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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 - ACTIV-3[/INST]
This study looks at the safety and effectiveness of different drugs in treating COVID-19 in
people who have been hospitalized with the infection. Participants in the study will be
treated with either a study drug plus current standard of care (SOC), or with placebo plus
current SOC.
</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 - Combination Viral Kinetics (Canada)[/INST]
The objective of this study is to undertake an initial evaluation of the safety,
tolerability, antiviral effect, and pharmacokinetics of celgosivir in combination with
peginterferon alfa-2b and ribavirin in patients with chronic HCV infection.
</s> |
<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>>
This is a multicenter, open-label, non-randomized, dose escalation study of ruxolitinib, a
small molecule Janus kinase (JAK) inhibitor, administered orally to patients with PMF,
PPEV-MF or PET-MF. The study is comprised of 3 parts:
Part 1: Dose escalation and determination of maximum tolerated dose (complete).
Part 2: Exploration of alternative dosing schedules (complete).
Part 3: Further evaluation of selected dose regimens, including additional response measures
to explore effect of ruxolitinib on symptoms and other parameters including daily physical
activity and long-term survival (ongoing).
[/INST]
To determine the safety, tolerability and effectiveness of ruxolitinib (INCB018424),
administered orally to patients with Primary Myelofibrosis (PMF), Post Polycythemia Vera
Myelofibrosis (PPV-MF) and Essential Thrombocythemia Myelofibrosis (PET-MF).
</s> |
<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase Ib/II - QUILT-3.090[/INST]
This is a phase 1b/2 study to evaluate the safety and efficacy of metronomic combination
therapy in subjects with SCC who have progressed on or after previous platinum-based
chemotherapy and anti-PD-1/PD-L1 therapy. Phase 2 will be based on Simon's two-stage optimal
design.
</s> |
<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>>
Erlotinib as a single-agent is currently approved for the treatment of patients with NSCLC
whose disease has progressed following one prior course of chemotherapy and is currently
being evaluated in NSCLC patients who have not received prior systemic treatment. However,
when studied with combination chemotherapy in the first-line setting, continuous daily
administration of erlotinib did not result in improved patient survival. Further clinical and
in vitro data suggest that the sequencing of cytotoxic chemotherapy with EGFR TKIs is
important to maximize their therapeutic potential when administered in combination.
Satraplatin is an orally administered platinum analogue that has shown promising single-agent
activity in multiple tumor types including prostate, ovarian, and small cell lung cancer.
Additionally, the single-agent activity of satraplatin in NSCLC is similar to that of other
commonly used platinum agents used to treat NSCLC. However, satraplatin is better tolerated
than cisplatin, causing less renal toxicity and ototoxicity, and it can be administered in
the outpatient setting. From a toxicity profile, it is more similar to carboplatin in that
myelosuppression is its dose limiting toxicity (DLT). Satraplatin is currently being
evaluated in a pivotal phase 3 clinical trial as 2nd-line therapy for patients with hormone
refractory prostate cancer.
The rationale for this study is to develop an active and well-tolerated oral regimen for
patients ≥ 70 years of age with NSCLC who may not be candidates for aggressive combination
systemic chemotherapy. Administration of the study drugs will be sequenced with satraplatin
administered on days 1-5 and erlotinib on days 8-21 of each 28-day cycle. As erlotinib has
shown an advantage in survival without a commensurate improvement in response rate, the
primary endpoint will be progression-free survival (PFS); thus patients will be randomized to
treatment with either the experimental regimen or single-agent continuous erlotinib.
[/INST]
Patients ≥ 70 years of age with locally advanced unresectable or metastatic non-small cell
lung cancer (NSCLC) frequently do not receive systemic cytotoxic chemotherapy due to concerns
regarding their inability to tolerate treatment. Epidermal growth factor receptor (EGFR)
tyrosine kinase inhibitors (TKIs) are agents with favorable toxicity profiles that have shown
activity in patients with NSCLC. Erlotinib as a single-agent is currently approved for the
treatment of patients with NSCLC whose disease has progressed following one prior course of
chemotherapy and is currently being evaluated in NSCLC patients who have not received prior
systemic treatment. However, when studied with combination chemotherapy in the first-line
setting, continuous daily administration of erlotinib did not result in improved patient
survival. Further clinical and in vitro data suggest that the sequencing of cytotoxic
chemotherapy with EGFR TKIs is important to maximize their therapeutic potential when
administered in combination.
Satraplatin is an oral, investigational anticancer drug that is a member of the
platinum-based class of chemotherapy drugs. Platinum-based drugs have been clinically proven
to be one of the most effective classes of anticancer therapies. Unlike the currently
marketed platinum-based drugs, satraplatin can be given orally and is currently being
evaluated in a pivotal phase 3 clinical trial as 2nd-line therapy for patients with hormone
refractory prostate cancer.
The rationale for this study is to develop an active and well-tolerated oral regimen for
patients ≥ 70 years of age with NSCLC. Administration of the study drugs will be sequenced
with satraplatin administered on days 1-5 and erlotinib on days 8-21 of each 28-day cycle.
The primary endpoint will be progression-free survival (PFS). Patients will be randomized to
treatment with either the experimental regimen or single-agent continuous erlotinib.
</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 - RRMS[/INST]
The purpose of this study is to determine whether BMS-188667 will decrease multiple sclerosis
disease activity on MRI examinations, as well as decrease the rate of clinical MS
exacerbations, compared to placebo
</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 1108 (Adolescents)[/INST]
An international, multi-centre, prospective, open-label, non-controlled, single-group, 4-week
trial in adolescent subjects with plaque psoriasis.
</s> |
<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>>
This study will be conducted in healthy male or female subjects using a double-blind,
randomized, placebo-controlled, single-dose design. Up to 30 subjects will be enrolled; 3
healthy subjects in Cohorts 1 and 2 (2 active, 1 placebo) and 8 healthy subjects in Cohorts 3
to 5 (6 active, 2 placebo). The following CPSI-2364 doses are proposed: 1 mg, 10 mg, 30 mg,
90 mg, and 270 mg. In Cohort 1 (1 mg) and Cohort 2 (10 mg), the three subjects will all be
dosed on the same day, with at least 60 minute intervals between dosing. In Cohorts 3 to 5,
the first two subjects of each cohort (one active, one placebo) will receive their drug on
the same day with at least a 60-minute interval between dosing, with the remainder of the
cohort being dosed the next day once these subjects have been assessed. Safety labs, physical
examination findings, and adverse events available up to and including Day 5 data of each
cohort will be reviewed by the Investigator, the Study Manager, and the Sponsor (or designee)
in order to determine the progression of dose escalation. Subjects will not be enrolled in
the next higher cohort until the dose in the preceding cohort is deemed safe and tolerable.
Doses will continue to be escalated in subsequent groups until a maximum tolerated dose (MTD)
is reached, or until a top dose of 270 mg is reached, whichever is sooner. Intermediate and
repeat dose levels may be administered in addition to or in place of the planned dose levels,
if it is deemed appropriate to increase the safety or scientific value of this Phase 1
exploratory study.Safety will be evaluated throughout the study and include physical
examinations, vital signs assessments, 12-lead electrocardiograms (ECGs), routine clinical
laboratory tests (including blood chemistry, hematology, coagulation, and urinalysis), and
adverse event (AE) assessments. Vital sign assessments and 12-lead ECGs will be performed
repeatedly over the 24-hour observation period.Venous blood samples will be taken at
specified intervals and tested for the presence of CPSI-2364.
[/INST]
This study will be conducted in healthy male or female subjects using a double-blind,
randomized, placebo-controlled, single-dose design. Up to 30 subjects will be enrolled; 3
healthy subjects in Cohorts 1 and 2 (2 active, 1 placebo) and 8 healthy subjects in Cohorts 3
to 5 (6 active, 2 placebo). The following CPSI-2364 doses are proposed: 1 mg, 10 mg, 30 mg,
90 mg, and 270 mg.Safety will be evaluated throughout the study and include physical
examinations, vital signs assessments, 12-lead electrocardiograms (ECGs), routine clinical
laboratory tests (including blood chemistry, hematology, coagulation, and urinalysis), and
adverse event (AE) assessments. Vital sign assessments and 12-lead ECGs will be performed
repeatedly over the 24-hour observation period. Venous blood samples will be taken at
specified intervals and tested for the presence of CPSI-2364.
</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]
OncoGel is a new experimental drug delivery system that allows the slow continuous release of
paclitaxel (an approved intravenous anticancer drug), from a gel (ReGel) over a long period
of time. The gel will disappear in 4 to 6 weeks as it releases the paclitaxel.
The protocol is directed towards evaluating the efficacy and safety of paclitaxel delivered
as a local, intralesional treatment when used in combination with chemotherapy (cisplatin and
5-FU) and radiation therapy before 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 I - Healthy/Obese (Australia)[/INST]
This study is a phase I, randomized, placebo-controlled, double-blind (sponsor unblind),
three part study. The primary objective of the study is to characterize the safety, and
tolerability of GSK3008356 single dose, 14 daily repeat doses in healthy subjects and 28
daily repeat doses in obese subjects. The study has three parts. Part 1, will be a single and
multiple-dose, dose-rising study in healthy subjects. Part 2, will be a 14-day, repeat-dose,
dose-rising study in healthy subjects, and part 3 will be a 28-day, repeat-dose study in
obese subjects. For Parts 1 and 2, data from prior doses cohorts will be available prior to
escalation decisions. Data from Parts 1 and 2 will be available prior to initiation of the
three parallel cohorts in Part 3. A dose escalation meeting will be held to review these data
and document the decision to proceed as planned or make any alterations in dosing, if
indicated. Part 1, Part 2 and Part 3 study will have approximately 88, 24 and 30 subjects,
respectively.
