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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 IIb/III - NU3 (Belgium); BRIEF: Fracture healing is a complex physiological process caused by interaction of cellular elements, cytokines and signaling proteins, which results in the formation of new bone (Gerstenfeld et al., 2003). Depending on fracture site, complexity, co-morbidities and other factors, 10% of all fractures will eventually fail to unite. Non-union fractures are defined as fractures that are at least six to nine months old and in which there have been no signs of healing for the last three months. Various causes have been evoked for impaired healing in hypotrophic (atrophic and oligotrophic) non-unions, including poor fracture stabilization, local infection and failure of the osteoblastic cells to multiply. Currently the treatment of choice for non-unions, particularly atrophic non-unions, is bone autograft (or allograft), combined or not with intramedullary nailing, plating, and external fixation devices (Kanakaris et al., 2007). This procedure produces good results but requires an invasive surgery of several hours under general anesthesia and a few days of hospitalization. Because of this, major complications have been reported in up to 20-30% of patients (Pieske et al., 2009, Zimmerman et al., 2009). This Phase 2b/3 study aims at demonstrating the safety and efficacy of PREOB®, a proprietary population of autologous osteoblastic cells, in the treatment of hypotrophic non-union fractures of long bones. PREOB® will be compared to Bone Autograft in a non-inferiority design. ; DRUG USED: PREOB; DRUG CLASS: Biologic; INDICATION: Bone Fractures and Mechanical Defects; TARGET: Stem Cells/Other Cell Therapies; THERAPY: Monotherapy; LEAD SPONSOR: Bone Therapeutics S.A; CRITERIA: Inclusion Criteria: - Ability to provide a written, dated, and signed informed consent prior to any study related procedure, and to understand and comply with study requirements - Diagnosis of a non-infected hypotrophic non-union fracture of a long bone of at least 6 months at the time of treatment - Normal hematology function Exclusion Criteria: - Positive serology for HIV, hepatitis B, hepatitis C, syphilis, HTLV-1 - Presence or previous history, or risk factors for diseases caused by prions - Renal impairment, hepatic impairment - Patient with poorly controlled diabetes mellitus, severe arterial diseases and/or neuropathy - Insufficient fracture stability - Recent osteosynthesis material or bone graft - Multifocal fracture/non-unions ; PRIMARY OUTCOME: Global Disease Evaluation as perceived by the patient using a Visual Analogue Scale; SECONDARY OUTCOME 1: Pain using a Visual Analogue Scale[/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 - ARTS-DN (Japan) ; BRIEF: This study will be conducted in Japanese subjects with type 2 diabetes mellitus and the clinical diagnosis of Diabetic Nephropathy( DN) using a multi-center, randomized, adaptive, double-blind, placebo-controlled, parallel-group design. Primary objective of the study is investigate the change of Urinary Albumin to Creatine Ratio (UACR) after treatment with different oral doses of BAY94-8862 given once daily from baseline to Visit 8 (Day 90) ; DRUG USED: Kerendia; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetic Nephropathy; TARGET: Mineralocorticoid Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Bayer; CRITERIA: Inclusion Criteria: - Japanese subjects with type 2 diabetes mellitus and a clinical diagnosis of DN (Diabetic Nephropathy) treated with at least the minimal recommended dose of an Angiotensin Converting Enzyme Inhibitor (ACEI) and/or Angiotensin Receptor Blocker (ARB) - Subjects with a clinical diagnosis of Diabetic Nephropathy (DN) based on at least 1 of the following criteria: - Persistent very high albuminuria defined as Urinary Albumin to Creatine Ratio (UACR) of >/=300 mg/g (>/=34 mg/mmol) in 2 out of 3 first morning void samples and estimated glomerular filtration rate (eGFR) >/=30 mL/min/1.73 m2 but <90 mL/min/1.73 m2 Chronic Kidney Disease-Epidemiology Collaboration (CKD-EPI) or - Persistent high albuminuria defined as UACR of >/=30 mg/g but <300 mg/g (>/=3.4 mg/mmol but <34 mg/mmol) in 2 out of 3 first morning void samples and eGFR>/=30 mL/min/1.73 m2 but <90 mL/min/1.73 m2 (CKD-EPI) - Serum potassium </=4.8 mmol/L at both the run-in visit and the screening visit Exclusion Criteria: - Non-diabetic renal disease (confirmed by biopsy) - Known bilateral clinically relevant renal artery stenosis (>75%) - Glycated hemoglobin(HbA1c) >12% at the run-in visit or the screening visit - UACR >3000 mg/g (339 mg/mmol) in any of the urinary first morning void samples at the run-in visit or screening visit - Hypertension with mean sitting systolic blood pressure (SBP) >/=180 mmHg or mean sitting diastolic blood pressure (DBP) >/=110 mmHg at the run-in visit or mean sitting SBP >/=160 mmHg or mean sitting DBP >/=100 mmHg at the screening visit - Subjects with a clinical diagnosis of heart failure with reduced ejection fraction (HFrEF) and persistent symptoms (New York Heart Association class II-IV) at the run-in visit - Concomitant therapy with eplerenone, spironolactone, any renin inhibitor, or potassium-sparing diuretic ; PRIMARY OUTCOME: Change of urinary albumin-to creatinine ratio; SECONDARY OUTCOME 1: Change in serum potassium concentration[/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 - Norway; BRIEF: The aim of the study is to find out if the experimental medicine, YF476, can make gastric carcinoids, a rare type of stomach tumour, shrink and disappear. Gastric carcinoids occur mainly in patients with chronic atrophic gastritis (CAG), a condition in which the acid-producing cells in the lining of the stomach cant make acid. Acid production is controlled by gastrin, a hormone (chemical messenger) thats released into the bloodstream. If the stomach cant make acid, blood levels of gastrin rise. High blood levels of gastrin in patients with CAG can cause other cells (ECL cells) in the lining of the stomach to grow and, over the years, to give rise to gastric carcinoids. Gastric carcinoids are usually benign, but they can become malignant. Therefore, patients with CAG and gastric carcinoids have the inside of their stomach checked regularly, by gastroscopy, to see if the gastric carcinoids need removing surgically. A gastroscope is a thin (1 cm), flexible tube at end of which is a mini video camera, which enables the user to inspect the lining of the stomach and a snare to take samples of tissue (biopsies). YF476 (netazepide) is a gastrin receptor antagonist (blocks the effects of gastrin), so its a potential new medical treatment for gastric carcinoids in patients with CAG. Up to 10 of these patients will take YF476 daily for up to 12 weeks. Theyll make up to seven outpatient visits for tests, including checks on the safety of YF476 and up to four gastroscopies. At each gastroscopy, the gastric carcinoids will be measured and biopsies taken for laboratory tests. Patients will take up to 24 weeks to finish the study. ; DRUG USED: YF-476; DRUG CLASS: New Molecular Entity (NME); INDICATION: Gastric Cancer; TARGET: Cholecystokinin 2 (CCK2 or CCKB) / Gastrin receptor; THERAPY: Monotherapy; LEAD SPONSOR: Trio Medicines Ltd.; CRITERIA: Inclusion Criteria: - Patients known to have gastric carcinoids associated with chronic atrophic gastritis and hypergastrinaemia, and who attend the outpatient clinic of the investigator; - Men, postmenopausal women, premenopausal women who have been sterilised by tubal ligation, hysterectomy or bilateral oophorectomy, or premenopausal women using reliable contraception: condom and spermicide or intrauterine device; - Adults ≥ 18 years; - Good general health; and - Able to give fully-informed, written consent. Exclusion Criteria: - Women who are pregnant, lactating or using a steroid contraceptive; - History of gastric surgery, apart from surgery for gastric carcinoids; - Evidence of Zollinger-Ellison syndrome; - Prolonged QTc interval (>450 msec); - Certain medicines and herbal remedies taken during the 7 days before visit 1; - Previous treatment with somatostatin; or - Participation in other clinical trials of unlicensed medicines within the previous 3 months. ; PRIMARY OUTCOME: Visual assessment of the number of gastric carcinoids.; SECONDARY OUTCOME 1: Safety and tolerability of YF476, as judged by medical examinations, vital signs, ECG, safety tests of blood and urine, and 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 - AK001-002; BRIEF: This is a phase 2 study to evaluate multiple doses of AK001 across 2 active doses. Pharmacodynamic activity will also be evaluated. ; DRUG USED: AK001; DRUG CLASS: Biologic; INDICATION: Nasal Polyposis; TARGET: Mast Cell, Sialic acid-binding Ig-like lectin 8 (SIGLEC8); THERAPY: Monotherapy; LEAD SPONSOR: Allakos Inc.; CRITERIA: Inclusion Criteria: - TPS of ≥5 for both nostrils with presence on endoscopy of nasal polyps of grade ≥2 in each nostril according to the polyp grading scale - History of sinusitis symptoms - SNOT-22 ≥30 - No clinically significant Screening 12-lead ECG, vital sign, hematology, chemistry, or urinalysis findings Exclusion Criteria: - Use of systemic corticosteroids within 6 weeks of screening - Chronic use of antibiotic therapy within 3 months prior to Screening - Nasal surgery (including polypectomy) within 6 months prior to Screening - Use of investigational drugs or participation in another clinical trial within 30 days prior to Screening or 5 half-lives, whichever is longer ; PRIMARY OUTCOME: Change in Total Polys Score (TPS); 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 - CS30; BRIEF: The purpose of this phase 3B trial was to see how well a new trial drug (degarelix) works in terms of reducing the size of the prostate volume in prostate cancer patients who were scheduled to undergo subsequent radiotherapy for treatment of their prostate cancer. Prior to receiving radiotherapy, it is recommended that patients with intermediate to high risk prostate cancer are pre-treated with hormone therapy (so-called neoadjuvant therapy) which is known to reduce the size of the prostate and thereby decrease the required radiation field and enable a more safe and effective treatment. In this trial, participants were randomly selected (like flipping a coin) to receive either degarelix given alone or a standard hormone therapy (combination of goserelin and bicalutamide. The treatment was given for three months and the prostate size was measured by ultra sound at the beginning and at the end of the trial. The participants were required to come to the clinic for 5 or 6 visits during the three months. ; DRUG USED: Firmagon; DRUG CLASS: New Molecular Entity (NME); INDICATION: Prostate Cancer; TARGET: Gonadotropin-Releasing Hormone (GnRH) Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Ferring Pharmaceuticals; CRITERIA: Inclusion Criteria: - Patient has given written informed consent before any trial-related activity is performed. - Has a confirmed prostate cancer in which this type of treatment is needed. Exclusion Criteria: - Previous treatment for prostate cancer - Previous trans-urethral resection of the prostate - Patients who are lymph node positive or have other metastatic disease - Use of urethral catheter - Current treatment with a 5-alpha reductase inhibitor or α-adrenoceptor antagonist. - History of severe untreated asthma, anaphylactic reactions, or severe urticaria and/or angioedema. - Hypersensitivity towards any component of the investigational product - Other previous cancers within the last five years with the exception of prostate cancer and some types of skin cancer. - Certain risk factors for abnormal heart rhythms/QT prolongation (corrected QT interval over 450 msec., Torsades de Pointes or use of certain medications with potential risk) - Clinical disorders other than prostate cancer including but not limited to renal, haematological, gastrointestinal, endocrine, cardiac, neurological, psychiatric disease, alcohol or drug abuse or other conditionals as judged by the investigator. ; PRIMARY OUTCOME: Change From Baseline in Prostate Size Based on Trans Rectal Ultra Sound (TRUS) at Week 12 (Full Analysis Set); SECONDARY OUTCOME 1: Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 4, 8, and 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 III - South Korea; BRIEF: The primary objective is to evaluate the effect of treatment with romosozumab for 6 months compared with placebo on percent changes in bone mineral density (BMD) at the lumbar spine as assessed by dual-energy X-ray absorptiometry (DXA) in postmenopausal women with osteoporosis. ; DRUG USED: Evenity; DRUG CLASS: Biologic; INDICATION: Osteoporosis / Osteopenia; TARGET: Sclerostin; THERAPY: Monotherapy; LEAD SPONSOR: Amgen; CRITERIA: Inclusion Criteria: - Ambulatory postmenopausal Korean women, ≥ 55 to ≤ 90 years of age at enrollment. - Postmenopause is defined as no spontaneous vaginal bleeding or spotting for 12 or more consecutive months prior to screening. - BMD T-score </= -2.50 at the lumbar spine, total hip or femoral neck. - At least 2 vertebrae in the L1 through L4 region and at least one hip are evaluable by DXA. - Other inclusion criteria may apply. Exclusion Criteria: - Subjects with a BMD T-score </= -4.0 at the lumbar spine, total hip, or femoral neck. - History of hip fracture. - Bone disease other than osteoporosis/ or evidence of any other clinically significant disorder, condition/ or disease or significant laboratory abnormalities. - Known sensitivity or intolerance calcium and vitamin D products. - Other exclusion criteria may apply. ; PRIMARY OUTCOME: Percent Change From Baseline to Month 6 in Bone Mineral Density at the Lumbar Spine; SECONDARY OUTCOME 1: Percent Change From Baseline to Month 6 in Bone Mineral Density at the Total Hip[/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 IIb - TIME-2b; BRIEF: The purpose of this study is to evaluate the safety and efficacy of subcutaneously administered AKB-9778 15mg once daily or 15mg twice daily for 12 months in patients with moderate to severe non-proliferative diabetic retinopathy (NPDR). ; DRUG USED: AKB-9778; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetic Retinopathy (Ophthalmology); TARGET: Angiopoietin Receptors (TIE-1 and TIE-2), Human protein tyrosine phosphatase beta (HPTP beta), Tie1/Tie2; THERAPY: Monotherapy; LEAD SPONSOR: EyePoint Pharmaceuticals, Inc.; CRITERIA: Key Inclusion Criteria: - Adults 18 through 80 years of age (inclusive) - Subjects with moderate to very severe NPDR (ETDRS Level 43 - 53 inclusive) - No evidence of central involved diabetic macular edema - ETDRS best-corrected visual acuity letter score ≥ 70 (Snellen 20/40 or better) Key Exclusion Criteria: - Ocular disease other than DR that may cause substantial reduction in visual acuity, including iris neovascularization, retinal detachment, visually significant epiretinal membrane, vitreous hemorrhage or fibrosis, ocular inflammation (uveitis), other retinal inflammatory or infectious diseases - Evidence of neovascularization on clinical examination or imaging - Hemoglobin A1C (HbA1C) ≥ 12.0% at Screening - Severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation ; PRIMARY OUTCOME: Percentage of Subjects With an Improvement in Study Eye Severity of Diabetic Retinopathy (DR) (ETDRS DR Severity Score or DRSS) of ≥ 2 Steps; SECONDARY OUTCOME 1: Summary of Subjects With a Worsening in the Study Eye DRSS of ≥ 2 Steps at Week 48[/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 - FREEDOM-3S; BRIEF: A Phase 3b, open-label, randomized, multicenter, safety and tolerability study of ITCA 650 in subjects with Type 2 diabetes taking liraglutide and metformin. ; DRUG USED: ITCA 650; DRUG CLASS: Non-NME; INDICATION: Diabetes Mellitus, Type II; TARGET: GLP-1 Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Intarcia Therapeutics; CRITERIA: Inclusion Criteria: - Diagnosis of type 2 diabetes ≥ 3 months. - Stable regimen of diet and exercise in combination with a stable treatment of liraglutide ≥1.2 mg/day and metformin ≥1000 mg/day. - HbA1c ≤9.5%. - Stable body weight ≥ 3 months. - Body mass index (BMI) ≥25 to ≤45 kg per meter squared. - Calcitonin <50 ng/L (50 pg/mL) at the Screening Visit. Exclusion Criteria: - History of type 1 diabetes. - Recent use or of anti-diabetic medications other than liraglutide or metformin. - History of significant/severe nausea and/or vomiting due to liraglutide. - Significant symptomatic hyperglycemia. - History or evidence, within the last 6 months prior to the Screening Visit, of myocardial infarction, coronary revascularization (coronary artery bypass grafting or percutaneous coronary intervention), unstable angina, or cerebrovascular accident or stroke. - History or evidence of acute or chronic pancreatitis. - History of liver disease. - History of medullary thyroid cancer or a family or personal history of multiple endocrine neoplasia type 2. - Poor thyroid, liver, or renal function. - Serum creatinine levels >1.5mg/dL (132 μmol/L) for male patients, or >1.4 mg/dL (123 μmol/L) for female patients. - Weight loss surgery or requires weight loss medications. - History of malignancy (not including basal or squamous cell carcinoma of the skin with past 5 years). - History of active alcohol or substance abuse. - Treatment with medications that affect GI motility. - History of hypersensitivity to exenatide or liraglutide. - Women that are pregnant, lactating, or planning to become pregnant. ; PRIMARY OUTCOME: Number (percentage) and severity of treatment-emergent adverse events (TEAEs) of nausea and/or vomiting; SECONDARY OUTCOME 1: Number (percentage) and severity of all treatment-emergent adverse events[/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 - VALOR-CKD (303); BRIEF: The purpose of this study is to evaluate the effect of TRC101 on the progression of chronic kidney disease (CKD) and to evaluate the safety profile of TRC101 in CKD patients with metabolic acidosis. ; DRUG USED: Veverimer; DRUG CLASS: New Molecular Entity (NME); INDICATION: Renal Disease / Renal Failure; TARGET: Chloride, Hydrogen; THERAPY: Monotherapy; LEAD SPONSOR: Tricida, Inc.; CRITERIA: Inclusion Criteria: - Estimated glomerular filtration rate (eGFR) 20 - 40 mL/min/1.73m^2. - Serum bicarbonate 12 - 20 mEq/L. - On maximum tolerated dose of ACE inhibitor and/or ARB. Exclusion Criteria: - Acute metabolic acidosis. - Anticipated dialysis or kidney transplant within 6 months. - Recent acute kidney injury. ; PRIMARY OUTCOME: Progression of chronic kidney disease; SECONDARY OUTCOME 1: Death (all-cause), ESRD or a confirmed ≥50% reduction in eGFR[/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 (Ovary/Breast Cancer); BRIEF: This is an open-label, multicenter study with a nonrandomized Phase 1 portion and an open-label, randomized, Phase 2 portion evaluating MLN8237 in combination with weekly paclitaxel in adult female participants with advanced breast cancer (Phase 1 portion only) and recurrent ovarian cancer (both Phase 1 and Phase 2 portions). ; DRUG USED: Alisertib; DRUG CLASS: New Molecular Entity (NME); INDICATION: Ovarian Cancer; TARGET: Aurora Kinase; THERAPY: Combination; LEAD SPONSOR: Millennium Pharmaceuticals, Inc.; CRITERIA: Inclusion Criteria: Each participant must meet all of the following inclusion criteria to be enrolled in the study: - Female participants 18 years or older - Previously treated, metastatic or locally recurrent malignancy with 1 of the following diagnoses, which has been confirmed histologically or cytologically: adenocarcinoma of the breast (Phase 1 only), recurrent epithelial ovarian, fallopian tube, or primary peritoneal carcinoma (Phase 1 and 2) - In the Phase 1 portion of the study, participants with breast cancer must have received treatment with at least 1 but no more than 4 prior chemotherapy regimens not including regimens received in the neoadjuvant and/or adjuvant setting - Participants with breast cancer must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 - No antineoplastic therapy or radiotherapy within 3 weeks before enrollment (2 weeks for regimens with recovery expected within 7 to 14 days) and recovered from toxicities of prior therapy (except alopecia); the participant must have recovered from all treatment-related toxicities and must have evidence of progressive disease (PD) or persistent disease - Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 - Adequate bone marrow, liver and renal function - Postmenopausal at least 1 year, OR Surgically sterile, OR If childbearing potential, agree to 2 effective methods of nonhormonal contraception, or agree to completely abstain from heterosexual intercourse - Able to provide written informed consent - Willing to comply with scheduled visits, treatment plan, laboratory tests and other trial procedures - Suitable venous access Specific Inclusion Criteria for participants with Recurrent Ovarian, Fallopian Tube or Peritoneal Cancer: - Prior treatments must have included a platinum and a taxane; the most recent treatment need not be a platinum-containing or taxane-containing regimen - Disease must have recurred ≤ 12 months after discontinuation of platinum therapy - Participants who previously received weekly taxane are potentially eligible, provided that they did not progress during therapy or within 3 months of completing therapy - Participants with platinum-refractory disease, as defined by progression during primary or subsequent platinum-based therapy or persistent radiographic disease after primary or subsequent platinum-based therapy, will be included - Participants must have measurable disease in target lesions or assessable disease (defined by cancer antigen-125 - CA-125 per protocol), and disease progression per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 or modified Gynecologic Cancer Intergroup (GCIG) CA-125 criteria Exclusion Criteria: Participants meeting any of the following exclusion criteria are not to be enrolled in the study: - Prior treatment with an Aurora A-targeted agent (including MLN8237) - Treatment with clinically significant enzyme inducers within 14 days prior to the first dose of MLN8237 and during the study - Treatment with more than 4 cytotoxic chemotherapy regimens in the metastatic setting; prior therapy cannot include more than 2 prior taxane-containing regimen. Current use of tamoxifen, thalidomide, or any agent used as maintenance or consolidation therapy for OC. - Known hypersensitivity to Cremophor® EL, paclitaxel or its components - Prior history of ≥ Grade 2 neurotoxicity or any toxicity requiring discontinuation from taxane chemotherapy that is not resolved to ≤ Grade 1 - Comorbid or unresolved toxicity that would preclude administration of weekly paclitaxel - Primary central nervous system malignancy or carcinomatous meningitis - Symptomatic brain metastasis - Inability to swallow oral medications or maintain a fast - History of hemorrhagic or thrombotic cerebrovascular event in past 12 months - Surgery within 3 weeks before study enrollment and not fully recovered - Diagnosis or treatment of another malignancy