include: - Ambulatory men - History of erectile dysfunction of at least 3 months duration - History of incomplete response to any phosphodiesterase type 5 inhibitor (PDE5i) at the maximum tolerated dose within the label - Anticipate having the same female sexual partner throughout the duration of the study - Are willing and able to make at least 4 sexual intercourse attempts with the female sexual partner during each 4-week segment of the study - Agree to use birth control during the study and for 60 days after the study, unless the female partner is postmenopausal - Agree not to use any other erectile dysfunction treatment, including herbal treatment, during the study and for 96 hours after the last dose of study drug - Screening laboratory tests within normal limits except for testosterone - Without a language barrier, are reliable and willing to follow study procedures - Prostate-specific antigen (PSA) less than 10 nanograms per milliliter (ng/ml). Men with PSA greater than 4 and less than 10 ng/ml must have documentation of a negative histological biopsy of carcinoma of prostate within 12 months prior to screening Exclusion Criteria include: - History of penile implant - History of no response to injection therapy for erectile dysfunction - History of radical prostatectomy or other pelvic surgery with subsequent failure to achieve any erection - Exhibit the presence of clinically significant penile deformity in the opinion of the investigator - History of prior sexual legal convictions - Bilateral hip replacements - History of cancer within the previous 5 years, except for excised superficial lesions such as basal cell carcinoma and squamous cell carcinoma of the skin - Chronic stable angina currently treated with long-acting nitrates - Chronic stable angina requiring treatment with short-acting nitrates within 90 days prior to screening - Angina occurring during sexual intercourse in the 6 months prior to screening - Unstable angina within 6 months prior to screening - Myocardial infarction or coronary artery bypass graft surgery within 90 days prior to screening - Angioplasty or stent placement within 90 days prior to screening - Congestive heart failure within 6 months prior to screening - History of sudden cardiac arrest - Supraventricular arrhythmia with an uncontrolled ventricular response at rest, or any history of spontaneous or induced sustained ventricular tachycardia, or use an automatic internal cardioverter-defibrillator - An abnormality in the 12-lead electrocardiogram (ECG) that in the opinion of the investigator places the subject in an unacceptable risk for study participation - Systolic blood pressure greater than 170 or less than 90 millimeters of mercury (mm Hg) or diastolic blood pressure greater than 100 or less than 50 mm Hg at screening - Hepatic, renal, human immunodeficiency virus (HIV), or clinically significant active neuropsychiatric disease - History of central nervous system injuries (including stroke or spinal cord injury) within 6 months prior to screening - Alcohol intake of 5 units or greater per day (1 unit = 12 ounces beer, 5 ounces wine, or 1.5 ounces of 80-proof distilled spirits) - Receiving treatment with antiandrogens or 5-alpha reductase inhibitor - Anabolic steroids, calcitonin, oral bisphosphonates, Vitamin D greater than 50,000 international units per week (IU/week), dehydroepiandrosterone (DHEA), steroidal supplements, nutritional products intended to have weight reduction or performance enhancing effects, herbal supplements within 7 days prior to screening - Currently treated with a potent cytochrome P450 (CYP) 3A4 inhibitor, such as systemic ketoconazole or ritonavir, or a CYP3A4 inducer such as rifampicin ; PRIMARY OUTCOME: Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF) Erectile Function (EF) Domain Score; SECONDARY OUTCOME 1: Change From Baseline to 12 Week Endpoint in the Percentage of Yes Responses on the Sexual Encounter Profile (SEP) Diary[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - CNS-102; BRIEF: This is a randomized, double-blind (Investigator and subject-blinded) placebo-controlled, multiple, ascending-dose study to evaluate the safety, tolerability, and pharmacokinetic profile of BPN14770 in healthy young and elderly male and female subjects and to provide a preliminary assessment of the cognitive effects of BPN14770 in healthy elderly subjects. ; DRUG USED: BPN14770; DRUG CLASS: New Molecular Entity (NME); INDICATION: Alzheimers Disease (AD); TARGET: Phosphodiesterase 4 (PDE4); THERAPY: Monotherapy; LEAD SPONSOR: Tetra Discovery Partners; CRITERIA: Inclusion Criteria: 1. Healthy young males or females between the ages of 21 to 45, inclusive (Cohorts 1, 2, 3 and 7; female subjects must not be pregnant or breastfeeding), and healthy elderly males or females ≥ 65 years of age (Cohorts 4, 5, 6). 2. Body mass index between 18 kg/m2 to 32 kg/m2, inclusive, and body weight of ≥50 kg (110 pounds). 3. Female subjects must be surgically sterile (bilateral tubal ligation, hysterectomy, or bilateral oophorectomy at least 6 months prior to dosing), at least two years post-menopausal, or willing to use two barrier methods of contraception from initial screening until one month after taking the last dose of study drug. Barrier methods of contraception include diaphragm, cervical cap, male condom, female condom, and spermicidal foam and sponges. Menopausal status declared by females in the young cohorts will be verified by a follicle stimulating hormone (FSH) test at Screening. In addition, all females must have a negative pregnancy test within 48 hours before dosing on Day 1 regardless of childbearing potential. 4. Male subjects must be willing to inform female partners of their participation in the study and must agree to use adequate contraceptive methods (vasectomy performed at least 6 months prior to dosing or use at least one barrier method of birth control). 5. Able to understand the study procedures, voluntarily consent to participate in this study, and provide written informed consent prior to start of any study-specific procedures. 6. Willing and able to remain in the study unit for the entire duration of the confinement period, and return for outpatient visits. Exclusion Criteria: 1. Clinically significant abnormality, in the Investigators judgement, indicated by the current hematology, biochemistry, or urinalysis tests, or from medical history, social history, vital signs, or physical examination. 2. Positive serology results for hepatitis B surface antigen (HbsAg), hepatitis C virus (HCV), or human immunodeficiency virus (HIV). 3. Marked hypotension (systolic blood pressure [BP] ˂90 mmHg or diastolic BP ˂50 mmHg) or hypertension (systolic BP ˃150 mmHg or diastolic BP ˃100 mmHg) based on supine and sitting values obtained at Screening, Day-1, or Day 1 predose. Out-of-range vital signs may be repeated once during each eligibility assessment (prior to the start of dosing on Day 1). 4. Marked bradycardia (heart rate ˂45 beats per minute [bpm]) or tachycardia (heart rate ˃110 bpm) based on supine ECG values obtained at Screening, Day -1, or Day 1 predose. Out-of-range vital signs may be repeated once at each eligibility assessment (prior to the start of dosing on Day 1). 5. Current or past history of significant (in the Investigators judgement) cardiovascular, cerebrovascular, pulmonary, renal, or liver disease. Stable, well-controlled hypertension and hyperlipidemias are allowed (see Exclusion #10). 6. History of hematological disorders (e.g., thrombocytopenia) in the immediate family (i.e., parents and siblings). 7. Clinically important or significant conduction abnormalities on single ECG (including QTc interval ˃450 msec) or evidence or history of long QT syndrome. This exclusion applies to the ECGs obtained at Screening, Day -1, and Day 1 predose. 8. Current or past history of gastric or duodenal ulcers or other diseases of the gastrointestinal tract that could interfere with absorption of study drug. Note: Subjects with a history of appendectomy or cholecystectomy may be enrolled. 9. Active acute or chronic infectious diseases. 10. Unable to discontinue medications including psychotropic drugs, sedative antihistamines, or other centrally active medications [e.g., CNS beta blockers], and moderate to strong inhibitors or inducers of CYP3A4, CYP2D6, or other cytochromes). Other prescription or non-prescription drugs such as antihypertensive or cholesterol lowering drugs are allowed if, in the Investigators judgement, they would not interfere with the test medication or the cognitive testing. 11. Any history of alcohol or drug abuse within the previous year prior to the Screening visit (per the current edition of the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition: DSM-5), or regular (daily) consumption of alcohol exceeding two bottles of beer, or the equivalent amount of other forms of alcohol (1 serving = 12 oz beer, 5.0 oz wine, or 1.5 oz distilled spirits). 12. Any use of alcohol within 24 hours of admission into the study on Day -2. 13. Active smokers or tobacco users (e.g., chew and snuff) who are unable to discontinue tobacco use at least 3 months prior to admission to the study on Day -2 and refrain from using tobacco during the study treatment and evaluation period. 14. Inability or unwillingness to comply with the protocol, or likely inability to complete the study. 15. Participation in other clinical studies involving investigational drug within the previous 30 days prior to the Screening visit. 16. Donation of blood or blood products (including plasma) during the 8 weeks before the first administration of study drug on Day 1. 17. Positive screen for drugs of abuse or cotinine (at screen or upon admission), or a positive alcohol result (upon admission). 18. History of allergy to penicillin or sulfonamides, or any other clinically significant drug allergy that includes symptoms such as shortness of breath, rash, or edema. 19. Inability or unwillingness to perform the tasks necessary for the CogState Cognitive Function Assessments (elderly cohorts). 20. A suicidal ideation intensity score of 2 or higher per screening C-SSRS assessment and/or any suicidal behavior within the past 30 days. Cognitive Testing Criteria: Eligibility requirements for subjects in the elderly cohorts include successful completion of a computerized battery of CogState cognitive function assessments, including: - Detection Task (DET) - Identification Task (IDN) - One Card Learning Task (OCL) - One Back Task (ONB) - Continuous Paired Associate Learning (CPAL) - International Shopping List Task (ISLT) - Groton Maze Learning Test (GMLT) ; PRIMARY OUTCOME: Number of Participants with Adverse Events as a Measure of Safety and Tolerability; SECONDARY OUTCOME 1: Area Under the Curve from Time Zero to Twelve Hours [AUC0-12][/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase Ib - V-FAST; BRIEF: JZP025-101 is an open-label, multicenter, multi-arm, nonrandomized phase 1b master trial to determine the recommended phase 2 dose (RP2D) of CPX-351 when administered in combination with various targeted agents in previously untreated subjects with Acute Myeloid Leukemia (AML) who are fit to receive intensive chemotherapy (ICT). Subjects will be assigned to treatment arms based on results of AML mutation testing. ; DRUG USED: Vyxeos; DRUG CLASS: Non-NME; INDICATION: Acute Myelogenous Leukemia (AML); TARGET: DNA polymerase, DNA synthesis, Topoisomerase II (DNA gyrase); THERAPY: Combination; LEAD SPONSOR: Jazz Pharmaceuticals; CRITERIA: Inclusion Criteria: - Age ≥ 18 to ≤ 75 years at the time of informed consent. - Newly diagnosed AML according to World Health Organization (WHO) pathological criteria (with at least 20% blasts in the peripheral blood or bone marrow). - ECOG performance status of 0 to 2. - Laboratory values fulfilling the following: - Serum creatinine < 2.0 mg/dL. - Serum total bilirubin < 2.0 mg/dL. (For subjects with Gilberts Syndrome and serum total bilirubin ≥ 2.0 mg/dL, the medical monitor should be contacted.) - Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) < 3 times the upper limit of normal (ULN). (Note: If elevated liver enzymes > ULN are related to disease, contact medical monitor to discuss.) - Cardiac ejection fraction ≥ 50% by echocardiography or multiple gated acquisition scan (MUGA). - Subjects with second malignancies in remission may be eligible if there is clinical evidence of disease stability for a period > 6 months off cytotoxic chemotherapy, documented by imaging, tumor marker studies, etc., at screening. Subjects maintained on long-term nonchemotherapy treatment (eg, hormonal therapy) are eligible. Exclusion Criteria: - Acute promyelocytic leukemia [t(15;17)]. - Subject has favorable risk cytogenetics ((t8;21), inv(16), t(16;16), or t15;17) karyotype abnormalities) as categorized by the National Comprehensive Cancer Network (NCCN) Guidelines Version 2.2014 for AML (NCCN 2014). - Clinical evidence of active central nervous system (CNS) leukemia. - Subjects with active (uncontrolled, metastatic) second malignancies. - Subjects who have received prior treatment intended for induction therapy of AML; only hydroxyurea is permitted for control of blood cell counts. (For example, a subject with myelodysplastic syndrome [MDS] who changes hypomethylating agent [HMA] dose and schedule after the diagnosis of AML is excluded. AML-type therapy, such as cytarabine alone [> 1g/m2/day] or cytarabine plus an anthracycline as well as prior HSCT are also excluded.) All-trans-retinoic acid (ATRA) used empirically is permitted. - Subjects receiving administration of any therapy for MDS (conventional or investigational) must be completed by 2 weeks prior to the first dose of study drug. In the event of rapidly proliferative disease, use of hydroxyurea is permitted until 24 hours before the start of study treatment. Toxicities associated with prior MDS therapy must have recovered to Grade 1 or less prior to start of treatment. - Subjects with myocardial impairment of any cause (eg, cardiomyopathy, ischemic heart disease, significant valvular dysfunction, hypertensive heart disease, and congestive heart failure) resulting in heart failure by New York Heart Association Criteria (Class III or IV staging). - Subjects with active or uncontrolled infection. Subjects with an infection receiving treatment (antibiotic, antifungal or antiviral treatment) may be entered into the study but must be afebrile and hemodynamically stable for ≥ 72 hours. - Current evidence of invasive fungal infection (blood or tissue culture). Subjects with recent fungal infection must have a subsequent negative culture to be eligible. - Subjects with known human immunodeficiency virus (new testing not required) or evidence of active hepatitis B or C infection. - Subjects with known history of Wilsons disease or other known copper-metabolism disorder. - Subjects with other comorbidity that the investigator judges to be incompatible with conventional ICT, and / or the targeted agent. ; PRIMARY OUTCOME: Determine the Recommended Phase 2 Dose (RP2D); SECONDARY OUTCOME 1: Proportion of subjects who have achieved CR, CRi, CRh, CR + CRi, CR + CRh, and morphologic leukemia-free state (MLFS)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - EFFECT I (vs. Fenofibrate); BRIEF: This study is a double-blind randomized, placebo-controlled, parallel-group, 12 week study performed in 2 centres in Sweden to assess the effect of Omega-3 carboxylic acids and fenofibrate on liver fat measured with magnetic resonance imaging (MRI) in patients with over-weight and hypertriglyceridemia. ; DRUG USED: Epanova; DRUG CLASS: Non-NME; INDICATION: Dyslipidemia / Hypercholesterolemia; TARGET: Diglycerol Acyltransferase (DGAT), Lipoprotein lipase, PPAR gamma; THERAPY: Monotherapy; LEAD SPONSOR: AstraZeneca; CRITERIA: Inclusion Criteria: - Provision of informed consent - Men or women ≥40 years and ≤75 years with suitable veins for cannulation or repeated venepuncture - Have serum