</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/IIb - FW-COV-003[/INST]
This is a two-part, Phase 2, multicentre, randomized, double blind, 2-arm placebo-controlled
study in adults with moderate COVID-19 with gastrointestinal signs and symptoms
</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 - EMBARC-RF[/INST]
This is a phase 3 randomized, active-controlled, open-label, multicenter study that will be
conducted in approximately 120 investigational sites worldwide. Subjects with either
recurrent or refractory NMIBC (Ta high grade, T1 low or high grade, CIS) will be eligible for
participation in this study.
Refractory disease is defined as evidence of persistent high grade bladder cancer (Ta HG, T1,
and/or CIS) at least 6 months from the start of a full induction course of BCG with or
without maintenance/re-treatment at 3 months.
Recurrent disease is defined as reappearance of disease after achieving a tumor-free status
by 6 months following a full induction course of BCG with or without maintenance/re-treatment
at 3 months. Subjects with recurrent disease must have recurred within 18 months following
the last dose of BCG.
Approximately 450 subjects will be randomized. The primary objective of this study is to
evaluate the efficacy of intravesical EN3348 as compared with mitomycin C in the treatment of
subjects with recurrent or refractory NMIBC. The secondary objective is to evaluate the
safety of EN3348 as compared with mitomycin C in the treatment of subjects with BCG recurrent
or refractory NMIBC. This study will consist of 4 phases: Screening, Induction, Maintenance
and Follow-Up and will be conducted over 3 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 III - NefIgArd (IgA Nephropathy)[/INST]
The overall aim of the study is to evaluate the efficacy, safety, and tolerability of Nefecon
16 mg per day in the treatment of patients with primary IgAN (Immunoglobulin A nephropathy)
at risk of progressing to end-stage renal disease (ESRD), despite maximum tolerated treatment
with renin-angiotensin system (RAS) blockade using angiotensin converting enzyme inhibitors
(ACEIs) or angiotensin II type I receptor blockers (ARBs).
</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 - REGAiN-1B (Ext)[/INST]
To evaluate the durability of efficacy and long-term safety of intramuscular (IM)
administration of Engensis or Placebo that was administered in the double-blind, randomized,
VMDN-003-2 Placebo-controlled Phase 3 Study.
</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 - 17119[/INST]
To assess the potential efficacy (in terms of objective response) of single agent copanlisib
in patients with relapsed or refractory Diffuse large B-cell lymphoma (DLBCL) and assess the
relationship between efficacy and a potentially predictive biomarker
</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 - BELLINI (w/Bortezomib and Dexamethasone)[/INST]
This was a Phase 3, multicenter, randomized, double blind, placebo-controlled study
evaluating the efficacy and safety of venetoclax plus bortezomib and dexamethasone in
participants with relapsed or refractory multiple myeloma who are considered sensitive or
naïve to proteasome inhibitors and received 1 to 3 prior lines of therapy for multiple
myeloma.
</s> |
<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>>
Phase 1 will determine the maximally tolerated or recommended dose of PX-866 to be given
orally on Days 1-21 in combination with cetuximab 250 mg/m2 administered IV weekly on Days 1,
8, and 15 of a 21-day cycle. All patients will receive an initial loading dose of 400 mg/m2
cetuximab rather than 250 mg/m2 on Cycle 1 Day 1. Patients may receive premedication with an
H1 antagonist per the cetuximab package insert. Up to 3 dose levels of PX-866 will be
evaluated to determine the MTD/RD in cohorts of up to 6 patients using a standard 3+3
dose-escalation design. At least 6 patients will be treated at the MTD/RD. All patients in
Phase 1 will be required to undergo PK assessments during Cycle 1 Week 3 to measure cetuximab
levels. Exploratory PD assessments will include evaluation of changes in levels of fasting
C-peptide as well as changes in EGFR and PI-3K signaling pathways in peripheral blood
mononuclear cells (PBMC) and platelets. Additional optional evaluations will include changes
in EGFR and PI-3K signaling in paired tumor biopsies provided before and after one cycle of
treatment. All patients will be asked, but not required, to provide an archived tumor biopsy
sample for evaluation for potential biomarkers of response to PX-866 and cetuximab.
Phase 2 is an open-label, randomized evaluation of the antitumor activity and safety of
PX-866 administered orally or via PEG tube (if applicable) at the MTD/RD in combination with
cetuximab, versus cetuximab alone in cetuximab-naïve patients with incurable metastatic CRC
who have a history of progression or recurrence following prior irinotecan and oxaliplatin
containing regimens or are intolerant of irinotecan (Group 1) or patients with incurable
progressive, recurrent or metastatic SCCHN (Group 2). Seventy two evaluable patients (36
patients per arm) will be evaluated per indication. Patients will be randomized 1:1 to
receive PX-866 + cetuximab or cetuximab alone.
[/INST]
The purpose of this Phase 1/2 open-label study is to determine the safety and efficacy of a
cetuximab and PX-866 combination treatment. In the Phase 1 part of the study, the dose of
PX-866 to be given in combination with cetuximab will be determined in patients with
incurable metastatic CRC or incurable progressive, recurrent or metastatic SCCHN. The Phase 2
part of the study is a randomized evaluation of the antitumor activity and safety of PX-866
in combination with cetuximab versus cetuximab alone in patients with either incurable
metastatic CRC who have a history of progression or recurrence following prior irinotecan and
oxaliplatin containing regimens or are intolerant of irinotecan (Group 1) or incurable
progressive, recurrent or metastatic SCCHN (Group 2).
</s> |
<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase Ib/II - METROmaJX (France)[/INST]
Assessment of the efficacy and safety of JX-594 and metronomic cyclophosphamide in patients
with advanced soft-tissue sarcoma and advanced breast cancer, once the Maximum Tolerated Dose
have been determined (phase I trial).
Phase I study: this is a prospective open-labeled phase I trial based on a dose escalating
study design assessing two dose levels of JX594 when prescribed in combination with
metronomic cyclophosphamide.
Phase II trials with two treatments strategies:
Metronomic CP + JX-594: phase II study sarcoma: this is a monocentric, randomized two-arm non
comparative phase 2 study assessing efficacy and safety of JX-594 in association with
metronomic cyclophosphamide in patients with advanced soft-tissue sarcoma.
Metronomic CP + JX-594: phase II study breast cancer: this is a monocentric, single-arm phase
II study, assessing efficacy and safety of JX-594 in association with metronomic
cyclophosphamide in patients with advanced breast cancer.
Metronomic CP + JX-594 + Avelumab: phase II study sarcoma: this is a monocentric, single arm
phase II study assessing efficacy and safety of avelumab in combination with IT JX-594 and
metronomic cyclophosphamide in patients with advanced soft-tissue sarcoma.
Metronomic CP + JX-594 + Avelumab:: phase II study breast cancer: this is a monocentric,
single-arm phase II study, assessing efficacy and safety of avelumab in combination with IT
JX-594 and metronomic cyclophosphamide in patients with advanced breast 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 II - w/R-CHOP in B-Cell[/INST]
The primary objective of this study is to evaluate the response rate and toxicity of the
association R-CHOP with two schedules of administration of Velcade, in B-cell CD 20 +
lymphoma patients, aged from 18 to 80 years
The goal is to get a response rate at least at what observed with R-CHOP alone and will be
evaluates with a sequential test.
The other objective is to evaluate the toxicity
</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 study to determine the efficacy following treatment with Aplidin® 5 mg/m2,
given as a 3 h iv infusion every 2 weeks, in patients with relapsed or refractory multiple
myeloma (MM) and to obtain the following :
- Additional pharmacokinetic information for Aplidin® given as 3-hour IV infusion every 2
weeks in patients with MM.
- To obtain additional genomic and pharmacodynamics information on MM and Aplidin.
- To assess the safety and tolerability of Aplidin® given as 3-hour IV infusion every 2
weeks in patients with MM alone or in combination with dexamethasone given orally as a
20 mg daily for 4 days
- To determine the response rate in the second cohort of patients following treatment with
Aplidin®, given as a 3 hour infusion every 2 weeks, plus dexamethasone given orally as a
20 mg daily for 4 days, starting the same day of Aplidin® administration, as a second
treatment stage in patients with suboptimal response to Aplidin® as single agent
(progressive disease after three cycles or stable disease after four cycles).
[/INST]
This is a phase II study to determine the efficacy following treatment with Aplidin® 5 mg/m2,
given as a 3 hours intravenous infusion every 2 weeks, in patients with relapsed or
refractory multiple myeloma (MM).
</s> |
<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>>
AV7909 is a new vaccine which is a combination of BioThrax (also called anthrax vaccine,
adsorbed or AVA), a FDA-licensed vaccine, and CPG 7909. CPG 7909 is a synthetic short DNA
sequence that has been shown to be an effective vaccine adjuvant, and one which increases the
speed and the degree of the immune response to Protective Antigen (PA), the major vaccine
antigen. In the current study, the safety, tolerability, and antibody response to PA will be
studied for four different combinations of AVA and CPG 7909, and compared to both AVA and a
saline placebo. All formulations of AV7909 have the same or less AVA than the licensed AVA
vaccine and all have less CPG 7909 per dose than the formulation used in the first Phase I
volunteer study of CPG 7909 combined with AVA.