within 2 years preceding first dose of MLN8237 and have any evidence of residual disease except nonmelanoma skin cancer or in situ malignancy completely resected - Pregnant or lactating - Serious illness that could interfere with protocol completion - Investigational treatment 21 days prior to first dose of MLN8237 - Prior allogeneic bone marrow or organ transplantation - Infection requiring systemic antibiotic therapy within 14 days prior to first dose of MLN8237 - Known history of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C - Radiotherapy to > 25% bone marrow or whole pelvic radiotherapy - Requirement for constant administration of proton pump inhibitor, H2 antagonist, or pancreatic enzymes. Intermittent uses of antacids of H2 antagonists are allowed ; PRIMARY OUTCOME: Phase 1: Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) for Alisertib in Combination With Paclitaxel; SECONDARY OUTCOME 1: Phase 1: Combined Best Overall Response Rate (ORR) in Participants With Recurrent Ovarian Cancer or Breast Cancer[/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 IIIa - MERLIN (Q4W); BRIEF: This clinical study was designed to compare the safety and efficacy of brolucizumab 6 mg dosed every 4 weeks to aflibercept 2 mg dosed every 4 weeks in those neovascular age-related macular degeneration (nAMD) patients with retinal fluid despite frequent anti-Vascular Endothelial Growth Factor (VEGF) injections. ; DRUG USED: Beovu; DRUG CLASS: Biologic; INDICATION: Wet Age-Related Macular Degeneration (Wet AMD) (Ophthalmology); TARGET: VEGF (Vascular endothelial growth factor); THERAPY: Monotherapy; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Inclusion Criteria: - Signed informed consent - Diagnosis of wet age-related macular degeneration (AMD) - Currently receiving anti-VEGF injections Exclusion Criteria: - Active infection or inflammation in either eye - Significant fibrosis in the study eye - Recent ocular surgery - Uncontrolled glaucoma - Use of medications as specified in the protocol - Pregnant, nursing - Of child-bearing potential unless using highly effective method of contraception ; PRIMARY OUTCOME: Change From Baseline in Best-Corrected Visual Acuity (BCVA) at Week 52; SECONDARY OUTCOME 1: Stable Visual Acuity (VA) or Improvement in VA at Week 52 and Week 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 - CCN006 (US); BRIEF: The purpose of this study is to evaluate the one-year data on the contraceptive efficacy and safety of the 150/15 NES/EE CVR as the basis for regulatory approvals of this CVR as a new delivery system for contraception. ; DRUG USED: Annovera; DRUG CLASS: New Molecular Entity (NME); INDICATION: Contraception; TARGET: Estrogen Receptor Alpha (ER1 or ER alpha), Estrogen Receptor Beta (ER2 or ER beta), Progesterone Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Health Decisions; CRITERIA: Inclusion Criteria: - Healthy women, aged 18-<40 years who wish to use a combined hormonal contraceptive. - Women not intending to become pregnant for 13 months. - Intact uterus and both ovaries. - Prior history of regular menstrual cycles of 28 ± 7 days when not using hormonal contraception; if postpartum or postabortal, history of regular menstrual cycles of 21-35 days in length and at least one cycle (2 menses) with a cycle length consistent with her past cycles. - Sexually active (currently) and willing to discontinue current contraceptive method to participate in the study. - In the opinion of the investigator, able to comply with the protocol, e.g. live within the study site catchment area or within a reasonable distance from the site. - Do not meet any of the exclusion criteria. - Signed informed consent prior to entry into the trial. Exclusion Criteria: - Known hypersensitivity to estrogens or progestins. - Known hypersensitivity to silicone rubber. - Known or suspected pregnancy. - History of infertility of >1.0 year in woman or her male partner. - History of vasectomy or sterility in male partner; tubal ligation (sterilization) in women - Undiagnosed abnormal genital bleeding. - Undiagnosed vaginal discharge or vaginal lesions or abnormalities. (Subjects diagnosed at screening with Chlamydia or gonorrhea may be included in the trial following treatment; partner treatment is also recommended. Investigators should make a determination if subjects are at high risk for reinfection, e.g. multiple sex partners, untreated partner, and whether such subjects can be included.) - History of pelvic inflammatory disease since last pregnancy episode. - History of toxic shock syndrome. - Current abnormal Pap smear (women who have abnormal Paps but are ASCUS HPV negative may participate provided there is follow up for this finding per standard of care). - Cystoceles or rectoceles or other anatomical abnormality that would preclude use of a vaginal ring. - Women planning to undergo major surgery. - Smoking in women who are 35 years and over or will be 35 years during the course of the trial; Women < 35 years who smoke 15 cigarettes or more must be evaluated by the PI for inclusion based on risk factors that would increase their risk for CVD, e.g. lipid levels, glucose level, BP, BMI, family history of CVD at a young age. - Breastfeeding. - Current or past thrombophlebitis or thromboembolic disorders. - History of venous thrombosis or embolism in a first-degree relative <55 years of age suggesting familial defect in blood coagulation system, which in the opinion of the principal investigator, suggests use of a hormonal contraceptive could pose a significant risk. - Cerebrovascular or cardiovascular disease. - History of retinal vascular lesions, unexplained partial or complete loss of vision. - Known or suspected carcinoma of the breast. - Carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia. - Past history of any other carcinoma unless in remission for more than 5 years. - Current or past medically diagnosed severe depression, which, in the opinion of the investigator, could be exacerbated by use of a hormonal contraceptive. - Headaches with focal neurological symptoms. - Severe constipation. - History of cholestatic jaundice of pregnancy or jaundice with prior steroid use. - Benign or malignant liver tumors; active liver disease. - Diastolic blood pressure (BP) ³85 mm Hg and/or systolic BP ³135 mm Hg after 5-10 minutes rest. - Known or suspected alcoholism or drug abuse. - Abnormal serum chemistry values according to the physicians judgment. - Participation in another clinical trial within last 30 days. - Weight >95 kg or >209 lbs. - Use of liver enzyme inducers on a regular basis. - Use of monthly injectable contraceptives (e.g. cyclofem) unless suspended 2 months before initiation of treatment. Use of Depo-Proveraâ [depo-medroxyprogesterone (DMPA)] unless suspended 6 months before treatment. - Current use of implanted hormonal contraceptives, including Mirenaâ [progestin containing intrauterine system (IUS)], Jadelleâ, Norplantâ or Implanonâ (subjects using any of these methods who request removal for reasons unrelated to the purpose of enrollment in this study may be considered for participation). - Current use of a non-hormonal IUD. Subjects with IUDs who request removal for reasons unrelated to the purpose of enrollment in this study may be considered for participation. - Known HIV infection. - Women at high risk of contracting HIV, e.g. women with multiple sex partners who need to use condoms consistently, injection drug users. If women enrolled in the study do use condoms to protect against STIs, they should be instructed that this occasional use should be with non-N-9 containing condoms and they should record condom use in their diaries. Women found to have an STI at screening will be treated prior to inclusion in the study (with the exception of those infected with HIV). ; PRIMARY OUTCOME: To evaluate one-year data on the contraceptive efficacy and safety of the 150/15 NES/EE CVR as the basis for regulatory approvals of this CVR as a new delivery system for contraception.; SECONDARY OUTCOME 1: To evaluate the cycle control, bleeding patterns and side effects[/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 - 027; BRIEF: This trial will assess the safety and efficacy of omarigliptin (MK-3102) compared with the sulfonylurea, glimepiride, in type 2 diabetes mellitus participants who are metformin intolerant or who have a contraindication to the use of metformin. The primary hypothesis is that after 54 weeks, the mean change from baseline in hemoglobin A1c (A1C) in participants treated with omarigliptin is non-inferior compared with that in participants treated with glimepiride. ; DRUG USED: Omarigliptin; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type II; TARGET: Dipeptidyl peptidase IV (DPP-IV, DPP-4); THERAPY: Combination; LEAD SPONSOR: Merck Sharp & Dohme LLC; CRITERIA: Inclusion Criteria: - Diagnosed with type 2 diabetes mellitus - Have intolerability to metformin ≥1000 mg/day or have a contraindication to the use of metformin - Females of reproductive potential agree to remain abstinent or use or have their partner use 2 acceptable methods of birth control Exclusion Criteria: - History of type 1 diabetes mellitus or a history of ketoacidosis or assessed by the investigator as possibly having type 1 diabetes - Has been treated with: 1. A thiazolidinedione (TZD) within 4 months of study participation, or 2. A glucagon-like peptide-1 (GLP-1) receptor mimetic or agonist (such as exenatide or liraglutide) within 6 months of study participation, or 3. Insulin within 12 weeks prior to study participation, or 4. Dual antihyperglycemic agent (AHA) therapy within 12 weeks of study participation (4 months if a component of the dual AHA therapy was a TZD) 5. Omarigliptin (MK-3102) at any time prior to study participation - On a weight loss program and is not in the maintenance phase; has started a weight loss medication in the past 6 months; or has undergone bariatric surgery within 12 months prior to study participation - Medical history of active liver disease (other than non-alcoholic hepatic steatosis), including chronic active hepatitis B or C, primary biliary cirrhosis, or symptomatic gallbladder disease - Human immunodeficiency virus (HIV) - New or worsening coronary heart disease, congestive heart failure, myocardial infarction, unstable angina, coronary artery intervention, stroke or transient ischemic neurological disorder within the past 3 months - History of malignancy ≤5 years prior to study participation except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer - Clinically important hematological disorder (such as aplastic anemia, myeloproliferative or myelodysplastic syndromes, thrombocytopenia) - Pregnant or breast-feeding, or is expecting to conceive or donate eggs during the trial, including 21 days following the last dose of study drug ; PRIMARY OUTCOME: Change From Baseline in Hemoglobin A1C (A1C) at Week 54; SECONDARY OUTCOME 1: Change From Baseline in Fasting Plasma Glucose (FPG) at Week 54[/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 - Multiple Dose; BRIEF: The primary objectives of this study were to evaluate the safety and efficacy of LKA651 in patients with macular edema from diabetic macular edema (DME), ; DRUG USED: LKA-651; DRUG CLASS: Biologic; INDICATION: Diabetic Macular Edema (Ophthalmology); TARGET: Erythropoietin Receptor (EPOR); THERAPY: Monotherapy; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Inclusion Criteria - Written informed consent must be obtained before any assessment is performed. - Male and female patients age 18 to 85 years of age inclusive at screening - Presence of type I or type II diabetes mellitus - The Early Treatment Diabetic Retinopathy Study (ETDRS) letter score in the study eye must be between 24 and 70 letters (approximate Snellen equivalent of 20/40-20/320). The non-study eye (fellow eye) should be ≥34 letters or better (approximate Snellen equivalent of 20/200) at screening - Presence of Diabetic macular edema (DME) in the study eye, with decrease in vision due to foveal thickening of central macular thickness ≥ 320 µm in the central subfield, as assessed on Spectral domain optical coherence tomography (SD-OCT) and confirmed by the central reading center at screening - Sufficiently clear ocular media and adequate pupil dilation in the study eye to permit fundus photographs of adequate clarity to measure diameters of retinal arteries and veins at screening Exclusion criteria - Patient with history of intravitreal (IVT) anti-vascular endothelial growth factor (VEGF) treatment in the study eye <90 days from baseline - Patient with history of intraocular corticosteroids including dexamethasone intravitreal implants during the 6 month period prior to baseline. Any prior use of fluocinolone acetonide intravitreal implant (Iluvien) is prohibited regardless of timing - Laser photocoagulation (macular or panretinal) in the study eye during the 3-month period prior to baseline. - High risk proliferative diabetic retinopathy - Patients, with type 1 or type 2 diabetes who have a hemoglobin A1C ≥ 12% at screening. - Any progressive disease of the retina in the study eye (e.g. uveitis,rod-cone dystrophy) or optic nerve - Area of macular retinal ischemia (as measured by the foveal avascular zone) ≥ 1000 μm. - Active intraocular inflammation (graded as trace or above) or active intraocular infection in either eye. - Current diagnosis of or laboratory evidence for anemia, defined as a hemoglobin <10 g/dL for women and <11 g/dL for men. ; PRIMARY OUTCOME: Number of Participants With Adverse Events; SECONDARY OUTCOME 1: Number of Participants Who Needed Retreatment With Anti-VEGF in Study Eye After Week 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 IIb - AURA-LV; BRIEF: To assess the efficacy of 2 doses of voclosporin compared to placebo in achieving complete remission after 24 weeks of therapy in subjects with active lupus nephritis. ; DRUG USED: Lupkynis; DRUG CLASS: New Molecular Entity (NME); INDICATION: Lupus Nephritis; TARGET: Calcineurin phosphatase ; THERAPY: Monotherapy; LEAD SPONSOR: Aurinia Pharmaceuticals Inc.; CRITERIA: Inclusion Criteria: Male or female subjects aged 18 to 75 years. Diagnosis of systemic lupus erythematosus (SLE) according to the American College of Rheumatology criteria. Kidney biopsy within 6 months prior to Screening (Visit 1) with a histologic diagnosis of lupus nephritis (International Society of Nephrology/Renal Pathology Society 2003 classification of lupus nephritis) Classes III, IV-S or IV-G, (A) or (A/C); or Class V, alone or in combination with Class III or IV. Laboratory evidence of active nephritis at screening, defined as: - Class III, IV-S or IV-G: Confirmed proteinuria ≥1,500 mg/24 hours when assessed by 24 hour urine collection, defined by a UPCR of ≥1.5 mg/mg assessed in a first morning void urine specimen (2 samples). - Class V (alone or in combination with Class III or IV): Confirmed proteinuria ≥2,000 mg/24 hours when assessed by 24 hour urine collection, defined by a UPCR of ≥2 mg/mg assessed in a first morning void urine specimen (2 samples). Exclusion Criteria: Estimated glomerular filtration rate (eGFR) as calculated by the Chronic Kidney Disease Epidemiology Collaboration equation of ≤45 mL/min/1.73 m2. Currently requiring renal dialysis (hemodialysis or peritoneal dialysis) or expected to require dialysis during the study period. A previous kidney transplant or planned transplant within study treatment period. In the opinion of the Investigator, subject does not require long-term immunosuppressive treatment (in addition to corticosteroids). Current or medical history of: - Pancreatitis or gastrointestinal hemorrhage within 6 months prior to screening. - Active unhealed peptic ulcer within 3 months prior to screening. If an ulcer has healed and the subject is on adequate therapy, the subject may be randomized. - Congenital or acquired immunodeficiency. - Clinically significant drug or alcohol abuse 2 years prior to screening. - Malignancy within 5 years of screening, with the exception of basal and squamous cell carcinomas treated by complete excision. Subjects with cervical dysplasia that is cervical intraepithelial neoplasia 1, but have been treated with conization or loop electrosurgical excision procedure, and have had a normal repeat PAP are allowed. - Lymphoproliferative disease or previous total lymphoid irradiation. - Severe viral infection (such as CMV, HBV, HCV) within 3 months of screening; or known human immunodeficiency virus infection. - Active tuberculosis (TB), or known history of TB/evidence of old TB if not taking prophylaxis with isoniazid. Other known clinically significant active medical conditions, such as: - Severe cardiovascular disease including congestive heart failure, history of cardiac dysrhythmia or congenital long QT syndrome. - Liver dysfunction (aspartate aminotransferase, alanine aminotransferase, or bilirubin greater than 2.5 times the upper limit of normal) at screening and confirmed before randomization. - Chronic obstructive pulmonary disease or asthma requiring oral steroids. - Bone marrow insufficiency unrelated to active SLE (according to Investigator judgment) with white blood cell count <2,500/mm3; absolute neutrophil count <1.3 x 103/μL; thrombocytopenia (platelet count <50,000/mm3). - Active bleeding disorders. - Current infection requiring IV antibiotics. Any overlapping autoimmune condition for which the condition or the treatment of the condition may affect the study assessments or outcomes. Overlapping conditions for which the condition or treatment is not expected to affect assessments or outcomes are not excluded. Subjects who are pregnant, breast feeding or, if of childbearing potential, not using adequate contraceptive precautions. ; PRIMARY OUTCOME: Number of Subjects Achieving Complete Renal Remission at 24 Weeks; SECONDARY OUTCOME 1: Number of Subjects Achieving Complete Renal Remission at 48 Weeks[/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 - ENIGMA Extension; BRIEF: This is a Phase 2, open-label, extension study to assess the safety and tolerability of AK002, given monthly for up to 26 doses. ; DRUG USED: AK002; DRUG CLASS: Biologic; INDICATION: Gastroenteritis; TARGET: Mast Cell, Sialic acid-binding Ig-like lectin 8 (SIGLEC8); THERAPY: Monotherapy; LEAD SPONSOR: Allakos Inc.; CRITERIA: Inclusion Criteria: 1. Provide written informed consent. 2. Completed Study AK002-003, defined as having received 4 infusions of study drug and followed through Day 113 (±3 days) in Study AK002-003 and willing to begin extended dosing on or about Day 113. 3. Able and willing to comply with all study procedures. 4. Female patients must be either post-menopausal for at least 1 year or surgically sterile (tubal ligation, hysterectomy, or bilateral oophorectomy) for at least 3 months, or if of childbearing potential, have a negative pregnancy test and agree to use dual methods of contraception, or abstain from sexual activity until the end of the study, or for 120 days following the last dose of study drug, whichever is longer. 5. Male patients with female partners of childbearing potential must agree to use a highly effective method of contraception until the end of the study or for 120 days following the last dose of study drug, whichever is longer. All fertile men with female partners of childbearing potential should be instructed to contact the Investigator immediately if they suspect their partner might be pregnant at any time during study participation. Exclusion Criteria: 1. Poor tolerance to previous administration of AK002 in the opinion of the Investigator. 2. Known hypersensitivity to any constituent of the study drug. 3. Any disease, condition (medical or surgical), or cardiac abnormality, which, in the opinion of the Investigator, would place the patient at increased risk. 4. Planned or expected vaccination with live attenuated vaccines during the treatment, or vaccination expected within 5 half-lives (4 months) of AK002 administration. 5. Women who are pregnant, breastfeeding, or planning to become pregnant while participating in the study. 