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<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase III - iNTEGRATE[/INST]
To evaluate the safety and efficacy of ibrutinib in combination with prednisone in subjects
with newly diagnosed moderate to severe cGVHD.
</s> |
<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase III - ROCKET 2[/INST]
Evaluation of the ocular hypotensive efficacy and safety of Netarsudil (AR-13324) Ophthalmic
Solution compared to Timolol Maleate Ophthalmic Solution
</s> |
<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase I/II - ACN01[/INST]
This is a Phase 1/2a study.
The purpose of Phase 1 was to evaluate the safety and tolerability of DRM01B Topical Gel in 6
healthy volunteers.
The purpose of Phase 2a was to assess the safety, tolerability and preliminary efficacy of
DRM01B Topical Gel compared to vehicle in subjects with acne vulgaris on the face.
</s> |
<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase I - DEPLETHINK[/INST]
This open-label Phase I study aims at assessing primarily the safety of the NKR-2 treatment
administered after a non-myeloablative preconditioning regimen in r/r AML/MDS patients.
This Phase I study will contain two different sequential segments. The first segment will
determine the recommended investigational treatment option (schedule of preconditioning and
NKR-2 dose) and the second segment will expand to a larger number of r/r AML/MDS patients.
</s> |
<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase III - Japan[/INST]
This prospective study is designed to evaluate the efficacy, safety, and tolerability of
ALXN2060 (also known as AG10), as well as to establish its pharmacokinetic and
pharmacodynamic profile in Japanese participants with symptomatic ATTR-CM administered on a
background of stable heart failure therapy.
</s> |
<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase II - Elderly - w/Cyclophosphamide/Dexamethasone[/INST]
The purpose of this study is to determine whether the association of Carfilzomib,
Cyclophosphamide and Dexamethasone (CCd) as induction treatment is safe and provides benefits
in patients with newly diagnosed Multiple Myeloma (MM).
</s> |
<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase III - RUXCOVID-DEVENT[/INST]
The purpose of this study is to evaluate the efficacy and safety of ruxolitinib in the
treatment of participants with COVID-19-associated Acute Respiratory Distress Syndrome (ARDS)
who require mechanical ventilation.
</s> |
<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase II - ATHOS[/INST]
This is a study to evaluate the safety and efficacy of GDC-0853 in combination with standard
of care therapy in participants with moderate to severe active systemic lupus erythematosus
(SLE).
</s> |
<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase II - COMIRB (Squamous Cell Carcinomas)[/INST]
The primary objective of this study is to determine if tumors in patients with papillomavirus
(HPV) positive or negative squamous cell carcinoma (SCC) that no longer responds to standard
therapy will decrease in size following treatment with the investigational drug, rigosertib
sodium (ON 01910.Na). A secondary objective is to determine if treatment with rigosertib
causes any side effects.
Rigosertib is an investigational drug, which means that it has not been approved by the U.S.
Food and Drug Administration (FDA) to treat any diseases. We are studying rigosertib as a new
anticancer drug. Tests that we have done in the laboratory suggest that rigosertib works by
blocking cell division in cancer cells and causing them to die.
</s> |
<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase IIIb - SOLANA (Eosinophilic Inflammation)[/INST]
The purpose of this study is to investigate the onset and maintenance of effect of
benralizumab on lung function, blood eosinophils, asthma control metrics and quality of life
during 12-week treatment in patients with uncontrolled, severe asthma with eosinophilic
inflammation. A subset of patients will take part in body plethysmography substudy to further
investigate the effect on lung function.
</s> |
<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase II - IND2-08-03[/INST]
The purpose of this study is to determine whether Indomethacin Test Formulation Capsules are
safe and effective for the treatment of dental pain.
</s> |
<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>>
4 weeks of screening, 12 weeks of main treatment, 12 weeks of cross-over (for GC-only group),
40 weeks of extension treatment and 4-week follow-up.
[/INST]
This is a Phase 2a, multi-center, open-label, two-arm study of approximately 25 patients with
active IgG4-related disease (IgG4-RD). The two arms include (1) Experimental: rilzabrutinib
with glucocorticoids and (2) Active Comparator: glucocorticoids only.
</s> |
<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase IV - PRISTINE[/INST]
The purpose of this study is to compare the safety and efficacy of different doses of
etanercept for the treatment of moderate to severe psoriasis.
</s> |
<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase I - Dose Escalation[/INST]
This is a Phase I, multicenter, open-label study of MEHD7945A in participants with incurable,
locally advanced, or metastatic epithelial malignancies that have progressed despite standard
therapy or for which no standard therapy exists. The study will be conducted in two stages: a
dose escalation stage and an expansion stage. The dose-escalation stage is designed to
evaluate the safety, tolerability, and PK of MEHD7945A administered (at five dose levels from
1 to 30 milligrams per kilogram [mg/kg]) every 2 week (Q2W). An expansion stage will be
initiated after establishment of maximum tolerated dose (MTD) in dose escalation stage.
Participants with refractory or recurrent metastatic colorectal cancer (CRC), non-small cell
lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), and pancreatic cancer
will be enrolled in an expansion stage to better characterize the safety, tolerability, PK
and preliminary assessment of the anti-tumor activity of MEHD7945A.
</s> |
<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase IIb - SOCRATES-PRESERVED[/INST]
Objective of the study is to find the optimal dose of the once daily oral soluble guanylate
cyclase stimulator (sGC) BAY1021189 for Phase III that can be given in addition to standard
diuretic and comorbidity treatment for heart failure with preserved ejection fraction (HFpEF)
</s> |
<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>>
T89 is a modernized and industrialized version of a traditional Chinese herbal medicine. T89
was approved for marketing as a drug, for the treatment of chronic stable angina pectoris due
to coronary heart disease, by the State Food and Drug Administration (SFDA) of China in 1993.
There were more than 2 billion doses have been prescribed or used, in about 10,000,000
subjects, in short or long-term administration worldwide.
The product is also marketed, as a drug, in Russia, South Korea, Mongolia, Singapore,
Vietnam, and South Africa. The current study is to determine the anti-angina effect and dose
response of T89 in patients with chronic stable angina pectoris in the United States.
T89 consists of Danshen (Radix Salviae Miltiorrhizae, RSM) and Sanqi (Radix Notoginseng, RN)
as active constitutes, and using Borneol as transporting enhancer.
[/INST]
The purpose of this study is to determine the anti-angina effect and dose response of T89, a
2-herb botanical drug product, in patients with chronic stable angina pectoris in the United
States.
</s> |
<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase III - vs. Bovine Thrombin[/INST]
The purpose of this study is to determine whether recombinant human Thrombin (rhThrombin) is
effective in stopping bleeding during surgery, in comparison with bovine thrombin.
</s> |
<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>>
This is an open-label, fixed-sequence, ascending-dose, first-in-human study to evaluate the
effect of a highly targeted rhGAA (ATB200) co-administered with a chaperone (AT2221).
The study aims to evaluate safety, tolerability, pharmacodynamics (PD), and immunogenicity of
ATB200 co-administered with AT2221. The study will be conducted in 3 stages.
In Stage 1, safety, tolerability, and PK will be evaluated following sequential single
ascending doses of intravenously infused ATB200.
In Stage 2, safety, tolerability, and PK will be evaluated following single- and
multiple-ascending dose combinations of ATB200 and AT2221.
In Stage 3, long term safety and efficacy will be assessed following 24 month treatment of
ATB200 co-administered with AT2221 (Miglustat)
In Stage 4, treatment period will begin at the end of Stage 3 and will continue as open label
extension until commercialization, study discontinuation or subject withdrawal, with
functional assessments every 6 months
No Muscle biopsies will be performed in this study.
[/INST]
This study is an international, multi-center, study of Pompe disease patients that are
currently receiving enzyme-replacement therapy (ERT). The purpose of this study is to find
out if the co-administration of investigational new drugs ATB200 and AT2221 is safe in adults
with Pompe disease.
</s> |
<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>>
The primary objective for this study is to compare headache relief (defined as a reduction
from moderate [Grade 2] or severe [Grade 3] pain to none [Grade 0] or mild [Grade 1] pain) at
120 minutes following a dose of 20 mg of OPTINOSE SUMATRIPTAN with placebo in the acute
treatment of a single migraine attack.