[/INST]
The purpose of this Phase 1 clinical trial is to evaluate the safety, tolerability, and
immunogenicity of AV7909 anthrax vaccine in healthy adults. In this study, healthy male and
female subjects between 18 and 50 years of age will receive vaccinations via the
intramuscular (IM) route at Days 0 and 14. Safety and tolerability will be evaluated via
laboratory tests, physical examinations, vital signs, adverse events (AEs), concomitant
medications, and local and systemic signs and symptoms of reactogenicity.
</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 - STELARA (Pediatric)[/INST]
The purpose of this study is to evaluate the pharmacokinetics (PK) of ustekinumab in subjects
from 2 through less than (<) 18 years old in the USA, or 6 through less than (<) 18 years old
in other countries and determine if it is similar to that observed in adults with moderately
to severely active Crohn's disease (CD). Also to assess the safety, immunogenicity and
efficacy of ustekinumab in the treatment of moderately to severely active CD. The main part
of the study continues to Week 16, at which point all subjects who are receiving benefit from
ustekinumab maintenance therapy (as determined by the investigator) are eligible to enter the
long-term extension (LTE) and continue to receive ustekinumab. The study extension ends at
Week 268 or upon availability of the LTE basket study (CNTO1275ISD3001) whichever occurs
first. If participants do not consent/assent to the LTE basket study, they will continue
safety follow-up for approximately 20 weeks after the last study agent administration.
</s> |
<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>>
ACTIV-1 IM is a master protocol designed to evaluate immune modulators for the treatment of
moderately or severely ill hospitalized patients infected with COVID-19. Trial participants
will be assessed daily while hospitalized. If the participants are discharged from the
hospital prior to Day 29, they will have follow-up study visits at Days 8, 11, 15, 22, and
29. For discharged participants, it is preferred that the Day 8, 11, 15, and 29 visits are in
person to obtain safety laboratory tests and blood (serum/plasma) samples for secondary
research as well as clinical outcome data. However, infection control or other restrictions
may limit the ability of the participant to return to the clinic. In this case, these visits
may be conducted by phone, and only clinical data will be obtained. The Day 22 visit does not
have laboratory tests or collection of samples and is conducted by phone. The Day 60
assessment will be conducted by phone.
The effectiveness of each therapeutic agent as add-on therapy to SoC plus remdesivir
(provided) will be evaluated based on the primary endpoint of time to recovery by Day 29. The
sample size requirements are based on the ability to detect a moderate improvement in time to
recovery (3-4 fewer days) for each agent. A total of 788 recoveries are required for each
comparison to provide approximately 85% power to detect a recovery rate ratio of 1.25.
Assuming 73% of participants achieve recovery in 28 days, consistent with the ACTT-1 results,
the total sample size to evaluate 1, 2, and 3 agents in ACTIV-1 IM is approximately 1080,
1620, and 2160, respectively. Because each agent is being compared to SoC with no
between-agent comparisons, no multiplicity adjustments for multiple agents are planned.
The CVC arm of the study was closed to enrollment on 3-Sep-2021.
[/INST]
ACTIV-1 IM is a master protocol designed to evaluate multiple investigational agents for the
treatment of moderately or severely ill patients infected with severe acute respiratory
syndrome coronavirus 2 (SARS-CoV-2). The research objectives are to evaluate each agent with
respect to speed of recovery, mortality, illness severity, and hospital resource utilization.
Each agent will be evaluated as add-on therapy to the standard of care (SoC) in use at the
local clinics, including remdesivir (provided). The SoC may change during the course of the
study based on other research findings. Comparisons of the agents among themselves is not a
research objective.
The study population corresponds to moderately and severely ill patients infected with the
coronavirus disease 2019 (COVID-19) virus. Recruitment will target patients already
hospitalized for treatment of COVID-19 infection as well as patients being treated for
COVID-19 infection in Emergency Departments while waiting to be admitted to the hospital.
Patients both in and out of the ICU are included in the study population.
</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 - Study 2a[/INST]
The primary objectives of this study are to evaluate safety and efficacy of topically applied
Glucoprime gel (GLYC-101, 0.1% and GLYC-101, 1.0%) in promoting wound healing in cosmetic
surgery patients undergoing Carbon Dioxide Laser Skin Resurfacing (CO2 LSR) of the lower
eyelids. The study will observe the effects of the topical agent over the course of 1 month
following the initial treatment.
</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, two-stage, open-label, single-agent study of the experimental drug RAD001
(everolimus) in patients with previously treated small cell lung cancer. Patients may have
received up to 2 prior chemotherapy regimens for small cell lung carcinoma, but no prior
therapy with an m-TOR inhibitor. RAD001 will be administered orally at a dose of 10 mg daily.
A cycle will be defined as 3 weeks of study drug administration, and patients will have tumor
measurements every 2 cycles. Study participation will continue until disease progression or
intolerable toxicities. In addition, in patients who consent, archival tumor tissue (paraffin
block from original biopsy) will be collected for research purposes.
[/INST]
This is a phase II, two-stage, open-label, single-agent study of the experimental drug RAD001
(everolimus) in patients with previously treated small cell lung cancer. RAD001 will be
administered orally at a dose of 10 mg daily.
</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 - J081-104 (JP)[/INST]
The purpose of this study is to assess the safety, tolerability, pharmacokinetics,
immunogenicity, and pharmacodynamic response of repeated intravenous infusions of BAN2401 in
subjects with mild cognitive impairment (MCI) due to Alzheimer's disease (AD) and mild
Alzheimer's disease.
</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 - 1321.5 (w/Dabigatran - Japan)[/INST]
The primary objective is to investigate the safety, tolerability and pharmacokinetics of BI
655075 following intravenous administration of single rising doses of BI 655075 when
administered alone and after administration of dabigatran.
</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 - 301 (Canada)[/INST]
This multicenter, randomised, double-dummy, Fumaderm® and placebo-controlled, parallel-group
study will compare the efficacy and safety of 500 mg of FP187 (250 mg twice daily) compared
to 720 mg Fumaderm® (240 mg three times daily) over 20 weeks of treatment. After an initial
wash-out non-drug treatment phase of 1 to 6 weeks, all patients will receive allocated Study
treatment up-titrated to the relevant dose level (i.e., 500 mg daily FP187, 720 mg daily
Fumaderm®, or placebo). The up-titration to full dose will last 4 weeks for FP187 and 9 weeks
for Fumaderm®. After 20 weeks of treatment, all patients will be asked to enter a separate
open label treatment protocol expected to continue for up to 5 years.
</s> |
<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>>
This study was a double blind, placebo-controlled, randomized trial in adult patients with
episodic migraine. There was a screening period of 2 weeks to assess initial eligibility, and
a 4-week baseline period. After randomization, participants entered the double-blind
treatment epoch (DBTE) and had clinic visits for 12 weeks. All participants who completed the
DBTE were eligible to enter the Open-Label Treatment Epoch (OLTE) for up to 156 weeks. All
participants had a 12 week Follow-Up Epoch and a a Follow-Up visit 16 weeks after the last
dose of AMG334 unless the participant continued on commercially available AMG334.
Participants who had demonstrated clinical benefit were eligible to enter a Post Trial Access
(PTA-Open Label Treatment Epoch) of flexible duration for approximately 6 months.
[/INST]
The purpose of this study is to determine if AMG 334 is effective in treating migraines in
patients who have failed other preventive migraine treatments.
</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 - GEMINI III[/INST]
This study in patients with moderately to severely active Crohn's disease is designed to
establish the efficacy and safety of vedolizumab for the induction of clinical response and
remission.
</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. Lantus (006)[/INST]
This 24-week study is a safety and efficacy comparison of MK-1293 and Lantus™ in participants
with type 2 diabetes mellitus (T2DM). The primary hypothesis is that after 24 weeks, the mean
change in hemoglobin A1c (A1C) from baseline is non-inferior (with margin of 0.4%) in
participants treated with MK-1293 compared with that in participants treated with Lantus™.
</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 - CL-023 (Moderate Hepatic Impairement)[/INST]
This is a non-randomized, open-label, single-dose study to compare the PK of 21-desacetyl-DFZ
and, if data permits, deflazacort in 8 subjects with moderate hepatic impairment (based on
the Child Pugh classification, Grade B) to that of 8 healthy matched control subjects (age,
body mass index [BMI], and gender).
</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 - Insulin Pump (105)[/INST]
The purpose of this study is to determine if recombinant human hyaluronidase PH20 (rHuPH20)
will change the exposure and action of approved insulin analogs when given by continuous
subcutaneous insulin infusion (CSII) in participants with Type 1 diabetes mellitus (T1DM).
This study is divided into Stage 1, 2, and 3. Stage 3 was started chronologically before
Stage 2 and, prior to performing Stage 2, the Sponsor made the decision to terminate Stage 2.
Stage 2 was not initiated due to a strategic business decision and termination was not based
on safety or efficacy concerns. No participants were enrolled in Stage 2.
</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 - COLUMBA (MEA112997 Extension)[/INST]
This is a multi-centre, open-label long term safety study of 100 milligrams (mg) mepolizumab
administered subcutaneously (SC) in addition to standard of care in subjects who participated
in the MEA112997 study. At each clinic visit, adverse events will be assessed and
exacerbations will also be reviewed.
</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 - w/SAR245408[/INST]
Primary Objective:
- To determine the maximum tolerated dose(s) (MTD) and the recommended Phase 2 dose(s) (RP2D)
of SAR245408 and MSC1936369B when combined in adult subjects with locally advanced or
metastatic solid tumors.