triglycerides ≥1.7 mM - Have liver fat content as assessed by MRI >5.5% - Have a body mass index (BMI) >25 and ≤40 kg/m2 , Exclusion Criteria: - History of or presence of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results or the subjects ability to participate in the study. - Creatinine clearance <60 mL/min at screening (Cockcroft-Gault formula). - Severe hepatic insufficiency and/or significant abnormal liver function defined as aspartate aminotransferase (AST) >3x upper limit of normal (ULN) and/or alanine aminotransferase (ALT) >3x ULN - Total bilirubin >2.0 mg/dL (34.2 µmol/L) - Type 2 diabetes, as defined by WHO criteria e.g. fasting plasma Glucose >7.0 mM or use of antidiabetic therapy - Any clinically significant abnormalities in clinical chemistry, haematology or urinalysis results as judged by the investigator. This includes signs of liver disease other than NAFLD that motivates further investigations of treatment based on clinical judgement - Recent history (past 12 months) of drug abuse or alcohol abuse. Alcohol abuse was to be defined as >14 drinks per week (1 drink = 35 cl beer, 14 cl wine, or 4 cl hard liquor) or as judged by the investigator ; PRIMARY OUTCOME: Geometric Mean Ratio (Week 12/Baseline) of % Liver Fat as Assessed by MRI (Epanova Versus Placebo); SECONDARY OUTCOME 1: Geometric Mean Ratio (Week 12/Baseline) of % Liver Fat as Assessed by MRI (Epanova Versus Fenofibrate)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - DIPG; BRIEF: Pediatric high-grade gliomas are highly aggressive and treatment options are limited. The purpose of this first-in-pediatrics study is to examine the safety, tolerability, and pharmacokinetics of GDC-0084 and to estimate its maximum tolerated dose (MTD) when administered to pediatric patients with diffuse intrinsic pontine glioma (DIPG) or other diffuse midline H3 K27M-mutant gliomas after they have received radiation therapy (RT). GDC-0084 is a brain-penetrant inhibitor of a growth-promoting cell signaling pathway that is dysregulated in the majority of diffuse midline glioma tumor cells. This study is also designed to enable a preliminary assessment of the antitumor activity of single-agent GDC-0084, in the hope of enabling rational combination therapy with systemic therapy and/or radiation therapy (RT) in this patient population, which is in desperate need of therapeutic advances. Primary Objectives 1. To estimate the maximum tolerated dose (MTD) and/or the recommended phase 2 dosage (RP2D) of GDC-0084 in pediatric patients with newly diagnosed diffuse midline glioma, including diffuse intrinsic pontine glioma (DIPG) 2. To define and describe the toxicities associated with administering GDC-0084 after radiation therapy (RT) in a pediatric population 3. To characterize the pharmacokinetics of GDC-0084 in a pediatric population Secondary Objectives 1. To estimate the rate and duration of radiographic response in patients with newly diagnosed DIPG or other diffuse midline glioma treated with RT followed by GDC-0084 2. To estimate the progression-free survival (PFS) and overall survival (OS) distributions for patients with newly diagnosed DIPG or other diffuse midline glioma treated with RT followed by GDC-0084 ; DRUG USED: Paxalisib; DRUG CLASS: New Molecular Entity (NME); INDICATION: Brain Cancer (Malignant Glioma; AA and glioblastoma (GBM)); TARGET: Mammalian Target of Rapamycin (mTOR)/mTORC, PI3K/AKT pathway; THERAPY: Combination; LEAD SPONSOR: St. Jude Childrens Research Hospital; CRITERIA: Inclusion Criteria: - Age greater than or equal to 2 years and less than 22 years at the time of enrollment - Subjects must have one of the following newly diagnosed tumors: - Non-biopsied typical DIPG, defined as a tumor with a pontine epicenter and diffuse intrinsic involvement of the pons. These subjects are eligible without histologic confirmation. - Biopsied typical DIPG: WHO grade II diffuse astrocytoma (IDH WT or IDH NOS), WHO grade III anaplastic astrocytoma (IDH WT or IDH NOS), WHO grade IV glioblastoma (IDH WT or IDH NOS), or diffuse midline glioma, H3 K27M mutant. Subjects with a typical DIPG who undergo a biopsy may be eligible for the study if the tumor does not harbor the H3 K27M mutation, yet eligibility is restricted to diffuse astrocytoma, anaplastic astrocytoma or glioblastoma, IDH WT or IDH NOS, tumors. - Atypical brainstem glioma: diffuse midline glioma, H3 K27M mutant. - Non-brainstem midline glioma, defined as tumors with an epicenter within midline structures, including the thalamus, spinal cord, and cerebellum: diffuse midline glioma, H3 K27M mutant. - Subjects must have localized, non-metastatic disease; MRI of spine must be performed if disseminated disease is suspected by the treating physician. - Subjects must be able to start radiation therapy no later than 42 days after radiographic diagnosis or surgery, whichever date is later. - Performance score ≥ 50 (Lansky for research subjects aged 16 years or younger and Karnofsky for subjects older than 16 years). Subjects who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score. - Subjects must not have received any prior therapy, including prior treatment with a PI3 kinase, mTOR, or PI3K/mTOR inhibitor, other than surgery and/or steroids. - Subjects must have adequate organ function documented at the time of study enrollment as follows: - Bone marrow: Hemoglobin ≥ 8g/dL [may have received packed red blood cell transfusion], absolute neutrophil count (ANC) ≥ 1000/mm^3, platelets ≥ 50,000/mm^3 [transfusion independent]. - Renal: Normal serum creatinine based on age (Age 2 to ≤5: 0.8; Age >5 to <10: 1.0; Age >10 to <15: 1.2; Age ≥15: 1.5) or GFR ≥ 70 mL/min/1.73m^2 - Hepatic: ALT and AST < 3 × the institutional upper limit of normal (ULN), total bilirubin concentration < 1.5 x the institutional ULN, albumin ≥ 2g/dL. - Shortening fraction of ≥ 27% by ECHO or ejection fraction of ≥ 50% by gated radionuclide study. - Subjects must not have congenital long QT syndrome and QTc < 500 ms. - Subjects must not require the use of any CYP34A-inducing or -inhibiting agents, with the exception of corticosteroids. - Female subjects of childbearing potential must not be pregnant or breastfeeding a child. Female subjects of childbearing potential aged 10 years or older must have a negative serum or urine pregnancy test. - Subjects of childbearing or child-fathering potential must be willing to use a medically acceptable form of birth control, which can be abstinence, while being treated on this study and for 3 additional months after completion of therapy. - Informed consent: All subjects and/or their parents or legally authorized representatives must sign a written consent. Assent, when appropriate, will be obtained according to institutional guidelines. Exclusion Criteria: - Subjects with evidence of tumor infiltration of three or more cerebral lobes on diagnostic MRI. - Subjects with any clinically significant, unrelated systemic illness (serious infections or significant cardiac, pulmonary, hepatic, or other organ dysfunction) that would compromise the subjects ability to tolerate protocol therapy or would probably interfere with the study procedures or results. - Diabetic subjects who require insulin therapy. - Subject with a history of clinically significant, uncontrolled heart disease and/or repolarization abnormalities as documented by a standard 12-lead ECG. - Subjects receiving any other anticancer (glucocorticoids are acceptable) or investigational drug therapy. - Subjects unable to return for follow-up visits or obtain follow-up studies required to assess toxicity of therapy. - Subjects with disseminated disease. - Pregnant subjects or subjects breast-feeding a child. ; PRIMARY OUTCOME: Estimate the maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D) of GDC-0084 after standard-of-care radiation therapy (RT); SECONDARY OUTCOME 1: Rate of best overall response by stratum[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIa - PoCP; BRIEF: This is a randomised, double-blind, placebo-controlled, proof of clinical principle study to explore the efficacy and safety of orally administered BBT-401-1S in subjects with ulcerative colitis. ; DRUG USED: BBT-401; DRUG CLASS: New Molecular Entity (NME); INDICATION: Ulcerative Colitis (UC); TARGET: Pellino E3 Ubiquitin Protein Ligase 1; THERAPY: Monotherapy; LEAD SPONSOR: Bridge Biotherapeutics, Inc.; CRITERIA: Inclusion Criteria: - Male or female, of any race, ≥18 and ≤60 years of age. - Have been diagnosed with active UC for ≥3 months prior to Day 1, as determined by clinical and endoscopic evidence and documented in a histopathology evaluation. - Have a total Mayo score ≥6, an endoscopic subscore ≥2, rectal bleeding subscore ≥1, and a stool frequency subscore ≥1, regardless of standard of care history. - Able to comprehend and willing to voluntarily sign an ICF and to abide by the study restrictions. Exclusion Criteria: - Have received: 1. intravenous corticosteroids, rectally administered corticosteroids, or rectally administered 5-aminosalicylic acid within 3 weeks, or 2. Janus kinase (JAK) inhibitors within 2 weeks, or 3. cyclosporine, mycophenolate, tacrolimus, or methotrexate within 5 weeks, or 4. anti-TNF-α biologics within 9 weeks, or 5. any other biologics (including ustekinumab and vedolizumab) for the treatment of UC within 12 weeks. - Have received orally administered azathioprine or 6-mercaptopurine that has been stable for <8 weeks. - Have received orally administered 5-aminosalicylic acid, sulphasalazine, or low-dose corticosteroids (prednisolone ≤20 mg/day or equivalent) that have been stable for <5 weeks. - Have received any other concomitant medications for UC that have been stable (ie, have not started dosing with a new drug or had a change to their dosing regimen) for <7 days or 5 half-lives, whichever is longer. - Have Crohns disease, indeterminate colitis, ischaemic colitis, fulminant colitis, toxic megacolon, chronic (as determined by the investigator) pancolitis, confined proctitis (distal, ≤15 cm), or symptomatic intestinal stenosis. - Have a history of extensive colonic resection (subtotal or total colectomy) or are anticipated to require surgical intervention for UC. - Have an ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine. - Have a positive test for Clostridium difficile, or have evidence of treatment for Clostridium difficile infection or other pathogenic bowel infection within 60 days or for another intestinal pathogen within 30 days prior to Day 1. ; PRIMARY OUTCOME: Percentage of Participants Who Achieved a Clinical Response by Total Mayo Score at Day 57; SECONDARY OUTCOME 1: Percentage of Participants Who Achieved a Clinical Remission by Total Mayo Score at Day 57[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIIb - SOLANA (Eosinophilic Inflammation); BRIEF: The purpose of this study is to investigate the onset and maintenance of effect of benralizumab on lung function, blood eosinophils, asthma control metrics and quality of life during 12-week treatment in patients with uncontrolled, severe asthma with eosinophilic inflammation. A subset of patients will take part in body plethysmography substudy to further investigate the effect on lung function. ; DRUG USED: Fasenra; DRUG CLASS: Biologic; INDICATION: Asthma; TARGET: IL-5 (Interleukin-5) and IL-5 Receptor (IL-5R); THERAPY: Monotherapy; LEAD SPONSOR: AstraZeneca; CRITERIA: Inclusion criteria 1. Written informed consent for study participation must be obtained prior to any study related procedures being performed and according to international guidelines and/or applicable European Union (EU) guidelines. 2. Female and male aged 18 to 75 years inclusively at the time of Visit 1 3. Documented current treatment with ICS and LABA for at least 30 days prior to Visit 1. The ICS and LABA can be parts of a combination product or given by separate inhalers. The ICS dose must be greater than or equal to 500 μg/day fluticasone propionate dry powder formulation or equivalent daily. Additional asthma controller medications, eg, oral corticosteroids, long-acting antimuscarinics (LAMAs), LTRAs, theophylline etc. are allowed if they have been used for at least 30 days prior to Visit 1 4. History of at least 2 asthma exacerbations that required treatment with systemic corticosteroids (intramuscular (IM), intravenous (IV), or oral) in the 12 months prior to Visit 1. For patients receiving corticosteroids as a maintenance therapy, the corticosteroid treatment for the exacerbation is defined as a temporary increase of their maintenance dose. 5. Pre-bronchodilator (pre-BD) FEV1 of < 80% predicted at Visit 2 or Visit 3 6. ACQ-6 score ≥1.5 at Visit 1 7. Evidence of asthma as documented by airway reversibility (FEV1 ≥12% and 200 ml) demonstrated at Visit 1, Visit 2 or Visit 3. For patients entering the body plethysmography sub-study, reversibility must be demonstrated at Visit 1 or at Visit 2 only 8. Peripheral blood eosinophil count of ≥300 cells/μL assessed by central lab at Visit 1 9. Women of childbearing potential (WOCBP) must use an effective form of birth control confirmed by the Investigator. WOCBP must also have negative serum pregnancy test result on Visit 1. Women not of childbearing potential are defined as women who are either permanently sterilized (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy), or who are postmenopausal. Women will be considered postmenopausal if they have been amenorrheic for 12 months prior to the planned date of randomization without an alternative medical cause. The following agespecific requirements apply: - Women <50 years old are considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatment and follicle stimulating hormone (FSH) levels in the postmenopausal range. - Women ≥50 years old are considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatment. 10. All male patients who are sexually active must agree to use a double barrier method of contraception (condom with spermicide) from the first dose of IP until 16 weeks after their last dose 11. Weight of ≥40 kg Additional inclusion criteria applicable for the Body Plethysmography substudy 1.Residual volume ≥125% of predicted at Visit 3. Inclusion criteria at randomization visit 1. At least 1 of the following within 7 days prior to randomization: - Daytime or nighttime asthma symptoms for 2 or more days; - Rescue SABA use for 2 or more days; - Nighttime awakenings due to asthma at least 1 night during the 7-day period 2. ACQ >0.75 at Visit 4 prior to randomization. 3. A negative urine pregnancy test in WOCBP prior to administration of IP Exclusion criteria 1. Clinically important pulmonary disease other than asthma (eg, active lung infection, COPD, bronchiectasis, pulmonary fibrosis, cystic fibrosis, hypoventilation syndrome associated with obesity, lung cancer, alpha 1 anti-trypsin deficiency, and primary ciliary dyskinesia) or ever been diagnosed with pulmonary or systemic disease, other than asthma, that are associated with elevated peripheral eosinophil counts (eg, allergic bronchopulmonary aspergillosis/mycosis, Churg-Strauss syndrome, hypereosinophilic syndrome) 2. Life-threatening asthma defined as episodes requiring intubation associated with hypercapnia, respiratory arrest, hypoxic seizures, or asthma related syncopal episodes within the 12 months prior to Visit 1. 