[/INST]
The study is being conducted to determine if OPTINOSE SUMATRIPTAN delivered nasally (through
the nose) using the OPTINOSE SUMATRIPTAN Device can reduce the pain and symptoms associated
with migraine headaches.
</s> |
<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase I - Umbrella (SR formulation)[/INST]
To investigate whether there is a food-effect with oral administration with EB-1020 as well
as to obtain information on the safety, and tolerability of EB-1020 in a range of doses.
</s> |
<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase III - UNCOVER-2[/INST]
This study will assess the safety and efficacy of ixekizumab (LY2439821) compared to
etanercept and placebo in participants with moderate to severe chronic plaque psoriasis.
</s> |
<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase II - PCTA204/09 - Moderate/Severe Acne[/INST]
The purpose of this trial is to study the efficacy and safety of Visonac PDT in patients from
9 to 35 years old with Aktilite® CL512. Patients was randomized to Visonac or vehicle cream
without occlusion and red light(dose: 37J/cm2)
</s> |
<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase III - JADE TEEN[/INST]
This is a randomized, double blind, placebo controlled, parallel group, Phase 3 study to
evaluate the efficacy and safety of PF 04965842 in adolescent participants 12 to <18 years of
age with moderate to severe AD.
</s> |
<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase I/II - BLU-945-1101[/INST]
This is a Phase 1/2, open-label, first-in-human (FIH) study designed to evaluate the safety,
tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and anticancer activity of
BLU-945, a selective EGFR inhibitor, as monotherapy or in combination with osimertinib.
</s> |
<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase II - NCI[/INST]
RATIONALE: Androgens can cause the growth of prostate cancer cells. Drugs, such as leuprolide
and bicalutamide, may stop the adrenal glands from making androgens. Squalamine lactate may
stop the growth of prostate cancer by blocking blood flow to the tumor. Giving hormone
therapy together with squalamine lactate before surgery may make the tumor smaller and reduce
the amount of normal tissue that needs to be removed.
PURPOSE: This randomized phase II trial is studying how well giving hormone therapy together
with squalamine lactate works compared to hormone therapy alone in treating patients who are
undergoing a radical prostatectomy for locally advanced prostate cancer.
</s> |
<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase Ia/b - Study 003 (w/Nivolumab)[/INST]
Phase 1a/1b does-escalation study of cabiralizumab alone and with nivolumab in advanced solid
tumors.
</s> |
<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase II - Study 216[/INST]
This is a Phase 2, open-label, single arm, multicenter, 2-stage study of eribulin mesylate
administered biweekly at 1.4 mg/m2 intravenously for the treatment of participants with
HER2-negative metastatic breast cancer previously treated with 2 to 5 chemotherapy regimens.
</s> |
<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>>
Diabetic women with clinical symptoms attributed to diabetic gastroparesis and documentation
of delayed gastric emptying who meet the protocol-specified entry criteria will be randomized
to Metoclopramide Nasal Spray 10 mg or placebo administered as a single intranasal spray four
(4) times daily; 30 minutes before meals and at bedtime for a total of four (4) weeks.
[/INST]
The purpose of this study is provide confirmation of the safety and efficacy of
Metoclopramide Nasal Spray compared to placebo in reducing the symptoms of diabetic
gastroparesis in adult women.
</s> |
<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase I - SAD (OA of the Knee)[/INST]
A study to evaluate safety, tolerability, and pharmacokinetics of a single intra-articular
injection of UBX0101 in patients diagnosed with painful osteoarthritis of the knee.
</s> |
<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>>
LUZ11 is a new photosensitizer for use in photodynamic therapy (PDT) of solid tumors, such as
head and neck cancer. PDT with LUZ11 involves the intravenous administration of LUZ11
followed by irradiation of the target tumor with laser light of an appropriate wavelength.
The light causes the drug to react with oxygen, which forms reactive oxygen species (ROS)
locally and induces tumor cells death and damages the blood vessels of the tumor thus
preventing it from receiving nutrients.
The primary objective of this study is to assess the tolerability of LUZ11 following single
ascending doses of LUZ11. The secondary objectives of this study are to explore the LUZ11
dose that has anti-tumor effect following photoactivation and to determine LUZ11
pharmacokinetics.
[/INST]
This study will investigate the tolerability, recommended dose and pharmacokinetics of LUZ11
following photodynamic therapy (PDT) of patients with advanced head and neck cancer.
</s> |
<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase III - COVERS Exp[/INST]
The purpose of this study is to evaluate the effects of Ceftaroline Fosamil versus Vancomycin
plus Aztreonam in treatment of patients with complicated bacterial skin and soft tissue
infections.
</s> |
<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase III - 8591A-018[/INST]
This study will evaluate the safety and efficacy of a switch to MK-8591A (a fixed dose
combination of doravirine and islatravir) in human immunodeficiency virus -1 (HIV-1)-infected
participants virologically suppressed on a regimen of bictegravir/emtricitabine/tenofovir
alafenamide (BIC/FTC/TAF). The primary hypothesis is that a switch to MK-8591A will be
non-inferior to continued treatment with BIC/FTC/TAF as assessed by the proportion of
participants with HIV-1 ribonucleic acid (RNA) ≥50 copies/mL at Week 48. Participants who
benefit from their assigned intervention (as determined by investigator) will be able to
continue treatment through a 24-week study extension.
</s> |
<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase I - PEG-asparaginase allergy (COG)[/INST]
This clinical trial is studying the side effects of Erwinia asparaginase and what happens to
the drug in the body in treating young patients with acute lymphoblastic leukemia who are
allergic to PEG-asparaginase. Drugs used in chemotherapy, such as Erwinia asparaginase, work
in different ways to stop the growth of cancer cells, either by killing the cells or by
stopping them from dividing.
</s> |
<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase II - AROAAT2002[/INST]
The purpose of this study is to evaluate the the safety and efficacy of the investigational
product, fazirsiran (TAK-999, ARO-AAT), administered subcutaneously to patients with Alpha-1
Antitrypsin Deficiency.
</s> |
<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase II - Dose-ranging[/INST]
This study is open for men and women with a liver disease called nonalcoholic steatohepatitis
(NASH) and liver fibrosis. The purpose of the study is to find out whether a medicine called
BI 456906 helps patients with NASH and liver fibrosis. The study tests 3 different doses of
BI 456906 to find the dose that helps best. Participants are put into 4 groups randomly,
which means by chance. There are 3 groups that each receive a different dose of BI 456906 and
there is 1 group that receives placebo. BI 456906 and placebo are given as an injection under
the skin once per week. The placebo injection looks like the BI 456906 injection but does not
contain any medicine.
Participants are in the study for a little over 1 year (60 weeks). During this time, they
visit the study site several times and have some video calls in addition. At the visits, the
study doctors take different measurements. To see whether the treatment works, the doctors
take a very small sample of liver tissue (biopsy) from each participant at the start and at
the end of the study. They also examine the liver by ultrasound and MRI. The doctors also
regularly check the general health of the participants.
</s> |
<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase I/II - w/Dexamethasone (T-ALL/T-LBL)[/INST]
The main purpose of this study is to evaluate the safety of the study drug known as LY3039478
in combination with dexamethasone in participants with T-cell acute lymphoblastic leukemia or
T-cell lymphoblastic lymphoma (T-ALL/T-LBL).
</s> |
<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase I/IIa - Oral Formulation[/INST]
First in human, open-label, sequential dose escalation and expansion study of oral BAL101553
in adult patients with advanced solid tumors and adult patients with recurrent or progressive
glioblastoma or high-grade glioma.
</s> |
<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>>
RB94, a tumor suppressor gene, is a modified form of the retinoblastoma gene, RB110. RB94 has
shown enhanced tumor suppressor and tumor cell killing activity compared to RB110 in all
tumor cell types studied to date, including bladder cancer cell lines. Moreover, RB94 has
shown no toxicity to any normal human cells tested.
SGT-94,the agent being tested, is a systemically administered complex composed of the RB94
gene (plasmid DNA)encapsulated in a liposome that is targeted to tumor cells by means of an
anti-transferrin receptor single chain antibody fragment (TfRscFv)attached to the outside of
the liposome. Pre-clinical in vivo efficacy studies have indicated that SGT-94, when
systemically administered, preferentially targets tumor cells and efficiently transfects
them. This results in cancer cell death via mechanisms that are unique for RB94 and also
increases the tumor's response to conventional radiation and chemotherapy.