Secondary Objective:
- To characterize the safety and tolerability of SAR245408 and MSC1936369B combination
therapy administered orally to adult patients with locally advanced or metastatic solid
tumors
- To evaluate the pharmacokinetic (PK) profile of SAR245408 and MSC1936369B when used in
combination
- To evaluate the pharmacodynamic (PD) effect of the SAR245408/MSC1936369B combination by
assessing target and pathway inhibition
</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[/INST]
This is a multicenter, open-label, Phase 1/2a dose escalation and expansion study of orally
administered emavusertib (CA-4948) monotherapy in adult patients with Acute Myelogenous
Leukemia (AML) or high risk Myelodysplastic Syndrome (MDS).
Patients enrolling in the Phase 1 portion of the study must meet one of the following
criteria prior to consenting to the study:
- R/R AML with FLT3 mutations who have been previously treated with a FLT3 inhibitor
- R/R AML with spliceosome mutations of SF3B1 or U2AF1
- R/R hrMDS with spliceosome mutations of SF3B1 or U2AF1
- Number of pretreatments: 1 or 2
The Phase 2a Dose Expansion will be in 3 Cohorts of patients:
1. R/R AML with FLT3 mutations who have been previously treated with a FLT3 inhibitor;
2. R/R AML with spliceosome mutations of SF3B1 or U2AF1; and
3. R/R hrMDS (IPSS-R score > 3.5) with spliceosome mutations of SF3B1 or U2AF1.
All patients above have had ≤ 2 lines of prior systemic anticancer treatment. In previous
versions of this protocol there was a Phase 1b portion of the study, in which patients with
AML or hrMDS received CA-4948 in combination with venetoclax. This part of the study is no
longer open for enrollment.
</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 - ECOG 5202[/INST]
This randomized phase III trial studies oxaliplatin, leucovorin calcium, fluorouracil, and
bevacizumab to see how well they work compared to oxaliplatin, leucovorin calcium, and
fluorouracil in treating patients who have undergone surgery for stage II colon cancer. Drugs
used in chemotherapy, such as oxaliplatin, leucovorin calcium, and fluorouracil, work in
different ways to stop the growth of tumor cells, either by killing the cells, by stopping
them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as
bevacizumab, may interfere with the ability of tumor cells to grow and spread. It is not yet
known whether giving combination chemotherapy together with bevacizumab is more effective
than combination chemotherapy alone in treating colon 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 I - Early Stage (Cream)[/INST]
The goal of this clinical research study is to learn if CD5789 is safe and tolerable when
given to patients with early stage CTCL.
CD5789 is designed to attach to tumor cells and change their genetic material. This may stop
the growth of the tumor cells.
</s> |
<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>>
High risk acute myeloid leukemia (AML) frequently relapses despite hematopoietic stem cell
transplant (HCT). Post-HCT targeted therapy to reduce relapse is limited by toxicity to the
engrafted cells. VOR33, an allogeneic CRISPR/Cas9 genome-edited hematopoietic stem and
progenitor cell (HSPC) therapy product, lacking the CD33 protein, is being investigated for
participants with CD33+ AML at high risk for relapse after HCT to allow post-HCT targeting of
residual CD33+ acute AML cells using Mylotarg™ without toxicity to engrafted VOR33 cells.
Participants will undergo a myeloablative HCT with matched related or unrelated donor
CD34+-selected hematopoietic stem and progenitor cells (HSPCs) engineered to remove CD33
expression (VOR33 product). Mylotarg™ will be given after engraftment for up to 4 cycles. The
primary endpoint assessing safety of VOR33 will be the incidence of successful engraftment at
28 days. Part 1 of this study will evaluate the safety of escalating Mylotarg™ dose levels to
determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D). Part 2 will
expand the number of participants to evaluate the Mylotarg™ RP2D.
[/INST]
This is a Phase 1/2a, multicenter, open-label, first-in-human (FIH) study of VOR33 in
participants with AML who are undergoing human leukocyte antigen (HLA)-matched allogeneic
hematopoietic cell transplant (HCT).
</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 - IND3-10-06[/INST]
The purpose of this study is to determine whether Indomethacin [Test] Capsules are safe and
effective for the treatment of postoperative bunionectomy 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 IIb - TARGET (+/- Docetaxel)[/INST]
This study will test the activity of single-agent EC145 and the combination of EC145 plus
docetaxel against the current standard docetaxel in second line Non Small Cell Lung Cancer
(NSCLC) (adenocarcinoma, squamous, adenosquamous or adenocarcinoma with other NSCLC variants
of the lung) in participants with all target lesions expressing the folate receptor [FR(++)].
</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 - QC-201[/INST]
Evaluating the safety and tolerability of QLS-101 versus timolol maleate ophthalmic solution
in glaucoma or ocular hypertension.
</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 - KEYNOTE166 (w/Pembrolizumab)[/INST]
Pembrolizumab alone and in combination with acalabrutinib in subjects with advanced non-small
cell lung cancer.
</s> |
<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>>
Short Title: Safety, blood levels and effects of MGB-BP-3
Trial medication MGB-BP-3 is a new class of antibacterial agent that binds selectively to the
bacterial DNA minor groove and possesses strong bactericidal in vitro and in vivo activity
against Clostridium difficile (C. difficile). In addition to its activity against C.
difficile MGB-BP-3 has very strong activity against all other Gram-positive bacteria tested,
including susceptible and resistant Staphylococcus aureus, Streptococcus and Enterococcus.
MGB-BP-3 is being developed for the treatment of C. difficile infections (CDI).
Objectives Primary: To assess the safety and tolerability of single and repeated oral doses
of MGB-BP-3 in healthy men Secondary: To assess the pharmacokinetics (PK) of single and
repeated oral doses of MGB-BP-3 in healthy men
Type of trial This trial will be done in 2 parts, as follows. Part A: Phase I, double-blind,
randomised, placebo-controlled, crossover, single ascending-dose trial in healthy men.
Part B: Phase I, double-blind, randomised, placebo-controlled, sequential-group, repeated
ascending-dose trial in healthy men.
Trial population Total up to 40 healthy men (excluding replacement subjects): 16 subjects in
Part A and 24 subjects in Part B.
Age 18-45 years Principal inclusion criteria Normotensive male, with a body mass index (BMI)
of 18.0-30.9 kg/m2; deemed healthy on the basis of a clinical history, physical examination,
electrocardiogram (ECG), vital signs, and laboratory tests of blood and urine; willing to use
reliable contraception; able to give fully informed written consent.
Principal exclusion criteria Positive tests for hepatitis B & C, HIV; severe adverse reaction
to any drug; drug or alcohol abuse; smoke more than 5 cigarettes (or use of equivalent
tobacco or nicotine products) daily; over-the-counter medication within previous 7 days (with
the exception of paracetamol), or prescribed medication during previous 28 days;
participation in other clinical trials of unlicensed medicines, or loss of more than 400 mL
blood, within the previous 3 months; vital signs outside the acceptable range; clinically
relevant abnormal findings at the screening assessment; acute or chronic illness; clinically
relevant abnormal medical history or concurrent medical condition; possibility that volunteer
will not cooperate.
Trial design and methods Part A Part A is a randomised, double-blind, placebo-controlled,
cross-over, single ascending-dose trial in 16 healthy men. Subjects will be enrolled in 2
groups of 8 (Groups 1 and 2). Each subject will have 3 study sessions - they will receive a
single oral dose of MGB-BP-3 in up to 3 study sessions; 6 volunteers will receive matching
placebo in 1 study session.
So, at each dose level, 6 subjects will be randomised to receive MGB-BP-3 and 2 subjects will
be randomised to receive placebo.
There will be a washout period of at least 4 days between doses for each subject, and an
interval of at least 6 days between the last dose in Group 1 and the first dose in Group 2.
The investigator and sponsor will review the safety and tolerability data for each dose level
before increasing the dose. The dose will only be escalated if the safety and tolerability of
the previous dose level are acceptable. The planned dose level may be changed, based on
emerging safety and tolerability data - a dose level may be repeated or a lower dose tested.
The maximum dose tested will not exceed 2000 mg MGB-BP-3, which is 2-fold lower than the
NOAEL (no observed adverse effect level) in male dog.
Because MGB-BP-3 has never been given to humans before, the first dose level will be
staggered: 2 leading subjects will be dosed no later than the day before the remaining
subjects in the group are dosed. The leading subjects will be dosed at intervals of at least
10 minutes, and the remaining subjects also at intervals of at least 10 minutes. To maintain
the blind nature of the study, 1 of the leading subjects will be randomised to receive
MGB-BP-3 and the other to placebo.
Part A is considered to be the 'first in human' portion of the study, so GP (General
Practioner) replies must be obtained for the subjects in Part A. Subjects will be screened
during the 4 weeks before their first dose of trial medication. In each of their 3 study
sessions, subjects will be resident on the ward from the day before dosing (Day -1), until
completion of procedures at 72 h after their dose of trial medication (Day 4). Subjects will
attend a follow-up visit at 7-10 days after their dose of trial medication.
Part B Part B is a randomised, double-blind, placebo-controlled, sequential-group, repeated
ascending-dose trial in 24 healthy men.
The sponsor and investigator will select 3 dose levels to be tested in Part B, based on
available safety and tolerability data from Part A. The highest total daily dose tested in
Part B will not exceed the highest dose in Part A that was acceptably tolerated and for which
there were no safety concerns. Part B can start before Part A has finished, provided that the
total daily dose to be given (or a higher dose) has previously been shown to be acceptably
tolerated and safe in Part A.