3. Acute upper or lower respiratory infections requiring antibiotics or antiviral medication within 30 days prior to the date informed consent is obtained or during the screening/run-in period 4. An upper respiratory tract infection or an asthma exacerbation that required treatment with systemic corticosteroids or an increase in regular maintenance dose of OCS during the screening/run-in period prior to randomization Visit 4 5. Any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, psychiatric, or major physical impairment that is not stable in the opinion of the Investigator and could: - Affect the safety of the patient throughout the study - Influence the findings of the studies or their interpretations - Impede the patients ability to complete the entire duration of study 6. Known history of allergy or reaction to any component of the investigational product formulation 7. History of anaphylaxis to any biologic therapy 8. History of Guillain-Barré syndrome 9. A helminth parasitic infection diagnosed within 24 weeks prior to the date informed consent is obtained that has not been treated with, or has failed to respond to standard of care therapy 10. Any clinically significant abnormal findings in physical examination, vital signs, hematology, clinical chemistry, or urinalysis during screening period, which in the opinion of the Investigator, may put the patient at risk because of his/her participation in the study, or may influence the results of the study, or the patients ability to complete entire duration of the study 11. Any clinically significant cardiac disease or any electrocardiogram (ECG) abnormality obtained during the screening/run-in period, which in the opinion of the Investigator may put the patient at risk or interfere with study assessments 12. History of alcohol or drug abuse within 12 months prior to the date informed consent is obtained 13. Positive hepatitis B surface antigen, or hepatitis C virus antibody serology, or a positive medical history for hepatitis B or C. Patients with a history of hepatitis B vaccination without history of hepatitis B are allowed to enroll 14. A history of known immunodeficiency disorder including a positive human immunodeficiency virus (HIV) test 15. Current smokers or former smokers with a smoking history of ≥10 pack years. A former smoker is defined as a patient who quit smoking at least 6 months prior to Visit 1 16. Current malignancy, or history of malignancy, except for: - Patients who have had basal cell carcinoma, localized squamous cell carcinoma of the skin or in situ carcinoma of the cervix are eligible provided that the patient is in remission and curative therapy was completed at least 12 months prior to the date informed consent was obtained. - Patients who have had other malignancies are eligible provided that the patient is in remission and curative therapy was completed at least 5 years prior to the date informed consent was obtained. 17. Use of immunosuppressive medication (including but not limited to: oral corticosteroids [for reasons other than asthma], methotrexate, troleandomycin, cyclosporine, azathioprine, intramuscular long-acting depot corticosteroids or any experimental anti-inflammatory therapy) within 3 months prior to the date informed consent 18. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level ≥1.5 times the upper limit of normal (ULN) confirmed during screening period 19. Receipt of immunoglobulin or blood products within 30 days prior to the date informed consent is obtained 20. Receipt of any marketed (eg, omalizumab, mepolizumab etc.) or investigational biologic within 4 months or 5 half-lives prior to the date informed consent is obtained, whichever is longer 21. Receipt of live attenuated vaccines 30 days prior to the date of randomization 22. Receipt of any investigational medication within 30 days or 5 half-lives prior to randomization, whichever is longer 23. Previously received benralizumab (MEDI-563) 24. Planned surgical procedures during the conduct of the study 25. Currently breastfeeding or lactating women 26. Previous randomization in the present study 27. Concurrent enrolment in another interventional or post-authorization safety study (PASS). 28. AstraZeneca staff involved in the planning and/or conduct of the study 29. Employees of the study center or any other individuals involved with the conduct of the study or immediate family members of such individuals Exclusion criteria at randomization Visit 4 1. Greater than/equal to 20% change in mean Pre BD FEV1 value at randomization Visit 4 from the mean pre BD FEV1 calculated from the pre BD FEV1 recorded at Visit 2 and Visit 3 ; PRIMARY OUTCOME: Change From Baseline (Visit 4) to Day 28 (Visit 8), Day 56 (Visit 9), and Day 84 (Visit 10) in Pre-BD FEV1; SECONDARY OUTCOME 1: Percent Change From Baseline to End of Treatment in Eosinophils Counts[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase Ib - JAVELIN Renal 100; BRIEF: This is a Phase 1b, open-label, multi-center, multiple-dose trial designed to estimate the maximum tolerated dose (MTD) and select the recommended phase 2 dose (RP2D) of avelumab (MSB0010718C) in combination with axitinib (AG-013736). Once the MTD of avelumab administered in combination with axitinib is estimated (dose finding portion), the dose expansion phase will be opened to further characterize the combination in term of safety profile, anti tumor activity, pharmacokinetics, pharmacodynamics and biomarker modulation. ; DRUG USED: Bavencio; DRUG CLASS: Biologic; INDICATION: Renal Cell Cancer (RCC); TARGET: Immune System, Programmed death-1 receptor (PD-1) / Programmed death ligands (PD-L1 and PD-L2); THERAPY: Combination; LEAD SPONSOR: Pfizer; CRITERIA: Inclusion Criteria: - Histologically or cytologically confirmed advanced RCC with clear cell component - Primary tumor resected - Availability of a recent formalin-fixed, paraffin-embedded (FFPE) tumor tissue block from a de novo tumor biopsy during screening (biopsied tumor lesion should not be a RECIST target lesion). Alternatively, a recently obtained archival FFPE tumor tissue block (not cut slides) from a primary or metastatic tumor resection or biopsy can be provided if the following criteria are met: 1) the biopsy or resection was performed within 1 year of enrollment AND 2) the patient has not received any intervening systemic anti-cancer treatment from the time the tissue was obtained and enrollment onto the current study. If an FFPE tissue block cannot be provided as per documented regulations,, 15 unstained slides (10 minimum) will be acceptable. - Availability of an archival FFPE tumor tissue block from primary diagnosis specimen (if available and not provided per above). If an FFPE tissue block cannot be provided, 15 unstained slides (10 minimum) will be acceptable - At least one measureable lesion as defined by RECIST version 1.1 that has not been previously irradiated. - Age ≥18 years (≥ 20 years in Japan). - Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 - Adequate bone marrow function, renal and liver functions Exclusion Criteria: - Prior systemic therapy directed at advanced RCC. - Prior adjuvant or neoadjuvant therapy for RCC if disease progression or relapse has occurred during or within 12 months after the last dose of treatment - Prior immunotherapy with IL-2, IFN-α, or anti PD 1, anti PD L1, anti PD L2, anti CD137, or anti cytotoxic T lymphocyte associated antigen 4 (CTLA 4) antibody (including ipilimumab), or any other antibody or drug specifically targeting T cell co stimulation or immune checkpoint pathways - Prior therapy with axitinib as well as any prior therapies with other VEGF pathway inhibitors. - Known severe hypersensitivity reactions to monoclonal antibodies (Grade ≥3), any history of anaphylaxis. - Any of the following in the previous 6 months: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack, deep vein thrombosis or symptomatic pulmonary embolism. - Vaccination within 4 weeks of the first dose of avelumab and while on trial is prohibited except for administration of inactivated vaccines (for example, inactivated influenza vaccines). ; PRIMARY OUTCOME: Number of Participants With Dose Limiting Toxicities (DLTs); SECONDARY OUTCOME 1: Number of Participants With All-causality Treatment Emergent Adverse Events (TEAEs)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I/II - PK Study; BRIEF: This is a First-in-Human (FIH), 2-part, Phase 1/2, open-label, multicenter study design to evaluate the safety, tolerability, PK, pharmacodynamics, PGx, and efficacy of TAS0728. This study consists of Phase 1 and Phase 2 components in subjects with advanced solid tumors with HER2 or HER3 overexpression, amplification, or mutation who have progressed despite standard therapy or for which no standard therapy exists, particularly urothelial cancer, biliary tract cancer, metastatic breast cancer, non-small cell lung cancer and colorectal cancer. ; DRUG USED: TAS0728; DRUG CLASS: New Molecular Entity (NME); INDICATION: Solid Tumors; TARGET: HER2/neu or ErbB-2; THERAPY: Monotherapy; LEAD SPONSOR: Taiho Oncology, Inc.; CRITERIA: Inclusion Criteria: 1. Male or females with an age ≥ 18 years. 2. Subjects with histological- or cytological-confirmed, advanced cancer, who have progressed on (or not been able to tolerate) standard therapy or for whom no standard anticancer therapy exists 1. For Phase 1, only subjects HER2 or HER3 molecular/genetic alterations will be enrolled. 2. For Phase 2a, subjects with one of the following tumor types will be enrolled: i. Urothelial cancer with HER2 or HER3 mutation ii. Biliary tract cancer with HER2 or HER3 mutation iii. Breast cancer with HER2 or HER3 mutation iv. Breast cancer with HER2 amplification or overexpression v. NSCLC with HER2 or HER3 mutation vi. CRC with HER2 mutation or amplification vii. Other tumors with HER2 mutation/amplification/overexpression or HER3 mutation (gastric/GEJ, endometrial). 3. At least 1 measurable lesion for solid tumor 4. Is able to take medications orally (e.g., no feeding tube). 5. Able to agree to and sign informed consent and to comply with the protocol 6. Has adequate organ function Exclusion Criteria: 1. Has a serious illness or medical condition(s) 2. Has received treatment with any proscribed treatments within specified time frames prior to study drug administration 3. Impaired cardiac function or clinically significant cardiac disease ; PRIMARY OUTCOME: Number of patients experiencing Dose Limiting Toxicity graded according to CTCAE Version 4.03, observed in the Cycle 1 in order to meet the objective of assessment of the MTD of TAS0728.; SECONDARY OUTCOME 1: Maximum Plasma Concentration (Cmax) after administration of TAS0728 (Phase 1)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - B0541013; BRIEF: The purpose of the study is to evaluate proof of mechanism of PF-04457845, using a well-established neuroimaging paradigm including behavioral tasks selected to activate neuro-circuitry relevant to Post Traumatic Stress Disorder. It is hypothesized that PF-04457845 will modulate the Blood-oxygen-level dependent Functional Magnetic Resonance Imaging signal from the relevant neuro-circuits in patients with Post Traumatic Stress Disorder. ; DRUG USED: JZP-150; DRUG CLASS: New Molecular Entity (NME); INDICATION: Post-Traumatic Stress Disorder (PTSD); TARGET: Fatty Acid Amide Hydrolase (FAAH); THERAPY: Monotherapy; LEAD SPONSOR: Pfizer; CRITERIA: Inclusion Criteria: - Men and women 18-60 years of age with a primary psychiatric diagnosis of Post Traumatic Stress Disorder Exclusion Criteria: - Other psychiatric illness requiring current treatment with medication. ; PRIMARY OUTCOME: Change From Baseline Blood-Oxygen-Level Dependent (BOLD) Functional Magnetic Resonance Imaging fMRI) Percent Signal Change in Fearful Versus Neutral Face Contrast in Bilateral Amygdala; SECONDARY OUTCOME 1: Change From Baseline in BOLD fMRI Percent Activation in Bilateral Ventromedial Pre-Frontal Cortex (vmPFC)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase Ib/IIa - PREVAIL; BRIEF: This Phase 1b study will evaluate the safety of PRV-3279 in healthy adult subjects ; DRUG USED: PRV-3279; DRUG CLASS: Biologic; INDICATION: Systemic Lupus Erythematosus (SLE); TARGET: CD79b, Fc receptors; THERAPY: Monotherapy; LEAD SPONSOR: Provention Bio, Inc.; CRITERIA: Inclusion Criteria: 1. Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations. 2. Body mass index (BMI) 18 to 32 kg/m2, inclusive. 3. Male or female 18 to 50 years of age, inclusive. 4. Nonpregnant women of childbearing potential (WOCBP) and sexually active men must agree to use effective birth control with male contraception during study participation through at least 3 months after the final dose. Women of non-childbearing potential may participate. Exclusion Criteria: 1. Women who are pregnant or breastfeeding. 2. Evidence of active or chronic infections. 3. Previous exposure to PRV-3279. 4. Any reason that, in the opinion of the Investigator, would contraindicate the subjects participation in the study or confound the results of the study. ; PRIMARY OUTCOME: Incidence and severity of treatment-emergent adverse events (TEAEs); SECONDARY OUTCOME 1: [/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - JAVELIN Gastric 100; BRIEF: The purpose of this study was to demonstrate superiority of treatment with avelumab versus continuation of first-line chemotherapy. ; DRUG USED: Bavencio; DRUG CLASS: Biologic; INDICATION: Gastric Cancer; TARGET: Immune System, Programmed death-1 receptor (PD-1) / Programmed death ligands (PD-L1 and PD-L2); THERAPY: Monotherapy; LEAD SPONSOR: EMD Serono Research & Development Institute, Inc.; CRITERIA: Inclusion Criteria: - Male or female participants greater than or equal to (>=) 18 years - Disease must be measurable by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) - Participants with histologically confirmed unresectable locally advanced or metastatic adenocarcinoma of the stomach or gastro-esophageal junction (GEJ) - Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1 at trial entry - Estimated life expectancy of more than 12 weeks - Adequate haematological, hepatic and renal functions defined by the protocol - Negative blood pregnancy test at Screening for women of childbearing potential - Highly effective contraception for both male and female participants if the risk of conception exists - Other protocol defined inclusion criteria could apply Exclusion Criteria: - Prior therapy with any antibody or drug targeting T-cell coregulatory proteins - Concurrent anticancer treatment or immunosuppressive agents - Prior chemotherapy for unresectable locally advanced or metastatic adenocarcinoma of the stomach or gastro-esophageal junction (GEJ) - Tumor shown to be human epidermal growth factor 2 plus (HER2+) - Major surgery for any reason, except diagnostic biopsy, within 4 weeks of enrolment and/or if the participant has not fully recovered from the surgery within 4 weeks of enrolment - Participants receiving immunosuppressive agents (such as steroids) for any reason should be tapered off these drugs before initiation of the study treatment (with the exception of participants with adrenal insufficiency, who may continue corticosteroids at physiologic replacement dose, equivalent to <= 10 mg prednisone daily) - All participants with brain metastases, except those meeting the following criteria: a. Brain metastases have been treated locally, have not been progressing at least 2 months after completion of therapy, and no steroid maintenance therapy is required, and b. No ongoing neurological symptoms that are related to the brain localization of the disease (sequelae that are a consequence of the treatment of the brain metastases are acceptable) - Previous malignant disease (other than gastric cancer) within the last 5 years with the exception of basal or squamous cell carcinoma of the skin or carcinoma in situ (bladder, cervical, colorectal, breast) - Prior organ transplantation, including allogeneic stem-cell transplantation - Significant acute or chronic infections - Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent - Known severe hypersensitivity reactions to monoclonal antibodies, any history of anaphylaxis, or uncontrolled asthma (that is, 3 or more features of partially controlled asthma) - Persisting toxicity related to prior therapy except alopecia - Neuropathy Grade > 3 - Pregnancy or lactation - Known alcohol or drug abuse - History of uncontrolled intercurrent illness including hypertension, active infection, diabetes - Clinically significant (i.e., active) cardiovascular disease - All other significant diseases might impair the participants tolerance of study treatment - Any psychiatric condition that would prohibit the understanding or rendering of informed consent and that would limit compliance with study requirements - Vaccination with live or live/attenuated viruses within 55 days of the first dose of avelumab and while on trial is prohibited except for administration of inactivated vaccines - Legal incapacity or limited legal capacity - Participants will be excluded from the Induction Phase and the Maintenance Phase if administration of their chemotherapy would be inconsistent with the current local labelling (SmPC) (e.g., in regard to contraindications, warnings/precautions or special provisions) for that chemotherapy. Investigators should check updated labelling via relevant websites at the time of entry into the Induction Phase and the Maintenance Phase - Other protocol defined exclusion criteria could apply ; PRIMARY OUTCOME: Overall Survival (OS); SECONDARY OUTCOME 1: Progression Free Survival (PFS) by Independent Review Committee (IRC)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - w/Tremelimumab (JP); BRIEF: A Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, PK and Preliminary Anti-tumor Activity when given as a monotherapy of Tremelimumab or Tremelimumab in combination with MEDI4736 in Japanese Patients with Advanced Solid Malignancies, and when given as a monotherapy of tremelimumab in Second- or Third-line Treatment of Japanese Subjects with Unresectable Pleural or Peritoneal Malignant Mesothelioma ; DRUG USED: Imfinzi; DRUG CLASS: Biologic; INDICATION: Solid Tumors; TARGET: Immune System, Programmed death-1 receptor (PD-1) / Programmed death ligands (PD-L1 and PD-L2); THERAPY: Combination; LEAD SPONSOR: AstraZeneca; CRITERIA: Part A and B: Inclusion Criteria: 1. Japanese aged at least 20 years old at a time of enrollment. 