This Phase I study is designed to evaluate the safety of SGT-94 and to establish a
practically attainable and/or tolerable dose of this anti-cancer agent for use in further
clinical trials. Additionally, evidence of RB94 expression within tumor tissue after systemic
administration of SGT-94 will be sought, and clinically observable anti-cancer effects in
patients will be documented. Enrollment will be targeted to individuals with "RB negative"
tumors, i.e. tumors in which there is no staining for RB protein by immunohistochemistry
(IHC). Preference will be given to patients with tumors in a location amenable to biopsy
following treatment with SGT-94. This would include the prostate, bladder, superficial lymph
nodes and any mass suitable for fine needle aspiration under CT or ultrasound guidance, or
any lesion reachable by endoscopy.
[/INST]
This is a Phase I study designed to evaluate the safety and maximum tolerated dose (MTD) of
SGT-94, a novel, tumor-targeted, systemic gene therapy agent for cancer. In addition, we will
look for evidence of RB94 expression within tumor tissue after systemic administration of
SGT-94.
</s> |
<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase II - NIAAA[/INST]
This study will determine whether the experimental drug LY686017 can reduce a person's desire
for alcohol. A brain chemical called Substance P acts at places in the brain called NK1
receptors. Substance P is released in response to stress and gives rise to behaviors that are
thought to represent anxiety. LY686017 blocks Substance P from acting at the NK1 receptors.
People between 21 and 65 years of age who have been drinking on a regular basis for at least
one month before entering the study, who meet the criteria for alcohol dependence and who
have an elevated score on a general test of anxiety may be eligible for this study.
Participants are admitted to the NIH Clinical Center for 35 days. They participate in an
alcohol treatment program in addition to the research study. After having been withdrawn from
alcohol for at least 2 days, participants receive either 50 mg of LY686017 or placebo (an
inactive substance that looks like the study drug) every morning for 28 days. In addition to
drug treatment, they undergo the following procedures:
- Functional magnetic resonance imaging (fMRI): In the last week of the study, subjects
undergo MRI to study the amount of blood going to brain structures thought to be
involved in anxiety and craving. During the procedure, they look at pictures of faces
exhibiting various emotions and pictures related to alcohol.
- Cue reactivity: At the beginning and towards the end of the study, subjects are asked to
rate their alcohol craving and their anxiety level while they sniff and handle their
favorite alcoholic beverage or water.
- Metyrapone test: During weeks 1 and 4 of the study, subjects are given metyrapone - a
drug that interferes with the body's ability to make the stress hormone cortisol - to
determine how LY686017 affects the body's hormonal response. The drop in cortisol from
metyrapone administration causes the brain to release ACTH, a hormone that causes the
adrenal gland to make cortisol.
- Trier test: In the last week of the study, subjects give a 5-minute speech to three
people and are then asked to subtract numbers in their head. Then they are asked to rate
their feelings and desire for alcohol on two rating scales. Blood is drawn from a saline
lock at the beginning and end of the test to measure hormone levels.
- Rating scales: Subjects complete an Obsessive Drinking Scale weekly and an Alcohol Urge
Questionnaire and Comprehensive Psychiatric Rating Scale twice a week.
- Blood tests: Blood samples are collected periodically to check blood chemistries,
clotting time, and the amount of LY686017 in the blood.
</s> |
<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>>
This is a phase II, single-arm study of combination therapy of avelumab, haNK, and N-803 in
patients with Merkel Cell Carcinoma who have progressed on or after checkpoint inhibitor
therapy as assessed by ORR. Patients must have progressed on or within six months of
completing treatment with either avelumab or pembrolizumab. Patients will received treatment
for a maximum of two years, with avelumab and haNK administered every two weeks, and N-803
administered every three weeks. Radiologic evaluation will occur every eight weeks during the
first year of treatment, and every twelve weeks during the second year of treatment.
[/INST]
Phase 2, single-arm study to evaluate combination therapy of avelumab, haNK and N-803 in
patients with Merkel Cell Carcinoma who have progressed on or after checkpoint inhibitor
therapy as assessed by ORR. Patients will receive treatment for a maximum of two years.
</s> |
<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase IIb - CIAS[/INST]
The primary objective of the study is to evaluate the efficacy of BIIB104 in participants
with CIAS, using the Working Memory Domain of the MATRICS Consensus Cognitive Battery (MCCB).
The secondary objectives of this study are to evaluate the safety and tolerability of BIIB104
in participants with CIAS, and to evaluate the efficacy of BIIB104 in participants with CIAS
on measures of cognition, functioning, and psychiatric symptomology.
</s> |
<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase II - Chinese Patients (2nd or 3rd Line)[/INST]
A phase II study to evaluate antitumor activity of oral cMET inhibitor INC280 in adult
Chinese patients with EGFR wild-type, advanced non-small cell lung cancer (NSCLC) who have
received one or two prior lines of systemic therapy for advanced/metastatic disease as
measured by overall response rate (ORR). The study will also evaluate safety and
pharmacokinetics of INC280.
</s> |
<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase II - CALGB-50701[/INST]
RATIONALE: Monoclonal antibodies, such as epratuzumab and rituximab, can block cancer growth
in different ways. Some block the ability of cancer cells to grow and spread. Others find
cancer cells and help kill them or carry cancer-killing substances to them. Giving
epratuzumab and rituximab together may be more effective in treating follicular non-Hodgkin
lymphoma.
PURPOSE: This phase II trial is studying how well giving epratuzumab together with rituximab
works in treating patients with previously untreated follicular non-Hodgkin lymphoma.
</s> |
<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>>
The first part (Part 1A) of this trial is a FIH, open-label, dose-escalation trial studying
BNT411 monotherapy in patients with different types of malignant solid tumors in order to
determine the safety profile of BNT411. The second part (Part 1B) aims to determine further
the safety profile of BNT411 in combination with atezolizumab, carboplatin and etoposide in
patients with chemotherapy-naïve ES-SCLC. The third part (Part 2) is the expansion phase to
explore BNT411 further as a monotherapy or in combination with atezolizumab, carboplatin and
etoposide in select tumor indications. Different treatment schedules and other indications
may also be explored in Part 2.
[/INST]
This first-in-human (FIH) trial aims to establish a safe dose of BNT411 as a monotherapy and
in combination with atezolizumab, carboplatin and etoposide. BNT411 is a toll-like receptor 7
(TLR7) agonist which is expected to mount broad innate and adaptive immune reactions,
especially in combination with cytotoxic therapies and immune checkpoint inhibitors.
</s> |
<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>>
PRIMARY OBJECTIVES:
I. To determine a recommended phase 2 dose (RP2D) and the toxicities associated with
liposome-encapsulated daunorubicin-cytarabine (CPX-351) in pediatric and young adult patients
with relapsed/refractory acute myeloid leukemia (AML).
II. To estimate the response rate (complete remission [CR] plus complete remission with
partial platelet recovery [CRp]) after CPX-351 (cycle 1) followed by fludarabine phosphate,
cytarabine, and filgrastim (FLAG) (cycle 2) in children with AML in first relapse.
SECONDARY OBJECTIVES:
I. To estimate the response rate (CR + CRp + complete remission with incomplete blood count
recovery [CRi]) after one cycle of CPX-351.
II. To describe the pharmacokinetics of plasma cytarabine and daunorubicin after CPX-351
administration to pediatric and young adult patients with relapsed/refractory AML.
TERTIARY OBJECTIVES:
I. To describe the response in biomarkers of cardiac injury to a single cycle of CPX-351.
II. To explore the effect of CPX-351 on novel biochemical and imaging markers of
cardiotoxicity, including plasma micro ribonucleic acid (RNAs) (miRNA) and myocardial
deformation.
III. To explore the role of rare coding variants as risk factors for anthracycline-induced
cardiomyopathy.
OUTLINE:
COURSE 1: Patients receive cytarabine intrathecally (IT) on day 0 and at day 28-30 or up to 7
days prior to day 1 of course 2, and liposome-encapsulated daunorubicin-cytarabine
intravenously (IV) over 90 minutes on days 1, 3, and 5. Patients without evidence of central
nervous system (CNS) disease (CNS1) receive no further CNS-directed therapy in course 1.