Subjects will be enrolled in 3 groups of 8 (Groups 3-5). Each subject will have 1 study
session, in which they will receive twice-daily oral doses of MGB-BP-3, or matching placebo,
for 9 days (Days 1-9) and a single dose on the morning of Day 10.
In each group, 6 subjects will be randomised to receive MGB-BP-3 and 2 subjects will be
randomised to receive placebo. Subjects in each group will be dosed at intervals of at least
10 minutes.
For each ascending dose level, there'll be a gap of least 6 days between the final dose of
the previous group and the first dose of the next group. The investigator and sponsor will
review safety and tolerability data for each dose level before increasing the dose. The dose
will be escalated only if the safety and tolerability of the previous dose level are
acceptable. The planned doses may be changed, depending on the safety and tolerability of
previous doses - a dose level may be repeated or a lower dose tested.
Subjects will be screened within 4 weeks before their first dose of trial medication. They
will be resident on the ward from admission on Day -2 until completion of procedures at 72 h
after their final dose of trial medication (Day 13). They will attend a follow-up visit at
7-10 days after their final dose of trial medication.
Methods: Parts A and B
The following assessments will be made:
Safety: laboratory assessments (routine haematology, biochemistry and urinalysis), physical
examination, 12-lead ECG, telemetry (Part A only) faecal occult blood, intestinal
permeability (the ratio of lactulose to mannitol excreted in urine, Part B only), faecal
flora (Part B only), vital signs, and adverse events.
Tolerability: adverse events. Pharmacokinetic: blood samples for assay of MGB-BP-3 and
possible metabolites will be taken before, and frequently up to 48 h after dosing in Part A,
and up to 12 h after subjects' morning dose on Day 1 and up to 48 h after dosing on Day 10 in
Part B. In addition, in Part B, a blood sample will be taken before the morning dose on each
of Days 2-9. Urine will be collected for 24 h after each dose for assay of MGB-BP-3 in Part
A, and for 12 h after the morning dose on Day 1 and 10 (Part B only). Faecal samples will be
collected daily until 72 h after subjects' (final) dose for assay of MGB-BP-3 in each study
session, and in Part B for 24 h after dosing on Days 1 and 5.
Primary variables Safety: vital signs, ECG, telemetry (Part A only), physical examination,
laboratory safety tests, faecal occult blood, intestinal permeability (Part B only), faecal
flora (Part B only) Tolerability: adverse events
Secondary variables
Pharmacokinetics: PK parameters of MGB-BP-3:
Cmax, tmax and if appropriate t½, AUC0-t, AUC0-∞, Ctrough, AUC 0-τ (Part B), Vd/f (in Part A
and Vdss/f in Part B) and CL/f (in Part A and CLss/f in Part B) in plasma Ae0-24 (Part A),
Ae0-τ (Part B) and CLr in urine The amount of MGB-BP-3 excreted in faeces.
[/INST]
This study is to assess the safety and tolerability aspects of oral MGB-BP-3, a treatment for
Clostridium difficile infections.
</s> |
<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>>
This study is designed to investigate the potential therapeutic effects and safety of oral
ALK4290 administered 800 mg daily over a 6-week dosing period as measured by Best Corrected
Visual Acuity (BCVA) in subjects with refractory wAMD (i.e., following monthly intravitreal
[IVT] anti-VEGF therapy for at least 3 months in the study eye).
[/INST]
This study will evaluate the therapeutic effects and safety of 800 mg ALK4290 administered
daily over a 6-week dosing period in subjects with refractory wet age-related macular
degeneration (wAMD).
</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 CS201[/INST]
In this double-masked, vehicle-controlled, dose-response study, subjects will be randomized
to receive AR-13324 Ophthalmic Solution 0.01%, 0.02%, and 0.04% or its vehicle (one eye),
once daily (QD)in the morning (AM) for 7 days. The first dose and last dose will be
administered in the clinic. Ocular safety and ocular hypotensive efficacy will be evaluated
in the clinic throughout the study.
</s> |
<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>>
As per the feedback from Center for Biologics Evaluation and Research (CBER) the scope of
this post-marketing commitment study has been extended to demonstrate the effectiveness,
immunogenicity and safety of GSK's investigational combined meningococcal ABCWY vaccine along
with the rMenB+OMV NZ vaccine. Note that the rMenB+OMV and MenACWY vaccines provided to
MenB_0_2_6, MenB_0_6 group and MenACWY group respectively at day 211 are only as part of
standard care of treatment and to maintain blinding. These vaccination schedules are not
considered for any endpoint evaluations.
[/INST]
The purpose of this study is to evaluate the effectiveness of 2 doses or 3 doses of GSK's
licenced meningococcal group B Bexsero (rMenB+OMV NZ) vaccine and of 2 doses of GSK's
investigational combined meningococcal (MenABCWY) vaccine (GSK3536819A) in healthy
adolescents and young adults. The immunogenicity and safety will also be evaluated in the
study.
</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 - SIGHT (China)[/INST]
This study will assess the efficacy and safety of intravitreally (IVT), i.e. directly into
the eye administered VEGF Trap-Eye compared with photodynamic therapy (PDT) on visual
function in Chinese subjects with age-related neovascular or "wet" age-related macular
degeneration.
Subjects will be randomized in a 3:1 ratio to either receive VEGF Trap-Eye or PDT. Both
treatment groups will receive the other treatment as a sham procedure.
</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 - RISE[/INST]
The purpose of the study is to evaluate the efficacy, safety, and tolerability of different
dose regimens of TV-46000 administered subcutaneously (SC) as compared to placebo during
maintenance treatment in adult and adolescent participants with schizophrenia. The study will
include male and female participants, 13 to 65 years of age, who have a confirmed diagnosis
of schizophrenia, are clinically stable, and are eligible for risperidone 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 - GAMES-RP[/INST]
This is a randomized, multi-center, prospective, double blind study. The primary objective is
to assess the efficacy and safety of glyburide (RP-1127) compared to placebo in participants
with a severe anterior circulation ischemic stroke who are likely to develop malignant
edema.This objective will be addressed by comparing the proportion of glyburide treated
particpants and placebo treated participants with a Day 90 modified Rankin Scale (mRS) ≤ 4
without decompressive craniectomy (DC). The secondary objective is to assess the efficacy of
RP-1127 compared to placebo in participants with a severe anterior circulation ischemic
stroke who were likely to develop malignant edema.
</s> |
<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>>
This is a randomized, placebo-controlled, parallel-group, multicenter, double-blind study of
BGE-175 administered PO or NG in participants ≥ 50 years of age and hospitalized with
documented COVID-19 who are not yet in respiratory failure.
After signing informed consent, participants will be screened upon presentation at the
hospital. Screening will include full physical examination, vital signs, safety laboratory
evaluation, oxygen saturation, pre-diagnostics to measure prostaglandin D2 (PGD2) status, and
baseline assessment of World Health Organization (WHO) Ordinal Scale for COVID-19. If
confirmed that the participant qualifies for this protocol according to listed inclusion and
exclusion criteria, participants will receive the first dose of study medication, PO. The
participant will then receive study medication PO or NG (if intubated or unable to swallow
medication) once daily, at approximately the same time each day for up to 13 additional days.
Study medication will be administered in addition to standard of care deemed appropriate by
the treating physician(s). Participants will be randomized to receive BGE-175 or placebo.
Participants will be monitored daily for all relevant efficacy outcomes, oxygen saturation,
and adverse events. Blood will be drawn periodically for safety laboratory measurements,
plasma kinetics, lymphocyte subsets, C-reactive protein, and cytokines. Nasopharyngeal swabs
will be collected to measure viral load. Participants will be monitored for 14 days after
administration of the last dose (Day 28) and followed through Day 57.
[/INST]
The primary objectives of this study are to evaluate the safety, tolerability, and efficacy
of BGE-175 in participants ≥ 50 years of age hospitalized with documented COVID-19.
</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 - GINAKIT[/INST]
This research study is for patients that have a cancer called Neuroblastoma that has either
come back after treatment or did not respond to the standard medicines used to treat it. This
study combines two different ways of fighting cancer: antibodies and Natural Killer T cells.
Antibodies are types of proteins that protect the body from infectious diseases and possibly
cancer. T cells, also called T lymphocytes, are special infection-fighting blood cells that
can kill other cells, including cells infected with viruses and tumor cells. Both antibodies
and T cells have been used to treat patients with cancers. The investigators have found from
previous research that they can put a new gene into T cells that will make them recognize
cancer cells and kill them. In a previous clinical trial, the investigators made a gene
called a chimeric antigen receptor (CAR), from an antibody called 14g2a that recognizes GD2,
a molecule found on almost all neuroblastoma cells (GD2-CAR). They put this gene into the
patients' own T cells and gave them back to patients that had neuroblastoma. Nineteen
patients were treated on that study and there were no long term side-effects seen after the
GD2 T cell infusion. As the investigators have followed the patients over time, they noticed
that for those patients with disease at the time of their infusion, the time to progression
(the amount of time it takes before their neuroblastoma got worse) was longer in those whom
they could find GD2 T cells in the blood for more than 6 weeks after the last T cell
infusion. Because of this, the investigators think that if effector cells are able to last
longer, they may have a better chance of killing neuroblastoma tumor cells.
Natural Killer T cells are a special subset of innate lymphocytes that can effectively go
into tumor tissues of neuroblastoma. Inside the tumor, there are certain white blood cells
which help the cancer cells to grow and recover from injury. Natural Killer T-cells can
specifically kill these cells. In this study, Natural Killer T cells will be genetically
engineered to express GD2-CAR to attack neuroblastoma cells and the white blood cells inside
the tumor tissue.