2. Histological or cytological confirmation of a solid malignant tumor excluding lymphoma that is refractory to standard therapies or for which no standard therapies exist. 3. ECOG Performance Status 0-1 with no deterioration over the previous 2 weeks and minimum life expectancy of 12 weeks at a time of randomization. 4. At least one lesion (measurable and/or non-measurable) that can be accurately assessed at baseline by CT, MRI or plain X-ray and is suitable for repeated assessment. 5. Adequate bone marrow, hepatic, and renal function 6. Willingness to provide consent for archival biopsy samples if available. Exclusion Criteria: 1. Received any prior treatment with monoclonal antibody against Programmed death 1 (PD1), Programmed death ligand 1 (PD-L1) and CTLA-4 (eg, ipilimumab) 2. The last dose of prior chemotherapy or radiation therapy was received less than 2 weeks prior to randomization 3 Currently receiving systemic corticosteroids or other immunosuppressive medications or has a medical condition that requires the chronic use of corticosteroids. 4. Receipt of live attenuated vaccination within 30 days of starting tremelimumab treatment 5. Active, untreated central nervous system (CNS) metastasis (subjects with brain metastases who are identified at screening 6. History of other malignancy unless the subject has been disease-free for at least 3 years. 7. Any unresolved chronic toxicity CTCAE grade ≥2 from previous anticancer therapy at the time of randomization, 8. Major surgical procedure within 30 days of starting Part C: Inclusion Criteria: 1. Japanese aged 20 and over at the time of consent 2. Histologically and/or cytologically confirmed pleural or peritoneal malignant mesothelioma 3. Disease not amenable to curative surgery 4. ECOG Performance status 0-1 5. Progressed after previous receipt of 1-2 prior systemic treatments for advanced disease that included a first-line pemetrexed (or anti-folate)-based regimen in combination with platinum agent. 6. Measurable disease, defined as at least 1 lesion (measurable) that can be accurately assessed at baseline by computed tomography CT or MRI and is suitable for repeated assessment. 7. Adequate bone marrow, hepatic, and renal function Exclusion Criteria: 1. Subjects who failed more than 2 prior systemic treatment regimens for advanced malignant mesothelioma 2. Received any prior mAb against CTLA-4, PD1 or PD-L1 3. History of chronic inflammatory or autoimmune disease. 4. Symptomatic, untreated CNS metastasis. 5. Any serious uncontrolled medical disorder or active infection that would impair the subjects ability to receive investigational product. 6. History of other malignancy. 7. History of diverticulitis, inflammatory bowel disease, sarcoidosis syndrome 8. Currently receiving systemic corticosteroids or other immunosuppressive medications. 9. Vaccinated with live attenuated vaccines within 30 days prior to starting tremelimumab treatment 10. Not recovered from all toxicities associated with prior cancer treatment to acceptable baseline status, or a NCI CTCAE ver.3.0 Grade of 0 or 1 ; PRIMARY OUTCOME: Adverse event; SECONDARY OUTCOME 1: [/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - Adolescents; BRIEF: This study will be conducted to evaluate the safety and efficacy of sumatriptan nasal powder (AVP-825) compared to placebo in the acute treatment of migraine in adolescent participants, 12 through 17 years of age. ; DRUG USED: Onzetra Xsail; DRUG CLASS: Non-NME; INDICATION: Migraine and Other Headaches; TARGET: Serotonin 5-HT1 receptor; THERAPY: Monotherapy; LEAD SPONSOR: Currax Pharmaceuticals; CRITERIA: Inclusion Criteria: - Male and female participants 12 to 17 years (inclusive) of age at the time of informed consent - Have a diagnosis of episodic migraine with or without aura according to International Classification of Headache Disorders-Third edition, beta version (ICHD-IIIB, 1.2.1 or 1.1) criteria, for at least 1 year prior to the screening/enrollment visit - Experienced migraine attacks of moderate-to-severe intensity and typically lasting ≥ 3 hours untreated, occurring at a frequency of ≥ 2 to ≤ 14 attacks per month for the past 6 months prior to the screening/enrollment visit - Participants parent or legal guardian must be willing to sign a copy of the informed consent form as well as documentation for Written Authorization for Use and Release of Health and Research Study Information, after the nature and risks of study participation have been fully explained. Participants must be willing to provide informed assent. Exclusion Criteria: - Participants with ≥ 15 headache days per month in total (migraine, probable migraine, or tension-type) - Participants with the following headache types: retinal (ICHD-IIIB, 1.2.4), with brainstem aura (ICHD-IIIB, 1.2.2), hemiplegic (ICHD-IIIB, 1.2.3), status migrainosus (ICHD-IIIB, 1.4.1), other forms of complicated migraine, or secondary headaches - Participants who have not responded to an adequate dose and appropriate duration of treatment with 2 or more triptans - Participants with known nasal obstruction, current uncontrolled nasopharyngeal illness, or known velum insufficiency (i.e., a cleft palate and/or structural abnormalities in the soft palate and nasopharynx) that may interfere with the proper use of study medication - Participants whose conditions in the investigators opinion may put the participant at significant safety risk or confound the study results. This includes participants who in the investigators opinion should not be enrolled in the study due to the risks described in the Warnings and Precautions or Contraindications sections of the ONZETRA Xsail Prescribing Information. ; PRIMARY OUTCOME: Number of Participants Who Were Headache Pain Free at 120 Minutes After Treatment; SECONDARY OUTCOME 1: [/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - SPIRE-2 (CV Outcomes 2); BRIEF: This study evaluates the PCSK9 inhibitor, Bococizumab (PF-04950615;RN316), compared to placebo, in reducing the occurrrence of major cardiovascular events, including cardiovascular death, myocardial infarction, stroke, and unstable angina requiring urgent revascularization in high risk subjects who are receiving background lipid lowering therapy and have cholesterol laboratory values of LDL-C >/= 100 mg/dL (2.6 mmol/L) or non-HDL-C >/=130 mg/dL (3.4 mmol/L). ; DRUG USED: Bococizumab; DRUG CLASS: Biologic; INDICATION: Dyslipidemia / Hypercholesterolemia; TARGET: Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9); THERAPY: Monotherapy; LEAD SPONSOR: Pfizer; CRITERIA: Inclusion Criteria: - Must be on background lipid lowering treatment. - Must be at high risk of a CV event. - Must have an LDL C >/=100 mg/dL (2.6 mmol/L) OR non HDL C >/=130 mg/dL (3.4 mmol/L). Exclusion Criteria: - Planned coronary (PCI or CABG) or other arterial revascularization. - New York Heart Association Class IV congestive heart failure or left ventricular ejection fraction < 25% by cardiac imaging. - Chronic renal insufficiency with creatinine clearance of <30 ml/min/1.73m^2 by MDRD formula or with end state renal disease on dialysis. - History of hemorrhagic stroke. - Prior exposure to bococizumab or other investigational PCSK9 inhibitor. ; PRIMARY OUTCOME: Event Rate Per 100 Participant-years for First Occurrence of Major Cardiovascular (CV) Event; SECONDARY OUTCOME 1: Event Rate Per 100 Participant-years for First Occurrence of Composite Endpoint of Cardiovascular (CV) Death, Non-fatal Myocardial Infraction (MI) or Non-fatal Stroke[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I/II - 002 (w/Safety Run-In); BRIEF: The main goal of this study is to determine the Maximum Tolerated Dose (MTD) and the Recommended Phase II Dose (RP2D) as well as preliminary antitumor activity of bimiralisib (PQR309) administered orally, as once daily capsules continuously and on intermittent schedule in patients with relapsed or refractory lymphomas. ; DRUG USED: Bimiralisib; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hematologic Cancer; TARGET: Mammalian Target of Rapamycin (mTOR)/mTORC, PI3K/AKT pathway; THERAPY: Monotherapy; LEAD SPONSOR: PIQUR Therapeutics AG; CRITERIA: Inclusion Criteria: 1. Histologically confirmed diagnosis* of relapsed or refractory lymphoma, received at least two prior lines of therapy including immuno-chemotherapy. Patients with relapsed Chronic Lymphoid Leukemia (CLL) are eligible if they have received one or more prior lines of any approved standard therapy. * archival biopsies may be used if obtained up to a year prior to enrollment; re-biopsy is strongly recommended if last biopsy was obtained more than a year ago. 2. Only for patients in the Phase 2 part: At least one measurable nodal or extra-nodal lesion defined as follows: Clearly measurable (i.e. well-defined boundaries) in at least two perpendicular dimensions on imaging scan with > 1.5 cm in longest transverse diameter. 3. Age ≥ 18 years 4. Eastern Cooperative Oncology Group (ECOG) Performance Score of 0-1 (See Appendix 2). 5. Adequate organ system functions defined as: 1. Absolute neutrophil count (ANC) ≥1.0x109/l 2. Platelets ≥ 75x109/l 3. Haemoglobin ≥ 85g/L 4. Adequate hepatic function, defined as Total bilirubin ≤ 1.5 times the upper limit of normal (ULN) and Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 times ULN (or ALT/AST ≤ 5 times ULN in patients with liver involvement) 5. Adequate renal function, defined as serum creatinine ≤ 1.5 times ULN 6. Fasting glucose < 7.0 mmol/L; Glycated haemoglobin (HbA1c) < 6.4% 6. Ability and willingness to swallow and retain oral medication. 7. Willingness and ability to comply with the trial procedures 8. Female and male patients with reproductive potential must agree to use effective contraception from screening until 90 days after discontinuation of PQR309 9. Signed informed consent Exclusion Criteria: Any of the following conditions precludes enrollment of a patient: 1. Immunosuppression due to: - Allogeneic hematopoietic stem cell transplant (HSCT) - Any immune-suppressive therapy within 4 weeks prior to trial treatment start - Known HIV infection 2. Autologous stem cell transplant within 3 months prior to trial treatment start. 3. Concomitant anticancer therapy (e.g. chemotherapy, radiotherapy, hormonal therapy, immunotherapy, biological response modifier, signal transduction inhibitors). 4. Concomitant treatment with medicinal products that increase the pH (reduce acidity) of the upper gastrointestinal tract, including, but not limited to, proton-pump inhibitors (e.g. omeprazole), H2-antagonists (e.g. ranitidine) and antacids. Patients may be enrolled in the study after a wash-out period sufficient to terminate their effect. 5. Use of any investigational drug within 21 days prior to trial treatment start. 6. Patients who experienced National Cancer Institute (NCI) Common Terminology Criteria For Adverse Events (CTCAE) ≥ Grade 3 on PI3K/mTOR inhibitors 7. Any major surgery, chemotherapy or immunotherapy within 21 days prior to trial treatment start. 8. Symptomatic or progressing Central nervous system (CNS) involvement. Exception: Patients with meningeal involvement can be included upon discussion between the sponsor and the investigator. 9. Persisting toxicities NCI CTCAE ≥2 related to prior anticancer therapy 10. Presence of gastrointestinal disease or any other condition that could interfere significantly with the absorption of the study drug. 11. Severe/unstable angina, myocardial infarction or coronary artery bypass within the last 3 years prior to trial treatment start, symptomatic congestive heart failure New York Heart Association (NYHA) Class 3 or 4, hypertension BP>150/100mmHg 12. A serious active infection at the time of treatment, or another serious underlying medical condition that could impair the ability of the patient to receive treatment. 13. Lack of appropriate contraceptive measures (male and female) 14. Pregnant or lactating women 15. Known HIV infection 16. Significant medical conditions which could jeopardize compliance with the protocol. 17. Uncontrolled diabetes mellitus; patients with controlled diabetes may be enrolled (see fasting glucose and HbA1c levels in inclusion criteria). ; PRIMARY OUTCOME: Assessment of Change of Tumor Response Criteria in lymphoma patients During Treatment with PQR309 in patients with relapsed or refractory lymphoma according to Cheston Criteria (5); SECONDARY OUTCOME 1: Incidence of serious adverse events (SAE) and severity of all adverse events (AEs)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - non-Gorlin HF-BCC; BRIEF: This is a multicenter, randomized, double-blind, stratified, vehicle-controlled study of the efficacy and safety of Patidegib Topical Gel, 2%, applied topically twice daily to the face of adult participants with non-Gorlin HF-BCC (high-frequency basal cell carcinoma). Participants will be randomized (1:1) to receive either Patidegib Topical Gel, 2%, or Vehicle for 9 months. Randomization will be stratified by gender. The primary endpoint is the number of nSEB (surgically eligible basal cell carcinoma) that develop on the face over the 9 month period. The primary end point will be assessed by imaging and tracking of BCCs consistently throughout the study in order to identify nSEBs. ; DRUG USED: Patidegib Gel; DRUG CLASS: Non-NME; INDICATION: Skin Cancer - Basal Cell Carcinoma (BCC); TARGET: Hedgehog Signaling Pathway; THERAPY: Monotherapy; LEAD SPONSOR: Sol-Gel Technologies, Ltd.; CRITERIA: Inclusion Criteria: 1. The subject must have had at least 10 (with at least 3 on the face) clinically typical BCCs present within 24 months prior to Screening and Randomization (Baseline/Day 1). Additionally, the subject must have at least 2 BCCs with longest diameter <5 mm present on the face prior to Screening and Randomization (Baseline/Day 1). 2. The subject must be willing to abstain from application of a non-study topical medication (prescription or over the counter) to facial skin for the duration of the trial except as prescribed by the Investigator. Exclusion Criteria: 1. The subject has been previously diagnosed with Gorlin syndrome 2. On medical history, family history or clinical examination there is a suspicion that the patient has Gorlin syndrome. 