6. Any other reason that, in the opinion of the Investigator or Medical Monitor, makes the patient unsuitable for enrollment. ; PRIMARY OUTCOME: The safety and tolerability of AK002 by evaluating adverse events assessed using the CTCAE version 4.03; 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 - Children/Adolescents (HoFH); BRIEF: Primary Objective: To evaluate the efficacy of alirocumab (75 or 150 milligrams [mg] depending on body weight [BW]), administered every 2 weeks (Q2W), on low-density lipoprotein cholesterol (LDL-C) levels at Week 12 of treatment in children and adolescents with homozygous familial hypercholesterolemia (hoFH) of 8 to 17 years of age on top of background treatments. Secondary Objectives: - To evaluate the efficacy of alirocumab after 24 and 48 weeks of treatment on LDL-C levels. - To evaluate the effects of alirocumab on other lipid parameters (eg, apolipoprotein B [Apo B], non-high density lipoprotein cholesterol [non-HDL-C], total cholesterol [Total-C], high density lipoprotein cholesterol [HDL-C], lipoprotein a [Lp (a)], triglycerides [TG], apolipoprotein A-1 [Apo A-1] levels) after 12, 24, and 48 weeks of treatment. - To evaluate the safety and tolerability of alirocumab up to 48 weeks of treatment. ; DRUG USED: Praluent; DRUG CLASS: Biologic; INDICATION: Dyslipidemia / Hypercholesterolemia; TARGET: Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9); THERAPY: Combination; LEAD SPONSOR: Sanofi; CRITERIA: Inclusion criteria : - Participants genetically diagnosed with hoFH. - Participants treated with optimal dose of statin +/- other lipid modifying therapies (LMTs), or non-statin LMTs if statin-intolerant at stable dose(s) for at least 4 weeks. - A signed informed consent indicating parental permission with or without participants assent. - For participants on apheresis, currently undergoing stable LDL apheresis therapy prior to the screening visit (Week -2) and had initiated apheresis treatment for at least 6 months. Exclusion criteria: - Participants with LDL-C <130 milligram per deciliter [mg/dL] (3.37 millimoles per liter [mmol/L]) obtained during the screening period after the participant had been on stable apheresis procedure or LMT (i.e., stable optimal dose of statin ± other stable LMTs, or stable non statin LMTs in statin-intolerant participants) treatment for at least 4 weeks. - Participants with BW <25 kg. - Participants aged 8 to 9 years not at Tanner Stage 1 and participants aged of 10 to 17 years not at least at Tanner Stage 2 in their development. - Participants with uncontrolled Type 1 or 2 diabetes mellitus. - Participants with known uncontrolled thyroid disease. - Participants with uncontrolled hypertension. - Participants who will receive statin de novo during the run-in period. - Fasting triglycerides greater than (>) 350 mg/dL (3.95 mmol/L) at the screening visit. - Severe renal impairment (i.e., estimated glomerular filtration rate <30 milliliter per minute/1.73 meter square) at the screening visit. - Alanine aminotransferase or aspartate aminotransferase >2 * upper limit of normal (ULN) at the screening visit. - Creatine phosphokinase >3 * ULN at the screening visit. The above information was not intended to contain all considerations relevant to a participants potential participation in a clinical trial. ; PRIMARY OUTCOME: Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12: Intent-to-Treat (ITT) Analysis; SECONDARY OUTCOME 1: Percent Change From Baseline in Low-Density Lipoprotein Cholesterol at Week 12: On-treatment Analysis[/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 - LOTUS; BRIEF: The purpose of this study is to evaluate the efficacy of ustekinumab in participants with active systemic lupus erythematosus (SLE) who have not adequately responded to one or more standard of care treatments. ; DRUG USED: Stelara; DRUG CLASS: Biologic; INDICATION: Systemic Lupus Erythematosus (SLE); TARGET: IL-12 (Interleukin-12) and IL-12 receptor, IL-23 (Interleukin-23) ; THERAPY: Monotherapy; LEAD SPONSOR: Janssen Research & Development, LLC; CRITERIA: Inclusion Criteria: - Be male or female - Has a documented medical history (that is, met at least 1 of the two criteria below) that participant met the Systemic Lupus International Collaborating Clinics (SLICC) classification criteria for systemic lupus erythematosus (SLE) at least 3 months prior to first dose of study agent: 1. Met a total of at least 4 SLICC criteria, including at least 1 clinical and at least 1 immunologic; 2. Has a diagnosis of lupus nephritis, confirmed by renal biopsy and at least 1 of the following autoantibodies: antinuclear antibodies (ANA) or anti-double-stranded deoxyribonucleic acid (anti-dsDNA) - Has a positive test in the medical history and confirmed at screening for at least 1 of the following autoantibodies: antinuclear antibodies, anti-double-stranded deoxyribonucleic acid, and/or anti-Smith - Has greater than or equal to (>=) 1 British Isles Lupus Assessment Group (BILAG) A and/or >= 2 BILAG B scores observed during screening - Has a Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) activity score >=4 (excluding diffuse non-inflammatory alopecia) or >= 4 joints with pain and signs of inflammation at screening, Week 0, or both - Has a Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score >=6 at screening. Must also have SLEDAI-2K >= 4 for clinical features (excluding headache and laboratory abnormalities) at Week 0 - Cannot be pregnant, nursing, intending to become pregnant, or unwilling to follow contraception or egg/sperm donation guidelines - Must be receiving stable doses of >=1 protocol-permitted standard of care SLE treatment: oral glucocorticoids, anti-malarials, immunomodulators (methotrexate, azathioprine, 6-mercaptopurine, mycophenolate mofetil, mycophenolic acid) Exclusion Criteria: - Has any unstable or progressive SLE manifestation (example: central nervous system lupus, systemic vasculitis, end-stage renal disease, severe or rapidly progressive glomerulonephritis, pulmonary hemorrhage, myocarditis) that may warrant escalation in therapy beyond permitted background medications. Participants requiring renal hemodialysis or peritoneal dialysis are also excluded - Has other co-existent inflammatory diseases (example: rheumatoid arthritis, psoriasis, psoriatic arthritis, Crohns disease) - Has a urinary protein to creatinine ratio of greater than (>)4 gram per gram (g/g) per day - Has an acute or chronic infectious illness (example: human immunodeficiency virus, hepatitis B or C virus, tuberculosis, opportunistic infections) - Has a history of cancer or lymphoproliferative disease within the last 5 years except for treated and non-recurrent cutaneous basal cell carcinoma, squamous cell carcinoma, or cervical carcinoma - Has any condition requiring multiple courses of systemic glucocorticoids (example: uncontrolled asthma, chronic obstructive pulmonary disease) - Has a history of major surgery within the last month - Has received live virus or bacterial vaccines within 16 weeks prior to first dose of study agent or Bacille Calmette-Guerin (BCG) vaccination within 12 months of screening - Has previously received ustekinumab - Has received cyclophosphamide orally within 90 days or intravenously within 180 days of screening - Has received a single B-cell targeted therapy (e.g. belimumab) within 3 months, >1 previous B-cell targeted therapy within 6 months, or B-cell depleting therapy (example: rituximab) within 12 months of first dose of study agent - Has received protocol-prohibited oral or biologic immunomodulatory therapy in the last 3 months or less than (<)5 half-lives (whichever is longer) prior to first dose of study agent - Has received adrenocorticotropic hormone (ACTH) within 1 month prior to first dose of study agent - Has received epidural, intravenous, intramuscular, intraarticular, intrabursal, intralesional glucocorticoids within 6 weeks of first dose of study agent - Locally-delivered therapies except for ophthalmic use of cyclosporine A or topical use of nonsteroidal anti inflammatory drugs (NSAIDs), analgesics, or high-potency glucocorticoids (World Health Organization criteria) are prohibited ; PRIMARY OUTCOME: Percentage of Participants Achieving a Systemic Lupus Erythematosus Responder Index-4 (SRI-4) Composite Response at Week 52; SECONDARY OUTCOME 1: Time to First Flare[/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 - Children (KP415.S01); BRIEF: This study is a multicenter, dose-optimized, open-label safety study with KP415 in children with Attention-Deficit/Hyperactivity Disorder (ADHD). ; DRUG USED: Azstarys; DRUG CLASS: New Molecular Entity (NME); INDICATION: Attention Deficit Hyperactivity Disorder (ADHD); TARGET: Dopamine Reuptake, Norepinephrine (Noradrenaline) Reuptake/Transporter; THERAPY: Monotherapy; LEAD SPONSOR: Zevra Therapeutics; CRITERIA: Inclusion Criteria: 1. Subject must meet Diagnostic and Statistical Manual of Mental Disorders - Fifth Edition (DSM-5) criteria for a primary diagnosis of ADHD (combined, inattentive, or hyperactive/impulsive presentation) per clinical evaluation and confirmed by the Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID). 2. Subject must have a score of at least 3 (mildly ill) on the clinician-administered Clinical Global Impressions-Severity (CGI-S) scale. 3. Subjects who completed the efficacy study with KP415 may be rolled over into the current study. 4. Subject, subjects parent/legal guardian and caregiver (if applicable) must understand and be willing and able to comply with all study procedures and visit schedule. Exclusion Criteria: 1. Subject with any clinically significant chronic medical condition that may interfere with the participants ability to participate in the study. 2. Subject has any diagnosis of bipolar I or II disorder, major depressive disorder, conduct disorder, obsessive-compulsive disorder, any history of psychosis, autism spectrum disorder, disruptive mood dysregulation disorder (DMDD), intellectual disability, Tourettes Syndrome, confirmed genetic disorder with cognitive and/or behavioral disturbances. 3. Subject has evidence of any chronic disease of the central nervous system (CNS) such as tumors, inflammation, seizure disorder, vascular disorder, potential CNS related disorders that might occur in childhood, or history of persistent neurological symptoms attributable to serious head injury. 4. Subject has a current (last month) psychiatric diagnosis other than specific phobia, motor skills disorders, oppositional defiant disorder, sleep disorders, elimination disorders, adjustment disorders, learning disorders, or communication disorders. Participants with school phobia or separation anxiety will not be eligible. 5. Subject has clinically significant suicidal ideation/behavior, based on a history of attempted suicide and the C-SSRS assessment at Screening or at any time before the last dose of study drug. 6. Subject has any clinically significant unstable medical abnormality, chronic disease, or a history of a clinically significant abnormality of the cardiovascular, gastrointestinal, respiratory, hepatic, or renal systems, or a disorder or history of a condition that may interfere with drug absorption, distribution, metabolism, or excretion of study drug. 7. Subject has a history or presence of abnormal ECGs. ; PRIMARY OUTCOME: Subjects With Treatment-Emergent Adverse Events (TEAEs); SECONDARY OUTCOME 1: Change From Baseline in ADHD-RS-5 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 III - STEADFAST; BRIEF: This is a study to evaluate the efficacy and safety of azeliragon in patients with mild Alzheimers disease. Patients will receive either azeliragon or placebo with a patients participation lasting approximately 18 months. ; DRUG USED: Azeliragon; DRUG CLASS: New Molecular Entity (NME); INDICATION: Alzheimers Disease (AD); TARGET: Receptor for Advanced Glycation End Products (RAGE) ; THERAPY: Monotherapy; LEAD SPONSOR: vTv Therapeutics; CRITERIA: Inclusion Criteria: - Diagnosis of probable Alzheimer Disease (AD) with documented evidence of progression of disease - Mini Mental State Examination (MMSE) score of 21-26, inclusive - Clinical Dementia Rating global score of 0.5 or 1 - Rosen-Modified Hachinski Ischemia Score less than or equal to 4 - Brain magnetic resonance imaging (MRI) consistent with the diagnosis of probable AD - Concurrent use of cholinesterase inhibitor or memantine with stable dose for at least 3 months prior to randomization - Caregiver willing to participate and be able to attend clinic visits with patient - Ability to ingest oral medications Exclusion Criteria: - Significant neurological or psychiatric disease other than Alzheimers disease - Participants with evidence or history of severe drug allergies (resulting in dyspnea or severe rash). - Any contraindications to MRI (e.g., clinically significant claustrophobia, non-removable ferromagnetic implants). Patients with contraindications to MRI may undergo computed tomography (CT) on approval by sponsor. - Any contraindications to the FDG-PET study (e.g. allergy to any component of the FDG dose) in the cohort undergoing a PET scan. - Previous exposure to investigational or non-investigational therapies for Alzheimers disease within 6 months of screening - History of cancer within the last 5 years except adequately treated cervical carcinoma in-situ, cutaneous basal cell or squamous cell cancer, or non-progressive prostate cancer not requiring treatment - Women of childbearing potential - Uncontrolled blood pressure and/or blood pressure above 160/100 - Prescription medical food intended for dietary management of the metabolic processes associated with Alzheimers disease. - Diagnosis or history of cerebrovascular stroke, severe carotid stenosis, cerebral hemorrhage, intracranial tumor, subarachnoid hemorrhage. - Patients with unstable, uncontrolled diabetes (HbA1c > 7.7%) and those requiring insulin. ; PRIMARY OUTCOME: Change From Baseline in Alzheimers Disease Assessment Scale - Cognitive (ADAS-cog) Total Score; SECONDARY OUTCOME 1: Change From Baseline in Magnetic Resonance Imaging (MRI) Brain Volumetric Measures[/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 - PIFR; BRIEF: This study is a randomized, double-blind, double-dummy, parallel group study to compare once daily nebulized Revefenacin with Spiriva once daily delivered via the HandiHaler® on lung function in subjects with COPD and a Low Peak Inspiratory Flow Rate. ; DRUG USED: Yupelri; DRUG CLASS: New Molecular Entity (NME); INDICATION: Chronic Obstructive Pulmonary Disease (COPD); TARGET: Muscarinic acetylcholine receptor; THERAPY: Monotherapy; LEAD SPONSOR: Mylan Inc.; CRITERIA: Inclusion Criteria: - Subject is a male or female subject 40 years of age or older with a diagnosis of COPD. - Subject has a current or past cigarette smoking history (or equivalent for cigar or pipe smoking history) of at least 10 pack-years. - Subject is willing and able to provide signed and dated written informed consent to participate prior to initiation of any study related procedures. Exclusion Criteria: - Subject has a concurrent disease or condition that, in the opinion of the investigator, would interfere with continued study participation or confound the evaluation of safety and tolerability of the study drug. - Subject has a history of reactions or hypersensitivity to inhaled or nebulized anticholinergics. - Subject suffers from any medical condition that would preclude the use of inhaled anticholinergics, including narrow-angle glaucoma, symptomatic benign prostatic hyperplasia, bladder neck obstruction, or urinary retention. ; PRIMARY OUTCOME: Change From Baseline in Trough FEV1 on Day 29; SECONDARY OUTCOME 1: Change From Baseline Trough FVC (Forced Vital Capacity) on Day 29[/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 - 101-08; BRIEF: This study is to evaluate the safety and clinical activity of idelalisib alone and in combination with rituximab in patients with CLL or SLL. This Phase 2 study will be the first time that idelalisib is administered to previously untreated patients with hematologic malignancies. Idelalisib has demonstrated clinical activity as a single agent in relapsed or refractory CLL and SLL with acceptable toxicity, which supports its evaluation in previously untreated patients. The study population is limited to patients over 65 years of age because younger patients are generally appropriate for standard immunochemotherapy regimens that are highly active. Since the mechanism of action of idelalisib is distinct from rituximab, it is hypothesized that the combination will be more active than either agent alone. This study will establish initial safety and clinical activity of idelalisib in combination with rituximab in patients with CLL or SLL. Cohort 2 of this study will establish safety and clinical activity of idelalisib alone in subjects with untreated CLL or SLL. ; DRUG USED: Zydelig; DRUG CLASS: New Molecular Entity (NME); INDICATION: Chronic Lymphocytic Leukemia (CLL)/Small Cell Lymphocytic Lymphoma (SLL) - NHL; TARGET: p110 delta/PIK3CD, PI3K/AKT pathway; THERAPY: Combination; LEAD SPONSOR: Gilead Sciences; CRITERIA: Key Inclusion Criteria: - Histologically or cytologically confirmed CLL or SLL. - Age ≥ 65 - Presence of measurable lymphadenopathy (defined as the presence of ≥1 nodal lesion that measures ≥ 1.5 cm in the longest diameter (LD) and ≥ 1.0 cm in the longest perpendicular diameter (LPD) as assessed by physical exam, computed tomography (CT) or magnetic resonance imaging (MRI)). - CLL - Binet Stage C or Rai Stage III or IV or has active disease defined by meeting at least one of the following criteria: - Evidence of progressive marrow failure as manifested by the development of, or worsening of, anemia and/or thrombocytopenia - Massive (ie, > 6 cm below the left costal margin) or progressive or symptomatic splenomegaly - Massive nodes (ie, > 10 cm in longest diameter) or progressive or symptomatic lymphadenopathy - Progressive lymphocytosis with an increase of more than 50% over a 2-month period or lymphocyte doubling time of less than 6 months - Autoimmune anemia and/or thrombocytopenia poorly responsive to corticosteroids or other standard therapy - At least one of the following disease-related symptoms: - Unintentional weight loss ≥ 10% within the previous 6 months - Significant fatigue - Fevers > 100.4 F for ≥ 2 weeks without other evidence of infection - Night sweats for ≥ 1 month without evidence of infection - SLL - has active disease as defined above for CLL, except the lymphocytosis criterion does not apply - World Health Organization (WHO) Performance Status of ≤ 2 - For men of child-bearing potential, willing to use adequate methods of contraception for the entire duration of the study - Able to provide written informed consent Key Exclusion Criteria: - Prior therapy for CLL or SLL, except corticosteroids for symptom relief - Treatment with a short course of corticosteroids for symptom relief within 1-week prior to Visit 1 - Known active central nervous system involvement of the malignancy - Ongoing active, serious infection requiring systemic therapy. Patients may be receiving prophylactic antibiotics and antiviral therapy at the discretion of the treating physician. - Serum creatinine ≥ 2.0 mg/dL - Serum bilirubin ≥ 2 mg/dL (unless due to Gilberts syndrome) or serum transaminases (ie, aspartate aminotransferase (AST), alanine aminotransferase (ALT)) ≥ 2 x upper limit of normal - Positive test for human immunodeficiency virus (HIV) antibodies - Active hepatitis B or C (confirmed by ribonucleic acid (RNA) test). Patients with serologic evidence of prior exposure are eligible. - History of a non-CLL 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 study entry, other adequately treated Stage 1 or 2 cancer currently in complete remission, or any other cancer that has been in complete remission for ≥ 5 years. Note: Other protocol defined Inclusion/Exclusion criteria may apply. ; PRIMARY OUTCOME: Overall Response Rate (ORR); SECONDARY OUTCOME 1: Overall Safety of Idelalisib[/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 - SHIP; BRIEF: This is an open-label study to compare systemic exposure to triamcinolone acetonide following a dose of extended-release FX006 or immediate-release TAcs (triamcinolone acetonide suspension) in patients with osteoarthritis of the shoulder (glenohumeral joint) or hip ; DRUG USED: Zilretta; DRUG CLASS: Non-NME; INDICATION: Osteoarthritis and Osteoarthritis Pain; TARGET: Glucocorticoid Receptor (GR); THERAPY: Monotherapy; LEAD SPONSOR: Pacira Pharmaceuticals, Inc; CRITERIA: Inclusion Criteria: - Written consent to participate in the study - Male or female greater than or equal to 40 years of age - Body mass index (BMI) less than or equal to 40 kg/m2 - Ambulatory and in good general health - Willing and able to comply with the study procedures and visit schedules and able to follow verbal and written instructions - Willing to abstain from use of protocol-restricted treatments from Screening through End-of-Study visit - Symptoms consistent with OA of the index joint for ≥ 6 months prior to Screening (patient reported is acceptable) - Pain in the index joint for greater than15 days over the last month (as reported by the patient) - For Shoulder OA patients: Radiologic findings of OA of the index shoulder meeting the Samilson-Prieto (S-P) Classification Grades 2 or 3 - For Hip OA patients: ACR Criteria (clinical and radiological) for OA of the index hip Exclusion Criteria: - Reactive arthritis, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or arthritis associated with inflammatory bowel disease - History of infection in the index joint - Clinical findings consistent with active infection or crystal disease in the index joint within 1 month of Screening - History of fracture in the index limb within 12 months of Screening, or fracture with sequelae at any time - Planned or anticipated surgery of the index joint during the study period - Index joint instability or history of acute dislocation within 12 months of Screening - If shoulder is the index joint, history of full or partial rotator cuff tear or significantly compromised rotator cuff function that, in the opinion for the Investigator, increases the difficulty or risk of IA injection - Presence of surgical hardware or other foreign body in the index joint - Surgery or arthroscopy of the index joint within 12 months of Screening - IA treatment of any joint with any of the following agents within 6 months of Screening: - Any corticosteroid preparation (investigational or marketed, including FX006), any biologic agent (e.g., platelet rich plasma (PRP) injection, stem cells, prolotherapy, amniotic fluid injection; investigational or marketed) - IA treatment of the index joint with hyaluronic acid (investigational or marketed) within 6 months of Screening - Parenteral or oral corticosteroids (investigational or marketed) within 3 months of Screening - Inhaled, intranasal or topical corticosteroids (investigational or marketed) within 2 weeks of Screening - Females who are pregnant or nursing or plan to become pregnant during the study; men who plan to conceive during the study ; PRIMARY OUTCOME: Concentration of Triamcinolone Acetonide (TA) in Blood Plasma; 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 - PCYC-1106-CA - DLBCL; BRIEF: The purpose of this study is to evaluate the efficacy of ibrutinib (PCI-32765) in relapsed/refractory de novo activated B-cell (ABC) and germinal-cell B-Cell (GCB) Diffuse Large B-cell Lymphoma (DLBCL). ; DRUG USED: Imbruvica; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diffuse Large B-Cell Lymphoma (DLBCL) - NHL; TARGET: Brutons Tyrosine Kinase (BTK), Interleukin-2-inducible T-cell kinase (ITK); THERAPY: Monotherapy; LEAD SPONSOR: Pharmacyclics LLC.; CRITERIA: Inclusion Criteria: 1. Men and women ≥ 18 years of age. 2. ECOG performance status ≤ 2. 3. Pathologically confirmed de novo DLBCL 4. Subjects must have available tissue for central pathology review to be eligible. Treatment Group 2: Subjects will be eligible if they have the non-GCB phenotype, as confirmed by Central IHC testing by the Hans method. 5. Relapsed or refractory disease, defined as either: 1) recurrence of disease after a CR, or 2) PR, SD, or progressive disease (PD) at completion of the treatment regimen preceding entry to the study (residual disease): Subjects must have previously received an appropriate first-line treatment regimen. Subjects who have not received HDT/ASCT must be ineligible for HDT/ASCT 6. Treatment Group 1: Subjects must have ≥ 1 measurable (> 2 cm in longest dimension) disease sites on CT scan. Treatment Group 2: Subjects must have ≥ 1 measurable (> 1.5 cm in longest dimension) disease sites on CT scan. Exclusion Criteria: 1. Transformed DLBCL or DLBCL with coexistent histologies (eg, FL or MALT). 2. Primary mediastinal (thymic) large B-cell lymphoma. 3. Known central nervous system lymphoma. In addition, for subjects in Treatment Group 2, known leptomeningeal involvement is exclusionary. 4. Certain exclusions on prior therapy 5. Major surgery within 2 weeks of first dose of study drug. 6. Any of the following laboratory abnormalities: 1. ANC < 0.75 x 10^9/L. Treatment Group 2: Eligible subjects must be independent of growth factor support for 7 days prior to the screening lab tests. 2. Platelet count < 50 x 10^9/L independent of transfusion support. Treatment Group 2 only: Eligible subjects must be independent of transfusion support for 7 days prior to the screening lab tests. 