Patients with < 5 white blood cells per microliter of blood with blast cells (CNS2) disease
may receive additional 4-6 doses of cytarabine IT twice weekly starting 48 hours after the
third dose of liposome-encapsulated daunorubicin-cytarabine until CNS is clear at the
discretion of the investigator. Patients meeting criteria for CR, CRp, and CRi may proceed to
course 2.
COURSE 2: Patients receive filgrastim on days 1-5 and then on day 15 until blood count
recovery, and fludarabine phosphate IV over 30 minutes and high-dose cytarabine IV over 1-3
hours once daily (QD) on days 1-5.
After completion of study treatment, patients are followed up periodically for 12 months, and
then yearly for 5 years.
[/INST]
This phase I/II trial studies the side effects and best dose of liposome-encapsulated
daunorubicin-cytarabine when given with fludarabine phosphate, cytarabine, and filgrastim and
to see how well they work in treating younger patients with acute myeloid leukemia that has
come back after treatment (relapsed) or is not responding to treatment (is refractory).
Liposome-encapsulated daunorubicin-cytarabine is made up of two chemotherapy drugs,
cytarabine and daunorubicin hydrochloride, and works to stop cancer cell growth by blocking
the cells from dividing. Drugs used in chemotherapy, such as fludarabine phosphate and
cytarabine, work in different ways to stop the growth of cancer cells, either by killing the
cells, by stopping them from dividing, or by stopping them from spreading. Filgrastim may
increase the production of blood cells and may help the immune system recover from the side
effects of chemotherapy. Giving liposome-encapsulated daunorubicin-cytarabine followed by
fludarabine phosphate, cytarabine, and filgrastim may be a better treatment for patients with
relapsed acute myeloid leukemia and may cause fewer side effects to the heart, a common
effect of other chemotherapy treatments for acute myeloid leukemia.
</s> |
<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase IIIb - CS30[/INST]
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.
</s> |
<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>>
This trial is a prospective, open-label, multicenter, single and repeated-dose study designed
to evaluate the reliability and sensitivity of TUV assessments in healthy control subjects
and subjects with active RA.
This study is stratified into 3 arms. The first 2 arms, consisting of [1] disease-free HCs
and [2] clinically diagnosed RA subjects on stable treatment, respectively, are designed to
evaluate the image re-image and/or test re-test (i.e., repeated dose) consistency of
joint-specific and global TUVs across a variety of image acquisition intervals.
The third arm consists of clinically-diagnosed subjects with active RA who are candidates for
initiation of, or change to, a new anti-TNFα bDMARD therapy. This arm is designed to assess
the efficacy of TUVglobal as an early predictor of response to the new anti-TNFα bDMARD
therapy.
[/INST]
This clinical trial will look at scans of the hands and wrists taken from healthy control
subjects (HCs) and from subjects with rheumatoid arthritis (RA). Before each scan, subjects
will be given an injection of Tc 99m tilmanocept to help the scan identify inflammation in
the hand and wrist joints, which can be a part of the RA disease. Data from the scans will be
used to calculate a number referred to as tilmanocept uptake value (or TUV) that is a measure
of how much Tc 99m tilmanocept has located in the joints. The questions this trial aims to
answer are:
- How consistent are the scan results (TUVs) when the scans are repeated over time?
- What are normal TUVs in healthy people? This will help define abnormally high values in
people with RA.
- Are TUVs calculated early after a person starts a new drug to treat RA able to predict
whether that person will have a good response to the drug later on (after it has had
time to take full effect several weeks later)?
</s> |
<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase II - OHR-1501 (w/Lucentis)[/INST]
The purpose of this study is to evaluate anatomical and functional effect of combination
therapy of Squalamine Lactate Ophthalmic Solution, 0.2% administered twice daily with monthly
ranibizumab intravitreal injections in patients with choroidal neovascularization due to AMD.
</s> |
<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase III - Study 014[/INST]
To compare the efficacy of prandial TI plus basal insulin versus prandial rapid acting,
subcutaneous insulin plus basal insulin in subjects with type 2 diabetes who had an HbA1c
>7.0% and <11.5%.
</s> |
<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase I - 0407[/INST]
Primary Objectives:
1. To determine the maximum tolerated dose (MTD) and the recommended Phase II dose(s) and
schedule of MSX-122
2. To characterize the dose limiting toxicities (DLTs) and determine the overall safety and
tolerability of MSX-122
Secondary Objectives:
1. To determine the pharmacokinetics and pharmacodynamics of orally administered MSX-122
2. To evaluate the preliminary evidence for anti-tumor activity of MSX-122
3. To perform correlative studies to elucidate signaling pathways involved in CXCR4
activation in blood and optional tissue specimens by IHC (immunohistochemistry) and RPPA
(reverse phase protein microarrays)
</s> |
<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase II - MCL15001[/INST]
This study is designed to investigate the efficacy, safety and tolerability of MTC896 Gel in
subjects with acne. In this study, MTC896 Gel will be applied at 3 concentrations, twice
daily (bid) for 12 weeks and compared against a vehicle control.
</s> |
<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase II (Europe)[/INST]
This study is designed to evaluate the long-term safety of daily oral treatment with BCX9930
in subjects who have participated in a previous BCX9930 trial for PNH and showed a benefit of
treatment as determined by the Investigator. The study allows continued access to BCX9930 for
enrolled subjects. The study will also evaluate the long-term effectiveness and impact on
quality of life and general well-being of BCX9930 treatment, and the subject's satisfaction
with the medication.
</s> |
<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase I/II - Hematological Malignancies[/INST]
Primary Objective:
Phase 1:
To determine the maximum tolerated dose (MTD)/maximum administered dose (MAD) of SAR650984
(Isatuximab).
Phase 2 (stage 1):
To evaluate the activity of single-agent Isatuximab at different doses/schedules and to
select dose and regimen to further evaluate the overall response rate (ORR) of Isatuximab as
single agent or in combination with dexamethasone.
Phase 2 (stage 2):
To evaluate the activity in terms of overall response rate (ORR) of Isatuximab at the
selected dose/schedule from stage1, as single agent (ISA arm) and in combination with
dexamethasone (ISAdex arm).
Secondary Objectives:
Phase 1:
- To characterize the global safety profile including cumulative toxicities.
- To evaluate the pharmacokinetic (PK) profile of Isatuximab in the proposed dosing
schedule(s).
- To assess the pharmacodynamics (PD), immune response, and preliminary disease response.
Phase 2 (stage 1): to evaluate the following objectives for Isatuximab as single agent:
- Safety
- Efficacy as measured by duration of response, clinical benefit rate, progression free
survival, overall survival.
Phase 2 (stage 2): to evaluate the following objectives in each arm (ISA and ISAdex):
- Safety
- Efficacy as measured by duration of response, clinical benefit rate, progression free
survival, overall survival.
- Participant-reported changes in health-related quality of life, symptoms of multiple
myeloma and generic health status.
- Pharmacokinetic profile of Isatuximab.
- Immunogenicity of Isatuximab.
- Investigate the relationship between CD38 receptor density and CD38 receptor occupancy
(Stage 1 only) on multiple myeloma cells and parameters of clinical response.
</s> |
<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>>
This is a randomized, open-label, single dose study that will be conducted in male and female
patients ≥40 years of age with OA of either the shoulder or the hip.
Approximately 24 patients with OA of the shoulder and approximately 24 patients with OA of
the hip will be randomized to one of two treatment groups (1:1) and treated with a single IA
injection of either:
- 32 mg FX006 (approximately 12 patients per joint) or
- 40 mg TAcs (approximately 12 patients per joint)
Each patient will be screened to confirm the diagnosis of OA of either the shoulder or hip
and eligibility based on the other inclusion/exclusion requirements and will be randomized to
treatment on Day 1. Each patient will be evaluated for a total of 12 weeks following the IA
injection. Following screening, sampling for pharmacokinetics (PK) and safety will be
completed at 10 out-patient visits scheduled on Study Days 1 [calendar day of injection], 2,
3, 5, 8, 15, 22, 29, 57, and 85.