3. Patients with a family history of medulloblastoma 4. The subject has used topical treatment to the face or systemic therapies that might interfere with the evaluation of the study IP. 5. The subject has uncontrolled systemic disease. 6. The subject has been treated for invasive cancer within the past 5 years excluding non-melanoma skin cancer, Stage I cervical cancer, ductal carcinoma in situ of the breast, or chronic lymphocytic leukemia (CLL) Stage 0. ; PRIMARY OUTCOME: Number of new surgically eligible BCCs (nSEBs); SECONDARY OUTCOME 1: Number of treatment emergent adverse events assessed with means and standard errors or proportions[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - Efficacy and Safety; BRIEF: To evaluate the efficacy of ACP-044 compared with placebo in the treatment of pain associated with osteoarthritis of the knee ; DRUG USED: ACP-044; DRUG CLASS: New Molecular Entity (NME); INDICATION: Osteoarthritis and Osteoarthritis Pain; TARGET: Peroxynitrite; THERAPY: Monotherapy; LEAD SPONSOR: ACADIA Pharmaceuticals Inc.; CRITERIA: Inclusion Criteria: - Male or female subjects ≥18 and <65 years of age at the time of Screening - Has a body mass index (BMI) ≤39 kg/m2 at Screening - Confirmed history of pain associated with OA in the index knee - Willing to maintain current activity and exercise levels throughout the study - Willing and able to comply with clinic visits and study-related procedures - Consent to allow all radiographs and medical/surgical/hospitalization records of care received elsewhere to be shared with the Investigator and third parties who will examine the images (i.e., central x-ray reader) Exclusion Criteria: - Pain anywhere else in the body which is greater than or equal to OA pain in the index knee, or likely to interfere with subjects assessment of pain throughout the study, as judged by the Investigator - History or presence on imaging of knee arthropathy (osteonecrosis, subchondral insufficiency fracture, rapidly progressive OA type 1 or type 2), recent fall, injury, or trauma affecting the index knee, ligament tear, neuropathic joint arthropathy, knee dislocation (patella dislocation is eligible), extensive subchondral cysts, Bakers cyst, evidence of bone fragmentation or collapse, or primary metastatic tumor with the exception of chondromas, or pathological fractures during the Screening Period - History or presence at Screening of non-OA inflammatory joint disease (e.g., rheumatoid arthritis, lupus erythematosus, psoriatic arthritis, pseudo-gout, gout, spondyloarthropathy, joint infections within the past 5 years, Pagets disease of the spine, pelvis, or femur, neuropathic disorders, multiple sclerosis, fibromyalgia, tumors or infections of the spinal cord, or renal osteodystrophy) or any condition that would interfere with the rating of OA pain - Recent arthroscopic surgery within 1 month of Screening; or has any planned surgery or procedure during the study - Use of monoamine reuptake inhibitors, tricyclic antidepressants, anticonvulsants, and/or serotonin norepinephrine reuptake inhibitors within 4 weeks prior to Screening - Unwilling to discontinue current use of analgesic medication following Screening and to adhere to study requirements for rescue treatments (study-provided acetaminophen to be taken as needed with a maximum daily dose of 2500 mg), including, but not limited to, nonsteroidal anti-inflammatory drugs (NSAIDs), opioids, selective cyclooxygenase 2 inhibitors, acetaminophen, or combinations thereof, within 7 days or five half-lives of the drug prior to the Baseline Pain Assessment Period, whichever is longer - Use of immediate- or extended-release or controlled-release opioids (e.g., oxycontin), transdermal fentanyl, or methadone within 3 months prior to Screening - Use of opioids, for the treatment of pain other than OA of the knee, with a morphine equivalent dose of ≥30 mg per day for more than 2 days per week within 1 month prior to Screening - Use of systemic (i.e., oral) corticosteroids or intra-articular corticosteroids in any joint within 30 days prior to the screening visit (topical, intranasal, and inhaled corticosteroids are permitted) - Intra-articular injection of any approved (i.e., hyaluronic acid and corticosteroids) or unapproved treatments (e.g., platelet-rich plasma, capsaicin) into the index knee within 3 months of Screening - Physical/occupational/chiropractic therapy for the lower extremities or acupuncture for the lower extremities within 30 days of Screening, or the need for such therapy during the study - Has current evidence, or history within the previous 12 weeks prior to Screening, of a serious and/or unstable psychiatric, neurologic, cardiovascular, respiratory, gastrointestinal, renal, hepatic, hematologic, endocrinologic, or other medical disorder, that in the judgment of the Investigator and/or Medical Monitor would jeopardize the safe participation of the subject in the study - Had a malignancy in the last year, with the exception of nonmetastatic basal cell of the skin or localized carcinoma in situ of the cervix Additional inclusion/exclusion criteria apply. Patients will be evaluated at screening to ensure that all criteria for study participation are met. Patients may be excluded from the study based on these assessments (and specifically, if it is determined that their baseline health and psychiatric condition do not meet all pre-specified entry criteria). ; PRIMARY OUTCOME: Change from Baseline to Week 4 in the weekly average of the daily average Numeric Rating Scale (NRS) pain intensity scores.; SECONDARY OUTCOME 1: Patient Global Impression of Change (PGIC) at Week 4 with reference to baseline status.[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIb - Moderate/Severe (005); BRIEF: This study is designed as a randomized, double blind, parallel group, placebo-controlled trial to study the efficacy and safety of two oral doses of Prurisol administered twice daily for twelve weeks to subjects with moderate to severe chronic plaque psoriasis. ; DRUG USED: Prurisol; DRUG CLASS: Non-NME; INDICATION: Psoriasis; TARGET: Folate Receptor (FOLR1); THERAPY: Monotherapy; LEAD SPONSOR: Innovation Pharmaceuticals, Inc.; CRITERIA: Inclusion Criteria: 1. Evidence of a personally signed and dated written informed consent to participate in the clinical study 2. Male or non-pregnant female adults at least 18 years of age at time of informed consent 3. Chronic plaque-type psoriasis diagnosed for at least 6 months prior to baseline (at time of first study dose) 4. Moderate to severe plaque psoriasis as defined at baseline by: 1. PASI score of 12 or greater, and 2. Static PGA score of moderate (3) or severe (4), and 3. Body Surface Area (BSA) affected by plaque-type psoriasis of 10% or greater 5. Candidate for systemic therapy or phototherapy 6. Willing to limit ultraviolet light exposure from sunbathing, use of tanning booths, prolonged outdoor exposure, or from other UV light sources during the study. 7. Willing and able to comply with scheduled visits, study assessments and l laboratory tests, and other study procedures Exclusion Criteria: 1. Positive blood test for HLA-B*5701 allele 2. Currently have forms of psoriasis other than chronic plaque-type, (e.g., guttate, erythrodermic, exfoliative, palmoplantar, pustular), with the exception of nail psoriasis 3. Evidence of drug-induced psoriasis, e.g., a new onset or current exacerbation of psoriasis from beta-blockers, calcium channel inhibitors, antimalarial drugs or lithium 4. Psoriasis flare or rebound within 4 weeks prior to Screening 5. Active inflammatory diseases other than psoriasis that might confound the evaluation of study treatment on signs and symptoms of psoriasis. 6. . Any of the following prohibited treatments that do not meet the specified minimum washout period: 1. Biologic immunomodulating treatments of brodalumab or ustekinumab within 24 weeks prior to start of study treatment 2. Biologic immunomodulating treatments such as adalimumab, etanercept, infliximab, ixekizumab, secukinumab or certolizumab pegol within 12 weeks prior to start of study treatment 3. Systemic immunomodulating treatments other than biologics within 4 weeks prior to start of study treatment, e.g., oral corticosteroids, injectable corticosteroids (intraarticular, intramuscular, cutaneous/subcutaneous or intravenous), methotrexate, cyclosporine, cyclophosphamide, apremilast - Inhaled or intranasal corticosteroids with predominantly local effect (e.g., to treat asthma) are allowable - Use of corticosteroids in the eye or the ear are allowable 4. Other systemic treatments for psoriasis within 4 weeks prior to start of study treatment, e.g., retinoids, fumarates - Any such treatment used to treat a symptom of psoriasis but not the condition itself (e.g., anti-histamines for pruritus) is not restricted 5. Photochemotherapy, e.g., Psoralens + UVA phototherapy (PUVA), within 4 weeks prior to start of study treatment 6. Phototherapy, e.g., UVA, UVB, within 2 weeks prior to start of study treatment 7. Topical treatments that could affect signs and symptoms of psoriasis within 2 weeks prior to start of study treatment, e.g., corticosteroids, vitamin D analogs, retinoids, pimecrolimus, tacrolimus, tars, keratolytics - Allowable exceptions are: low or least potent (Class 6 or 7) topical corticosteroids for use on face, palms, soles, and intertriginous areas only; tar and salicylic acid preparations/shampoos for use on scalp only; bland emollient for use on any body region 7. Past vaccination with live vaccine within 6 weeks prior to start of study treatment, or plans for administration during the study 8. Any investigational or experimental therapy or procedure or participation in any interventional trial within 4 weeks or 5 half-lives (whichever is longer) prior to start of study treatment 9. Women of child-bearing potential who are not using reliable means of contraception, e.g., abstinence, surgical sterilization (hysterectomy and/or bilateral oophorectomy or partner vasectomy) or tubal ligation, double barrier method, oral/ injected/ implanted/ transdermal hormonal contraception, intrauterine device or intrauterine system, throughout study participation, and for 4 weeks after the end of treatment 10. Women of child-bearing potential who are pregnant or nursing (lactating), or planning a pregnancy while participating in the study 11. History of any ongoing, chronic or recurrent infectious disease (with the exception of episodic herpes labialis and herpes genitalis, and vaginal yeast infections) 12. Evidence of tuberculosis infection as defined by a positive QuantiFERON®-TB Gold In-Tube test (QFT-G) at Screening, or subjects with an indeterminate QFT-G test result with any retest result as indeterminate or positive 13. History of either untreated or incompletely treated latent or active tuberculosis infection 14. Ongoing or recent history of any non-psoriatic uncontrolled (in the Investigators medical opinion) systemic disease, including, but not limited to renal, hepatic, hematologic, gastrointestinal, endocrine, metabolic, pulmonary, cardiac, neurologic, or psychiatric disease. (e.g., A past or current history of hypertension that is controlled with diet and/or medications is not exclusionary.) 15. History of lymphoproliferative disease or any known malignancy or history of malignancy of any organ system within the past 5 years with the exception of: basal cell or squamous cell carcinoma or actinic keratoses that have been treated or excised with no evidence of recurrence in the past 12 weeks; cervical carcinoma in situ or non-invasive malignant colon polyps that have been removed 16. Active systemic infections during the past two weeks (exception: common cold) prior to start of study treatment or any infection that reoccurs on a regular basis 17. Past medical history of infection with HIV, hepatitis B or hepatitis C 18. History of any allergic reaction to any formulation of abacavir 19. Previous treatment with any abacavir-containing product, e.g., Ziagen®, Epzicom®, or Trizivir® 20. Previous participation in a clinical study of Prurisol 21. Presence of any medical or psychiatric condition that, in the Investgators opinion, makes it unlikely that the requirements of the protocol will be completed 22. History of alcohol or substance abuse, unless in full remission for more than 6 months prior to start of study treatment 23. Electrocardiogram (ECG) obtained at Screening visit which shows medically relevant abnormalities which may affect subject safety or interpretation of study results 24. Observed clinical laboratory values/abnormalities during Screening that show any one or more of the following: 1. Screening total white blood cell (WBC) count <2.5 x 10^9/L, or platelets <100 x 10^9/L or neutrophils <1.2 x 10^9/L or hemoglobin <8.5 g/dL 2. Screening serum creatinine level exceeding 2.0 mg/dL (176.8 µmol/L) 3. Screening alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels > 2 x ULN 25. Any other severe acute or chronic medical or psychiatric condition or test abnormality(ies) that, in the Investigators opinion, puts the subject at significant risk, could confound the study results, or may interfere significantly with the subjects participation in the study ; PRIMARY OUTCOME: Proportion of participants achieving at least a 75% reduction from baseline in PASI score (PASI75) at Week 12; SECONDARY OUTCOME 1: Proportion of subjects achieving a static Physician Global Assessment (sPGA) score of clear (0) or almost clear (1) with at least a 2-point reduction from baseline[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase Ia/Ib - EMBER; BRIEF: The reason for this study is to see if the study drug LY3484356 alone or in combination with other anticancer therapies is safe and effective in participants with advanced or metastatic breast cancer or endometrial cancer. ; DRUG USED: LY3484356; DRUG CLASS: New Molecular Entity (NME); INDICATION: Breast Cancer; TARGET: Estrogen, Selective Estrogen Receptor Degrader (SERD); THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: Eli Lilly and Company; CRITERIA: Inclusion Criteria: All study parts: - Participants must be willing to provide adequate archival tissue sample - Participants must be willing to use highly effective birth control - Participants must have adequate organ function - Participants must be able to swallow capsules Dose escalation- Participants must have one of the following: - Parts A and B: ER+ HER2- breast cancer with evidence of locally advanced unresectable or metastatic disease who have had the following: - Part A: may have had up to 1 prior regimen of any kind for in the advanced/metastatic setting and no prior cyclin-dependent kinase 4/6 (CDK4/6) inhibitor therapy. - Part B: may have had up to 2 prior regimens, no more than 1 of which may be endocrine therapy in the advanced/metastatic setting, and must have received a prior CDK4/6 inhibitor - Cohort E4: No prior everolimus. - Cohort E5: No prior alpelisib and must have a phosphatidylinositol 3-kinase catalytic α (PIK3Cα) mutation as determined by local testing. - Part C: ER+, human epidermal growth factor receptor 2 positive (HER2+) breast cancer with evidence of locally advanced unresectable or metastatic disease who have had at least 2 HER2-directed therapies in any setting. - Part D: ER+, EEC that has progressed after platinum containing chemotherapy and no prior fulvestrant or aromatase inhibitor therapy. - Part E: ER+ and HER2+ breast cancer with evidence of locally advanced, unresectable, or metastatic disease. - Part E: Participants must have received induction taxane chemotherapy combined with trastuzumab + pertuzumab as first-line treatment for advanced/metastatic disease and must not have progressed on this regimen. - Part E: Participants must not have received more than 1 HER2-directed regimen or any endocrine therapy for advanced disease or any prior CDK4/6 inhibitor therapy. Participants with ER+/HER2- breast