3. AST or ALT ≥ 3.0 x upper limit of normal (ULN) 4. Creatinine > 2.0 x ULN 5. Treatment Group 2 only: Hemoglobin < 8.0 g/dL 6. Treatment Group 2 only: Total Bilirubin > 1.5 x ULN 7. Requires or has received anticoagulation treatment with warfarin or equivalent Vitamin K antagonists (eg, phenprocoumon) 8. Treatment Group 2: Requires treatment with a strong cytochrome P450 (CYP) 3A4/5 inhibitor 9. Treatment Group 2: Known bleeding diathesis, eg, von Willebrands disease, hemophilia. ; PRIMARY OUTCOME: Percentage of Patients With an Overall Response to Study Drug; SECONDARY OUTCOME 1: Number of Patients With Adverse Events as a Measure of Safety and Tolerability[/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 - w/Bortezomib/Dexamethasone; BRIEF: Phase 1(a & b): To evaluate the side effects and determine the best dose of oral ACY-1215 as monotherapy, and also in combination with bortezomib and dexamethasone in patients with relapsed or relapsed/refractory multiple myeloma. Phase 2a: To determine the objective response rate of oral ACY-1215 in combination with bortezomib and dexamethasone in patients with relapsed or relapsed/refractory multiple myeloma. ; DRUG USED: Ricolinostat; DRUG CLASS: New Molecular Entity (NME); INDICATION: Multiple Myeloma (MM); TARGET: Histone Deacetylase (HDAC); THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: Celgene; CRITERIA: Inclusion Criteria: - Patient has relapsed or relapsed/refractory MM with measurable disease parameters according to the International Myeloma Working Group (IMWG) Criteria - Refractory is defined as experiencing less than minimal response (MR) to or progressive disease (PD) within 60 days after completion of the most recent anti-MM regimen - Relapsed is defined as experiencing PD that requires therapy but which is not refractory following the achievement of stable disease (SD) or better to the most recent anti-MM regimen. - Patient received at least 2 prior regimens for MM. - Patient received prior treatment for MM with a proteasome inhibitor and an immunomodulatory drug, unless not a candidate for a proteasome inhibitor or an immunomodulatory drug. - Patient either is not a candidate for autologous stem cell transplant (ASCT), has declined the option of ASCT, or has relapsed after prior ASCT. - Patient is ≥18 years of age. - Patient has a Karnofsky Performance Status score of ≥70 - Patient has adequate bone marrow reserve, as evidenced by: - Absolute neutrophil count (ANC) of ≥1.0x109/L. - Platelet count of ≥ 75x109/L in patients in whom <50% of bone marrow nucleated cells are plasma cells and ≥50x109/L in patients in whom more than 50% of bone marrow nucleated cells are plasma cells. - Patient has adequate renal function (calculated creatinine clearance of ≥30 mL/min according to the Cockroft-Gault) - Patient has adequate hepatic function (serum bilirubin values <2.0 mg/dL and ALT and/or AST values <3 × the upper limit of normal ULN). - Patient has a corrected serum calcium ≤ULN. Exclusion Criteria - Patient has received any of the following therapies: - Radiotherapy or systemic therapy within 2 weeks of baseline - Prior peripheral autologous stem cell transplant within 12 wks of Baseline. - Prior allogeneic stem cell transplant. - Prior treatment with an HDAC inhibitor. - Patient has an active systemic infection requiring treatment. - Patient has a history of other malignancies unless has undergone definitive treatment more than 5 yrs prior to study and without evidence of recurrent malignant disease (excluding basal cell carcinoma of the skin; superficial carcinoma of the bladder; carcinoma of the prostate with a current prostate-specific antigen <0.1 ng/mL; or cervical intraepithelial neoplasia). - Patient has known or suspected HIV, positive for hepatitis B or is known or suspected to have active hepatitis C infection. - Patient has a history of significant cardiovascular, neurological, endocrine, gastrointestinal, respiratory, or inflammatory illness including recent myocardial infarction (within 6 months)or stroke; hypertension requiring >2 medications for adequate control; diabetes mellitus with >2 episodes of ketoacidosis in the preceding 12 months; or chronic obstructive pulmonary disease (COPD) requiring >2 hospitalizations in the preceding 12 months. - Patient has a QTcF value of >480 msec; family or personal history of long QTc syndrome or ventricular arrhythmias including ventricular bigeminy; previous history of drug-induced QTc prolongation - Patient has > Grade 2 painful neuropathy or peripheral neuropathy - Patient has a history of allergic reaction attributable to bortezomib or other compounds containing boron or mannitol (Phase 1b and 2a only) ; PRIMARY OUTCOME: Phase 1 (a & b): To determine the maximum tolerated dose of ACY-1215 as monotherapy or in combination with bortezomib and dexamethasone in patients with relapsed or relapsed/refractory multiple myeloma.; SECONDARY OUTCOME 1: Characterize the safety of ACY-1215 alone or in combination with bortezomib and dexamethasone in patients with relapsed or relapsed/refractory multiple myeloma[/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 - AURORA; BRIEF: The purpose of this study is to assess the efficacy of voclosporin compared with placebo in achieving renal response after 52 weeks of therapy in subjects with active lupus nephritis. ; DRUG USED: Lupkynis; DRUG CLASS: New Molecular Entity (NME); INDICATION: Lupus Nephritis; TARGET: Calcineurin phosphatase ; THERAPY: Monotherapy; LEAD SPONSOR: Aurinia Pharmaceuticals Inc.; CRITERIA: Key Inclusion Criteria: - Subjects with evidence of active nephritis, defined as follows: - Kidney biopsy result within 2 years prior to screening indicating Class III, IV-S, IV-G (alone or in combination with Class V), or Class V LN with a doubling or greater increase of UPCR within the last 6 months to a minimum of ≥1.5 mg/mg for Class III/IV or to a minimum of ≥2 mg/mg for Class V at screening. Biopsy results over 6 months prior to screening must be reviewed with a medical monitor to confirm eligibility. OR - Kidney biopsy result within 6 months prior to screening indicating Class III, IV-S or IV-G (alone or in combination with Class V) LN with a UPCR of ≥1.5 mg/mg at screening. OR - Kidney biopsy result within 6 months prior to screening indicating Class V LN and a UPCR of ≥2 mg/mg at screening. - Women of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test at baseline. Exclusion Criteria: - Estimated glomerular filtration rate (eGFR) of ≤45 mL/minute at screening. - Current or medical history of: - Congenital or acquired immunodeficiency. - In the opinion of the Investigator, clinically significant drug or alcohol abuse within 2 years prior to screening. - Malignancy within 5 years of screening, with the exception of basal and squamous cell carcinomas treated by complete excision. - Lymphoproliferative disease or previous total lymphoid irradiation. - Severe viral infection or known HIV infection. - Active tuberculosis (TB), or known history of TB/evidence of old TB if not taking prophylaxis with isoniazid. - Other known clinically significant active medical conditions, such as: - Severe cardiovascular disease, liver dysfunction or chronic obstructive pulmonary disease or asthma requiring oral steroids or any other overlapping autoimmune condition for which the condition or the treatment of the condition may affect the study assessments or outcomes. ; PRIMARY OUTCOME: Number of Participants With Adjudicated Renal Response at Week 52; SECONDARY OUTCOME 1: Number of Participants With Reduction in Urine Protein Creatinine Ratio to 0.5 mg/mg or Less[/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 - Europe; BRIEF: This study will explore the relationship of different DEB025 doses in combination with RBV to pharmacokinetic, pharmacodynamic (i.e. viral load reduction) and safety profiles in chronic hepatitis C GT 2 and 3 treatment naïve patients. ; DRUG USED: Debio 025; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hepatitis C (HCV) (Antiviral); TARGET: Cyclophilin; THERAPY: Monotherapy; LEAD SPONSOR: Debiopharm International SA; CRITERIA: Inclusion Criteria: 1. Written informed consent must be obtained before any assessment is performed. 2. No previous treatment for Hepatitis C (HCV) infection (i.e. HCV treatment-naïve) 3. Chronic hepatitis C (G2 or G3) virus infection diagnosed Exclusion criteria: 1. Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of that medication before enrollment. 2. History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes 3. Hepatitis B Surface Antigen (HBsAg) positive 4. Human immunodeficiency virus (HIV) positive. - ; PRIMARY OUTCOME: Viral load drop from baseline through Week 12; SECONDARY OUTCOME 1: Number of participants with Sustained Virologic Response at Week 12 follow-up (SVR12)[/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 - ION; BRIEF: The study objectives are to assess any changes in visual acuity and visual field observed following the administration of RPh201 during an overall treatment period of at least 13 consecutive weeks with an option to extended the treatment phase to another 13 weeks (26 weeks total), and at the follow-up visit at 3 month after end of treatment in patients with optic nerve neuropathy. ; DRUG USED: RPh201; DRUG CLASS: Biologic; INDICATION: Optic Neuritis (Ophthalmology); TARGET: Myelin; THERAPY: Monotherapy; LEAD SPONSOR: Regenera Pharma Ltd; CRITERIA: Inclusion Criteria: 1. Participants, either men or women are ≥ 18 years of age. 2. Diagnosis of ischemic optic neuropathy unilateral or bilateral: 1. Traumatic Neuropathy 2. Ischemic optic neuropathy - Non Arteritic Ischemic Neuropathy (NAION) 3. Corrected Visual acuity equal or worse than 6/60 or visual field of less than 15 degrees or both. 4. Field of view with a reduction from 10 degrees to one quarter situations functions. 5. Participant understands the nature of the procedure and provides written informed consent prior to any study procedure. 6. Women of child bearing potential must use adequate birth-control precautions. Exclusion Criteria: 1. Glaucoma 2. Neuropathy caused by tumors. 3. Neuropathy caused by infections 4. Mitochondrial optic neuropathies 5. Nutritional, Radiation, Toxic optic neuropathies 6. Retinal diabetic complications 7. Hereditary optic neuropathies 8. Patients with complete SCOTOMA beyond three quarters. 9. Clinical evidence for presence of infection. 10. Patient is receiving, or has received within one month prior to enrollment corticosteroids, immunosuppressive drugs, cytotoxic agents, radiation therapy and chemotherapy. 11. Patient has a history of alcohol or drug abuse within the last two years. 12. Female patients who are pregnant or nursing, or of childbearing potential and are not using adequate contraception. 13. Participation in another clinical trial within 60 days prior to the Screening Visit or during this study. 14. Clinically significant and/or uncontrolled condition or other significant medical disease 15. Clinically significant uncontrolled retinal disease (AMD) ; PRIMARY OUTCOME: Mean Increase From Baseline in ETDRS Letters Read at 26 Weeks and Off-drug Follow-up Visit; SECONDARY OUTCOME 1: Number of Participants With Adverse Events Assessed by Vital Signs, Clinical Laboratory and Physical Exam[/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 - DAV-CL002; BRIEF: The purpose of this study is evaluate the safety and tolerability of Diannexin in kidney transplant recipients. ; DRUG USED: ASP8597; DRUG CLASS: Biologic; INDICATION: Kidney Transplant Rejection; TARGET: Phosphatidylserine; THERAPY: Monotherapy; LEAD SPONSOR: Alavita Pharmaceuticals Inc; CRITERIA: Inclusion Criteria: - Scheduled to receive a kidney transplant from a deceased expanded criterion donor (ECD) or a donor cardiac death (DCD) donor that was exposed to no more than 36 hr of cold ischemia prior to transplantation, or scheduled to receive a kidney transplant from a standard criterion donor (SCD) that was exposed to 24-36 hr of cold ischemia prior to transplantation - Willing to use adequate contraception for at least 4 weeks after dosing - Willing and able to provide written Informed Consent and to comply with the requirements of the study Exclusion Criteria: - If female, subject is pregnant or lactating - Known bleeding diathesis - INR at Screening > 1.5 - Platelet count at Screening below LLN and judged clinically significant - Use of Plavix, anticoagulants other than aspirin, antithrombotics, and/or blood-thinning agents within 10 days prior to study entry - Previous receipt of an organ transplant - Will receive concurrent transplant of any additional organ(s) - Clinically significant active infection at study entry - Surgery within 2 weeks prior to study entry - Believed to have used an illicit drug and/or abused alcohol within 3 months prior to study entry - Presence of a psychiatric illness that might interfere with study participation - Cancer, other than basal cell or squamous cell cancer of the skin, within 2 years prior to study entry - Scheduled to receive a kidney transplant from a low risk donor - Currently participation, or participated within 30 days prior to study entry, in an investigational drug study - Known allergy to kanamycin - History or presence of any medical condition or disease that could place the subject an unacceptable risk for study participation ; PRIMARY OUTCOME: Safety assessments -- physical examinations, vital signs, clinical safety laboratory tests, ECGs, immunogenicity testing, adverse events; SECONDARY OUTCOME 1: Population 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 I/II - MF, Post PV/ET; BRIEF: This study seeks to (i) determine a safe and tolerated dose of CYT387 (momelotinib) given to patients with PMF, post-PV or post-ET and, (ii) assess the effectiveness of orally-administered CYT387 as a treatment for PMF, post-PV or post-ET. ; DRUG USED: Momelotinib; DRUG CLASS: New Molecular Entity (NME); INDICATION: Myelofibrosis (MF); TARGET: ALK-2 (activin receptor-like kinase-2)/Activin A receptor, type I (ACVR1), JAK/STAT ; THERAPY: Monotherapy; LEAD SPONSOR: Sierra Oncology LLC - a GSK company; CRITERIA: Inclusion Criteria: - Diagnosis of PMF or post-polycythemia Vera (PV) or post-essential Thrombocythemia (ET) MF as per revised World Health Organization (WHO) criteria. - High-risk or Intermediate-2 risk MF (as defined by the International Prognostic Scoring System [IPSS]; Appendix 13.6); or intermediate-I risk MF (IPSS) associated with symptomatic splenomegaly/hepatomegaly and/or unresponsive to available therapy. - Must be at least 18 years of age with life expectancy of ≥ 12 weeks. - Must be able to provide informed consent and be willing to sign an informed consent form. - Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2. - Must have evidence of acceptable organ function within 7 days of initiating study drug as evidenced by the following: - Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤ 2.5 x upper limit of normal (ULN) (or ≤ 5 x ULN if in the investigators opinion the elevation is due to extramedullary hematopoiesis) - Bilirubin ≤ 2.0 x ULN or direct bilirubin < 1.0 - Serum creatinine ≤ 2.5 x ULN - Absolute neutrophil count ≥ 500/µL - Platelet count ≥ 50,000/µL - Females of childbearing potential must have a negative pregnancy test within 4 days of initiating study drug. Exclusion Criteria: - Any chemotherapy (eg, hydroxyurea), immunomodulatory drug therapy (eg, thalidomide), immunosuppressive therapy, corticosteroids > 10 mg/day prednisone or equivalent, or growth factor treatment (eg, erythropoietin) within 14 days prior to initiation of study drug. - Incomplete recovery from major surgery within four weeks of study entry. - Radiation therapy within four weeks of study entry. - Women of childbearing potential, unless surgically sterile for at least 3 months (ie, hysterectomy), OR postmenopausal for at least 12 months (FSH > 30 U/mL), OR unless they agree to take appropriate precautions to avoid pregnancy (with at least 99% certainty) from screening through end of study. Permitted methods for preventing pregnancy must be communicated to study subjects and their understanding confirmed. - Men who partner with a woman of childbearing potential, unless they agree to take appropriate precautions to avoid pregnancy (with at least 99% certainty) from screening through to the end of study. Permitted methods for preventing pregnancy must be communicated to study subjects and their understanding confirmed. - Females who are pregnant or are currently breastfeeding. - Known positive status for HIV. - Clinically active hepatitis B or C. - Diagnosis of another malignancy unless free of disease for at least three years following therapy with curative intent. Patients with early-stage basal cell or squamous cell skin cancer, cervical intraepithelial neoplasia, cervical carcinoma in situ or superficial bladder cancer may be eligible to participate at the Investigators discretion. - Any acute active infection. - Cardiac dysrhythmias requiring treatment, or prolongation of the QTc (Fridericia) interval to > 450 msec for males or > 470 msec for females at prestudy screening, unless attributable to pre-existing bundle branch block. - Presence of ≥ Grade 2 peripheral neuropathy. - Uncontrolled congestive heart failure (New York Heart Association Classification 3 or 4), uncontrolled or unstable angina, myocardial infarction, cerebrovascular accident, or pulmonary embolism within 3 months prior to initiation of study drug. - Uncontrolled inter current illness or any concurrent condition that, in the Investigators opinion, would jeopardize the safety of the patient or compliance with the protocol. ; PRIMARY OUTCOME: Safety and tolerability, dose-limiting toxicities (DLTs) and maximum tolerated dose (MTD) of orally-administered CYT387 in patients with PMF or post-ET/PV MF.; SECONDARY OUTCOME 1: Effect of CYT387 on bone marrow or peripheral blood cytogenetic findings in patients with PMF or post-ET/PV MF.[/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 - 004 - vs. DuraSite; BRIEF: The purpose of this study is to evaluate the ocular safety, tolerability and efficacy of topical administration of ISV-303 compared with Durasite Vehicle. ; DRUG USED: BromSite; DRUG CLASS: Non-NME; INDICATION: Ocular Pain and/or Inflammation (Ophthalmology); TARGET: Cyclooxygenases (COX-1, COX-2, and COX-3); THERAPY: Monotherapy; LEAD SPONSOR: Sun Pharmaceutical Industries Limited; CRITERIA: Inclusion Criteria: - Male or female subjects age 18 or older scheduled for unilateral cataract surgery with posterior chamber intraocular lens implantation - If a female is of childbearing potential, the subject must agree to and submit a negative pregnancy test before any protocol-specific procedures are conducted. The subject must use effective contraception for the duration of the study. Post menopausal is defined as having no menses for at least 12 consecutive months - Signature of the subject on the Informed Consent Form - Willing to avoid disallowed medications for the duration of the study - Willing and able to follow all instructions and attend all study visits - Able to self-administer the IMP (or have a caregiver available to instill all doses of study drugs ) - Additional inclusion criteria also apply Exclusion Criteria: - Known hypersensitivity or poor tolerance to bromfenac sodium or any component of the IMP or any of the procedural medications - Currently pregnant, nursing, or planning a pregnancy; or be a woman that has a positive pregnancy test - Currently suffer from alcohol and/or drug abuse - Prior (within 30 days of beginning study treatment) or anticipated concurrent use of an investigational drug or device - A condition or a situation, which in the investigators opinion may put the subject at increased risk, confound study data, or interfere significantly with the subjects study participation - Additional inclusion criteria also apply ; PRIMARY OUTCOME: Ocular Inflammation; 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 - EUREKA; BRIEF: It is anticipated that 548 subjects will be recruited from approximately 27 centres in South Korea. This is an investigator-sponsored, double-blind, placebo-controlled, randomized, multi-centre study to assess the effects of rosuvastatin 20 mg compared to placebo in acute ischemic stroke patients, with the first dose within 18 hours after baseline MRI and continued treatment for 14 days. Subjects will be male or female, over 20 years, with diagnosis of acute ischemic stroke with baseline MRI, and who are either statin-naïve or untreated with statin for the previous 3 months. The objective would be to compare the recurrence rate of ischemic stroke by comparing the imaging parameters during 14 days of treatment and clinical improvement as defined by percent improvement based on NIHSS scores measurements at baseline, 5 days and 14 days of treatment. ; DRUG USED: Crestor; DRUG CLASS: New Molecular Entity (NME); INDICATION: Dyslipidemia / Hypercholesterolemia; TARGET: HMG CoA Reductase (HMGR); THERAPY: Monotherapy; LEAD SPONSOR: Severance Hospital; CRITERIA: Inclusion Criteria: 1. Male or female over 20 years of age 2. Ischemic stroke patients who were undertaken MRI within 48 hrs after onset of symptoms 3. Patients underwent baseline MRI (DWI, FLAIR, GRE and MRA) 4. Ischemic stroke patients with any degree of stenosis on the relevant artery of atherothrombotic origin appearing on DWI through MRA or CTA 5. Statin-naïve (untreated with statin for the past 3 months) Exclusion Criteria: 1. Hemorrhagic stroke/ history of symptomatic hemorrhagic stroke. 2. Presence of high-risk potential cardiac sources of embolism based on the TOAST classification or other determined etiology of stroke at the time of enrollment. 3. Known major hematologic, neoplastic, metabolic, gastrointestinal or endocrine dysfunction which, in the judgment of the Investigator, may affect the subjects ability to complete the study. 4. History of malignancy, except in subjects who have been disease-free >5 years or whose only malignancy has been basal or squamous cell skin carcinoma. 5. Life-threatening illness indicating the subject is not expected to survive for at least 2 years. 6. Secondary causes of nephrotic syndrome, and/or renal dysfunction (serum creatinine >2.0 mg/dL [177 mmol/L]) at screening. 7. Significant medical or psychological condition that, in the opinion of the Investigator, would compromise the subjects safety or successful participation in the study. 8. Unreliability as a study participant based on the Investigators knowledge of the subject, such as drug or alcohol abuse. 9. Pregnant or lactating women or women of childbearing potential who were not protected from pregnancy by an accepted method of contraception, such as the oral contraceptive pill, an intrauterine device or surgical sterilization 10. Uncontrolled hypertension defined as either a resting diastolic blood pressure of >110 mmHg or a resting systolic blood pressure of >185 mmHg recorded at screening despite blood pressure lowering therapy. 11. Clinically significant heart disease which, in the opinion of the Principal Investigator (or designee), is likely to require coronary bypass surgery, cardiac transplantation, surgical repair and/or replacement during the course of the study. 12. Subjects who have symptoms consistent with moderate or greater severity of] congestive heart failure (CHF) (New York Heart Association [NYHA] Class III or IV), or whose most recent determination of left ventricular ejection fraction (LVEF) is <0.35. 13. Triglyceride (TG) level of greater than 500 mg/dL at screening. 14. LDL level of greater than 190 mg/dL at screening. 15. Creatine kinase (CK) >3 times the upper limit of the normal (ULN) range at screening, because of the potential of statins to cause muscle abnormalities. 