[/INST]
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
</s> |
<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase III - vs. Oxycodone[/INST]
Evaluate how NUCYNTA (tapentadol) immediate release (IR) compares with oxycodone IR in the
treatment of acute low back pain.
</s> |
<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase I/II - Japan[/INST]
The purpose of this study is to assess the safety and efficacy of ponatinib in Japanese
patients with chronic myeloid leukemia (CML) who have experienced failure of dasatinib or
nilotinib or with Ph+ acute lymphoblastic leukemia (ALL) following failure of prior tyrosine
kinase inhibitors (TKIs).
</s> |
<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase II - SAD[/INST]
The purpose is to evaluate the efficacy and safety of IOP Injection (MPB-1514) for the
treatment of iron-deficient anemia (IDA).
</s> |
<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase II - Study 2001[/INST]
RATIONALE: Drugs used in chemotherapy, such as PR-104, work in different ways to stop the
growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase II trial is studying how well PR-104 works in treating patients with
previously untreated or relapsed small cell lung cancer (SCLC).
</s> |
<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase IIa - Pts Previously Treated w/ Alendronate[/INST]
The study will evaluate the both the efficacy of odanacatib on Bone Mineral Density (BMD) and
the safety of odanacatib for postmenopausal osteoporosis in patients previously treated with
alendronate. The primary hypothesis of the trial is that treatment with odanacatib 50 mg once
weekly will increase bone mineral density at the femoral neck compared to placebo at the end
of 24 months.
</s> |
<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase IIb[/INST]
Arimoclomol is a small molecule that upregulates "molecular chaperones" in cells under
stress. Arimoclomol extends survival by five weeks when given both pre-symptomatically and at
disease onset in a mutant superoxide dismutase (SOD1) transgenic mouse model of ALS.
Furthermore, it has been demonstrated to have neuroprotective and neuroregenerative effects
in other rat models of nerve damage. Molecular chaperone proteins are critical in the
cellular response to stress and protein misfolding. Recent data suggest that the SOD1
mutation responsible for ALS in some patients with familial disease reduces the availability
of a variety of molecular chaperones, and thus weakens their ability to respond to cellular
stress. Protein misfolding and consequent aggregation may play a role in the pathogenesis of
both the familial and sporadic forms of ALS. Therapeutic agents such as arimoclomol that
improve cellular chaperone response to protein misfolding may be helpful in ALS.
</s> |
<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase I - Japan[/INST]
This is an uncontrolled, open-label, non-randomized phase I / pharmacokinetic study of oral
BAY86-9766 to investigate the safety, tolerability, pharmacokinetics, and efficacy profiles
in Japanese patients with advanced solid tumors
</s> |
<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase III - DISRUPT (U.S.)[/INST]
The purpose of this superiority study is to evaluate the efficacy and safety of exebacase in
addition to standard of care antibiotics (SoCA) compared with SoCA alone for the treatment of
patients with Staphylococcus aureus (S. aureus) bloodstream infections (BSI), including
right-sided infective endocarditis (IE). Patients will be randomized to receive a single
intravenous dose of exebacase or placebo. Patients will receive SoCA selected by the
investigators based on the protocol.
Exebacase, a direct lytic agent, is an entirely new treatment modality against S. aureus.
Exebacase is a recombinantly-produced, purified cell wall hydrolase enzyme that results in
rapid bacteriolysis, potent biofilm eradication, synergy with antibiotics, low propensity for
resistance, and the potential to suppress antibiotic resistance when used together with
antibiotics. Exebacase represents a first-in-field, first-in-class treatment with the
potential to improve clinical outcome when used in addition to SoCA to treat S. aureus BSI
including IE.
</s> |
<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase IIIb - IMMerge[/INST]
The main objective of this study is to evaluate the efficacy and safety of risankizumab
compared with secukinumab for the treatment of adult subjects with moderate to severe plaque
psoriasis who are candidates for systemic therapy.
</s> |
<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>>
The drug being tested in this study is called MLN1117. MLN1117 is being tested to treat
people who have locally advanced or metastatic gastric or gastroesophageal junction
adenocarcinoma. This study will look at the dose-limiting toxicity and response to treatment
in participants who take MLN1117 in combination with TAK-659, alisertib, paclitaxel, or
docetaxel.
The study will enroll 32 participants in the dose escalation phase (Part 1) and 118
participants in the dose expansion phase (Part 2). Participants will be assigned to 1 of the
7 treatment groups:
- MLN1117 300 mg+Alisertib
- MLN1117 600 mg+Alisertib
- MLN1117 300 mg+Paclitaxel
- MLN1117 600 mg+Paclitaxel
- MLN1117 300 mg+TAK-659
- MLN1117 200 mg+Docetaxel
- MLN1117 300 mg+Docetaxel
In Part 1, the dose of MLN1117 will be increased step by step. All participants will be asked
to take tablets of MLN1117 for 3 days on and 4 days off per week in 28-day treatment cycles
or 21-day treatment cycles when given in combination with the other companion drugs.
This multi-center trial will be conducted in Spain and United States. The overall time to
participate in this study is 10 months for Part 1 and 24 months for Part 2. Participants will
make multiple visits to the clinic, and be contacted by telephone, e-mail or mail every 12
weeks for up to 6 months or 1 year after the last dose of study drug for a follow-up
assessment.
[/INST]
The purpose of this study is to evaluate the maximum tolerated dose (MTD) or recommended Part
2 dose, safety and efficacy of MLN1117 (TAK-117) in combination with docetaxel, paclitaxel,
investigational TAK-659 or investigational alisertib in adult participants with advanced and
metastatic gastric or gastroesophageal adenocarcinoma. The study consists of a dose
escalation phase (Part 1) and a dose expansion phase (Part 2).
</s> |
<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>>
This is a phase II, multicenter, blinded within cohort, dose-escalation study to evaluate the
safety and tolerability of two ascending doses of tralokinumab in Japanese patients aged ≥ 50
years with mild to moderate Idiopathic Pulmonary Fibrosis.
[/INST]
The purpose of the study is to evaluate the safety and tolerability of multiple-doses of
tralokinumab in Japanese patients with Idiopathic Pulmonary Fibrosis.
</s> |
<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase I/II - AML/MDS/CML (Fred Hutch)[/INST]
This phase I/II trial studies the side effects of laboratory-treated T cells and to see how
well they work in treating patients with high-risk acute myeloid leukemia (AML),
myelodysplastic syndrome (MDS), or chronic myelogenous leukemia (CML) that has returned after
a period of improvement (relapsed), previously treated with donor stem cell transplant.
Biological therapies, such as cellular adoptive immunotherapy, may stimulate the immune
system in different ways and stop cancer cells from growing. Placing a gene that has been
created in the laboratory into a person's T cells may make the body build an immune response
to kill cancer cells.
</s> |
<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase I/II - RRMM/NDMM[/INST]
The purpose of this study is to evaluate the safety and preliminary efficacy of CC-92480 in
combination with standard treatments.
</s> |
<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>>
The main objective of this study is to evaluate the dose-response relationship of 2
concentrations of A-101 Solution and its matching A-101 Solution Vehicle when applied to
seborrheic Keratosis (SK) target lesions on the face. A further objective is to evaluate the
safety and efficacy of 2 concentrations of A-101 Solution and its matching A-101 Solution
Vehicle when applied topically up to 2 times to SK target lesions on the face.
[/INST]
The purpose of this study is to evaluate the safety and dose-response of 2 concentrations of
A-101 versus a vehicle control in the treatment of seborrheic keratosis.
</s> |
<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase III - A2304 - SCULPTURE[/INST]
This study will assess the safety and efficacy of two different doses and two different dose
regimens of subcutaneous secukinumab in patients that have moderate to severe, chronic,
plaque-type psoriasis.
</s> |
<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase II - Accelerated Phase CML (MACS1881)[/INST]
This is an open label, non randomized, prospective, multicenter, phase II clinical trial
evaluating nilotinib 400 mg BID for the treatment of newly diagnosed CML-AP patients.
Patients enrolled into the study will receive 400mg of nilotinib, orally, twice daily
(800mg/day)
</s> |
<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>>
OBJECTIVES:
- To determine the recommended phase II dose of AZD2281 and irinotecan hydrochloride in
patients with locally advanced or metastatic colorectal cancer.