cancer enrolled in this study must have had evidence of clinical benefit while on endocrine therapy for at least 24 months in the adjuvant setting or at least 6 months in the advanced/metastatic setting or have untreated de novo metastatic breast cancer Exclusion Criteria: - Participants must not have certain infections such as hepatitis or tuberculosis or HIV that are not well controlled - Participants must not have another serious medical condition - Participants must not have cancer of the central nervous system that is unstable - Participants must not be pregnant or breastfeeding ; PRIMARY OUTCOME: Number of Participants with Dose Limiting Toxicities (DLTs) and DLT-Equivalent Toxicities; SECONDARY OUTCOME 1: Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3484356[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - LADDER; BRIEF: This is a Phase II multicenter, dose-ranging, randomized, active treatment (monthly ITV injection)-controlled study to evaluate the efficacy, safety, and pharmacokinetics of ranibizumab delivered through the Implant using three ranibizumab formulation arms (10 mg/mL, 40 mg/mL, and 100 mg/mL) compared with the control arm (0.5-mg monthly ITV injections of 10-mg/mL formulation) in participants with subfoveal neovascular age-related macular degeneration (nAMD). ; DRUG USED: PDS-1.0; DRUG CLASS: Biologic; INDICATION: Wet Age-Related Macular Degeneration (Wet AMD) (Ophthalmology); TARGET: VEGF (Vascular endothelial growth factor); THERAPY: Monotherapy; LEAD SPONSOR: Genentech, Inc.; CRITERIA: Inclusion Criteria: - Newly diagnosed with wet AMD within 9 months of screening visit - Participant must have received at least 2 prior ITV anti-vascular endothelial growth factor (VEGF) injections. However, the most recent anti-VEGF injection must have been ranibizumab and must have occurred at least 7 days prior to the screening visit - Demonstrated response to prior ITV anti-VEGF treatment - Best Corrected Visual Acuity (BCVA) using Early Treatment Diabetic Retinopathy Study (ETDRS) charts of 20/20-20/200 Snellen equivalent Exclusion Criteria: - Treatment with ITV anti-VEGF agents other than ranibizumab within 1 month prior to the randomization visit in either eye - Study eye treatment with ITV anti-VEGF agents other than ranibizumab within 1 month prior to the randomization visit - History of laser photocoagulation, Visudyne®, ITV corticosteroid injection, vitrectomy surgery, submacular surgery, device implantation, or other surgical intervention for AMD in the study eye - Prior participation in a clinical trial involving anti-angiogenic drugs, other than ranibizumab, in either eye within 2 months of the randomization visit - Subretinal hemorrhage in the study eye that involves the center of the fovea - Subfoveal fibrosis, or atrophy in the study eye - Choroidal neovascularization (CNV) in either eye due to other causes, such as ocular histoplasmosis, trauma, or pathologic myopia - Uncontrolled ocular hypertension or glaucoma in the study eye - History of glaucoma-filtering surgery, tube shunts, or microinvasive glaucoma surgery in the study eye - Uncontrolled blood pressure - Uncontrolled atrial fibrillation within 3 months of informed consent - History of myocardial infarction or stroke within the last 3 months prior to informed consent - History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of ranibizumab or placement of the Implant, that might affect interpretation of the results of the study or renders the participant at high risk of treatment complications - Use of oral corticosteroids - Current treatment for any active systemic infection - Use of anticoagulants, anti-platelets (other than aspirin), or medications known to exert similar effects - Active malignancy within 12 months of randomization - History of allergy to fluorescein - Previous participation in any non-ocular (systemic) disease studies of investigational drugs within 1 month preceding the informed consent (excluding vitamins and minerals) ; PRIMARY OUTCOME: Time Until a Participant First Requires the Implant Refill According to Protocol-Defined Refill Criteria; SECONDARY OUTCOME 1: Change From Baseline in Best Corrected Visual Acuity (BCVA) Averaged At Month 9 and 10[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - M14-561; BRIEF: This open-label positron emission tomography (PET) study is designed to determine the effect of ABT-555 on translocator protein expression level in participants with relapsing forms of multiple sclerosis. ; DRUG USED: Elezanumab; DRUG CLASS: Biologic; INDICATION: Multiple Sclerosis (MS); TARGET: ; THERAPY: Monotherapy; LEAD SPONSOR: AbbVie; CRITERIA: Inclusion Criteria: Diagnosis of relapsing-remitting MS (RRMS) or relapsing secondary progressive MS (SPMS) Neurologically stable at Screening, in the investigators judgment and not actively experiencing or recovering from a recent relapse in the 30 days preceding the Screening Visit A Kurtzke Expanded Disability Status Scale (EDSS) score of 1.0 to 6.0, inclusive at the Screening Visit High or mixed affinity binder of the TSPO, as determined by rs6971 polymorphism genotyping at screening Exclusion Criteria: Diagnosis of primary progressive or non-relapsing secondary progressive MS Smoking more than 10 cigarettes per day or use of a nicotine patch Known history of, or positive screening test result for hepatitis C virus or hepatitis B virus Varicella or herpes zoster virus infection or any severe viral infection within 6 weeks before Screening Any type of live virus vaccine from 4 weeks before randomization History of abnormal laboratory results ; PRIMARY OUTCOME: Change in translocator protein expression; SECONDARY OUTCOME 1: [/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - PRINCE; BRIEF: Evaluation of the Efficacy and Safety of Pegcetacoplan in Patients with Paroxysmal Nocturnal Hemoglobinuria . ; DRUG USED: Empaveli; DRUG CLASS: New Molecular Entity (NME); INDICATION: Paroxysmal Nocturnal Hemoglobinuria (PNH); TARGET: Complement Pathway; THERAPY: Monotherapy; LEAD SPONSOR: Apellis Pharmaceuticals, Inc.; CRITERIA: Inclusion Criteria: - Be at least 18 years old (inclusive). - Have LDH ≥1.5 x ULN at the screening visit. - Have PNH diagnosis, confirmed by high sensitivity flow cytometry (granulocyte or monocyte clone >10%). - Have Hb less than the lower limit of normal (LLN) at the screening visit. - Have ferritin greater than/equal to the LLN, or total iron binding capacity (TIBC) less than/equal to ULN at the screening visit, based on central laboratory reference ranges. If a subject is receiving iron supplements at screening, the Investigator must ensure that the subjects dose has been stable for 4 weeks prior to screening, and it must be maintained throughout the study. Subjects not receiving iron at screening must not start iron supplementation during the course of the study. - Body mass index (BMI) ≤ 35 kg/m2 at the screening visit. - Have a platelet count of >50,000/mm3 at the screening visit. - Have an absolute neutrophil count >500/mm3 at the screening visit. Exclusion Criteria: - Treatment with any complement inhibitor (eg, eculizumab) within 3 months prior to screening. - Hereditary complement deficiency. - History of bone marrow transplantation. - Concomitant use of any of the following medications is prohibited if not on a stable regimen for the time period indicated below prior to screening: - Erythropoietin or immunosuppressants for at least 8 weeks - Systemic corticosteroids for at least 4 weeks - Vitamin K antagonists (eg, warfarin) with a stable international normalized ratio (INR) for at least 4 weeks - Iron supplements, vitamin B12, or folic acid for at least 4 weeks - Low-molecular-weight heparin for at least 4 weeks ; PRIMARY OUTCOME: Number of Subjects Who Achieved Hemoglobin (Hb) Stabilization; SECONDARY OUTCOME 1: Number of Subjects With an Hb Response in the Absence of Transfusions[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIIb - MO28347 (w/Lomustine); BRIEF: This multicenter, double-blind, placebo-controlled, randomized study will evaluate the efficacy and safety of the addition of bevacizumab treatment to lomustine (in 2nd-line [2L] treatment) and SOC (in 3rd-line [3L] and subsequent lines of treatment) following first-line disease progression (PD1) in participants with newly diagnosed glioblastoma. All enrolled participants will receive 1L treatment with radiotherapy, temozolomide, and bevacizumab. At PD1, eligible participants will be randomized (1:1) to receive 2L treatment with either bevacizumab plus lomustine or placebo plus lomustine. After second-line disease progression (PD2), participants will receive 3L treatment and will continue blinded bevacizumab or placebo with the addition of an SOC agent. Following third-line disease progression (PD3), participants will receive subsequent lines of treatment and will either continue blinded bevacizumab or placebo (at the discretion of the investigator), or switch to open-label bevacizumab (at the choice of the participant). ; DRUG USED: Avastin; DRUG CLASS: Biologic; INDICATION: Brain Cancer (Malignant Glioma; AA and glioblastoma (GBM)); TARGET: VEGF (Vascular endothelial growth factor); THERAPY: Combination; LEAD SPONSOR: Hoffmann-La Roche; CRITERIA: Inclusion Criteria at Enrollment (before PD1): - Newly diagnosed, histologically confirmed glioblastoma not previously treated with chemotherapy or radiotherapy - If female and not postmenopausal (less than [<] 12 months of amenorrhea) or surgically sterile, must agree to use a highly effective contraceptive method during the treatment period and for at least 6 months after the last dose of study drug - Karnofsky performance status (KPS) greater than or equal to (>/=) 60 - Mandatory tissue collection during pre-study surgery or biopsy for confirmation of the diagnosis and pathology - Craniotomy or intracranial biopsy site must be adequately healed. Study treatment should be initiated > 28 days following the last surgical procedure Inclusion Criteria at Randomization (following PD1): - Documented PD1 according to RANO criteria - Eligibility for second-line treatment with lomustine and bevacizumab as investigational medicinal products - Eastern Cooperative Oncology Group (ECOG) performance status 0-2 - Bevacizumab well tolerated and not interrupted for longer than 60 days during first-line treatment - Tissue submission among participants for whom operation/re-operation is indicated before second-line treatment starts; operation/re-operation performed >/=28 days after last bevacizumab administration and second-line treatment initiated >/=28 days after surgical wound healed - Randomization within 28 days after PD1 among participants for whom operation/re-operation is not necessary - First administration of second-line treatment no later than 2 days from randomization Exclusion Criteria at Enrollment (before PD1): - Any prior chemotherapy for glioblastoma and low-grade astrocytomas - Any prior radiotherapy to the brain or prior radiotherapy resulting in a potential overlap in the radiation field - Prior or current anti-angiogenic treatment - Treatment with any other investigational drug within 28 days or 2 investigational agent half-lives (whichever is longer) prior to first study treatment - Inadequate hematological, renal, or liver function - Inadequately controlled hypertension - Prior history of gastrointestinal perforation or abscess - Clinically significant cardiovascular disease - History or evidence of central nervous system disease unrelated to cancer unless adequately treated with standard medical therapy - History or evidence of inherited bleeding diathesis or significant coagulopathy at risk of bleeding - Serious non-healing wound, active ulcer, or untreated bone fracture - Known hypersensitivity to any component of bevacizumab/placebo or any of the study drugs - Active infection requiring IV antibiotics at start of study treatment - Other malignancy within 5 years prior to study enrollment, except for carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer, or ductal carcinoma in situ treated with curative intent - Pregnant or lactating women - Participation in any other study ; PRIMARY OUTCOME: Overall Survival (OS); SECONDARY OUTCOME 1: Percentage of Participants Alive at 6, 12, and 18 Months from Randomization[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - 02 (IBS-D); BRIEF: This is a randomized, double-blind, placebo-controlled, 2-arm parallel group study. After qualifying for the study and signing informed consent, patients will undergo a two-week observation period during which stool consistency and frequency data and symptom data will be collected. Patients will then be randomized 60:40 to RHB-102 12 mg (BEKINDA) or placebo. Patients will continue on treatment for 8 weeks. Each medication will be given once daily. ; DRUG USED: Bekinda; DRUG CLASS: Non-NME; INDICATION: Irritable Bowel Syndrome (IBS); TARGET: Serotonin 5-HT3 receptor; THERAPY: Monotherapy; LEAD SPONSOR: RedHill Biopharma Limited; CRITERIA: Inclusion Criteria: 1. Male and female patients age≥18 years (with a minimum of 35% males in the study) 2. Patient meets FDA guidance and Rome III criteria for IBS-D: a. Recurrent abdominal pain or discomfort over ≥6 months, with frequency ≥3 days/month in the last 3 months associated with ≥2 of the following: i. Improvement with defecation ii. Onset associated with a change in frequency of stool iii. Onset associated with a change in the form of stool b. Loose or watery stools (Bristol stool form scale 6 or 7) ≥2 days per week 3. Average worst daily pain intensity ≥3.0 for each of the two baseline weeks 4. Major laboratory parameters within the following limits (no worse than grade 1 abnormalities per NCI-CTCAE v4): a. Adequate hematologic function, as demonstrated by i. Hemoglobin ≥10 g/dL ii. Absolute neutrophil count (ANC) 1.5-10 x 10^9/L iii. Platelets ≥100 x 10^9/L b. Adequate liver and renal function as demonstrated by i. Aspartate transaminase (AST) and Alanine transaminase (ALT) each ≤ 3.0 x upper limit of normal (ULN) ii. Total bilirubin ≤1.5 x ULN iii. Creatinine ≤1.5 X ULN c. Euthyroid based on thyroid-stimulating hormone (TSH) and free T4 levels 5. Patients on thyroid hormone replacement must be on a stable dose for at least one month prior to study entry. 6. C-reactive protein ≤2 x ULN for lab 7. Patients of childbearing potential and male patients with partners of childbearing potential must utilize effective contraceptive measures Women of childbearing potential are women who have menstruated in the past 12 months, with the exception of women who have undergone surgical sterilization 8. All patients must sign informed consent. Exclusion Criteria: 1. Evidence of other cause for bowel disease: 1. Relevant abnormalities seen on colonoscopy if previously performed or if required per this protocol. These include but are not limited to Crohns disease, ulcerative colitis, diverticulitis, ischemic colitis, microscopic colitis. 2. History of and/or positive serologic test for celiac disease 3. Known or suspected lactose intolerance. 2. History of abdominal surgery other than appendectomy or cholecystectomy at any time 3. Any elective major surgery (of any organ) planned for the period of the study, including follow-up 4. History of organic abnormalities of the GI tract including but not limited to intestinal obstruction, stricture, toxic megacolon, GI perforation, fecal impaction, gastric banding, adhesions or impaired intestinal circulation (e.g., aortoiliac disease) 5. Current or previous diagnosis of neoplasia (except non-GI neoplasia in complete remission ≥5 years, squamous and basal cell carcinomas). With approval of the medical monitor patients with curatively treated neoplasm in complete remission <5 years may be entered in the study. 6. Patients with a history of positive tests for ova or parasites or Clostridium difficile must be retested during the screening period and tests for the relevant agents must be negative 7. Use of any 5-HT3 antagonist (5hydroxytryptamine receptor antagonists) within 4 weeks of the start of baseline data collection. 