16. Active liver disease or hepatic dysfunction, as determined by aspartate aminotransferase (AST [SGOT]), alanine aminotransferase (ALT [SGPT]) or bilirubin levels >3 x ULN at screening, because of the potential of statins to cause disturbances in liver function. 17. Uncontrolled primary hypothyroidism (defined as thyroid stimulating hormone [TSH] >1.5 x ULN. 18. Modified Rankin scale score 4 to 6 before stroke. 19. Participation in any investigational clinical study for drug or device within 30 days prior to study entry or expectation to participate in any other investigational clinical study for drug or device during the course of this study. 20. Patients who may need conventional angiography or intervention within 14 days after enrollment. 21. Known serious hypersensitivity reactions to HMG-CoA reductase inhibitors. 22. Use of any medication listed in the Prohibited Medications Section 23. History of myopathy. 24. Patients who has Galactose intolerance,lactose intolerance,Glucose- Galactose absorption problem. ; PRIMARY OUTCOME: Presence Of Newly Developed DWI Lesions; SECONDARY OUTCOME 1: Volume Of DWI Lesions With Percent Improvement Of NIHSS Score[/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 - Long-Term Extension; BRIEF: Patients who were previously enrolled in Study IMM-101-001 and who provided informed consent were eligible to participate in this study. Once eligibility was confirmed, a full medical history covering the period from completion of Study IMM-101-001 to date was taken. The treatment regimen with IMM-101 was one dose given every 4 weeks or as close to this interval as permitted due to practical or logistic considerations. The dose interval could be modified at the discretion of the Investigator provided the minimum period between doses was no less than 14 days. The overall objective was to determine the long term safety profile of IMM-101 administered intradermally for extended use. ; DRUG USED: IMM-101; DRUG CLASS: Biologic; INDICATION: Melanoma; TARGET: Immune System; THERAPY: Monotherapy; LEAD SPONSOR: Immodulon Therapeutics Ltd; CRITERIA: Inclusion Criteria: - Patient was previously enrolled in Study IMM-101-001 - Patient gave consent to make their disease and treatment history for the intervening period between their completion of Study IMM-101-001 and enrollment in this study available to the Sponsor - Patient gave signed informed consent for participation in the study Exclusion Criteria: - Female patient of child-bearing potential who was not, in the opinion of the Investigator, using an approved method of birth control (e.g., physical barrier [patient and partner], contraceptive pill or patch, spermicide and barrier, or intrauterine device [IUD]). Those patients that utilised hormonal contraceptives must have used the same method for at least three months before additional barrier contraception (as described above) was discontinued from being used concomitantly with the hormonal contraception. - Patient of non-child-bearing potential were defined as having 12 month amenorrhoea or were surgically sterile. - Female patient who was pregnant, breast feeding or planning a pregnancy during the course of the study. A pre-treatment urine pregnancy test measuring human chorionic gonadotrophin (hCG) must be negative. - Patient was unable or unwilling to comply with the protocol. ; PRIMARY OUTCOME: Adverse Events With a Causal Relationship to IMM-101; SECONDARY OUTCOME 1: Survival[/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 - FIRST; BRIEF: The purpose of the study is to evaluate the safety and efficacy of intravenous (IV) ferumoxytol compared to IV iron sucrose for the treatment of iron deficiency anemia (IDA) in participants with chronic kidney disease (CKD). ; DRUG USED: Feraheme; DRUG CLASS: Non-NME; INDICATION: Anemia Due to Chronic Renal Failure, Dialysis-Independent; TARGET: Iron; THERAPY: Monotherapy; LEAD SPONSOR: AMAG Pharmaceuticals, Inc.; CRITERIA: Inclusion Criteria: Key Inclusion Criteria include: 1. Males and females ≥18 years of age 2. An estimated glomerular filtration rate <60 mL/minute or a diagnosis of CKD (such as nephropathy, nephritis) 3. Hemoglobin <11.0 g/deciliter (dL) 4. Transferrin saturation <30% 5. Hemodialysis participants on maintenance dialysis for at least 3 months prior to screening and currently receiving dialysis 3 times per week 6. Female participants of childbearing potential who are sexually active must be on an effective method of birth control for at least 1 month prior to screening and agree to remain on birth control until completion of the study Exclusion Criteria: Key Exclusion Criteria include: 1. History of allergy to IV iron 2. Allergy to 2 or more classes of drugs 3. Female participants who are pregnant or intend to become pregnant, breastfeeding, within 3 months postpartum, or have a positive serum or urine pregnancy test 4. Hemoglobin ≤7.0 g/dL 5. Received another investigational agent within 4 weeks prior to screening, or planned receipt of an unspecified investigational agent during the study period 6. Known causes of anemia other than iron deficiency (such as hemolysis and vitamin B12 or folate deficiency) ; PRIMARY OUTCOME: Mean Change In Hemoglobin From Baseline (Day 1) To Week 5; 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 - Adults; BRIEF: The study will consist of a Screening period (up to 14 days), a Treatment period, and a Follow-Up period. Sixteen subjects will be enrolled into two sequential dose cohorts - 10 or 30 mg (or matching placebo) across four study centers. ; DRUG USED: STX107; DRUG CLASS: New Molecular Entity (NME); INDICATION: Fragile X Syndrome; TARGET: Metabotropic Glutamate Receptor subtype 5 (mGluR5); THERAPY: Monotherapy; LEAD SPONSOR: Seaside Therapeutics, Inc.; CRITERIA: Inclusion Criteria: - Male subjects 18 to 50 years of age, inclusive. - Molecular documentation of the full fragile X mutation. Exclusion Criteria: - Subjects with a history of seizure disorder who are, in the opinion of the Investigator and Medical Monitor, not currently considered to be well controlled. - Subjects currently being treated with psychoactive medications (including stimulants and anxiolytics). - Subjects with any condition, including alcohol and drug abuse, which might interfere with the conduct of the study, confound interpretation of the study results, or endanger their own well-being. 4. Subjects who plan to initiate or change pharmacologic or non-pharmacologic interventions during the course of the study. - Subjects who, in the Investigators opinion, might not be suitable for the study ; PRIMARY OUTCOME: Adverse events will be monitored for tolerability; SECONDARY OUTCOME 1: Blood levels of STX107 will be measured to define pharmacokinetics[/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 - US; BRIEF: The purpose of this study is to assess the efficacy (decrease in profound fatigue), safety and pharmacokinetics of RSLV-132 in subjects with long Corona Virus (COVID) syndome ; DRUG USED: RSLV-132; DRUG CLASS: Biologic; INDICATION: COVID-19 Treatment; TARGET: Immune System, Interferon-alpha (IFNa), RNA; THERAPY: Monotherapy; LEAD SPONSOR: Resolve Therapeutics; CRITERIA: Inclusion Criteria: - Laboratory-confirmed novel coronavirus (SARS-CoV-2) infection as determined by qualitative Polymerase Chain Reaction (PCR) at least 24 weeks prior to Baseline - PROMIS Fatigue SF 7a raw score of 21 or greater at Screening (confirm onset of fatigue was post-infection) - Able to communicate and able to provide valid, written informed consent - Ages 18 to 75 inclusive - Minimum weight of 45 kg - Female participants shall be either of non-child-bearing potential (permanently sterilized by bilateral tubal occlusion, hysterectomy, or bilateral salpingectomy), or menopausal (more than one year since last menstrual cycle and confirmed by blood FSH levels > 22 mIU/mL) OR practicing highly effective contraception (e.g., oral (but not including progestogen-only oral contraceptives), injectable, implantable or transdermal contraceptives, a non-hormonal intrauterine device [IUD] or an intrauterine hormone releasing system [IUS]) for at least 2 months prior to dosing and until 125 days after the last dose. In terms of sexual relations, female participants not practicing highly effective contraception as described above should abstain or only engage with male partners who are sterile or vasectomized. Female participants of child-bearing potential will also be required to have a negative serum pregnancy test [beta human chorionic gonadotropin [ß-hCG]) at Screening and negative pregnancy urine test at Baseline. Female participants must agree not to donate eggs from the first dose until 125 days after the last dose - Male participants, who are not sterile or vasectomized, must agree to abstain or only engage with female partners who use highly effective contraception from the first dose until 125 days after the last dose. Male participants must also agree not to donate sperm from the first dose until 125 days after the last dose Exclusion Criteria: - Previous admission to the intensive care unit for COVID-19-related symptoms - Presence of orthostatic hypotension or tachycardia at Screening - Completion of COVID-19 vaccination less than 4 weeks of Baseline (i.e., 4 weeks after the second dose of a two-dose vaccine or 4 weeks after a single dose vaccine) - Use of therapies to treat COVID-19 symptoms such as remdesivir, dexamethasone (or any other corticosteroid), or convalescent plasma within 14 days of Baseline - Use of concomitant medications that are sedating - Screening lab abnormalities that may cause fatigue such as severe anemia or hypocalcaemia - History of anaphylaxis to a medication, diet, or environmental exposure such as bee sting - Previous diagnosis of chronic fatigue syndrome, fibromyalgia, lupus, Sjogrens syndrome, or postural orthostatic tachycardia syndrome (POTS) - Previous diagnosis of sleep apnea - Participation in another clinical study with receipt of an investigational product within 3 months or 5 half- lives, of last administration (whichever is longer) from Baseline - The presence of a clinically significant infection in the judgement of the Investigator, within seven days of Baseline - Positive test for hepatitis B, C, or HIV at Screening - Positive pregnancy test at Screening or Baseline - Female subjects currently pregnant or breast feeding at Baseline - Inability or unwillingness to comply with protocol-specified procedures which, in the opinion of the Investigator, would make the subject unsuitable for study participation ; PRIMARY OUTCOME: PROMIS Fatigue SF 7a T-score; SECONDARY OUTCOME 1: FACIT Fatigue questionnaire[/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 VEGA-1 (Presbyopia); BRIEF: The objectives of this study are: To evaluate the efficacy of Nyxol + Pilocarpine to improve DCNVA in subjects with presbyopia ; DRUG USED: Nyxol; DRUG CLASS: Non-NME; INDICATION: Other Ophthalmological Indications (Ophthalmology); TARGET: Alpha 1 Adrenergic Receptor , Alpha 2 Adrenergic Receptor; THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: Ocuphire Pharma, Inc.; CRITERIA: Inclusion Criteria: 1. Males or females ≥ 40 and ≤ 64years of age. 2. BCDVA of 0.0 LogMAR(20/20 Snellen equivalent) or better in each eye under photopic conditions. 3. DCNVA of 0.4 LogMAR (20/50 Snellen equivalent) or worse under photopic conditions in each eye and binocularly. 4. Subjects who depend on reading glasses or bifocals in which their binocular best-corrected near VA is 0.1 LogMAR (20/25 Snellen equivalent) or better. Exclusion Criteria: Ophthalmic (in either eye): 1. Use of any topical prescription or OTC ophthalmic medications of any kind within 7 days of Screening until study completion. 2. Use of any over-the-counter (OTC) artificial tears (preserved or unpreserved) at least once per day within 7 days of Screening until study completion. 3. Current use of any topical ophthalmic therapy for dry eye. 4. Tear break-up time of < 5 seconds or corneal fluorescein staining. 5. Clinically significant ocular disease that might interfere with the study as deemed by the Investigator. 6. Recent or current evidence of ocular infection or inflammation in either eye. 7. Any history of herpes simplex or herpes zoster keratitis. 8. History of diabetic retinopathy or diabetic macular edema. 9. Known allergy, hypersensitivity, or contraindication to any component of the phentolamine, pilocarpine, or vehicle formulations. 10. History of cauterization of the punctum or punctal plug (silicone or collagen) insertion or removal. 11. Ocular trauma, ocular surgery, ocular laser treatment within the 6 months prior to Screening. Any subject with multifocal intraocular lenses are excluded. 12. History of any traumatic (surgical or nonsurgical) or non traumatic condition affecting the pupil or iris. 13. Unwilling or unable to discontinue use of contact lenses. 14. Conjunctival hyperemia ≥ grade 2 on the CCLRU 4-point scale. Systemic: 15. Known hypersensitivity or contraindication to alpha- and/or beta adrenoceptor antagonists. 16. Known hypersensitivity or contraindication to any systemic cholinergic parasympathomimetic agents. 17. Clinically significant systemic disease that might interfere with the study as deemed by the Investigator. 18. Participation in any investigational study within 30 days prior to Screening. 19. Females of childbearing potential who are pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control. 20. Resting HR outside the specified range of 50 to 110 beats per minute. 21. Hypertension with resting diastolic BP > 105 mmHg or systolic BP > 160 mmHg. ; PRIMARY OUTCOME: Percent of Subjects With ≥ 15 Letters of Improvement in Photopic Binocular DCNVA; SECONDARY OUTCOME 1: Percentage of Subjects With Improvement of ≥ 5, ≥ 10, and ≥ 15 Letters in DCNVA (Photopic) From Baseline[/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 IIb - Severe Hypertriglyceridemia (AROAPOC3-2001); BRIEF: The purpose of AROAPOC3-2001 is to evaluate the efficacy and safety of ARO-APOC3 in participants with severe hypertriglyceridemia. Participants will receive 2 subcutaneous injections of ARO-APOC3. ; DRUG USED: ARO-APOC3; DRUG CLASS: New Molecular Entity (NME); INDICATION: Dyslipidemia / Hypercholesterolemia; TARGET: Apolipoprotein C-III (apoCIII, apo-CIII, apo-C3); THERAPY: Monotherapy; LEAD SPONSOR: Arrowhead Pharmaceuticals; CRITERIA: Inclusion Criteria: - Based on medical history, evidence of TG ≥ 500 mg/dL and ≤ 4000 mg/dL at Screening - Fasting TG ≥ 500 mg/dL at Screening - Willing to follow diet counseling per Investigator judgment based on local standard of care - Women of childbearing potential must have a negative pregnancy test, cannot be breastfeeding, and must be willing to use contraception - Willing to provide written informed consent and to comply with study requirements Exclusion Criteria: - Active pancreatitis within 12 weeks prior to first dose - Any planned bariatric surgery or similar procedures to induce weight loss from consent to end of study - Acute coronary syndrome event within 24 weeks of first dose - Major surgery within 12 weeks of first dose - Planned coronary intervention (e.g., stent placement or heart bypass) or any non-cardiac major surgical procedure throughout the study - Uncontrolled hypertension - Human immunodeficiency virus (HIV) infection, seropositive for Hepatitis B (HBV), seropositive for Hepatitis C (HCV) - Uncontrolled hypothyroidism or hyperthyroidism - Hemorrhagic stroke within 24 weeks of first dose - Malignancy within the last 2 years prior to date of consent requiring systemic treatment (some exceptions apply) Note: additional inclusion/exclusion criteria may apply per protocol ; PRIMARY OUTCOME: Percent Change from Baseline in Fasting Triglycerides (TG) at Week 24; SECONDARY OUTCOME 1: Percent Change from Baseline in Fasting TG Over Time Through Week 48[/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 - PoC (Renal Transplantation); BRIEF: The purpose of this study was to investigate the safety, tolerability, pharmacokinetics (PK) and potential for CFZ533 to replace calcineurin inhibitors (CNI), while providing a similar rate of acute rejection prophylaxis and renal function in a de novo renal transplant population receiving an allograft from standard criteria donors. ; DRUG USED: Iscalimab; DRUG CLASS: Biologic; INDICATION: Kidney Transplant Rejection; TARGET: Cluster of Differentiation 40 (CD40); THERAPY: Combination; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Main Inclusion Criteria: - Written informed consent must be obtained before any assessment is performed. - Recipients of a kidney transplant from a heart-beating deceased, living unrelated or non-human leukocyte antigen (HLA) identical living related donor. - Recipients of a kidney with a cold ischemia time (CIT) < 30 hours. Main Exclusion Criteria: - Recipients of an organ from a non-heart beating donor. - ABO incompatible or complement-dependent lymphocytotoxic (CDC) crossmatch positive transplant. - Subjects receiving a second kidney allograft, unless the first allograft was lost due to surgical complication. - Subjects at high immunological risk for rejection - Subjects at risk for tuberculosis (TB) - Subject with severe systemic infections, current or within the two weeks prior to randomization/enrollment. - Any additional contraindication to the use of tacrolimus or mycophenolate mofetil according to the national labeling information of these products (see local product label). ; PRIMARY OUTCOME: Mean Cmax Pharmacokinetic Parameter- Part I; SECONDARY OUTCOME 1: Total Soluble CD40 and Total Soluble CD154 Concentrations in Plasma - Part 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 - 1114 (Columbia); BRIEF: The intravesical treatment of bladder cancer with Abraxane is more desirable than other taxanes due to its ability to be diluted in water and not lipid-based solutions allowing it greater access to sites in the bladder. Thus, we are interested in investigating Abraxanes safety, toxicity, and efficacy profile for the treatment of recurrent transitional cell cancer of the urinary bladder in a combined phase I & II trial. The phase I trial is designed as a dose-escalation study with cohorts of threes that will enroll a maximum of 18 patients. Dose increases will occur in groups of three patients, with each successive group receiving an increased concentration of Abraxane intravesically. No dose increase will occur until each member of the previous cohort has undergone the first instillation of the medication without experiencing a dose-limiting toxicity (DLT). Any patient who experiences a DLT will be removed from the trial and treated appropriately. If one patient in the cohort experiences a DLT an additional three patients will be enrolled and treated at that dose-level. If none of the additional three patients experience a DLT, the next group of patients will be started on the next higher dose level. If at any dose level, two or more patients experience a DLT the previous dose level will be considered as the maximum tolerated dose (MTD). An additional three patients (for a total of six patients) will then be treated at the MTD. If less than two patients experience a DLT this dose level will be established as the MTD. The phase II aspect is designed in a Simon II stage format in which to satisfy our study powering, the first stage there will be 10 patients enrolled. If there are 2 or more successful treatments in that group (negative urine cytology and bladder biopsy after 6 months), then the first stage will pass the rejection rule, and up to another 19 patients will be enrolled. If at any point in the study, there have been a total of 6 or more successes, then the phase II aspect will be considered a successful trial and the study will be completed at that point. ; DRUG USED: Abraxane; DRUG CLASS: Non-NME; INDICATION: Bladder Cancer; TARGET: Microtubules (Tubulin); THERAPY: Monotherapy; LEAD SPONSOR: Columbia University; CRITERIA: Inclusion Criteria: - Patients must have a diagnosis of transitional cell carcinoma (TCC) of the urinary bladder confirmed at the study institution. The patient must have demonstrated superficial recurrent bladder cancer refractory to standard intravesical therapy. This will include stage Ta, T1, Tis and exclude all patients with muscle invasion (T2). All patients with stage Ta will require documentation of high-grade histology. All grossly visible disease must be fully resected and pathologic stage will be confirmed at the institution where the patient is enrolled. Patients must exhibit disease recurrence after receiving some form of standard intravesical therapy, including BCG, mitomycin, interferon or any combination thereof. - Age > 18 and must be able to read, understand and sign informed consent - Performance Status: ECOG 0,1 (See Appendix II ) - Peripheral neuropathy: must be < grade 1 - Hematologic-Inclusion within 2 weeks of start of treatment - Absolute neutrophil count > 1,500/mm3 - Hemoglobin >9.0 g/dl - Platelet count > 100,000/mm3 - Hepatic-Inclusion within 2 weeks of entry - Total Bilirubin must be within normal limits. - Adequate renal function with serum creatinine ≤ 2.0 mg/dL - Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 x ULN for the institution, Alkaline phosphatase ≤ 2.5 x ULN for the institution, unless bone metastasis is present in the absence of liver metastasis - Women of childbearing potential must have a negative pregnancy test. - All patients of childbearing potential must be willing to consent to using effective contraception, i.e., IUD, Birth control pills, Depo-Provera, and condoms while on treatment and for 3 months after their participation in the study ends. - No intravesical therapy within 6 weeks of study entry - No prior radiation to the pelvis Exclusion Criteria: - Prior systemic docetaxel or paclitaxel therapy. - Any other malignancy diagnosed within 2 years of study entry (except basal or squamous cell skin cancers or non-invasive cancer of the cervix) is excluded. - Concurrent treatment with any chemotherapeutic agent. - Women who are pregnant or lactating. - History of vesicoureteral reflux or an indwelling urinary stent. - Participation in any other research protocol involving administration of an investigational agent within 3 months prior to study entry aside from the phase I segment of this study. - History of neuropathy of any cause ; PRIMARY OUTCOME: To determine the safety, toxicity and efficacy profiles of intravesically administered Abraxane at the Maximum Tolerated Dose.; SECONDARY OUTCOME 1: To further evaluate the safety and toxicity profile of intravesically administered Abraxane therapy.