- To determine the safety, tolerability, toxicity profile, dose-limiting toxicities, and
pharmacokinetic profile of this regimen.
- To assess the correlation, if any, between the toxicity profile and pharmacokinetics of
this regimen.
- To assess, preliminarily, the antitumor activity of this regimen in patients with
measurable disease.
- To demonstrate the pharmacodynamic activity of this regimen by establishing its effects
in tumor biopsies, cheek swabs, and blood samples.
- To assess the correlation, if any, between patients with tumors demonstrating
microsatellite instability and antitumor activity and pharmacodynamic effects of this
regimen.
- To investigate the impact of common genetic polymorphisms of genes of relevant pathways
(drug metabolism, DNA repair, and apoptosis) on outcome and toxicity as well as other
pharmacodynamic effects.
OUTLINE: This is a multicenter, dose-escalation study of AZD2281 and irinotecan
hydrochloride.
- Part I: Patients receive oral AZD2281 twice a day on days -7 to 21 in course 1 and on
days 1-21 in all subsequent courses. Patients also receive irinotecan hydrochloride IV
over 90 minutes on day 1. Courses repeat every 21 days (course 1 is 28 days) until the
maximum tolerated dose is determined in the absence of disease progression or
unacceptable toxicity.
- Part II: Patients then receive oral AZD2281 once daily on days 1-5 and irinotecan
hydrochloride IV over 90 minutes on day 3 at the maximum tolerated dose determined in
Part I. Courses repeat every 14 days in the absence of disease progression or
unacceptable toxicity.
Patients undergo cheek swabs, tumor tissue, and blood sample collection periodically for
pharmacokinetic, pharmacodynamic, and correlative studies.
After completion of study treatment, patients are followed at 4 weeks and then every 3 months
thereafter.
[/INST]
RATIONALE: AZD2281 may stop the growth of tumor cells by blocking some of the enzymes needed
for cell growth. Drugs used in chemotherapy, such as irinotecan, work in different ways to
stop the growth of tumor cells, either by killing the cells or by stopping them from
dividing. Giving AZD2281 together with irinotecan may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of AZD2281 and
irinotecan in treating patients with locally advanced or metastatic colorectal cancer.
</s> |
<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>>
Maximum Age:
Part A SAD 65 years
Part B MAD 75 years
Part C MAD Japanese 75 years
[/INST]
The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK) and
pharmacodynamics (PD) of a single and multiple oral doses of BMS-986141 in healthy subjects.
</s> |
<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase III - 160902 (Long-Term Extension w/rHuPH20)[/INST]
The original purpose of the study is to assess the long-term safety, tolerability, and
practicability of the subcutaneous (SC) treatment with Immune Globulin Subcutaneous Solution
(IGSC), 10% facilitated with recombinant human hyaluronidase (rHuPH20) in participants with
Primary Immunodeficiency Diseases (PID) who have completed Baxter Clinical Study Protocol No.
160603.
Following a discussion with the FDA, all participants still active in the study stopped
treatment with rHuPH20 to assure safety of the participants participating in the study and
went into a safety follow-up.
During this safety follow-up period, participants underwent either intravenous (IV) or SC
treatment with IGSC, 10%. The IV or SC administration route was at the discretion of the
participant and the investigator.
</s> |
<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase IIa - Proof-of-Concept[/INST]
This is an open-label, proof-of-concept, single group study in adult patients with newly
diagnosed, moderate to extensive BP.
The study will consist of three periods: a screening period of up to 2 weeks, an open-label
treatment period lasting 4 weeks consisting of IV infusion of bertilimumab on Days 0 and 14
and 28, and a safety and efficacy follow-up period of approximately 13 weeks.
Patients will receive concomitant oral steroids during the treatment and follow-up period.
</s> |
<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>>
This is a 6-week, multiple-dose, dose escalation study of SPR001 for the treatment of adults
with classic CAH. After screening, eligible patients will be enrolled into a 6-week treatment
period followed by a 4-week washout/safety follow-up period.
It is initially planned that up to approximately 18 patients in 2 dose cohorts will be
enrolled. Additional patients or dose groups may be considered based upon specific safety,
PK/PD, and/or efficacy findings, or if an active dose has not yet been reached.
SPR001 will be administered as an oral daily dose. Patients will undergo titration of SPR001
through three escalating dosage strengths at 2-week intervals. Patients will have overnight
PK/PD assessments performed at baseline, which include an pre-dose overnight assessment and a
post-dose overnight assessment for PK/PD following administration of the first dose. At the
end of each 2-week dosing period, patients will return for single overnight visits for
steady-state PK/PD assessments.
A follow-up outpatient visit will occur 30 days after their last dose.
[/INST]
This is a multicenter Phase 2, multiple dose, dose escalation study to evaluate the safety,
pharmacokinetics (PK), pharmacodynamics (PD), and efficacy of SPR001 in adult patients with
classic congenital adrenal hyperplasia (CAH).
</s> |
<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase III - Axial Spondyloarthritis (ex-US)[/INST]
The purpose of this study is to assess the efficacy and safety of ustekinumab in adult
participants with active nonradiographic axial spondyloarthritis (nr-AxSpA) measured by the
reduction in signs and symptoms of nonradiographic axial spondyloarthritis (nr-AxSpA).
</s> |
<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase II - 002 (U.S/Taiwan)[/INST]
The purpose of this study is to evaluate the safety and efficacy in patients with major
depressive disorder.
</s> |
<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase IIa -w/Keytruda[/INST]
This is an open, single arm, multicenter phase 2 trial in which BO-112 will be administered
intratumorally in combination with intravenous pembrolizumab in patients with liver
metastasis from colorectal, gastric or gastroesophageal junction cancers. The objective is to
reverse the primary resistance that a subgroup of patients from these tumors having
microsatellite stability present to the PD-1 inhibitors. Treatment will be administered every
3 weeks, with the exception of the first cycle, in which BO-112 will be also administered on
D8, for up to 2 years.
The primary objective is overall response rate based on RECIST 1.1 and safety, specifically
referred to treatment emergent adverse events (TEAEs) with severity ≥ Grade 3 related to the
study treatment (NCI-CTCAE v 5.0). The secondary endpoints include other efficacy endpoints
(duration of response, disease control rate, progression-free survival, overall survival at 6
months, all based on RECIST 1.1, and overall response rate based on a specific tumor
assessment criteria to evaluate the response to immunotherapies, IRECIST) and safety, in this
case considering the number and proportion of subjects with treatment TEAEs (any grade) . In
addition, the changes in the tumor microenvironment induced by the injection of BO-112 will
be also evaluated as exploratory endpoints.
</s> |
<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>>
PRIMARY OBJECTIVES:
I. To determine a tolerable dose of XL184 (cabozantinib-s-malate) in combination with
vemurafenib.
SECONDARY OBJECTIVES:
I. To determine the objective response rate (ORR) and disease control rate (DCR) per Response
Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
II. To determine the progression-free survival (PFS). III. To determine the response rate
according to the molecular phenotype.
OUTLINE: This is a dose-escalation study of cabozantinib-s-malate.
Patients receive cabozantinib-s-malate orally (PO) once daily (QD) and vemurafenib PO twice
daily (BID) on days 1-28. Courses repeat every 28 days in the absence of disease progression
or unacceptable toxicity.
After completion of study treatment, patients are followed up for 4 weeks.
[/INST]
This phase I trial studies the side effects and best dose of cabozantinib-s-malate when given
together with vemurafenib in treating patients with solid tumors or melanoma that is
metastatic or that cannot be removed by surgery. Cabozantinib-s-malate and vemurafenib may
stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
</s> |
<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase I - Study 102[/INST]
The purpose of this study is to evaluate the safety and tolerance of multiple intravenous
(through a vein) doses of trodusquemine (MSI-1436) in obese or overweight, type 2 diabetics.
</s> |
<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>>
The study comprises 2 consecutive parts. The first part will be to test safety and
feasibility of the dosing procedures. Results from Part I of the study will standardise the
optimal dose and frequency of INT230-6 for participants in Part II.
Part I: Open-label 2:1 randomized study of up to 30 patients. Treatment arm patients will be
given up to 3 doses of INT230-6 injected weekly prior to breast surgery, at a dose based on
longest diameter. The control arm patients receive no treatment.