8. Use of rifaximin within 4 months of the start of baseline data collection. 9. Use of any other agent specific for IBS (such as alosetron or eluxadoline) or for symptomatic treatment of IBS (such as antispasmotics and antidiarrheals other than loperamide) within 2 weeks of the start of baseline data collection. 10. Uses of any investigational agent for any indication within 4 weeks of the start of baseline data collection. 11. Congestive heart failure, bradyarrhythmia (baseline pulse<55/min), known long QT syndrome 12. Patients who have Corrected QT interval (QTc) prolongation>450 msec noted on screening ECG, or who are taking medication known to cause QT prolongation Note: For current list of medications known to cause QT prolongation see: https://www.crediblemeds.org/healthcare-providers/drug-list/ There are several risk categories. Use the list showing those drugs known to cause torsade de pointes (TdP) 13. Hypersensitivity or other known intolerance to ondansetron or other 5-HT3 antagonists 14. Patient has taken apomorphine within 24 hours of screening 15. Pregnant or lactating 16. Patients with other major illnesses, either physical or psychiatric, or social situations which may interfere with participation in the study or interpretation of results 17. Patients with severe hepatic impairment, defined as Child-Pugh score ≥10 at baseline ; PRIMARY OUTCOME: Summary and Analysis of Overall Stool Consistency Response Rate - mITT Population; SECONDARY OUTCOME 1: Summary and Analysis of Overall Worst Abdominal Pain Response Rate - mITT Population[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - SUMIT (w/Dacarbazine); BRIEF: Selumetinib therapy in patients with metastatic uveal melanoma. ; DRUG USED: Koselugo; DRUG CLASS: New Molecular Entity (NME); INDICATION: Uveal Melanoma; TARGET: Mitogen-activated ERK kinase (MEK, MAPKK, MAP2K); THERAPY: Combination; LEAD SPONSOR: AstraZeneca; CRITERIA: Inclusion Criteria: Clinical diagnosis of metastatic uveal melanoma; Written consent from female or male patients aged 18 years and over. Histological or cytological confirmation of melanoma who are suitable for treatment with dacarbazine chemotherapy. - At least one lesion that can be accurately measured at baseline as>/=10mm in the longest diameter. (except lymph nodes which must have short axis ≥15 mm) with CT or MRI and which is suitable for accurate repeated measurements - ECOG performance status 0-1 - life expectancy >12 weeks - Normal organ and marrow function - Evidence of post-menopausal status, or negative urinary or serum pregnancy test for female pre-menopausal patients - Patients should be able to swallow selumetinib/placebo capsules Exclusion Criteria:-Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site) - Previous randomisation in the present study - Patients cannot have previously been treated with a systemic anti-cancer therapy. Patients can have prior intra-hepatic or non-systemic therapy. -Having received any of the following within the specified timeframe: Any prior systemic anti-cancer therapy for the treatment of this current diagnosis, An investigational drug within 30 days of starting treatment or within five half-lives of the compound (whichever is the most appropriate is at the discretion of the Investigator), or have not recovered from side effects of an investigational drug Any non-systemic anti-cancer therapy which has not been cleared from the body by the time of starting study treatment Radiation therapy within 4 weeks prior to starting study treatment, or limited field of radiation for palliation within 7 days of the first dose of study treatment Major surgery within 4 weeks prior to entry into the study (excluding the placement of vascular access) which would prevent administration of study treatment, Any prior investigational therapy comprising inhibitors of RAS, RAF or MEK at any time, Previous treatment with dacarbazine. Any unresolved toxicity >CTCAE grade 2 from previous anti-cancer therapy, excluding alopecia -History of allergic reactions attributed to compounds of similar chemical or biologic composition to selumetinib or dacarbazine --Symptomatic brain metastases or spinal cord compression (patients must be treated and stable off steroids and anti-convulsants for at least 1 month prior to entry into the study) Cardiac conditions as follows: - Uncontrolled hypertension (BP ≥150/95 mmHg despite medical therapy) - Acute coronary syndrome within 6 months prior to starting treatment - Uncontrolled Angina - Canadian Cardiovascular Society grade II-IV despite medical therapy - Symptomatic heart failure (New York Heart Association [NYHA] Class II-IV,- Prior or current cardiomyopathy - Baseline LVEF <55% measured by echocardiography or MUGA. Appropriate correction to be used if a MUGA is performed - Severe valvular heart disease - Atrial fibrillation with a ventricular rate >100 bpm on ECG at rest - QTcF >450 ms or other factors that increase the risk of QTc prolongation - Any evidence of severe or uncontrolled systemic disease, active infection, active bleeding diatheses or renal transplant, including any patient known to have hepatitis B, hepatitis C or human immunodeficiency virus (HIV) - Refractory nausea and vomiting, chronic gastrointestinal diseases (eg inflammatory bowel disease), or significant bowel resection that would preclude adequate absorption - History of another primary malignancy within 5 years prior to starting study treatment, except for adequately treated basal or squamous cell carcinoma of the skin or cancer of the cervix in situ and the disease under study - Ophthalmologic conditions: - Current or past history of central serous retinopathy - Current or past history of retinal vein occlusion - IOP >21 mmHg or uncontrolled glaucoma (irrespective of IOP) - Female patients who are breast-feeding a child and male or female patients of reproductive potential who are not employing an effective method of birth control - Clinical judgement by the Investigator that the patient should not participate in the study. ; PRIMARY OUTCOME: Assessment of the Efficacy of Selumetinib in Combination With Dacarbazine Compared With Placebo in Combination With Dacarbazine Measured as Progression Free Survival (PFS) Using BICR According to RECIST 1.1.; SECONDARY OUTCOME 1: Assessment of the Efficacy of Selumetinib in Combination With Dacarbazine Compared With Placebo in Combination With Dacarbazine in Terms of Objective Response Rate (ORR) by BICR[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I/II - w/5-Azacytidine or Low Dose Cytarabine (M.D. Anderson); BRIEF: This phase I/II trial studies the side effects and best dose of quizartinib when given in combination with azacitidine or cytarabine in treating patients with acute myeloid leukemia or myelodysplastic syndrome that have come back (relapsed) or are not responding to treatment (refractory). Quizartinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as azacitidine and cytarabine work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving quizartinib with azacitidine or cytarabine may work better in patients with acute myeloid leukemia or myelodysplastic syndrome. ; DRUG USED: Quizartinib; DRUG CLASS: New Molecular Entity (NME); INDICATION: Acute Myelogenous Leukemia (AML); TARGET: FMS-like tyrosine kinase 3 (FLT-3) , KIT/c-KIT, Platelet-derived growth factor receptor (PDGFR); THERAPY: Combination; LEAD SPONSOR: M.D. Anderson Cancer Center; CRITERIA: Inclusion Criteria: - PHASE I - Refractory or relapsed disease defined as follows: patients with MDS or chronic myelomonocytic leukemia (CMML) should have failed prior therapy (e.g., with a hypomethylating agent, clofarabine, and/or with lenalidomide); patients with AML should have failed any prior induction therapy or have relapsed after prior therapy; patients (any age) with MDS or CMML who received therapy with a hypomethylating agent and progress to AML are eligible at the time of diagnosis of AML regardless any prior therapy for AML. The World Health Organization (WHO) classification will be used for AML; patients with any of the eligible diagnoses who have received no prior therapy are eligible if not candidates to receive standard intensive therapy (i.e., high-dose cytarabine-based chemotherapy). - Patients are eligible regardless of their FLT3 mutation status. - PHASE II - COHORT 2A: Patients with MDS, CMML or AML who are either: age 60 years or older and newly diagnosed, previously untreated. Prior therapy with hydroxyurea or single agent ara-C for the purpose of control of white blood cells (WBC) is acceptable.; age 18 years or older and with refractory or relapse disease who have received no more than one prior treatment regimen and will be receiving first salvage. For this purpose, a second induction cycle with the same drugs used during the first cycle, consolidation chemotherapy or stem cell transplant in complete remission (CR) (or complete response with incomplete platelet recovery [CRp] or complete response with incomplete bone marrow recovery [CRi]) will be considered part of the prior regimen. Prior therapy for MDS (or other malignancies) is not considered a prior regimen for AML in patients who progress from MDS (or other malignancies). - COHORT 2A: Patients (any age) with MDS or CMML who received therapy with a hypomethylating agent and progress to AML are eligible at the time of diagnosis of AML regardless any prior therapy for AML. The WHO classification will be used for AML. - COHORT 2A: Patients must have evidence of FLT3 ITD in their most recent assessment. - COHORT 2B: Patients with MDS, CMML or AML who are either: Age 60 years or older and newly diagnosed, previously untreated. Prior therapy with hydroxyurea or single agent ara-C for the purpose of control of WBC is acceptable or age 18 years or older and with refractory or relapse disease who have received no more than two prior treatment regimens and will be receiving second salvage, or who have received a prior SCT and will be receiving their first salvage. For this purposes, a second induction cycle with the same drugs used during the first cycle, consolidation chemotherapy or stem cell transplant in CR (or CRp or CRi) will be considered part of the prior regimen. Prior therapy for MDS (or other malignancies) is not considered a prior regimen for AML in patients who progress from MDS (or other malignancies) - COHORT 2B: Patients (any age) with MDS or CMML who received therapy with a hypomethylating agent and progress to AML are eligible at the time of diagnosis of AML regardless any prior therapy for AML. The WHO classification will be used for AML - COHORT 2B: Patients must have no evidence of FLT3 mutations in their most recent assessment - PHASE I AND II - Eastern Cooperative Oncology Group (ECOG) performance status =< 2. - Bilirubin =< 2 x upper limit of normal (ULN). - Alanine aminotransferase (ALT) =< 2.5 x ULN. - For patients with suspected liver infiltration from leukemia ALT should be =< 5 ULN. - Creatinine =< 2 x ULN. - Serum potassium, magnesium, and calcium (normalized for albumin) levels should be at least within institutional normal limits. - Patients must provide written informed consent. - Patients must have been off chemotherapy for 2 weeks prior to entering this study, unless there is evidence of rapidly progressive disease, and must have recovered from the toxic effects of that therapy to at least grade 1. Use of hydroxyurea for patients with rapidly proliferative disease is allowed before the start of study therapy and for the first four weeks on therapy. The additional days of hydrea after 28 is permitted as clinically indicated, on case by case basis after discussion with the principal investigator (PI). Other agents given transiently with the intention to control rapid proliferation such as 1-2 doses of single agent ara-C or few doses of sorafenib are also allowed. - Women of childbearing potential must practice contraception. Women considered not of childbearing potential include any of the following: no menses for at least 2 years or menses within 2 years but amenorrheic for at least 2 months and luteinizing hormone (LH) and follicular stimulating hormone (FSH) values within normal range (according to definition of postmenopausal for laboratory used) or bilateral oophorectomy or radiation castration and amenorrheic for at least 3 months. Females of childbearing potential should practice effective methods of contraception. Effective methods of contraception include barrier methods (e.g., condoms, diaphragm), spermicidal jelly or foam, oral, depo provera, or injectable contraceptives, intrauterine devices, tubal ligation, and abstinence. Male patients with female partners who are of childbearing potential should also practice contraception. - Negative urine or serum pregnancy test. Exclusion Criteria: - Patients with known allergy or hypersensitivity to quizartinib, mannitol, AZA, cytarabine or any of their components. - Serum potassium < 3.5 mEq/L despite supplementation, or > 5.5 mEq/L. - Serum magnesium above or below the institutional normal limit despite adequate management. - Serum calcium (corrected for albumin levels) above or below institutional normal limit despite adequate management. - Patients with known significant impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of quizartinib. - Patients with any other known disease concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled diabetes, cardiovascular disease including congestive heart failure, myocardial infarction within 6 months and poorly controlled hypertension, chronic renal disease, or active uncontrolled infection) which could compromise participation in the study. Patients with current active malignancies or any remission for < 6 months, except patients with carcinoma in situ or with non-melanoma skin cancer who may have active disease or be in remission for less than 6 months. - Patients with a known confirmed diagnosis of human immunodeficiency virus (HIV) infection or active viral hepatitis. - Patients who have had any major surgical procedure within 14 days of day 1. - Patients with known malignant disease of the central nervous system. - Impaired cardiac function including any of the following: screening electrocardiography (ECG) with a corrected QT (QTc) > 450 msec. The QTc interval will be calculated by Fridericias correction factor (QTcF) at screening and on day 5 prior to the first dose of AC220. The QTcF will be derived from the average QTcF in triplicate; if QTcF > 450 msec on day 5, AC220 will not be given; patients with congenital long QT syndrome; history or presence of sustained ventricular tachycardia requiring medical intervention; any history of clinically significant ventricular fibrillation or torsades de pointes; Known history of second or third degree heart block (may be eligible if the patient currently has a pacemaker); sustained heart rate of < 50/minute on pre-entry ECG; right bundle branch block + left anterior hemiblock (bifascicular block); patients with myocardial infarction or unstable angina within 6 months prior to starting study drug; congestive heart failure (CHF) New York (NY) Heart Association class III or IV. Atrial fibrillation documented within 2 weeks prior to first dose of study drug; patients who require treatment with concomitant drugs that prolong QT/QTc interval or strong CYP3A4 inhibitors or inducers with the exception of antibiotics, antifungals, and antivirals that are used as standard of care to prevent or treat infections and other such drugs that are considered absolutely essential for the care of the subject. - Known family history of congenital long QT syndrome. ; PRIMARY OUTCOME: Maximum tolerated dose of quizartinib (Phase I); SECONDARY OUTCOME 1: Incidence of adverse events (Phase II)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - AUX-CC-806; BRIEF: This study is a Phase 3, open-label study of the safety