</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 - RACE (Long-Term Ext.)[/INST]
This study is a long-term, open-label study using NPSP558 for the treatment of adult patients
with Hypoparathyroidism.
</s> |
<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>>
This research study is a Phase II clinical trial. Phase II clinical trials test the safety
and effectiveness of an investigational intervention to learn whether the intervention works
in treating a specific disease. "Investigational" means that the intervention is being
studied.
The FDA (the U.S. Food and Drug Administration) has approved Neratinib as a treatment for
breast cancer. Fulvestrant has been FDA approved for treatment of metastatic hormone receptor
positive breast cancer.
The purpose of this research study is to determine how well neratinib, by itself or together
with Fulvestrant, works in treating breast cancer that has spread to other parts of the body.
Neratinib is a recently discovered oral drug that may stop breast cancer cells from growing
abnormally by inhibiting (or blocking) members of a family of proteins that include Human
Epidermal Growth Factor Receptor 2 (HER2).
Neratinib has been used in other research studies and information from those other research
studies suggests that neratinib may help to shrink or stabilize HER2-positive breast cancer
in this research study.
[/INST]
This research study is studying a drug called Neratinib with and without Fulvestrant as
possible treatments for HER2-positive breast cancer .
The interventions involved in this study are:
- Neratinib and Fulvestrant
- Neratinib alone
</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 - Dose Finding[/INST]
This is a four-way crossover (non-parallel) study with each subject receiving three of the
four arms. The study will enroll approximately 30 adult subjects with T2DM from age 20 to 75
inclusive.
Following a 7-10 day Screening period, eligible subjects will enter a 3-day single-blind
placebo run-in. On Day 4, each subject will be randomized to a treatment sequence that will
include three treatment assignments for each of three treatment Periods according to the
randomization scheme.
</s> |
<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>>
All patients who fulfill the eligibility criteria for this trial , will initiate at least one
treatment course of ofatumumab, and depending of subsequent worsening in disease activity
will be eligible to received further treatment through the 156 week treatment period: a
maximum of a further 8 treatment courses will be given at individualized time intervals . The
interval between each treatment course will be at least 16 weeks with the last treatment
course given no later than week 130 after baseline (Visit 2A).
After each treatment course the patients will attend their next trial visit 8 weeks after
Infusion 1, followed by trial visits every 4 weeks up to Week 24, and subsequently every 8
weeks until the next treatment course.
After completing the Treatment Period or after withdrawing from the Treatment Period
prematurely patients will be followed every 12 weeks (Follow-up Period) until CD19+ cells
&/or IgG levels have returned to baseline or normal levels.
[/INST]
A 3-year open-label trial for patients who previously participated in Trial Hx-CD20-403 and
who fulfill the eligibility criteria for this trial (GEN413) . Th e primary purpose of the
trial is to evaluate the long-term effectiveness of repeated courses ( a maximum of 9
treatment courses) of ofatumumab in RA patients who previously received ofatumumab or placebo
in Trial Hx-CD20-403.
</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. Venofer (China)[/INST]
The primary objective is to demonstrate the efficacy of ferric carboxymaltose (FCM) given in
a simple dosing regimen in correcting iron deficiency anaemia (IDA), by demonstrating
non-inferiority to treatment with the currently approved intravenous (IV) iron therapy of
iron sucrose (IS, Venofer™) in the Chinese population. The secondary objectives are to assess
the safety of FCM compared to IS in the Chinese population and to evaluate the effect of FCM
compared to IS on relevant laboratory parameters (haematology, chemistry, iron parameters) in
the Chinese population.
</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 - Open Label[/INST]
This study will evaluate the safety, tolerability and efficacy of VX-880 infusion in
participants with Type 1 diabetes mellitus (T1D) and impaired awareness of hypoglycemia (IAH)
and severe hypoglycemia.
</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 further evaluates the efficacy of bermekimab in treating moderate to severe
hidradenitis suppurativa in adults. 1/3 of patients will receive weekly injections of
bermekimab, 1/3 will receive alternating every other week injections of bermekimab or
placebo, and 1/3 will receive weekly injections of placebo.
</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 144 (Pediatric)[/INST]
The primary objective of this study is to evaluate the antiviral efficacy of tenofovir
disoproxil fumarate (tenofovir DF; TDF) versus placebo in pediatric population (aged 2 to <
12 years at the time of enrollment) with chronic hepatitis B (CHB) infection.
</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 - AWARD-10 (w/SGLT2 inhibitors)[/INST]
The main purpose of this study is to evaluate the efficacy and safety of the study drug known
as dulaglutide when added to sodium-glucose co-transporter 2 (SGLT2) inhibitors in
participants with type 2 diabetes mellitus.
</s> |
<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>>
This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled study to
evaluate the efficacy and safety of imsidolimab in adolescent and adult participants with
acne vulgaris (AV). This study also will characterize the pharmacokinetic (PK) profile of
imsidolimab and explore the immune response to imsidolimab in participants with AV.
[/INST]
Efficacy and Safety of Imsidolimab in Participants with Acne Vulgaris
</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 - 19519[/INST]
The main purpose of this study is to investigate how quickly and to what extent BAY1817080 is
absorbed (taken up), distributed, metabolized (broken down) and eliminated from the body
(this is called pharmacokinetics). The pharmacokinetics of BAY1817080 administered as tablets
will be compared to the pharmacokinetics of BAY1817080 administered as intravenous (iv; in
the vein) infusion (this is called absolute bioavailability). Furthermore, 2 different types
of tablets with BAY1817080 (Formulation A and Formulation B) will be compared with regard to
pharmacokinetics (this is called relative bioavailability). The effect of a meal on the
pharmacokinetics of BAY1817080 administered as tablets will be investigated as well. Finally,
it will also be investigated how safe BAY1817080 is and how well BAY1817080 is tolerated.
</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 - 001 (PAD/DFU)[/INST]
This clinical study is being conducted to assess the safety and determine the maximum
tolerated dose (MTD) of PDA-002 [human placenta-derived cells] administered into the lower
leg muscles of subjects with peripheral arterial disease and diabetic foot ulcers. It will
look to see if PDA-002 helps reduce some of the symptoms of PAD and/or improves ulcer
healing. This study will also help to find the best dose of PDA-002 to use in future studies.
</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 - Flexible-Dose (7-17yrs)[/INST]
The goal of the current study is to determine efficacy and safety of once-weekly aripiprazole
in reducing Total Tic Severity (TTS) score in children and adolescents with Tourette's
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 Ib/II - w/Cytarabine[/INST]
This study will assess the safety and efficacy of vismodegib in patients with
relapsed/refractory acute myelogenous leukemia (AML) and relapsed/refractory high-risk
myelodysplastic syndrome (MDS). Patients in Cohort 1 will receive single-agent vismodegib 150
mg orally daily. In Cohort 2, patients will receive vismodegib 150 mg orally daily in
combination with cytarabine 20 mg subcutaneously for 10 days.
Anticipated time on study treatment is until disease progression, intolerable toxicity, or
patient withdrawal of consent.
</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/Gemcitabine + Nab-paclitaxel[/INST]
This is a Phase Ib/II, open-label, multi-center, competitive enrollment and dose escalation
study of ALT-803 in combination with gemcitabine and nab-paclitaxel in patients with advanced
pancreatic cancer in conjunction with gemcitabine and nab-paclitaxel.
</s> |
<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>>
This is a four-part Phase 2b study comprised of a 16-week, double-blind, placebo-controlled,
Induction Period, a 12-week double-blind, placebo-controlled, Maintenance Period, a 24-week,
Open-label Period and a post-treatment 28 week observational safety follow-up period designed
to evaluate the short-term efficacy and the short- and long term safety of brazikumab in
participants with moderate to severe, active Crohn's disease (CD) who have failed or are
intolerant to anti-TNFα therapy as determined by the Investigator.
[/INST]
A Phase 2b study to evaluate the efficacy and safety of brazikumab (MEDI2070) in participants
with moderate to severe Crohn's disease who have failed or are intolerant to anti-tumor
necrosis factor-alpha (anti-TNFα) 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 - BC-CO-2[/INST]
Current therapies for metastatic or unresectable Colon Cancer provide very limited benefit to
the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove
beneficial in the treatment of metastatic or unresectable Colon Cancer.
PURPOSE: This study is being performed to determine the effects (good and bad) that
Antineoplaston therapy has on patients with metastatic or unresectable Colon 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 - KIDS A-LONG (Pediatric)[/INST]
The primary objective of the study is to evaluate the safety of Recombinant Coagulation
Factor VIII Fc Fusion Protein (rFVIIIFc) in previously treated pediatric subjects with
hemophilia A. Secondary objectives of this study in this study population are as follows: to
evaluate the efficacy of rFVIIIFc for prevention and treatment of bleeding episodes; to
evaluate and assess the pharmacokinetics (PK) of rFVIIIFc; and to evaluate rFVIIIFc
consumption for prevention and treatment of bleeding episodes.
</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[/INST]
This was a study to determine whether therapy with pazopanib was effective and safe in women
with epithelial ovarian, fallopian tube, or primary peritoneal cancer whose cancer had not
progressed on first line chemotherapy.
</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 - ARDENT[/INST]
Phase 1/2 dose escalation study to assess the safety and tolerability of ARV-110 in men with
mCRPC who have progressed on prior approved systemic therapies for their castrate resistant
disease (one of which must be enzalutamide or abiraterone).
</s> |
<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>>
OBJECTIVES:
Primary
- To compare the progression-free survival of women with HER2/neu-positive metastatic
breast cancer treated with taxane-based chemotherapy in combination with lapatinib
ditosylate or trastuzumab (Herceptin®).