Part II: Double-blind, 2:1 randomized study of up to an additional 60 patients. The placebo
arm includes a saline injection of similar dose and frequency as the treatment arm (up to 2
doses of INT230-6/saline injected weekly prior to breast surgery).
[/INST]
This is a phase II, randomized, multi-center, parallel design, window of opportunity trial
evaluating intratumoral INT230-6 in up to 90 patients with early stage breast cancer. In a
2:1 randomization, patients on the treatment arm will receive intratumoral INT230-6
injections prior to breast surgery.
</s> |
<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase II - 24201[/INST]
The aim of the current study was the determination of the recommended standard treatment dose
of FSH-GEX(TM) in women undergoing intracytoplasmic sperm injection (ICSI) treatment as
assessed by follicle growth.
</s> |
<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase III - Study 102[/INST]
The purpose of this 13 month study (12 month treatment period and 1 month follow-up period)
is to determine whether inhaled insulin is safe and effective in the treatment of type 2
diabetes.
</s> |
<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>>
Later-line therapies after failure of standard treatments for advanced colorectal and
non-colorectal cancer patients are limited. Mismatch repair (MMR) deficiency or
microsatellite instability-high (MSI-H) played a role of positive predictive factor, which
had been documented after the pembrolizumab and nivolumab trial were reported, for PD-1
blockade monotherapy in patients with advanced colorectal and non-colorectal cancers.
In this study, patients with previously-treated locally-advanced or metastatic mismatched
repair deficient (dMMR) or microsatellite instability-high (MSI-H) colorectal carcinoma (CRC)
and other solid tumors will be treated with KN035 monotherapy.
For colorectal cancer participants, who are required to have been previously treated with
standard therapies or refuse standard of care therapy. For other solid tumor participants,
who are required to have been previously treated with at least one line of systemic standard
of care therapy.
[/INST]
In this study, patients with previously-treated locally-advanced or metastatic mismatched
repair deficient (dMMR) or microsatellite instability-high (MSI-H) colorectal carcinoma (CRC)
and other solid tumors will be treated with KN035 monotherapy.
For colorectal cancer participants, who are required to have been previously treated with
standard therapies or refuse standard therapy, other solid tumor participants, who are
required to have been previously treated with at least one line of systemic standard of care
therapy.
</s> |
<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase II - A3921009[/INST]
This Phase 2 study was designed to evaluate the safety and efficacy of 2 dose levels of
CP-690,550 (15 mg twice daily and 30 mg twice) against tacrolimus, in combination with
basiliximab induction, mycophenolate mofetil and corticosteroids, in kidney transplant
patients. Stage 1 was to randomize approximately 54 subjects. After all Stage 1 subjects had
completed 6 months of treatment, Stage 2 was to randomize an additional 195 subjects to the
same treatment groups.
</s> |
<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase II - Study 14853[/INST]
This study is designed to define the amount and duration of cholesterol lowering and to
assess the safety and tolerability of different dose regimens of LY3015014 in participants
with high cholesterol. The study will also investigate how the body processes the drug and
how the drug affects the body. Participants will remain on a stable diet and will continue
taking cholesterol-lowering medications (statins with or without ezetimibe). After signing
the informed consent document, the participant will complete a screening/run-in period that
will last at most 8 weeks. Then, the treatment period will last approximately 16 weeks. After
the treatment period, the participants will complete a follow-up period lasting approximately
8 weeks for a total study duration ranging from approximately 25 to 32 weeks.
</s> |
<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>>
The study will be conducted in two (2) parts and each part will consist of a ramp-up period,
dose escalation and dose expansion portions. The duration of the ramp-up period will depend
on the dose schedule being tested and will be conducted for both monotherapy and combination
therapy. The ramp-up will consist of treatment with APG-2575 given once a day starting at 20
mg on Day 1, 50 mg on Day 2, 100 mg on Day 3, 200 mg on Day 4, 400 mg on Day 5¸ 600 mg on Day
6, 800 mg on Day 7, 1000 mg on Day 8 and 1200 mg on Day 9. Scheduled maximum cohort doses for
evaluation will start at 200 mg of APG-2575 to a maximum of 1200 mg of APG-2575.
Consequently, patients with a scheduled maximum dose of 200 mg will have a 3-day ramp-up
period, those scheduled at 400 mg, a 4-day ramp-up, and those scheduled at 600 mg, a 5-day
ramp-up, etc, see Figure 1. Part 1 will study APG-2575 at different dose levels as
monotherapy using a 3+3 dose escalation design with dose expansion at RP2D. Part 2 will be
combination of APG-2575 with rituximab or acalabrutinib or voruciclib Part 2 will be a 3+3
dose escalation of combination APG-2575 plus rituximab or acalabrutinib or voruciclib.
Expansion cohorts at RP2D for the respective combinations will be conducted to further
evaluate safety and anticancer activity
[/INST]
Assess the safety and tolerability, identify dose-limiting toxicities (DLT) and determine the
maximum tolerated dose (MTD) / recommended phase 2 dose (RP2D) of APG-2575.
</s> |
<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase I/II - Active Rheumatoid Arthritis[/INST]
Phase 1b. To evaluate the safety and tolerability of subcutaneous (SC) dose administrations
of Efavaleukin alfa in subjects with active rheumatoid arthritis (RA).
Phase 2a. To evaluate the efficacy of Efavaleukin alfa at week 12 as measured by the American
College of Rheumatology 20 percent improvement criteria (ACR 20) in adult subjects with
moderate to severe RA.
</s> |
<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>>
Study Groups:
If you are found to be eligible to take part in this study, you will be assigned to a study
group based on when you join this study. Up to 3 groups of 3 - 6 participants will be
enrolled in Phase 1 of the study, and up to 70 participants will be enrolled in Phase 2.
If you are enrolled in Phase 1, the dose of nivolumab you receive will depend on when you
join this study. There are 3 dose levels being tests in this part of the study: a low dose, a
middle dose, and a high dose. The first group of participants will receive the middle dose
level of nivolumab. If no intolerable side effects are seen, the next group will receive the
highest dose level. However, if there are intolerable side effects, 3 more participants will
receive the middle dose. If there are further intolerable side effects seen, the next group
will receive the lowest dose of nivolumab.
If you are enrolled in Phase 2, you will receive nivolumab at the highest dose that was
tolerated in Phase 1.
All participants will receive the same dose levels of idarubicin and cytarabine.
Study Drug Administration:
You will receive 1- 7 cycles of the drug combination. These cycles will be 28-35 days long.
- On Days 1-3 of each cycle, you will receive idarubicin by vein over about 15-30 minutes.
- On Days 1-4 of each cycle, you will receive cytarabine by vein over about 24 hours. If
you are age 60 or older, you will receive the drugs on Days 1-3 only. On these days you
will receive drugs to help decrease the risk of side effects.
- On Day 24 (+/- 2 days) of each cycle, you will receive nivolumab by vein over about 1
hour.
After 2 cycles, if the disease appears to get better, you will receive nivolumab by vein
about every 2 weeks for up to 1 year.
Study Visits:
At least one (1) time a week during Cycle 1 and then at least once each cycle after that:
- You will have a physical exam.
- Blood (about 2-3 teaspoons) will be drawn for routine tests.
You will have a bone marrow aspirate collected for cytogenetics testing between Day 21-28 of
each cycle and then, if the doctor thinks it is needed, you will have this performed every
1-2 weeks after that unless a complete response is achieved. After that, you will have bone
marrow collected every 3-6 months for 1 year.
After your last dose of study drug, you will have a physical exam.
Length of Study:
You may continue taking nivolumab for up to 1 year. You will no longer be able to take the
study drug if the disease gets worse, if intolerable side effects occur, or if you are unable
to follow study directions.
Your participation on the study will be over after the follow-up visits.
[/INST]
The goal of this clinical research study is to find the highest tolerable dose of nivolumab
that can be give in combination with idarubicin and cytarabine in patients with MDS and AML.
The safety and effectiveness of this drug combination will also be studied.
This is an investigational study. Nivolumab is not FDA-approved or commercially available.
Idarubicin is FDA-approved and commercially available for the treatment of patients with AML.
Cytarabine is FDA approved and commercially available for treatment of patient with AML. The
use of these drugs in combination is investigational. The study doctor can explain how the
drugs are designed to work.