[/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 - ROCKET; BRIEF: This two-stage study is designed to compare the safety and activity between RRx-001 against regorafenib followed by irinotecan-based therapies in a parallel comparative study. Patients who are suffering from advanced or metastatic (meaning the disease has spread) colorectal cancer are invited to participate in this study. There will be two groups of patients (Randomized, open label study), one of these will receive RRx-001 and the other one will receive regorafenib. If patients qualify to participate in this study, they will be randomly assigned to the interventional arm where patients will receive the experimental drug, RRx-001, or the control arm where they will receive the current standard-of-care, Regorafenib. Patients have a 66% chance (2 out of 3) of receiving RRx-001 and a 33 % chance (1 out of 3) of receiving regorafenib. On progression in the first part of the study, provided ECOG performance status is adequate, and if clinically appropriate i.e. there are no absolute or relative contraindications in the opinion of the Investigator, all subjects will enter the second part of the study and receive irinotecan plus bevacizumab. Whether patients are given RRx-001 or regorafenib, they will also receive best supportive care, which includes treatments to help manage side effects and symptoms of cancer. This is an open label study, which means patients will know to which of these treatments, RRx-001 or regorafenib, they are assigned. ; DRUG USED: RRx-001; DRUG CLASS: New Molecular Entity (NME); INDICATION: Colorectal Cancer (CRC); TARGET: Cluster of Differentiation 47 (CD47), Immune System, Reactive Oxygen Species/Free Radicals, SIRP-alpha; THERAPY: Monotherapy; LEAD SPONSOR: EpicentRx, Inc.; CRITERIA: Inclusion Criteria: - Histological or cytological documentation of adenocarcinoma of the colon or rectum; - Subject must have received at least oxaliplatin-, and irinotecan-based regimens with bevacizumab and with, cetuximab or panitumumab if KRAS wildtype and are refractory to irinotecan; - Subject has measurable disease by radiographic techniques (computerized tomography [CT] or magnetic resonance imaging [MRI]); - Subjects with a history of brain metastasis are eligible for the study as long as they meet all the following criteria: their brain metastases have been treated, they have no evidence of progression or hemorrhage after treatment, have been off dexamethasone for 4 weeks prior to first study drug administration, and have no ongoing requirement for dexamethasone or anti-epileptic drugs; - Life expectancy of at least 12 weeks - Subjects Eastern Cooperative Group (ECOG) performance status is 0 or 1; - Adequate organ function - Fertile subjects must use effective contraception during the course of the study and for 30 days following withdrawal from the study; Exclusion Criteria: - Clinically significant cardiovascular disease; - Unresolved toxicity higher attributed to any prior therapy/procedure excluding alopecia, hypothyroidism and oxaliplatin- induced neurotoxicity ≤ Grade 2 for at least 14 days; - Evidence or history of tendency or predisposition to active bleeding. Any hemorrhage or bleeding event of Grade 3 or higher within 4 weeks of start of study medication; - Symptoms or signs of active brain metastases; - History of an allergic reaction or intolerance to irinotecan - Hepatic encephalopathy - Cholangitis that required treatment or intervention within 4 weeks of study enrollment - Concurrent anticancer therapy or any cytotoxic therapy within 1 month prior to Day 1. Corticosteroid therapy is not allowed except on dosing days; - Subject has previously received regorafenib; - Clear contraindication for systemic corticosteroids (diabetes mellitus is not per se a clear contraindication); - Severe hypoalbuminemia (albumin < 3.0 g/dL); - Subjects who are pregnant or lactating or who are planning to become pregnant during the course of the study are excluded. ; PRIMARY OUTCOME: Overall Survival; SECONDARY OUTCOME 1: Number of Participants with Serious and Non-Serious Adverse Events[/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 - hoFH, heFH, Severe heFH (Ext.); BRIEF: To evaluate the safety and efficacy of extended dosing with mipomersen (ISIS 301012) in participants with familial hypercholesterolemia or severe hypercholesterolemia on lipid-lowering therapy who had completed either the 301012-CS5 (NCT00607373), 301012-CS7 (NCT00706849), 301012-CS17 (NCT00477594) or MIPO3500108 (NCT00794664) clinical drug trials. ; DRUG USED: Kynamro; DRUG CLASS: New Molecular Entity (NME); INDICATION: Dyslipidemia / Hypercholesterolemia; TARGET: Apolipoprotein - B100 (Apo-B100); THERAPY: Monotherapy; LEAD SPONSOR: Kastle Therapeutics, LLC; CRITERIA: Inclusion Criteria: - Satisfactory completion of dosing in their initial study (Protocol 301012-CS5 [NCT00607373], 301012-CS7 [NCT00706849], 301012-CS17 [NCT00477594], or MIPO3500108 [NCT00794664]) Exclusion Criteria: - Had any new condition or worsening of existing condition which in the opinion of the Investigator would make the participant unsuitable for enrollment, or could interfere with the participant participating in or completing the study ; PRIMARY OUTCOME: Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C); SECONDARY OUTCOME 1: Percent Change From Baseline in Triglycerides[/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/Docetaxel; BRIEF: This study is for patients who have been treated with surgical removal of the testes or hormone therapy (Lupron or Zoladex) and whose prostate cancer has worsened despite this treatment. PS 341 is a type of drug known as a proteasome inhibitor. By inhibiting the proteasome in cancer cells, PS-341 alters the way those cells divide). We hope to learn whether this combination chemotherapy decreases cancer symptoms and tests (prostate specific antigen, also called PSA), and to determine how frequently serious side effects might occur with this treatment for this stage of prostate cancer. ; DRUG USED: Velcade; DRUG CLASS: New Molecular Entity (NME); INDICATION: Prostate Cancer; TARGET: Proteasome; THERAPY: Combination; LEAD SPONSOR: University of Southern California; CRITERIA: Inclusion Criteria: - Patient must have had a histological or cytological diagnosis of adenocarcinoma of prostate and currently must have metastatic disease (stage TxNxM1) that is unresponsive or refractory to hormone therapy. Patients must have metastatic prostate cancer deemed to be hormone refractory by one or more of the following (despite androgen ablation and anti-androgen withdrawal where applicable): - Progression of measurable disease assessed within 28 days prior to registration. OR - Progression of non-measurable (i.e. bone scan or PET scan) disease assessed within 42 days prior to registration. AND - Rising PSA - defined as at least 2 consecutive rises in PSA documented over a reference value (measure 1). The first rising PSA (measure 2) should be taken at least 7 days after the reference value. A third confirmatory PSA measure is required (2nd beyond the reference level) to be greater then the second measure and it must be obtained at least 7 days after the 2nd measure. Patient must have a PSA concentration of at least 5 ng/ml in addition to increasing PSA to be eligible Note: The PSA result (done within 28 days prior to registration) need not be elevated for inclusion provided other criteria for progression are met and the serum PSA is at least 2 ng/ml. - Must have received prior hormonal therapy and have a castrate level of testosterone (less than 100ng/ml within 90 days of entry to the study). Patients treated with orchiectomy are eligible. If patients have been treated with non-steroidal anti-androgens, the patients must have ceased taking flutamide or nilutamide at least 28 days prior to enrollment and at least 42 days prior to enrollment for biclutamide. Either method of castration can have been supplemented with nonsteroidal antiandrogen (e.g. flutamide, biclutamide, nilutamide). Patients may have been treated with second-line hormonal therapy such as ketoconazole, aminoglutethimide and/or estrogen therapies but these must have ceased at least 7 days prior to commencement of study therapy. - May have received at most one prior chemotherapy for hormone refractory prostate cancer provided they have not received docetaxel or Bortezomib for that indication or otherwise within 2 years of trial entry. - Prior radiation therapy is allowed but it must have been to less than 25% of total body bone marrow. This includes prior use of samarium, but patients can not have received strontium. (>10 days must have elapsed since completion of RT with recovery from side effects. Soft tissue disease irradiated in the prior 2 months is not and may not be designated as measurable - Creatinine less than or equal to 1.5x the institutional upper limit of normal (within 28 days prior to registration) - Hepatic function Total Bilirubin less than or equal to ULN AST and ALT and Alkaline Phosphatase must be within the range allowing for eligibility. In determining eligibility the more abnormal of the two values (AST or ALT) should be used. - Adequate bone marrow function. Complete blood count with differential must be done within 14 days prior to registration Absolute neutrophil count greater than or equal to 1,500/mm3 Hemoglobin greater than or equal to 8.0 g/dl Platelet count greater than or equal to 100,000/mm3 - ECOG performance status 0-3. (For patients with PS of 3, cause must be due to pain secondary to bone metastases to be eligible) - Patients should (for good medical practice) have stabilization of their analgesic medications for at least one week prior to receiving study medication - No other chemotherapy, biological response modifiers, RT, radioisotope therapy (e.g. samarium or strontium), corticosteroid, or concomitant hormonal therapy may be given during protocol treatment. - Bisphosphonate therapy is permitted provided it commences prior to study entry and is maintained at recommended dosing intervals. - Completed baseline McGill Pain Questionnaire and Pain Medication Log prior to registration. The nurse or CRA must complete MPQ and PML cover sheet for baseline assessment prior to registration. If unable to complete questionnaires in English or Spanish, patient can be registered without contributing to QOL study). - Men of childbearing potential must be willing to consent to using effective contraception while on treatment and for a reasonable period (90 days) thereafter. - Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care. Exclusion Criteria: - Myocardial infarction or angina pectoris within one year of registration - History of brain metastases, treated or untreated. (Patients with neurological symptoms must have CT or MRI brain negative for metastatic disease within 56 days prior to registration). Patients who have recovered from spinal cord compression and are clinical stable may enter the study provided they fulfill other criteria. - Not recovered from major infections and/or surgical procedures, or has significant active concurrent other medical illness precluding protocol therapy or survival. - Known or anticipated severe hypersensitivity reaction to bortezomib, boron, mannitol, docetaxel or polysorbate 80. - Other prior malignancy (except patients who have had another stage I or II malignancy currently in complete remission or other cancer with no evidence of disease for greater than 5 years from accrual to the current trial. Patients with basal or squamous cell carcinoma of the skin that have been treated with curative intent can be accrued to this trial 30 days after treatment. Solar keratoses treated topically do not preclude entry). - Patient has greater than or equal to Grade 2 peripheral neuropathy within 14 days before enrollment. - Prior therapy with docetaxel or paclitaxel - Prior treatment with more than one prior chemotherapy for hormone refractory prostate cancer. - Ongoing therapy with drugs known to inhibit P4503A4 drug metabolism including: Macrolide antibiotics: erythromycin, troleandomycin, azithromycin Imidazole antifungal agents: ketoconazole, itraconazole, fluconazole HIV protease inhibitors Immunosuppressive agents: cyclosporin, FK-506 - Ongoing therapy with drugs known to induce P4503A4 drug metabolism including: Phenobarbital, phenytoin, carbamazepine, griseofuvin and rifampin. ; PRIMARY OUTCOME: Number of patients with improved serum PSA response rate; SECONDARY OUTCOME 1: Pain response rate[/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 - SS0004; BRIEF: This is a Phase 2, multicenter, double-blind, placebo-controlled, 12-week proof-of-concept study to assess the efficacy, safety, and tolerability of UCB5857 in subjects with primary Sjögrens Syndrome (pSS). The primary objective of this study is to evaluate the efficacy on overall disease activity and safety of UCB5857 added to current treatment relative to placebo in subjects with pSS. ; DRUG USED: UCB5857; DRUG CLASS: New Molecular Entity (NME); INDICATION: Sjogrens Syndrome; TARGET: PI3K/AKT pathway; THERAPY: Monotherapy; LEAD SPONSOR: UCB Celltech; CRITERIA: Inclusion Criteria: - Subject must be between 18 years and 75 years of age - Women of childbearing potential must agree to use a highly effective method of birth control during the study and for a period of 3 months after their final dose of study drug. Women not agreeing to use birth control must be of non-childbearing potential defined as; permanently sterile, congenitally sterile or postmenopausal for at least 2 years prior to Screening (Visit 1). Women of childbearing potential are required to have a serum pregnancy test taken at Screening (Visit 1), which is confirmed to be negative by urine testing prior to the first dose of study drug at Week 1 (Visit 2) Male subjects with a partner of childbearing potential must be willing to use a condom when sexually active during the study and for 3 months after the last dose of study drug In addition female partner of childbearing potential of male subject must be willing to use a highly effective method of contraception for duration of study and for 3 months after last dose of study drug - Subject must meet the 2002 AECG (American-European Consensus Group) criteria for Primary Sjӧgrens Syndrome - Subject must have a serum test positive for anti-SSA/Ro (Ro-52 or Ro-60) and/or anti SSB/La autoantibodies Exclusion Criteria: - Subject has a diagnosis of any other autoimmune disease, ie, secondary Sjögrens syndrome (eg, rheumatoid arthritis, systemic lupus erythematosus - Subject has a diagnosis of any other sicca syndrome (eg, history of head and neck radiation treatment, sarcoidosis chronic graft-versus-host disease) - Subject has significant fibromyalgia syndrome as defined by the American College of Rheumatology 2010 classification criteria - Subject has significant depression as defined by the 5th edition of the Diagnostic and Statistical Manual of Mental Disorders - Subject has oral candidiasis - Subject is female and is breast-feeding, pregnant, or plans to become pregnant or to start breastfeeding during the study or within 3 months after the final dose of the investigational medicinal product (IMP) - Subject has evidence of an immunosuppressive state, including human immunodeficiency virus (HIV) infection, hypogammaglobulinemias, T-cell deficiencies, or human T-cell leukemia virus type 1 (HTLV-1) o Positive testing for HIV-1/2 at Screening (Visit 1) - Subject has a history of chronic infections, including but not limited to concurrent acute or chronic viral hepatitis B (HBV) or hepatitis C (HCV) - Positive testing for HBV at Screening (Visit 1) - Positive testing for HCV at Screening (Visit 1) - A subject with a history of a recent serious or life-threatening infection or any current signs or symptoms that may indicate a significant infection at Screening (Visit 1) to randomization, as per the Investigators clinical judgment is also excluded Subject must have completed any prior anti-infective therapy prior to the first dose of study drug with the exception of anti-infectives taken specifically for the treatment of acne, rosacea, onychomycosis, or vaginal yeast infections; for the prophylaxis of urinary tract infections; or prophylaxis for pre-surgical or pre-procedural reasons (including dental procedures). Note: minocycline may not be used for these purposes - Subject is at a particularly high risk of significant infection due to their lifestyle and/or occupation - Subject has received intranasal influenza vaccine within the 8 weeks prior to Screening (Visit 1) - Subject has significant hematologic abnormalities of hemoglobin <10.0 g/dL, or white blood cell (WBC) <2000 /mm^3, or absolute neutrophil count <1000 /mm^3, or platelets <100,000 /mm^3 at Screening (Visit 1) - Subject has a history of cancer ; PRIMARY OUTCOME: Change from Baseline to Week 12 in the European League Against Rheumatism Sjögrens Syndrome Disease Activity Index (ESSDAI); SECONDARY OUTCOME 1: Change from Baseline to Week 4 in the European League Against Rheumatism Sjögrens Syndrome Disease Activity Index (ESSDAI)[/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 - Stent Restenosis; BRIEF: The main study objective is to assess the efficacy and safety of different bindarit dosages compared to placebo in preventing restenosis, in patients submitted to coronary stenting and using a bare metal stent (Vision BMS, by Abbott). ; DRUG USED: Bindarit; DRUG CLASS: New Molecular Entity (NME); INDICATION: Percutaneous Coronary Intervention Restenosis; TARGET: Chemokine (C-C motif) Ligand 2 (CCL2)/MCP-1, Chemokine (C-C motif) Ligand 7 (CCL7)/MCP-3, Chemokine (C-C motif) Ligand 8 (CCL8)/MCP-2; THERAPY: Monotherapy; LEAD SPONSOR: Aziende Chimiche Riunite Angelini Francesco S.p.A; CRITERIA: Inclusion Criteria: - Male and female patients with no limitation of race, > 18 years of age (or minimum age as required by local regulations). Female patients of childbearing potential, required to have a negative pregnancy test and use a birth control method. Oral contraceptive are not allowed. - Diagnosis of angina pectoris as defined by Canadian Cardiovascular Society Classification (CCS I,II, III, IV) OR unstable angina pectoris (Braunwald Classification B&C, I-II-III), or patients with documented silent ischemia. - Maximum of two de novo lesions (>70% stenosis) per patients, to be treated with no other planned procedure within six months from the index intervention. - Each lesion should require a single stent not longer than 28 mm and with a diameter of 2.5 mm or larger. In case additional stents are needed, the operator will be allowed to implant them in order to treat a suboptimal result such as residual edge stenosis or dissection. Additional stents should be implanted with minimal overlap. Multiple stenting should not be allowed as intention to treat strategy due to the specific inclusion criteria which has been set. - Patients eligible for the placement of the Vision (Abbott) bare metal stent. - The patient willing and able to cooperate with the protocol procedures, particularly attending the scheduled visits. - Patients legally able to give written informed consent to the trial. - A written informed consent to the trial signed and dated by the patient is available. Exclusion Criteria: - Patients with hypersensitivity or allergies to aspirin, heparin, clopidogrel, ticlopidine, drugs such the study medication, or any other analogue or derivative, cobalt, chromium, nickel, molybdenum or contrast media, or with a positive history for drug allergy. - Lesions in venous or arterial grafts. - Total occlusions. - In-stent restenosis. - Unprotected Left Main lesions. - Acute myocardial infarction (ST elevation and/or Non ST Elevation) in the 48 hours prior to the procedure. - Women with known pregnancy or who are lactating. - Patients in whom anti-platelet and/or anticoagulation therapy is contraindicated. - Current medical condition with a life expectancy of less than 24 months. - The subject is participating in another device or drug study. Subject must have completed the follow-up phase of any previous study at least 30 days prior to enrolment in this trial. - Patients under the influence of alcohol or narcotics. - Patients with medical conditions that preclude the follow-up as defined in the protocol or that otherwise limits participation in this registry. m. Potassium value above the upper limit normal range. ; PRIMARY OUTCOME: in-segment late loss (in-stent and 5 mm proximally and distally to the stent) measured by QCA; SECONDARY OUTCOME 1: Major Adverse Cardiac Events (MACE)[/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 - AiME - 13; BRIEF: The purpose of this study is to demonstrate therapeutic equivalence of subcutaneous (SC) Epoetin Hospira compared to SC Epogen (Amgen), based on maintenance of hemoglobin (Hb) levels and study drug dose requirements in patients treated for anemia associated with chronic renal failure and on hemodialysis. ; DRUG USED: Retacrit; DRUG CLASS: Biosimilar; INDICATION: Anemia Due to Chronic Renal Failure, Dialysis-Dependent; TARGET: Erythropoietin Receptor (EPOR); THERAPY: Monotherapy; LEAD SPONSOR: Pfizer; CRITERIA: Inclusion Criteria: 1. Patient is able to provide written informed consent after risks and benefits of the study have been explained prior to any study related activities 2. Hemodialysis patients with chronic renal failure and renal anemia currently on stable Epogen (Amgen) dose administered IV or SC, 1 to 3 times per week for whom the following apply: - A change in Epogen dosing of no more than 10% from the mean - Mean hemoglobin between 9.0 and 11.0 g/dL - No more than one hemoglobin result outside of range from 9.0-11.0 g/dL - No hemoglobin result more than ±1 g/dL from the mean hemoglobin level 3. Patients on stable, adequate dialysis for at least 12 weeks prior to randomization, defined as no clinically relevant changes of dialysis regimen and/or dialyzer 4. Patients with adequate iron stores, defined as plasma ferritin > 100 μg/L and TSAT >20%, prior to randomization 5. Male or female patients aged 18 to 80 years (both inclusive) 6. If female, patient must be postmenopausal for at least one year prior to randomization, surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or practicing at least one of the following methods of birth control: - hormonal contraceptives (oral, parenteral or transdermal) for at least 3 months prior to randomization - intrauterine device (IUD) - double-barrier method (condoms, contraceptive sponge, diaphragm or vaginal ring with spermicidal jellies or cream) If hormonal contraceptives are used, the specific contraceptive must have been used for at least 3 months prior to randomization. If the patient is currently using a hormonal contraceptive, she should also use a barrier method during this study and for at least 30 days following the administration of the patients last dose Exclusion Criteria: 1. Maintenance epoetin dosage >600 U/kg per week (1-3 times per week) 2. Treatment with long-acting epoetin analogues such as Aranesp ® within 12 weeks prior to randomization 3. Any of the following within 3 months prior to randomization: - Myocardial infarction - Stroke (cerebrovascular accident)/cerebrovascular insult (minor stroke) or transient ischemic attack/intracerebral bleeding/cerebral infarction - Severe/unstable angina - Coronary angioplasty, bypass surgery, or peripheral artery bypass graft - Decompensated congestive heart failure (New York Heart Association [NYHA] class IV) - Pulmonary embolism - Deep vein thrombosis or other thromboembolic event - Received live or attenuated vaccination (except