Secondary
- To compare the overall survival.
- To compare the time to CNS metastases at the time of first progression.
- To compare the incidence rates of CNS metastases at the time of progression.
- To compare the overall objective response rate (complete or partial response), time to
response, and duration of response in patients with measurable disease at baseline.
- To compare the clinical benefit response rate.
- To compare the adverse event profile.
- To compare the quality of life.
- To compare clinical outcomes using biomarker changes in biological samples.
- To compare health economics, including healthcare utilization and health utilities.
OUTLINE: This is a multicenter study. Patients are stratified according to prior
neoadjuvant/adjuvant anti-HER2/neu-targeted therapy (yes vs no), prior neoadjuvant/adjuvant
taxane chemotherapy (yes vs no), planned taxane therapy (paclitaxel vs docetaxel), and liver
metastasis (yes vs no). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive either paclitaxel IV on days 1, 8, and 15; treatment with
paclitaxel repeats every 4 weeks for 6 courses in the absence of disease progression or
unacceptable toxicity. Alternatively, patients may receive docetaxel IV on day 1;
treatment with docetaxel repeats every 3 weeks for 8 courses in the absence of disease
progression or unacceptable toxicity. Patients on docetaxel also receive filgrastim
(G-CSF) according to institutional standard. All patients receive oral lapatinib
ditosylate once daily during taxane treatment and continue after completion of taxane
treatment, in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive paclitaxel IV on days 1, 8, and 15 and trastuzumab (Herceptin®)
IV on days 1, 8, 15, and 22. Treatment repeats every 4 weeks for 6 courses in the
absence of disease progression or unacceptable toxicity. Alternatively, patients may
receive docetaxel IV and trastuzumab IV on day 1. Treatment repeats every 3 weeks for 8
courses in the absence of disease progression or unacceptable toxicity. After completion
of taxane chemotherapy and trastuzumab, all patients receive trastuzumab alone IV once
every 3 weeks in the absence of disease progression or unacceptable toxicity.
Formalin-fixed paraffin-embedded tissue samples are analyzed for ER, PgR, EGFR, CK5/6, Ki67,
and other molecular biomarkers by tissue microarray and immunohistochemistry.
Patients complete quality of life questionnaires (EORTC QLQ-C30 and a Trial Specific
Checklist) at baseline, every 12 weeks for 96 weeks, and then every 24 weeks until disease
progression.
After completion of study treatment, patients are followed at 4 weeks post treatment, and
then every 12 weeks thereafter (counting from the beginning of study therapy).
[/INST]
RATIONALE: HER2/neu is a receptor (protein) which is found in unusually high amounts in
approximately 1 in 5 cancer patients. Scientific evidence suggests that having high amounts
of the HER2/neu receptor is important for breast cancer to grow and spread. Women with
previously untreated metastatic breast cancer (breast cancer that has spread to other organs)
and with high levels of the HER2/neu receptor receive as their usual treatment chemotherapy
with one of the approved chemotherapy drugs paclitaxel or docetaxel (called "taxanes")
together with another approved drug called "trastuzumab". Chemotherapy drugs, such as
paclitaxel and docetaxel, work either by killing tumour cells or by stopping them from
dividing. Trastuzumab is an antibody that is given through a vein in the arm and it works by
specifically "targeting" the HER2/neu i.e. it attaches to it and "turns it off". Although
some of the patients who receive this taxane plus trastuzumab treatment feel better for some
months, the cancer usually starts to grow again. Lapatinib is a new drug. Like trastuzumab,
it also works by specifically "targeting" the HER2/neu receptor, but it does so in a
different way. Lapatinib is not an antibody. It is a pill that is taken daily by mouth.
Because lapatinib works in a different way than trastuzumab, it may be worse, as good as or
better than trastuzumab in keeping metastatic HER/neu positive cancer from growing. However,
this is not known.
Purpose: This randomized Phase III trial is comparing chemotherapy (a taxane) given together
with lapatinib with chemotherapy (a taxane) given together with trastuzumab in women with
HER2/neu positive breast cancer.
</s> |
<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>>
The trial will be conducted in 2 parts: an initial dose escalation phase of larotrectinib in
subjects with advanced solid tumors will be followed by an expansion phase in subjects with
solid tumors having a NTRK fusion.
The objectives of the study are to determine the safety, pharmacokinetic profile, recommended
dose and efficacy of orally administered larotrectinib in patients with NTRK fusions.
[/INST]
This research study is done to test the safety of the drug larotrectinib in adult cancer
patients. The drug may be used to treat cancer with a change in a particular gene (NTRK1,
NTRK2 or NTRK3), because it blocks the action of these genes in cancer cells. The study also
investigates how the drug is absorbed and processed in the human body. This is the first
study to test larotrectinib in humans with cancer, for whom no other effective therapy
exists.
</s> |
<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>>
MDCO-PCS-16-01 (ORION-3) was a Phase II, open-label, multicenter, non-randomized, active
comparator long term extension study. Total study duration was 4 years from first participant
enrolled to the last subject completed. The study consisted of three study periods:
Screening Period: Participants completing study MDCO-PCS-15-01 (ORION-1) were screened for
all inclusion and exclusion criteria of study ORION-3.
Treatment Period: Participants fulfilling all eligibility criteria of ORION-3 were enrolled.
Participants who received inclisiran in ORION-1 received inclisiran sodium throughout this
study up to 4 years (Group 1; Inclisiran-only arm), and participants who received placebo in
ORION-1 received evolocumab as open-label comparator up to Day 336, and then transitioned to
inclisiran on Day 360 and every 180 days thereafter for up to 4 years (Group 2; Switching
arm).
Safety follow up: Participants were followed up for safety during 4 weeks after the last dose
of study treatment. Including the Screening Period, the total study duration for a
participant was up to 4 years.
[/INST]
This clinical study was designed to assess the efficacy, safety, and tolerability of
long-term dosing of inclisiran and evolocumab given as subcutaneous injections in
participants with high cardiovascular risk and elevated low-density lipoprotein cholesterol
(LDL-C).
</s> |
<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>>
This is a Phase III, multi-center, double-blind, randomized, placebo-controlled, crossover
study to evaluate the efficacy of armodafinil at a dosage of 150 mg/day for the treatment of
cancer-related fatigue (CRF) in adult patients with multiple myeloma. The study consists of a
screening period, followed by a 56 day treatment phase, and a final assessment to occur 28
days after the end of the last treatment.
The screening period will occur within 14 days before baseline, where "baseline" refers to
day 1 when assessments will be made before drug administration. During this period, a medical
history will be obtained along with a complete physical examination including vital sign
measurements and Eastern Cooperative Oncology Group (ECOG) performance status. Clinical
laboratory tests including hematology, clinical chemistry (blood urea nitrogen [BUN], serum
creatinine, total bilirubin, alkaline phosphatase, aspartate aminotransferase [AST] and
alanine aminotransferase [ALT]), electrolytes (potassium, sodium, chloride and calcium),
random glucose, total protein, albumin, and urinalysis will also be performed during the
screening period as well as serum pregnancy tests for women of childbearing potential.
During the screening period, patients will also be assessed for the presence of
cancer-related fatigue using the International Classification for Disease Tenth Edition
(ICD-10) diagnostic criteria and the Brief Fatigue Inventory (BFI). Only those patients
showing evidence of cancer-related fatigue will be enrolled in the study. The criteria for
inclusion for any given patient consist of meeting the International Classification for
Disease Tenth Edition (ICD-10) criteria for cancer-related fatigue and a score ≥ 4 on the
BFI. ICD-10 CRF classification will be established using a standard interview guide.
Patients eligible for the study will be randomized to either receive armodafinil at an
initial fixed dosage of 150 mg/day (Group A) or a placebo (Group B) during the first 28 days
of the treatment phase. On day 29, patients randomized to receive placebo will then cross
over to receive armodafinil at a dosage of 150 mg/day until day 56. Group A patients
randomized to receive armodafinil will continue their current treatment with the drug until
day 56. The duration of the treatment phase is 56 days.
Assessments for CRF will be conducted on day 1 (baseline) prior to drug treatment, and after
drug administration on days 15, 28, 43, and 56. These assessments will be conducted as verbal
interviews, paper-and-pencil surveys, paper-and-pencil tests, and electronic tests as
appropriate per assessment.
During the treatment phase, each patient will also have clinical laboratory tests performed
on days 1, 15, 28, 43 and 56 to monitor for potential toxicity. Additional procedures
performed at these visits will include monitoring for adverse events, review of concomitant
medications and other support therapies (e.g., growth factors and transfusion), ECOG
performance status, vital signs measurements, and physical examinations.
Twenty-eight days after the last dose of study drug, patients are to complete a final
assessment (herein referred to as the end-of-treatment visit). Procedures to be conducted at
this visit include measurement of vital signs, a complete physical examination, assessment of
adverse events, a review of concomitant medications, assessment of ECOG performance status,
hematology and clinical chemistry laboratory tests including electrolytes, total protein and
albumin. Patients who withdraw from the study before the completion of the 56 day cycle will
still have all end-of-treatment assessments performed 28 days after their last dose of study
drug.
[/INST]
The purpose of this study is to evaluate the efficacy of armodafinil for the treatment of
cancer-related fatigue in adult patients with multiple myeloma. The study consists of a
screening period, followed by a 56-day treatment phase, and a final assessment to occur 28
days after the end of the last treatment.