Up to 75 patients will take part in this study. All will be enrolled at MD Anderson.
</s> |
<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>>
A Phase 3, international, multicenter, randomized, double-blind, placebo-controlled trial to
evaluate the efficacy and safety of glepaglutide subcutaneous (SC) injections in patients
with short bowel syndrome (SBS).
[/INST]
The primary objective of the trial is to confirm the efficacy of glepaglutide in reducing
parenteral support volume in patients with short bowel syndrome.
Glepaglutide is the International Nonproprietary Name and USAN for ZP1848.
</s> |
<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>>
This is an open-label, multi-part, first-in-human, proof of concept study in infants with
Type 1 spinal muscular atrophy who have exactly 2 copies of SMN2, to evaluate safety,
tolerability, PK, PD and efficacy of oral branaplam after 13 weeks treatment.
Parts 1 and 2 are intended to be non-confirmatory. In Part 1 of the study, patients will be
dosed once weekly with branaplam. The branaplam dose will be escalated in subsequent cohorts
until MTD is determined or when sufficient PK results confirm that the MTD cannot be reached
due to a potential pharmacokinetic plateau at higher doses. A decision to dose escalate the
next cohort will be made after safety data have been collected for 14 days following the
first dose (14-day DLT window). PK will be used to confirm that there is no accumulation of
the compound.
Part 2 of the study will enroll new patients into one of up to 3 dose cohorts with once
weekly dosing for 52 weeks. The branaplam dose will be escalated in subsequent cohorts after
6 patients have been enrolled and at least 3 patients from the previous cohort will have
completed 13 weeks of treatment. After 52 weeks, patients may continue treatment if Novartis,
the investigator and the independent DMC agree that this is in the best interest of the
patient.
In all cases continuation of the treatment will be done at a dose selected as optimum,
considering existing safety as well as efficacy data
[/INST]
An open-label, multi-part, first-in-human study of oral branaplam in infants with Type 1
spinal muscular atrophy. The purpose of this study is to evaluate the safety, tolerability,
pharmacokinetics (PK), pharmacodynamics (PD) and efficacy after 13 weeks; and to estimate the
Maximum Tolerated Dose (MTD) of orally administered branaplam; and to identify the dose that
is safe for long term use as well as that can provide durable efficacy optimal dosing regimen
in patients with Type 1 SMA.
</s> |
<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase III - ENSURE-AF[/INST]
The purpose of this study is to compare edoxaban to warfarin (with enoxaparin, if needed). It
will see if edoxaban prevents stroke and other blood clotting problems as well and as safely
as warfarin. People with atrial fibrillation (irregular heartbeat) might be able to join.
Their doctors must plan to use shock to make their hearts beat normally. About 2200 people
from different countries will join. They will have an equal chance of receiving either
treatment. They are anticipated to be in the study for around 82 days. Tests will include
physicals and finger-pricks. Participants will provide blood and urine samples.
</s> |
<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase I - J2W-MC-PYAA [/INST]
The purpose of this study is to test the safety and tolerability of LY3819253 when it is
given by injection into a vein to participants hospitalized with COVID-19. Blood tests will
be done to check how much LY3819253 is in the bloodstream and how long the body takes to
eliminate it. Participation could last about 8 weeks and may include up to 15 visits in the
hospital or the home.
</s> |
<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase III - 3839 - BEGIN (SIMPLIFY)[/INST]
This trial is conducted in the United States of America (USA). The aim of this clinical trial
is to assess the implications of switching from insulin glargine (IGlar) to insulin degludec
(IDeg) in subjects with type 2 diabetes mellitus.
</s> |
<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase III - REFLECT (Italy)[/INST]
The purpose of this study was, starting from the Italian clinical practice in liver
transplantation, to optimize the immunosuppressive therapy, considering specific patient
characteristics as alcoholic cirrhosis, hepatitis C virus (HCV), hepatocellular carcinoma
(HCC), and short/long-term implications. Then efficacy and safety of a calcineurin inhibitor
(CNI)-withdrawal regimen was evaluated in comparison with a CNI-minimization regimen.
</s> |
<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase II/III - Leopold II[/INST]
The objective of the trial is to demonstrate that 2-3 times per week prophylaxis therapy with
BAY81-8973 is superior to on-demand therapy with BAY81-8973 in patients with severe
Hemophilia A. The hypothesis is that prophylaxis will result in fewer bleeds than on-demand
treatment.
</s> |
<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase II - CL205 (Pediatric)[/INST]
The primary objectives of the study are to:
- Establish the safety profile of KRN23 for the treatment of XLH in children between 1 and
4 years old
- Determine the PD effects of KRN23 treatment on serum phosphorus and other PD markers
that reflect the status of phosphate homeostasis in children between 1 and 4 years old
with XLH
</s> |
<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>>
This is an open-label, Phase 1 study to evaluate the safety, tolerability, PK, and MTD of TBI
302 in patients with non-resectable, non-transplantable HCC. Tumor response will be assessed
at Week 9 (5 weeks following cessation of treatment) according to RECIST (ver 1.1) and AASLD
criteria.
[/INST]
Hepatocellular carcinoma (HCC) is one of the most common cancers worldwide. TBI 302 is being
developed for the treatment of inoperable HCC by intravenous infusion. The objective is to
determine the safety and tolerability of TBI 3002.
</s> |
<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>>
This first in human study consists of 2 parts: a) The dose escalation part and b) The dose
expansion part. This is an openlabel (all participants know the identity of the
intervention), multicenter (more than one study site) study to evaluate the safety, establish
a recommended Phase 2 dose (RP2D), and to determine the preliminary efficacy of
duvortuxizumab in participants with relapsed or refractory B cell malignancies. The dose
escalation part of the trial (Part 1) will be comprised of 3 different patient groups based
on disease indication: Group 1 (DLBCL, FL, MCL); Group 2 (CLL); Group 3 (ALL). The
duvortuxizumab dosing will be done on biweekly and weekly basis. Duvortuxizumab weekly
escalating dosing will be investigated. Dose escalation will begin with Group 1 and will
initially follow an accelerated dose titration design, followed by a traditional 3+3 design.
At each dose escalation level the treatment of the second participant should be initiated
after at least 72 hours of observation after the start of the first duvortuxizumab dose of
the first participant. Dose escalation in Groups 2 and 3 will follow a 3+3 design and will
begin after the initial dose level in Group 1 is deemed safe. Participants [Group 1 (DLBCL,
FL, MCL), Group 2 (CLL) Group 3 (ALL)] are enrolled into cohorts of increasing dose levels of
duvortuxizumab administered in 28 day treatment cycles. Up to 3 RP2Ds may be determined in
Part 1 (one RP2D for Group 1, one RP2D for Group 2, and one RP2D for Group 3). In the cohort
expansion part of the trial (Part 2), participants with relapsed or refractory B cell
malignancies (DLBCL, FL, MCL, CLL and ALL) will be enrolled according to tumor type in up to
5 cohorts and receive duvortuxizumab at the RP2D determined in Part 1 for their disease type.
The study consists of 3 periods: Screening period (up to 28 days prior to the first dose of
study drug); Treatment period [first dose of study drug until the End of Treatment Visit
(within 30 days after the last dose)]; and follow up period [End of Treatment Visit and
continue until death, lost to follow up, consent withdrawal, or study end (as determined by
the sponsor), whichever occurs first]. Number of participants who achieve an overall response
in each Dose Expansion cohort will be evaluated primarily. Participants' safety will be
monitored throughout the study.
[/INST]
The purpose of this study is to evaluate the safety, tolerability, dose-limiting toxicities
(any harmful effect of a drug) (DLT), maximum tolerated dose (MTD), recommended Phase 2 dose
(RP2D) and preliminary clinical activity of duvortuxizumab when administered intravenously to
participants with relapsed or refractory B-cell malignancies [diffuse-large B cell lymphoma
(DLBCL), follicular lymphoma (FL), mantle-cell lymphoma (MCL), chronic lymphocytic leukemia
(CLL), and acute lymphoblastic leukemia (ALL)].
</s> |
<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase III - MIYABI ND-C[/INST]
The purpose of this study is to evaluate the efficacy and safety of molidustat in
non-dialysis subjects with renal anemia who are not treated with Erythropoiesis-Stimulating
Agents (ESAs).
</s> |