and efficacy of AA4500 0.58 mg in subjects with Peyronies disease. Subjects will be screened for study eligibility within 21 days before the initial injection of study drug in the first treatment cycle. Enrollment will include all subjects who meet the eligibility criteria and who received placebo and completed one of the Auxilium-sponsored studies AUX-CC-803 or AUX-CC-804. ; DRUG USED: Xiaflex; DRUG CLASS: Biologic; INDICATION: Peyronies Disease; TARGET: Collagen; THERAPY: Monotherapy; LEAD SPONSOR: Endo Pharmaceuticals; CRITERIA: Inclusion Criteria: No subject should be enrolled until all eligibility criteria have been satisfied. Subjects who completed their participation in Auxilium-sponsored studies AUX-CC-803 or AUX-CC-804 and received placebo in that study may enroll in this study provided they continue to meet the eligibility requirements. To qualify for the study a subject must: 1. Have penile curvature of at least 30° in the dorsal, lateral, or dorsal/lateral plane at screening. It must be possible to delineate the single plane of maximal curvature for evaluation during the study 2. Be judged to be in good health, based upon the results of a medical history, physical examination,and laboratory profile 3. Have participated in Study AUX-CC-803 or Study AUX-CC-804, received placebo in that study,and completed that study 4. Voluntarily sign and date an informed consent agreement approved by the Institutional Review Board/Independent Ethics Committee (IRB/IEC). The subject must also sign an authorization form to allow disclosure of his protected health information (PHI). The PHI authorization form and informed consent form may be an integrated form or may be separate forms depending on the institution 5. Be able to read, complete and understand the various rating instruments in English. Exclusion Criteria: A subject will be excluded from study participation if he: 1. Has a penile curvature of less than 30° or greater than 90° at the screening visit 2. Has any of the following conditions: - Chordee in the presence or absence of hypospadias - Thrombosis of the dorsal penile artery and/or vein - Infiltration by a benign or malignant mass resulting in penile curvature - Infiltration by an infectious agent, such as lymphogranuloma venereum - Ventral curvature from any cause - Presence of an active sexually transmitted disease - Known active hepatitis B or C - Known immune deficiency disease or be positive for human immunodeficiency virus (HIV) 3. Has previously undergone surgery for Peyronies disease 4. Fails to have an erection which in the opinion of the investigator is sufficient to accurately measure the subjects penile deformity after administration of prostaglandin E1 or trimix or another suitable injectable pharmacologic stimulant according to the standard practice at the investigators institution 5. Has a calcified plaque as evident by appropriate radiographic evaluation, penile x-ray or penile ultrasound that would prevent proper injection of study medication. Non-contiguous stippling of calcium is acceptable for inclusion provided the calcium deposit does not interfere with the injection of AA4500 into the plaque 6. Has an isolated hourglass deformity of the penis 7. Has the plaque causing curvature of the penis located proximal to the base of the penis, so that the injection of the local anesthetic would interfere with the injection of AA4500 into the plaque 8. Has previously received alternative medical therapies for Peyronies disease administered by the intralesional route (including, but not limited to, steroids, verapamil, and the naturally occurring low molecular weight protein, interferon-α2b) within 3 months before the first dose of study drug or plans to use any of these medical therapies at any time during the study 9. Has received alternative medical therapies for Peyronies disease administered by the oral (including, but not limited to, vitamin E [>500 U], potassium aminobenzoate [Potaba], tamoxifen, colchicine, and pentoxifylline, ,) or topical routes (including, but not limited to, verapamil applied as a cream) within 3 months before the first dose of study drug or plans to use any of these medical therapies at any time during the study 10. Has had extracorporeal shock wave therapy (ESWT) for the correction of Peyronies disease within the 6-month period before screening or plans to have ESWT at any time during the study 11. Has used any mechanical type device for correction of Peyronies disease within the 2-week period before screening or plans to use any these devices at any time during the study 12. Has used a mechanical device to induce a passive erection within the 2-week period before screening or plans to use any of these devices at any time during the study 13. Has significant erectile dysfunction that has failed to respond to oral treatment with phosphodiesterase type 5 (PDE5) inhibitors 14. Has a penile Duplex Doppler ultrasound evaluation at screening that shows compromised penile hemodynamics that in the opinion of the investigator is clinically significant 15. Has uncontrolled hypertension, as determined by the investigator 16. Has a known recent history of stroke, bleeding, or other significant medical condition, which in the investigators opinion would make the subject unsuitable for enrollment in the study 17. Has received an investigational drug or treatment within 30 days before the first dose of study drug, except for placebo in Studies AUX-CC-803 or AUX-CC-804 18. Has a known systemic allergy to collagenase or any other excipient of AA4500 19. Has a known allergy to any concomitant medication required as per the protocol 20. Has received anticoagulant medication (except for ≤ 150 mg aspirin daily) during the 7 days before each dose of study drug 21. Has received any collagenase treatments within 30 days of the first dose of study drug 22. Has, at any time, received AA4500 for the treatment of Peyronies disease 23. Is unwilling or unable to cooperate with the requirements of the study including completion of all scheduled study visits ; PRIMARY OUTCOME: Percentage Change From Baseline in Penile Curvature; SECONDARY OUTCOME 1: Change From Baseline in the Severity of Peyronies Disease Symptoms Domain of the PDQ[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I/II - C31001 (ER+/HER2-); BRIEF: This is a phase 1b/2 study of the safety and efficacy of sapanisertib (MLN0128) in combination with exemestane or fulvestrant therapy in women with estrogen receptor positive/human epidermal growth factor receptor 2 negative (ER+/HER2-) advanced or metastatic breast cancer who progressed on treatment with everolimus in combination with exemestane or fulvestrant. ; DRUG USED: TAK-228; DRUG CLASS: New Molecular Entity (NME); INDICATION: Breast Cancer; TARGET: Mammalian Target of Rapamycin (mTOR)/mTORC, PI3K/AKT pathway; THERAPY: Monotherapy; LEAD SPONSOR: Calithera Biosciences, Inc; CRITERIA: Inclusion Criteria Each patient must meet all of the following inclusion criteria to be enrolled in the study: Phase 1b and Phase 2 1. Advanced or metastatic breast cancer. 2. Histological or cytological confirmation of ER+ status (defined as > 1% positive tumor cells), and histological or cytological confirmation of HER2-negative (HER2-) status by local laboratory testing using criteria in the American Society of Oncology (ASCO)/College of American Pathologists (CAP) Clinical Practice Guideline update. 3. Female patients 18 years of age or older who are postmenopausal for at least 1 year before the Screening visit, where menopause is defined by: Age ≥ 55 years and 1 year or more of amenorrhea. Surgical menopause with bilateral oophorectomy Age < 55 years and 1 year or more of amenorrhea, with an estradiol assay < 20 pg/mL Note: Ovarian radiation or treatment with a luteinizing hormone-releasing hormone agonist (goserelin acetate or leuprolide acetate) is not permitted for induction of ovarian suppression. 4. Have a history of brain metastasis are eligible for the study provided that all the following criteria are met: Brain metastases which have been treated - No evidence of disease progression for ≥ 3 months or hemorrhage after treatment - Off-treatment with dexamethasone for 4 weeks before administration of the first dose of MLN0128 - No ongoing requirement for dexamethasone or anti-epileptic drugs 5. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2. 6. Clinical laboratory values as specified below within 4 weeks before the first dose of MLN0128: - Bone marrow reserve consistent with absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L; platelet count ≥ 100 x 10^9/L; hemoglobin ≥ 9 g/dL - Total bilirubin ≤ 1.5 x the upper limit of the normal range (ULN), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN (≤ 5 x ULN if liver metastases are present) - Creatinine clearance ≥ 50 mL/min based either on Cockcroft-Gault estimate or based on a 12- or 24-hour urine collection - Fasting serum glucose ≤ 130 mg/dL and fasting triglycerides ≤ 300 mg/dL 7. Left ventricular ejection fraction (LVEF) within 5 absolute percentage points of institutional standard of normal as measured by echocardiogram (ECHO) or multiple gated acquisition scan (MUGA) within 4 weeks before the first dose of MLN0128 (ie, if the institutional standard of normal is 50%, LVEF may be as low as 45% to be eligible for the study). 8. Able to provide paraffin blocks or a minimum of 10 unstained slides of available archival tumor tissues (paraffin blocks are preferred). If archival tumor tissue is not available, a tumor biopsy may be performed before the patient begins treatment with MLN0128. If fewer than 10 slides are available or the tumor content/area requirements are not met, study eligibility will be determined upon discussion with the sponsor. 9. Ability to swallow oral medications, willingness to perform mucositis prophylaxis, and suitable venous access for the study-required blood sampling. 10. Voluntary written consent must be given before the performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care. Phase 1b Only: In addition to the previously mentioned inclusion criteria, each patient must meet the following inclusion criterion to be enrolled in the phase 1b portion of the study: 11. Patients may have SD or disease progression during their most recent treatment with exemestane or fulvestrant, or everolimus in combination with either exemestane (any country) or fulvestrant (US only). Exemestane or fulvestrant in combination with MLN0128 can also be initiated as a new line of therapy. Phase 2 Only: In addition to the previously mentioned inclusion criteria, each patient must meet all of the following inclusion criteria to be enrolled in the phase 2 portion of the study: 12. Measurable disease defined as follows: - At least 1 extra-osseous lesion that can be accurately measured in at least 1 dimension. The lesion must measure ≥ 20 mm with conventional imaging techniques or ≥ 10 mm with spiral computed tomography (CT) or magnetic resonance imaging (MRI), or - Bone lesions (lytic or mixed [lytic plus sclerotic]) in the absence of measurable disease as defined above 13. Patients must have had disease progression during treatment with everolimus in combination with either exemestane (any country) or fulvestrant (US only) (duration of treatment ≥ 4 weeks) and must have tolerated everolimus treatment in combination with exemestane (any country) or fulvestrant (US only) adequately according to the treating physicians judgment. Everolimus in combination with exemestane or fulvestrant is not required to be the most recent treatment before enrollment, but progression on the most recent anticancer therapy is required for enrollment. Exclusion Criteria Patients meeting any of the following exclusion criteria are not to be enrolled in the study: Phase 1b and Phase 2 1. Prior anticancer therapy or other investigational therapy within 2 weeks before administration of the first dose of MLN0128 (except for exemestane or fulvestrant, which should be continued). Treatment with everolimus must be discontinued 2 weeks before administration of the first dose of MLN0128. 2. Chronic concomitant therapy with bisphosphonates or denosumab for the prevention of bone metastases. Concomitant treatment with bisphosphonates or denosumab is permitted for treatment of osteoporosis or management of existing bone metastases if initiated at least 4 weeks before administration of the first dose of MLN0128. 3. Initiation of treatment with hematopoietic growth factors, transfusions of blood and blood products, or systemic corticosteroids (either IV or oral steroids, excluding inhalers) within 1 week before administration of the first dose of MLN0128 (patients already receiving erythropoietin on a chronic basis for ≥ 4 weeks are eligible). 4. Previous treatment with dual PI3K/mTOR inhibitors or TORC1/2 inhibitors. 5. Manifestations of malabsorption due to prior gastrointestinal (GI) surgery, GI disease, or for an unknown reason that may alter the absorption of MLN0128. 6. Poorly controlled diabetes mellitus defined as glycosylated hemoglobin (HbA1c) > 7%; patients with a history of transient glucose intolerance due to corticosteroid administration may be enrolled in this study if all other inclusion/exclusion criteria are met. 7. Other clinically significant co-morbidities, such as uncontrolled pulmonary disease, active central nervous system disease, active infection, or any other condition that could compromise participation of the patient in the study. 8. Known human immunodeficiency virus infection. 9. History of any of the following within the last 6 months before administration of the first dose of MLN0128: - Ischemic myocardial event, including angina requiring therapy and artery revascularization procedures - Ischemic cerebrovascular event, including transient ischemic attack and artery revascularization procedures - Requirement for inotropic support (excluding digoxin) or serious (uncontrolled) cardiac arrhythmia (including atrial flutter/fibrillation, ventricular fibrillation, or ventricular tachycardia) - Placement of a pacemaker for control of rhythm - New York Heart Association Class III or IV heart failure - Pulmonary embolism 10. Significant active cardiovascular or pulmonary disease before administration of the first dose of MLN0128, including: - Uncontrolled hypertension (ie, systolic blood pressure > 180 mm Hg; diastolic blood pressure > 95 mm Hg) - Pulmonary hypertension - Uncontrolled asthma or oxygen saturation < 90% by arterial blood gas analysis or pulse oximetry on room air - Significant valvular disease; severe regurgitation or stenosis by imaging independent of symptom control with medical intervention; or history of valve replacement - Medically significant (symptomatic) bradycardia - History of arrhythmia requiring an implantable cardiac defibrillator - Baseline prolongation of the rate-corrected QT interval (QTc; eg, repeated demonstration of QTc interval > 480 ms, or history of congenital long QT syndrome, or torsades de pointes) 11. Diagnosed or treated for another malignancy within 2 years before administration of the first dose of MLN0128 or previously diagnosed with another malignancy and have any evidence of residual disease. Patients with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection. Phase 1b Only: In addition to the previously mentioned exclusion criteria, patients meeting the following exclusion criterion are not to be enrolled in the phase 1b portion of the study: 12. More than 3 prior chemotherapy regimens for locally advanced or metastatic disease. Phase 2 Only: In addition to the previously mentioned exclusion criteria, patients meeting the following exclusion criterion are not to be enrolled in the phase 2 portion of the study: 13. More than 1 prior chemotherapy regimen for locally advanced or metastatic disease. ; PRIMARY OUTCOME: Phase 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs); SECONDARY OUTCOME 1: Phase 2: Clinical Benefit Rate at 24 Weeks (CBR-24)[/INST]No</s>