flu vaccination) 4. Uncontrolled hypertension within the 4 weeks prior to randomization defined as more than 10% of post-dialysis blood pressures >170 mmHg systolic and/or >110 mmHg diastolic, based on blood pressure readings obtained when the patients post-dialysis body weight was not more than 0.5 kg above their listed dry weight 5. Known, clinically manifested deficiency of folic acid and/or vitamin B12 (irrespective of whether currently treated or not) 6. A patient with any active, uncontrolled systemic, inflammatory or malignant disease that in the Investigators opinion may be significant to exclude participation in the study, including but not limited to demyelinating diseases such as multiple sclerosis, microbial, viral or fungal infection or mental disease 7. Contraindication for the test drug or have been previously treated with Epoetin Hospira 8. Relative or absolute iron deficiency prior to randomization into the Maintenance Period 9. Platelet count below 100 x 10^9/L 10. Clinically relevant increase of CRP (>10 mg/dL) for at least 2 weeks 11. Significant drug sensitivity or a significant allergic reaction to any drug, as well as known hypersensitivity or idiosyncratic reaction to epoetin (or its excipients, including albumin) or any other related drugs that in the judgment of the Investigator is exclusionary for the study participation 12. History of any of the following: - Detectable anti-rhEPO antibodies - Clinically relevant malnutrition - Confirmed aluminum intoxication - Myelodysplastic syndrome - Known bone marrow fibrosis (osteitis fibrosa cystica) - Known seizure disorder - Liver cirrhosis with clinical evidence of complications (portal hypertension, splenomegaly, ascites) 13. A female patient who is pregnant, lactating or planning a pregnancy during the study 14. History of drug abuse or alcohol abuse within 2 years prior to randomization as determined by the Investigator 15. Current participation or participation in a drug or other investigational research study within 30 days prior to randomization 16. May not be able to comply with the requirements of this clinical study, communicate effectively with study personnel, or is considered by the Investigator, for any reason, to be an unsuitable candidate for the study 17. Donated or lost >475 mL (i.e., 1 pint) blood volume (including plasmapheresis) or had a transfusion of any blood product within 3 months prior to randomization 18. A patient who in the Investigators opinion, has any clinically significant abnormal laboratory evaluations, including liver function taken at Screening Visit 19. Positive laboratory test for human immunodeficiency virus (HIV) or hepatitis B surface antigen (HBsAg) ; PRIMARY OUTCOME: Mean Weekly Hemoglobin Level From Week 30 to Week 34: Maintenance Period; SECONDARY OUTCOME 1: Mean Weekly Hemoglobin Level From Week 19 to Week 34: Maintenance Period[/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. Paroxetine; BRIEF: To assess the efficacy of acute treatment with 10 mg/day vortioxetine versus placebo on cognitive performance (focusing on the aspect concerning speed of processing, executive functioning, attention) in working patients with major depressive disorder (MDD). ; DRUG USED: Trintellix; DRUG CLASS: New Molecular Entity (NME); INDICATION: Major Depressive Disorder (MDD); TARGET: Serotonin 5-HT1A receptor, Serotonin 5-HT1B receptor , Serotonin 5-HT1D receptor , Serotonin 5-HT3 receptor, Serotonin 5-HT7 receptor, Serotonin Reuptake; THERAPY: Monotherapy; LEAD SPONSOR: H. Lundbeck A/S; CRITERIA: Inclusion Criteria: - The patient has MDD, diagnosed according to Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM-IV-TR™) recurrent major depressive disorder (MDD) (classification 296.3x). - The patient has a MADRS total score ≥26. - The patient has had the current major depressive episode (MDE) for ≥3 months. - The patient is aged ≥18 and ≤65 years. - The patient is employed full or part-time (defined as minimum 50% full time working hours per week). Part time work should not be due to a medical or mental illness other than MDD. - The patient has been in the current job/position for at least 3 months. - The patient has no plans to change jobs or retire within treatment period. - The patient is not on a sick leave, and at the Screening and Randomisation Visits, there are no plans to send the patient on a sick leave. - The patient is not receiving disability benefits. Exclusion criteria: - The patient has a score ≥70 on the DSST (number of correct symbols) at the Baseline Visit. - The patient is, in the opinion of the investigator, not able to complete the neuropsychological tests validly at the Baseline Visit. - The patient has physical, cognitive, or language impairment of such severity as to adversely affect the validity of the data derived from the neuropsychological tests. - The patient is diagnosed with reading disability (dyslexia). - The patient has a history of lack of response to previous adequate treatment with vortioxetine or paroxetine. - The patient has any current psychiatric disorder or Axis I disorder (according to DSM-IV-TR™ criteria) other than MDD, as assessed using MINI. - The patient has a current or has had a diagnosis of dysthymic disorder within 3 months preceding the onset of current episode (DSM-IV-TR™ criteria). - The patient has borderline, schizotypal, schizoid, paranoid, or histrionic, antisocial personality disorders (axis II) as comorbid or primary diagnosis (DSM-IV-TR™ criteria). - The patient suffers from personality disorders, mental retardation, pervasive development disorder, attention-deficit/hyperactivity disorder, organic mental disorders, or mental disorders due to a general medical condition (DSM-IV-TR™ criteria). - The patient has a current diagnosis or history of manic or hypomanic episode, schizophrenia or any other psychotic disorder, including major depression with psychotic features (DSM-IV-TR™ criteria). Other protocol-defined inclusion and exclusion criteria may apply. ; PRIMARY OUTCOME: Change in Digit Symbol Substitution Test (DSST): number of correct symbols; SECONDARY OUTCOME 1: Change in Trail Making Test (TMT) score: TMT-A; speed of processing[/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 - Elsubrutinib + Upadacitinib +/- ABBV-599; BRIEF: The main objective of this study was to evaluate the safety and efficacy of elsubrutinib, upadacitinib (UPA), and ABBV-599 (elsubrutinib/upadacitinib) High Dose and Low Dose combinations vs placebo for the treatment of signs and symptoms of Systemic Lupus Erythematosus (SLE) in participants with moderately to severely active SLE and to define doses for further development. ; DRUG USED: ABBV-599; DRUG CLASS: New Molecular Entity (NME); INDICATION: Systemic Lupus Erythematosus (SLE); TARGET: Brutons Tyrosine Kinase (BTK), JAK/STAT ; THERAPY: Combination; LEAD SPONSOR: AbbVie; CRITERIA: Inclusion Criteria: - Participant has clinical diagnosis of Systemic Lupus Erythematosus (SLE) at least 24 weeks prior to Screening, meeting at least 4 of the 11 revised Criteria for Classification of SLE according to the 1997 Update of the 1982 American College of Rheumatology (ACR) OR meeting at least 4 of the 2012 SLICC classification criteria, including at least 1 clinical criterion and 1 immunologic criterion. - At Screening, must have at least one of the following: - antinuclear antibody (ANA)+ (titer ≥ 1:80) - anti-dsDNA+ - anti-Smith+ - SLEDAI-2K (SLE Disease Activity Index) ≥ 6 despite background therapy as reported and independently adjudicated (clinical score ≥ 4, excluding lupus headache and/or organic brain syndrome) at Screening: - If 4 points of the required entry points are for arthritis, there must also be a minimum of 3 tender and 3 swollen joints. - If participant has rash and Principal Investigator (PI) considers it to be attributable to SLE, participant must consent to skin photograph collection for adjudication. - Score must be re-confirmed at the Baseline visit. - Physicians Global Assessment (PhGA) ≥ 1 during screening period. - Must be on background treatment, stable for 30 days prior to Baseline and throughout the study with antimalarial(s), prednisone (or prednisone equivalent) (≤ 20 mg), azathioprine (≤ 150 mg), mycophenolate (<2 g), leflunomide (≤ 20 mg), cyclosporine, tacrolimus, and/or methotrexate (MTX) (≤ 20 mg). - No combinations of the above with immunomodulators other than prednisone (or equivalents) and antimalarials. Exclusion Criteria: - Participant using intravenous (IV) or intramuscular (IM) corticosteroids greater than or equal to a 40 mg prednisone-equivalent bolus within 30 days of planned randomization. ; PRIMARY OUTCOME: Percentage of Participants Achieving SLE Responder Index (SRI)-4 and Steroid Dose ≤ 10 mg Prednisone Equivalent Once a Day (QD) at Week 24; SECONDARY OUTCOME 1: Percentage of Participants Achieving SLE Responder Index (SRI)-4 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 III - 01 - PROVIDE (vs. Venofer); BRIEF: The purpose of the trial is to evaluate and compare the effect of iron isomaltoside 1000 to iron sucrose in its ability to increase haemoglobin (Hb) in subjects with IDA when oral iron preparations are ineffective or cannot be used or where there is a clinical need to deliver iron rapidly. ; DRUG USED: Monoferric; DRUG CLASS: Non-NME; INDICATION: Anemia; TARGET: Iron; THERAPY: Monotherapy; LEAD SPONSOR: Pharmacosmos A/S; CRITERIA: Inclusion Criteria: 1. Men or women > 18 years having IDA caused by different aetiologies such as abnormal uterine bleeding, gastrointestinal diseases, cancer, bariatric procedures (gastric bypass operations), and other conditions leading to significant blood loss and with a documented history of intolerance or unresponsiveness to oral iron therapy for at least one month prior to study enrollment or where there at investigators judgment is a clinical need to deliver iron rapidly 2. Hb < 11 g/dL 3. TSAT < 20 % 4. S-ferritin < 100 ng/mL 5. Willingness to participate and signing the informed consent form Exclusion Criteria: 1. Anaemia predominantly caused by factors other than IDA (e.g. anaemia with untreated vitamin B12 or folate deficiency, haemolytic anaemia) 2. Iron overload or disturbances in utilisation of iron (e.g. haemochromatosis and haemosiderosis) 3. Decompensated liver cirrhosis or active hepatitis (ALAT > 3 times upper limit of normal) 4. Active acute or chronic infections (assessed by clinical judgement supplied with white blood cells (WBC) and C-reactive protein (CRP)) 5. Body weight < 50 kg 6. Rheumatoid arthritis with symptoms or signs of active inflammation 7. Pregnant or nursing women. In order to avoid pregnancy, women have to be surgically sterile or use adequate contraception (e.g. intrauterine devices, hormonal contraceptives, or double barrier method) during the whole study period and after the study has ended for at least 5 times plasma biological half-life of the investigational medicinal product 8. History of multiple allergies 9. Known hypersensitivity to parenteral iron or any excipients in the investigational drug products 10. Erythropoietin treatment within 8 weeks prior to the screening visit 11. Other iron treatment or blood transfusion within 4 weeks prior to the screening visit 12. Planned elective surgery during the study 13. Participation in any other clinical study within 3 months prior to the screening 14. Any other medical condition that, in the opinion of Investigator, may cause the subject to be unsuitable for the completion of the study or place the subject at potential risk from being in the study, e.g. uncontrolled hypertension, unstable ischaemic heart disease, or uncontrolled diabetes mellitus ; PRIMARY OUTCOME: Number of Subjects With an Haemoglobin (Hb) Increase of ≥ 2 g/dL From Baseline at Any Time From Week 1 to Week 5; SECONDARY OUTCOME 1: Change in Hb Concentration[/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 Octreotide LAR; BRIEF: The patients received either Pasireotide LAR or Octreotide LAR for one year of treatment. The objective of this study was to compare the proportion of patients with a reduction of mean GH level to <2.5 µg/L and the normalization of IGF-1 to within normal limits (age and sex related) between the two treatment groups (pasireotide LAR and octreotide LAR) at 12 months. Following one year of treatment patients could proceed into the study extension. Patients who did not respond to the treatment they were randomized to (based on month 12 assessment results) were switched to the other treatment arm at month 13. ; DRUG USED: Signifor; DRUG CLASS: Non-NME; INDICATION: Acromegaly; TARGET: Somatostatin Receptors; THERAPY: Monotherapy; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Inclusion criteria: - Patients with active acromegaly (based on elevated GH and IGF-1 levels) - Patients who have undergone one or more pituitary surgeries, but have not been treated medically, or de-novo patients presenting a visible pituitary adenoma on MRI and who refuse pituitary surgery or for whom pituitary surgery is contraindicated - Patients for whom written informed consent to participate in the study has been obtained prior to any study related activity Exclusion criteria: - Patients who are being or were treated with octreotide, lanreotide, dopamine agonists or GH antagonists with the exception of a single dose of short-acting octrotide or short-acting dopamine agonists. In case of a single dose of short-acting octrotide, the dose should not be used to predict the response to the octretide treatment. The single dose of short-acting octreotide or short-acting dopamine agonists should not be administered in the 3 days prior to randomization - Patients with compression of the optic chiasm causing any visual field defect - Patients who have received pituitary irradiation within the last ten years prior to visit 1 - Poorly controlled diabetic patients Other protocol-defined inclusion/exclusion criteria may apply ; PRIMARY OUTCOME: Percentage of Participants With a Reduction of Mean GH Level to <2.5 μg/L and the Normalization of IGF-1; SECONDARY OUTCOME 1: Percentage of Participants With a Reduction of Mean GH Level to < 2.5μg/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 II - PALLET - w/Letrozole (NSABP); BRIEF: This study will look at effects the combination of palbociclib and letrozole may have on estrogen receptor (ER)-positive/human epidermal growth factor receptor 2 (HER2)-negative breast cancer tumors which have not yet been treated. Letrozole is a type of endocrine therapy called an aromatase inhibitor (AI) and is standard treatment for post-menopausal women with ER-positive/HER2-negative breast cancer. ; DRUG USED: Ibrance; DRUG CLASS: New Molecular Entity (NME); INDICATION: Breast Cancer; TARGET: Cyclin Dependent Kinase (CDK); THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: NSABP Foundation Inc; CRITERIA: Inclusion Criteria: - Patients must be postmenopausal women defined as: Age 56 or older with no spontaneous menses for at least 12 months prior to study entry; or Age 55 or younger with no menses for at least 12 months prior to study entry (e.g., spontaneous or secondary to hysterectomy) and with a documented estradiol level in the postmenopausal range according to local institutional/laboratory standard; or Age greater than or equal to 18 with documented bilateral oophorectomy. - Operable ER-positive/HER2- negative, invasive early breast cancer, suitable for neoadjuvant AI treatment. HER2-negative as determined by American Society of Clinical Oncology - College of American Pathologists (ASCO-CAP) guidelines. - No known severe hypersensitivity reactions to compounds similar to palbociclib or palbociclib excipients or to endocrine treatments. - A breast tumor with an ultrasound size of at least 2.0 cm. - Patients must have the ability to swallow oral medication. - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. - At the time of randomization, blood counts performed within 4 weeks prior to randomization must meet the following criteria: absolute neutrophil count (ANC) must be greater than or equal to 1500/mm3; Platelet count must be greater than or equal to 100,000/mm3; Hemoglobin must be greater than or equal to 10 g/dL. - international normalized ratio (INR) must be within normal limits of the local laboratory ranges. - The following criteria for evidence of adequate hepatic function performed within 4 weeks prior to study entry must be met: total bilirubin must be less than or equal to upper limit of normal (ULN) for the lab unless the patient has a bilirubin elevation greater than ULN to 1.5 x ULN due to Gilberts disease or similar syndrome involving slow conjugation of bilirubin; and alkaline phosphatase must be must be less than or equal to 1.5 x ULN for the lab; and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) must be less than or equal to 1.5 x ULN for the lab. - Serum creatinine performed within 4 weeks prior to study entry must be less than or equal to 1.25 x ULN or estimated creatinine clearance less than 60 mL/min (as calculated using the method standard for the institutions). Exclusion Criteria: - Active hepatitis B or hepatitis C with abnormal liver function tests. - HIV positive patients receiving antivirals. - Premenopausal or peri-menopausal women. - Inflammatory/inoperable breast cancer. - HER2-positive as determined using ASCO-CAP Guidelines. - Concurrent use (defined as use within 4 weeks prior to baseline tissue sample being taken) of hormone replacement therapy (HRT) or any other estrogen-containing medication (including vaginal estrogens) - Prior endocrine therapy for breast cancer. - Any invasive malignancy within previous 5 years (other than basal cell carcinoma or cervical carcinoma in situ). - Other nonmalignant systemic disease that would preclude the patient from receiving study treatment or would prevent required follow up such as: Active infection or chronic infection requiring chronic suppressive antibiotics; Malabsorption syndrome, ulcerative colitis, inflammatory bowel disease, resection of the stomach or small bowel, or other disease or condition significantly affecting gastrointestinal function; Chronic daily treatment with corticosteroids with a dose of greater than or equal to 10 mg/day methylprednisolone equivalent (excluding inhaled steroids); Seizure disorders requiring medication. - Diagnosis by fine needle aspiration (FNA) alone or excisional biopsy or lumpectomy performed prior to study entry. - Surgical axillary staging procedure prior to study procedure (with exception of FNA or core biopsy). - Definitive clinical or radiologic evidence of metastatic disease. - History of ipsilateral invasive breast cancer regardless of treatment or ipsilateral ductal carcinoma in situ (DCIS) treated with radiotherapy or contralateral invasive breast cancer at any time. - Any treatment, including radiotherapy, chemotherapy, and/or targeted therapy, administered for the currently diagnosed breast cancer prior to study entry. - Use of any medication or substances that are strong inhibitors or inducers of CYP3A isoenzymes. - Class III or Class IV myocardial disease as described by the New York Heart Association; a recent history (within 6 months) of myocardial infarction, or symptomatic arrhythmia at the time of randomization. Class III: Patients with cardiac disease resulting in marked limitation of physical activity. Such patients are comfortable at rest. Less than ordinary physical activity that causes fatigue, palpitation, dyspnea, or anginal pain. Class IV: Patients with cardiac disease resulting in inability to perform any physical activity without discomfort. Symptoms of cardiac insufficiency or anginal syndrome may be present even at rest. - QTc greater than 480 msec or a family or personal history of long or short QT syndrome, Brugada syndrome or know history of QTc prolongation, or Torsade de Pointes (TdP). - The investigator should assess the patient to determine if she has any psychiatric or addictive disorder or other condition that, in the opinion of the investigator, would preclude her from meeting the study requirements. ; PRIMARY OUTCOME: Measurement of the Proliferation Marker Ki67 (% Positive Tumor Cells); SECONDARY OUTCOME 1: Pathological Complete Response (pCR): Number of Patients With no Lesions in Breast and Nodes at Time of Surgery[/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 - BR1-142; BRIEF: The purpose of this study was to assess the safety and efficacy of Lumason-enhanced dobutamine stress echo (DSE) in subjects having a suboptimal left ventricular endocardial border delineation (LV EBD) at rest and who were scheduled for coronary angiography. ; DRUG USED: Lumason; DRUG CLASS: New Molecular Entity (NME); INDICATION: Coronary Artery Disease Imaging; TARGET: Blood plasma; THERAPY: Monotherapy; LEAD SPONSOR: Bracco Diagnostics, Inc; CRITERIA: Inclusion Criteria: - Provided written Informed Consent and comply with protocol requirements; - Was at least 18 years of age; - Had suspected of having CAD and undergoing coronary angiography within 6 months after the LUMASON DSE. - Had undergone a previous echocardiography prior to enrollment; resulting in suboptimal unenhanced images at rest, defined as ≥ 2 suboptimal adjacent segments in any apical view. Exclusion Criteria: • Was a pregnant or lactating female. Exclude the possibility of pregnancy: by testing on site at the institution (serum or urine βHCG) within 24 hours prior to the start of LUMASON administration(s), by surgical history (e.g., tubal ligation or hysterectomy), post menopausal with a minimum 1 year without menses; - Had any known hypersensitivity to 1 or more ingredients of LUMASON (sulfur hexafluoride or to any components of LUMASON); - Had any known hypersensitivity to dobutamine; - Had an ongoing or recent (within the last 30 days) acute myocardial infarction; - Had known right-to-left, bidirectional or transient cardiac shunt (ruled out with agitated saline study performed before administration of LUMASON); - Had electrolyte (especially potassium and magnesium) abnormalities; - Had unstable pulmonary and/or systemic hemodynamic conditions e.g.: decompensated or inadequately controlled congestive heart failure (NYHA Class IV); - hypovolemia; - uncontrolled hypertension, i.e. resting systolic blood pressure >200 mmHg or diastolic blood pressure >110 mmHg; - unstable angina; - acute coronary syndrome; - aortic dissection; - acute pericarditis, - myocarditis, or endocarditis; - stenosis of the main left coronary artery; - hemodynamically significant outflow obstruction of the left ventricle, including hypertrophic obstructive cardiomyopathy; - hemodynamically significant cardiac valvular defect; - acute pulmonary embolism; - Had uncontrolled cardiac arrhythmias; - Had significant disturbance in conduction; - Had hypertrophic subaortic stenosis; - Had an acute illness (e.g., infections, hyperthyroidism, or severe anemia); - Was previously entered into this study or received an investigational compound within 30 days before admission into this study; - Had been treated with any other contrast agent either intravascularly or orally within 48 hours of the first LUMASON administration; - Had any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study and/or postdose follow-up examinations; In addition, due to the use of Atropine in subjects who had not reached targeted heart rate with peak dobutamine infusion, subjects with the following were excluded: - Glaucoma; - Pyloric stenosis; - Prostatic hypertrophy. ; PRIMARY OUTCOME: Sensitivity and Specificity of Lumason Enhanced Dobutamine Stress Echo (DSE) for Detection or Exclusion of Coronary Artery Disease (CAD); SECONDARY OUTCOME 1: Change in Total LV EBD[/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 - C14012; BRIEF: This is a phase 3, randomized, 2-arm, open-label, international trial evaluating alisertib compared with single-agent treatment, as selected by the investigator from the offered options of pralatrexate or gemcitabine or romidepsin, in participants with relapsed or refractory peripheral T-cell lymphoma (PTCL). Note: romidepsin was not used as a single-agent comparator outside the United States of America (USA) as supply was not available. ; DRUG USED: Alisertib; DRUG CLASS: New Molecular Entity (NME); INDICATION: Peripheral T-Cell Lymphoma (PTCL) - NHL; TARGET: Aurora Kinase; THERAPY: Monotherapy; LEAD SPONSOR: Millennium Pharmaceuticals, Inc.; CRITERIA: Inclusion Criteria: - Male or female participants age 18 or older - Participants with Peripheral T cell lymphoma (PTCL) (selected subtypes) according to World Health Organization (WHO) criteria and have relapsed or are refractory to at least 1 prior systemic, cytotoxic therapy for PTCL. Participants must have received conventional therapy as a prior therapy. Cutaneous-only disease is not permitted. Participants must have documented evidence of progressive and measurable disease. - Tumor biopsy available for central hematopathologic review - Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 - Female participants who are post menopausal for at least 1 year, surgically sterile, or agree to practice 2 effective methods of contraception through 30 days after the last dose of study drug or agree to abstain from heterosexual intercourse. - Male participants who agree to practice effective barrier contraception through 6 months after the last dose of alisertib or agree to abstain from heterosexual intercourse - Suitable venous access - Voluntary written consent Exclusion Criteria - Known central nervous system lymphoma - Systemic antineoplastic therapy, immunotherapy, investigational agent or radiation therapy within 4 weeks of first dose of study treatment or concomitant use during study - Prior administration of an Aurora A kinase-targeted agent, including alisertib; or all of the 3 comparator drugs (pralatrexate, or romidepsin or gemcitabine; or known hypersensitivity) - History of uncontrolled sleep apnea syndrome or other conditions that could result in excessive daytime sleepiness - Cardiac condition as specified in study protocol, including left ventricular ejection fraction (LVEF) <40% - Concomitant use of other medicines as specified in study protocol - Participants with abnormal gastric or bowel function who require continuous treatment with H2-receptor antagonists or proton pump inhibitors - Known active infection with human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C - Autologous stem cell transplant less than 3 months prior to enrollment - Participants who have undergone allogeneic stem cell or organ transplantation any time - Inadequate blood levels, bone marrow or other organ function as specified in study protocol - The participant must have recovered to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Grade ≤ 1 toxicity, to participants baseline status (except alopecia), or deemed irreversible from the effects of prior cancer therapy - Major surgery, serious infection, or infection requiring systemic antibiotic therapy within 14 days prior to the first dose of study treatment - Female participants who are breastfeeding or pregnant - Coexistent second malignancy or history of prior solid organ malignancy within previous 3 years - Serious medical or psychiatric illness or laboratory abnormality that could, in the investigators opinion, potentially interfere with the completion of treatment according to the protocol ; PRIMARY OUTCOME: Overall Response Rate (ORR) Based on Independent Review Committee (IRC) Assessment; 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 III - w/Trastuzumab + Docetaxel; BRIEF: This is an Asia-Pacific regional, randomized, double-blind, multicenter trial designed to evaluate treatment with trastuzumab + pertuzumab + docetaxel compared with trastuzumab + placebo + docetaxel in chemotherapy-naïve participants with early-stage or locally advanced HER2-positive breast cancer. The anticipated treatment duration is approximately 17 months. ; DRUG USED: Perjeta; DRUG CLASS: Biologic; INDICATION: Breast Cancer; TARGET: HER2/neu or ErbB-2; THERAPY: Combination; LEAD SPONSOR: Hoffmann-La Roche; CRITERIA: Inclusion Criteria: - Histologically confirmed invasive breast carcinoma with a primary tumor size of more than (>) 2 centimeters (cm) by standard local assessment technique - Breast cancer stage at presentation: early-stage (T2-3, N0-1, M0) or locally advanced (T2-3, N2 or N3, M0; T4, any N, M0) - HER2-positive breast cancer confirmed by a Sponsor-designated central laboratory and defined as 3+ score by immunohistochemistry in > 10 percent (%) of immunoreactive cells or HER2 gene amplification (ratio of HER2 gene signals to centromere 17 signals equal to or more than [>=] 2.0) by in situ hybridization - Known hormone receptor status (estrogen receptor and/or progesterone receptor) - Eastern Cooperative Oncology Group Performance Status equal to or less than (<=) 1 - Baseline left ventricular ejection fracture >= 55% measured by echocardiography (preferred) or multiple gated acquisition scan - Negative serum pregnancy test Exclusion Criteria: - Stage IV metastatic breast cancer - Inflammatory breast cancer - Previous anti-cancer therapy or radiotherapy for any malignancy - History of other malignancy within 5 years prior to screening, except for appropriately-treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or Stage I uterine cancer - Concurrent anti-cancer treatment in another investigational trial, including hormone therapy, bisphosphonate therapy, or immunotherapy - Major surgical procedure unrelated to breast cancer within 4 weeks prior to randomization or from which the participant has not fully recovered - Serious cardiac illness or medical condition - Other concurrent serious diseases that may interfere with planned treatment, including severe pulmonary conditions/illness - Any abnormalities in liver, kidney or hematologic function laboratory tests immediately prior to randomization - Sensitivity to any of the study medications, any of the ingredients or excipients of these medications, or benzyl alcohol - Pregnant or lactating ; PRIMARY OUTCOME: Percentage of Participants With Total Pathologic Complete Response (tpCR) as Assessed by the Independent Review Committee (IRC); SECONDARY OUTCOME 1: Percentage of Participants With tpCR as Assessed by the Local Pathologist[/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 - 20060102 - MDS; BRIEF: This is a dose and schedule finding study of AMG 531 designed to assess the activity of AMG 531 to reduce the rate of clinically significant bleeding and blood transfusions in subjects with myelodysplastic syndrome (MDS) receiving lenalidomide. Subjects with MDS that are planned to receive at least four cycles of lenalidomide for treatment of their disease are appropriate to screen for this study. All subjects meeting the eligibility criteria will receive lenalidomide 10 mg capsule by mouth daily every day of each 28-day cycle. Subjects will receive AMG 531 or placebo once a week by subcutaneous injection for 16 weeks. ; DRUG USED: Nplate; DRUG CLASS: Biologic; INDICATION: Thrombocytopenia; TARGET: Thrombopoietin Receptor (TPO-R, c-Mpl, CD110); THERAPY: Combination; LEAD SPONSOR: Amgen; CRITERIA: Inclusion Criteria: - Diagnosis of MDS by bone marrow biopsy based on the World Health Organization (WHO) classification - Low or Intermediate-1 risk category MDS using the IPSS - Planned to receive lenalidomide 10 mg capsule by mouth daily for all 28 days of each cycle for at least 4 cycles - Eastern Cooperative Oncology (ECOG) performance status of 0-2 - Subjects must be at least 18 years of age or older Exclusion Criteria: - Prior exposure to >3 cycles of lenalidomide - Exposure to lenalidomide within the last 30 days - Prior history of leukemia or aplastic anemia - Prior history of stem cell transplantation - Prior malignancy (other than in situ cervical cancer or basal cell cancer of the skin) unless treated with curative intent and without evidence of disease for 3 years before randomization - Active or uncontrolled infections - Unstable angina, congestive heart failure [NYHA > class II], uncontrolled hypertension [diastolic > 100 mmHg], uncontrolled cardiac arrhythmia, or recent (within 1 year) myocardial infarction - History of arterial thrombosis ( eg, stroke or transient ischemic attack) in the past year - History of venous thrombosis in the past year - Received IL-11 within 4 weeks of screening - Less than 4 weeks since receipt of any investigational drug or device - Have previously received any other thrombopoietic growth factor - Pregnant or breast feeding - Subjects of reproductive potential who are not using adequate contraceptive precautions, in the judgment of the investigator - Known hypersensitivity to any recombinant E coli-derived product ; PRIMARY OUTCOME: Occurrence of a Clinically Significant Thrombocytopenic Event; SECONDARY OUTCOME 1: Lenalidomide Dose Reduction and Delay Due to Thrombocytopenia[/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 - Asian PREVAIL (Progressive, Metastatic); BRIEF: Purpose of the study was to assess the effect of enzalutamide on time to Prostate Specific Antigen (PSA) progression as compared to placebo in chemotherapy naïve participants with progressive metastatic prostate cancer who have failed androgen deprivation therapy. ; DRUG USED: Xtandi; DRUG CLASS: New Molecular Entity (NME); INDICATION: Prostate Cancer; TARGET: Androgen receptors; THERAPY: Monotherapy; LEAD SPONSOR: Astellas Pharma Inc; CRITERIA: Inclusion Criteria: - Histologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features - Ongoing androgen deprivation therapy with a GnRH analogue or bilateral orchiectomy - Progressive disease despite androgen deprivation therapy as defined by rising PSA levels or progressive soft tissue or bone disease - No prior treatment with cytotoxic chemotherapy - Asymptomatic or mildly symptomatic from prostate cancer Exclusion Criteria: - Severe concurrent disease, infection, or co-morbidity that, in the judgment of the Investigator, would make the patient inappropriate for enrollment - Known or suspected brain metastasis or active leptomeningeal disease - History of another malignancy within the previous 5 years other than curatively treated non-melanomatous skin cancer - History of seizure including febrile seizure or any condition that may predispose to seizure (e.g., prior stroke, brain arteriovenous malformation, head trauma with loss of consciousness requiring hospitalization). ; PRIMARY OUTCOME: Time to Prostate-specific Antigen (PSA) Progression; SECONDARY OUTCOME 1: Duration of Overall Survival[/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 - Sante Cannabis; Canada; BRIEF: Cancer causes pain in many of the patients that it affects. Physicians specialized in palliative care help advanced cancer patients to maintain as good pain control as possible through the use of medications such as opioids. Even with palliative care and optimal use of medications, many patients still suffer enormously as the cancer spreads. Because of this, some cancer patients also try or use cannabis in different ways to relieve their pain and improve the way they feel. However, there has not been much high-quality research done yet to prove whether or not cannabis products are truly useful to relieve severe cancer pain. This study is to test if advanced cancer patients who use inhaled medical cannabis (PPP001), in addition to palliative care management, will experience improvement in quality of life and relieve uncontrolled pain, providing safety conditions. ; DRUG USED: QIXLEEF; DRUG CLASS: Non-NME; INDICATION: Chronic Pain; TARGET: Cannabinoid-1 (CB1) receptor, Cannabinoid-2 (CB2) receptor; THERAPY: Monotherapy; LEAD SPONSOR: Tetra Bio-Pharma; CRITERIA: Inclusion Criteria: 1. Written informed consent 2. Adult male and female patients at least 18 years of age 3. Subject agreed to follow the protocol 4. Advanced cancer for which there is no known curative therapy 5. Patients experiencing pain ≥4 on NRS due to cancer related pain 6. Life expectancy six weeks or longer 7. PPI score less than or equal to 4 (survival more than 6 weeks) 8. PPS greater than or equal 70% 9. PaP Score Group A (30-day survival probability >70%) 10. An Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 11. The patient has a clinical diagnosis of cancer related pain, which is not alleviated with their current optimized opioid treatment 12. The patient is using no more than one type of breakthrough opioid analgesia 13. Normal cognitive status according to MDAS and MiniCog 14. Normal liver function (defined as aspartate aminotransferase 10-40 U/L and alanine aminotransferase 7-56 U/L) 15. Normal renal function (defined as serum creatinine level <133 µmol/L and Estimated Glomerular Filtration Rate (eGFR) greater than or equal to 60) 16. The patient is able to perform deep inhalations and hold breath for at least 5 to 10 seconds. If there is any pulmonary disease diagnosed previously (obstructive and/or restrictive pathology), the patient must be able to perform a maximal inhalation of at least 12-15 ml/kg measured with an incentive spirometer, followed by a normal exhalation 17. Ability to read and respond to questions in French or English. 18. Previous or current use of opioid analgesics (at least 1 week) 19. A female volunteer must meet one of the following criteria: If of childbearing potential - agrees to use one of the accepted contraceptive regimens from at least 28 days prior to the first drug administration, during the study and for at least 60 days after the last dose. An acceptable method of contraception includes one of the following: - Abstinence from heterosexual intercourse - Systemic contraceptives (birth control pills, injectable/implant/insertable hormonal birth control products, transdermal patch) - Intrauterine device (with or without hormones) - Condom with spermicide or condom with intravaginally applied spermicide If of non-childbearing potential - should be surgically sterile (i.e. has undergone complete hysterectomy, bilateral oophorectomy, or tubal ligation) or in a menopausal state (at least one year without menses) 20. A male volunteer with sexual partners who are pregnant, possibly pregnant, or who could become pregnant must meet the following criteria: - Participant is unable to procreate, defined as surgically sterile (i.e. has undergone a vasectomy within the last 6 months) - Participant agrees to use one of the accepted contraceptive regimens from first drug administration until 3 months after the last drug administration. An acceptable method of contraception includes one of the following: A. Abstinence from heterosexual intercourse. B. Condom with spermicide or condom with intravaginally applied spermicide Exclusion Criteria: 1. Pain due to other causes different than cancer related pain 2. Previous serious adverse event or hypersensitivity to cannabis or cannabinoids 3. Inability to understand and comply with the instructions of the study 4. Presence of significant cardiac disease (history of unstable ischemic heart disease, heart failure, severe and uncontrolled hypertension) that, in the opinion of the investigator, would put the patient at risk of a clinically significant arrhythmia or myocardial infarction 5. Current substance use disorder according to the Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM 5) 6. Life-time history of dependence on cannabis or diagnosis of cannabis use disorder (CUD) according to the DSM 5 7. Life-time history of DSM 5 schizophrenia, bipolar disorder, or previous psychosis with or intolerance to cannabinoids 8. Current or history of suicidal ideation according to the Columbia-Suicide Severity Rating Scale (C-SSRS) approved by FDA in 2012 for assessment of suicidal ideation and behaviour 9. Pregnant, breast-feeding or female patients of child-bearing potential and male patients whose partner is of child-bearing potential, unless willing to ensure that they or their partner use effective contraception, for example, oral contraception, double barrier, intra-uterine device, during the study and for three months thereafter (however, a male condom should not be used in conjunction with a female condom as this may not prove effective) 10. Hepatic impairment (aspartate aminotransferase more than three times normal) or renal function impairment (serum creatinine level >133 µmol/L, Estimated Glomerular Filtration Rate (eGFR) <60) 11. Cognitive impairment according to MDAS and MiniCog 12. Patient has any planned clinical interventions that would affect their pain (e.g., chemotherapy or radiation therapy where, in the clinical judgment of the investigator, these would be expected to affect pain) 13. Cancer treatments that may interfere with stability of treatment (epidural, radiotherapy, chemotherapy, hormonal therapy) 14. Epilepsy 15. The patient is currently using or has used cannabinoid based medications within 30 days of study entry and is unwilling to abstain for the duration of the study 16. Positive urine drug screen for cannabinoids and other potential abuse substances (e.g. alcohol, cocaine, amphetamines and methamphetamines, hallucinogens, unprescribed opioids and ketamine, etc.) 17. Participation in another clinical trial within 30 days of enrolment in our trial ; PRIMARY OUTCOME: improve Health Related Quality of Life (HRQoL) of patients with uncontrolled cancer pain and incurable malignancy; SECONDARY OUTCOME 1: Does the daily use of PPP001-kit improve uncontrolled cancer pain[/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 - Study 002; BRIEF: This study is being conducted to determine the safety, tolerability, pharmacokinetics, and effects of EVP-0962 on cerebral spinal fluid Amyloid concentrations in healthy subjects and in subjects with mild cognitive impairment or early Alzheimers disease. ; DRUG USED: EVP-0962; DRUG CLASS: New Molecular Entity (NME); INDICATION: Alzheimers Disease (AD); TARGET: Gamma-secretase; THERAPY: Monotherapy; LEAD SPONSOR: FORUM Pharmaceuticals Inc; CRITERIA: Inclusion Criteria: - Part 1: Male and female subjects between the ages of 45 to 65 (inclusive) in good health with a BMI of 18-32 kg/m2 and negative urine drug screen of abuse test. - Part 2: Male and female subjects between the ages of 45 to 85 (inclusive), MRI/CT scans compatible with diagnosis of MCI or early AD, meets the classification of MCI due to AD as defined by the National Institute on Aging-Alzheimers Association, and a BMI of 18-32 kg/m2(inclusive). Subjects must meet the following Cognitive criteria: Subject Memory Complaint, cognitive impairment in one or more areas, CDR-SB score less than or equal 1.0, MMSE greater than 24, and no impairment in social or occupational functioning. Exclusion Criteria: - History of seizure disorder, symptomatic orthostatic hypotension, QTc values greater than 450 ms, positive drug screening tests - Pregnancy, nursing, (or if fertile female) not willing to utilize birth control measures during study - C-SSRS suicidal ideation score of 4 or 5 - Unwilling to abstain from vigorous exercise - Concurrent disease other than MCI or early AD that is attributing to patients cognitive impairment. - Lumbar spine X-rays show anatomic contraindications to lumbar puncture - History of spinal surgery or chronic low back pain - History of migraine headaches ; PRIMARY OUTCOME: The number of adverse experiences reported by subjects and/or observed by investigator and repeated clinical evaluations of physical examinations, vital signs, 12-lead ECG (electrocardiogram), and lab tests (hematology, chemistry, urinalysis); SECONDARY OUTCOME 1: To measure the rate of synthesis of Amyloid Beta and steady-state levels in the cerebral spinal fluid in MCI or early Alzheimers disease patients[/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 - AIPAC (EU); BRIEF: The proposed Phase IIb clinical study aims to investigate the safety and efficacy of the active immunotherapy IMP321 in combination (adjunctive) with paclitaxel chemotherapy in patients with hormone receptor-positive metastatic breast cancer. ; DRUG USED: Eftilagimod Alpha; DRUG CLASS: Biologic; INDICATION: Breast Cancer; TARGET: Immune System, LAG3 (Lymphocyte-Activation Gene)/CD223; THERAPY: Combination; LEAD SPONSOR: Immutep S.A.S.; CRITERIA: Inclusion Criteria: 1. Able to give written informed consent and to comply with the protocol 2. Metastatic oestrogen receptor positive and/or progesterone receptor positive breast adenocarcinoma, histologically proven by biopsy of the primary tumour and/or metastasis 3. Female of age 18 years or above 4. Patients who are indicated to received first line chemotherapy with weekly paclitaxel 5. Evidence of measurable disease as defined by Response Evaluation Criteria version 1.1 6 Laboratory criteria: haematology and biochemistry results within the limits normally expected for the patient population. Exclusion Criteria: 1. Prior chemotherapy for metastatic breast adenocarcinoma 2. Disease-free interval of less than twelve months from the last dose of adjuvant chemotherapy 3. Inflammatory carcinoma 4. Candidate for treatment with trastuzumab (or other Her2/neu targeted agents) 5. Systemic chemotherapy, radiation therapy or any other investigational agent within 4 weeks, endocrine therapy within 1 week prior to first dose of study treatment or CDK4/6 inhibitors within 5 times half-life (acc.to SPC) prior to first dose of study treatment and until completion of study treatment 6. Symptomatic known cerebral and/or leptomeningeal metastases 7. Serious intercurrent infection 8. Evidence of severe or uncontrolled cardiac disease (NYHA III-IV) within 6 months prior to first dose of study treatment 9. Active acute or chronic infection 10. Active autoimmune disease requiring immunosuppressive therapy 11. Previous malignancies within the last three years other than breast carcinoma 12. Patients with prior organ or stem cell transplantation 13. Any condition requiring continuous systemic treatment with either corticosteroids or other immunosuppressive medications within 4 weeks prior to first dose of study treatment. ; PRIMARY OUTCOME: Stage 1 to determine the recommended phase two dose for the randomised phase; SECONDARY OUTCOME 1: Assessment of the safety and tolerability of IMP321 as compared to placebo[/INST]Yes</s> |
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