</s> |
<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>>
Subjects 11-25 years of age will be randomized to receive either the meningococcal vaccine
GSK134612 or Menactra®. An additional non-randomized group of subjects aged 10 years (< 11
years of age) will be enrolled to receive meningococcal vaccine GSK134612 only (At the time
the study begun, Menactra® was only licensed in the United States for individuals above 11
years of age and therefore could not be used as a control vaccine in subjects less than 11
years old).
This study will be single-blind for the subjects 11 to 25 years of age and open for the
subjects 10 to < 11 years of age.
[/INST]
The purpose of the study is to characterize the safety and immunogenicity of 1 dose of GSK
Biologicals' meningococcal vaccine GSK134612 as compared to Menactra® in adolescents/adults
11-25 years of age.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep
2007.
The protocol posting has been updated following a protocol amendment.
</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 - PK (China)[/INST]
First-in-human study is conducted to assess the maximum tolerated dose (MTD) and
dose-limiting toxicity(DLT), safety and tolerability, pharmacokinetics (PK), and preliminary
anti-tumor activity of Theliatinib .
</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/PD-L1 Inhibitor[/INST]
This phase I/II trial studies the side effects of gene-modified immune cells (FH-MCVA2TCR)
and to see how well they work in treating patients with Merkel cell cancer that has spread to
other parts of the body (metastatic) or that cannot be removed by surgery (unresectable).
Placing a gene that has been created in the laboratory into immune cells may improve the
body's ability to fight Merkel cell 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 - Perfect 1[/INST]
Assessment of the efficacy and safety of CD5789 (trifarotene) 50μg/g cream applied once daily
for 12 weeks in subjects with acne vulgaris.
</s> |
<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>>
Patients should have received at least 6 and up to 8 cycles of the R-CHOP 14 or R-CHOP 21
regimen or 6 R-CHOP-14 or -21 completed by 2 Rituximab alone in accordance to local
preferences.
Patients can be registered to participate in the study at two time points:
- At time of initial diagnosis and study enrolment (signature of informed consent) before
the first cycle of treatment with R-CHOP.
- At randomization (signature of informed consent) after treatment in first line with
R-CHOP and have reached at least PR or CR.
Evaluation of the response to R-CHOP must be in accordance with Revised Response Criteria for
Malignant Lymphoma(2007).
Stratification: Before randomization, the patients will be stratified according to the
country and the response to R-CHOP (PR vs CR).
Randomization: Patients in CR/PR after R-CHOP will be randomized to maintenance therapy with
lenalidomide or placebo.
[/INST]
This study is designed as a phase III, randomized, double-blind, placebo-controlled trial to
explore the effect of maintenance therapy with lenalidomide versus placebo on
progression-free survival (PFS) in patients treated with R-CHOP responding to induction
therapy
For the primary efficacy variable, PFS, an improvement in median PFS from 38.6 months for
Treatment Arm B to 54 months for Treatment Arm A (corresponding to a 2-year PFS of 65% vs
73.6%), is considered clinically relevant.
</s> |
<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>>
This is a randomized, vehicle controlled, dose-ranging study enrolling subjects with axillary
hyperhidrosis and designed to assess the safety and efficacy of four doses of glycopyrrolate
compared to vehicle. There are 5 arms in this study.
Efficacy will be assessed through the Hyperhidrosis Disease Severity Score (HDSS),
Dermatology Life Quality Index (DLQI) and a gravimetric assessment of sweat production.
Safety will be assessed, at specified times during the study, through adverse events, local
skin responses, serum chemistry and hematology laboratory testing, ECGs, physical examination
and vital signs.
PK samples will be taken from 20 to 30 subjects participating in the study.
[/INST]
The purpose of this study is to evaluate the safety and efficacy of glycopyrrolate compared
to vehicle for the treatment of axillary hyperhidrosis.
</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 - R477-202[/INST]
This is a randomized, placebo-controlled, double-blind study to evaluate the efficacy,
safety, and pharmacodynamics (PD) of multiple doses of REMD-477 in subjects who have Type 1
diabetes and are currently receiving insulin treatment. This study will determine whether
REMD-477 can decrease daily insulin requirements and improve glycemic control after 12 weeks
of treatment in subjects diagnosed with Type 1 diabetes with fasting C-peptide < 0.7 ng/mL at
Screening.
The study will be conducted at multiple sites in the United States. Approximately 150
subjects with type 1 diabetes on stable doses of insulin will be randomized in a 1:1:1
fashion into one of three 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 I/II - w/Ionizing Radiation[/INST]
The purpose of this trial is to study A-dmDT390-bisFv(UCHT1) in combination with ionizing
irradiation for the treatment of stage IV melanoma, a disease that is essentially incurable
with median overall survival periods that range from 8-16 months.
</s> |
<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>>
Following completion of at least 1 week of study drug for all subjects in group 1, the
Sponsor will review the safety information of these subjects prior to enrolling off-treatment
subjects into the next dose group. Dose escalation will continue in this manner (unless
stopping criteria are met) until all groups have completed the study.
[/INST]
The purpose of this study is to explore the efficacy and safety of multiple, escalating doses
of ASP015K when compared to placebo in subjects with moderate to severe 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 - A23 (Early Symptomatic AD)[/INST]
This protocol is designed to serve as a pre-screening study for subjects who are potentially
eligible for Alzheimer's Disease (AD) therapeutic trials that require tau imaging for
inclusion by means of a flortaucipir F18 Positron Emission Tomography (PET) scan.
</s> |
<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>>
This study is a Phase 2, double-blind, randomized, placebo-controlled study to evaluate the
safety and efficacy of CTX-4430 administered once-daily for 48 weeks for treatment of CF. A
total of 195 pulmonary CF patients that meet all the inclusion and no exclusion criteria and
provide written informed consent will be randomized to receive 50 mg CTX-4430, 100 mg
CTX-4430, or placebo in a 1:1:1 ratio. Follow-up visits will be conducted approximately every
4 weeks from Week 4 to Week 52 (4 weeks after completion of treatment).
[/INST]
This study is a Phase 2, double-blind, randomized, placebo-controlled study to evaluate the
safety and efficacy of CTX-4430 administered once-daily for 48 weeks for treatment of CF.
</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 - SWORD-1[/INST]
A phase 1/2, first-in-human, open-label study to determine the safety, tolerability, PK, and
preliminary efficacy of the novel RET/SRC inhibitor TPX-0046 in adult subjects with advanced
or metastatic solid tumors harboring RET mutations or alterations. The study consists of
three portions: 1) Phase 1 Dose Escalation and Food Effect Sub-study, and 2) Phase 1 dose
expansion and 3) Phase 2 efficacy evaluation.
</s> |
<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>>
This was a randomized, double-blind, parallel-group, dose-finding study assessing the safety
and efficacy of three dose levels of CNS 7056 compared with midazolam in patients undergoing
diagnostic upper GI endoscopy.
Patients who met all study entry criteria and completed screening procedures were randomly
assigned to 1 of 4 treatment groups: CNS 7056 0.10 mg/kg,0.15 mg/kg, or 0.20 mg/kg; or
midazolam 0.075 mg/kg. Patients received their assigned treatment administered as a single
intravenous injection by a syringe driver over 1 minute. The endoscopy started when a
Modified Observer's Assessment of Alertness/Sedation (MOAA/S) score of ≤3 has been reached,
but no earlier than 90 seconds after Time 0 (the start of study drug injection). Rescue with
sedative medication (midazolam 1-2 mg) was be permitted at the discretion of the
administering physician.
Efficacy assessments consisted of the MOAA/S scores, Aldrete scores, and drowsiness measures
using a Visual Analogue Scale (VAS). Cognitive function was assessed by the Hopkins Verbal
Learning Test-Revised™ (HVLT-R™) and memory for the procedure by the Brice Questionnaire.
Safety assessments included adverse events, physical examinations, vital signs, ECGs, pulse
oximetry measurements, clinical laboratory tests, and pain on injection using a VAS.
[/INST]
The purpose of this study was to assess the safety and efficacy of CNS 7056 as a procedural
sedative at three dose levels compared to midazolam during a diagnostic upper GI endoscopy.
</s> |
<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>>
This is a placebo-controlled, double-blind, 2-period study in 3 sequential groups of 8
healthy subjects each. Subjects will be admitted on two occasions to the clinical research
center: Day -1 for 14 days and discharged on Day 13 and then re-admitted on Day 19 for 3 days
and discharged on Day 21. Subjects will fast after midnight on the day of each admission.
On Day 1 of study of the low-dose group (cohort 1), subjects will be randomized to a single
dose of 20 mg EPX-100 (N=6) or placebo (N=2) in the morning and then remain fasting for 4
hours after dosing. Safety will be assessed and blood samples will be obtained to calculate
PK at the following time points: 0, 0.5, 1, 2, 4, 6, 8, 12, 18, and 24 hours following the
first dose of EPX-100 or placebo. The subjects will remain in the study research center for
daily 8 AM (± 2 hours) blood samples for 5 consecutive days (Days 3 - 7; one blood sample per
day). On Days 8 - 11, subjects will be administered 20 mg EPX-100 or placebo twice daily
(BID) at least one hour prior to the morning meal and at least 2 hours after the evening meal
(approximately 12 hours apart). A single dose of 20 mg EPX-100 or placebo will be
administered on Day 12 in the fasting state and subjects will remain fasting for 4 hours
after dosing. Blood samples will be drawn at the following time points: 0, 0.5, 1, 2, 4, 6,
8, 12, 18, and 24 hours to determine multiple-dose PK. After a washout period of at least one
week following the last dose of EPX-100 or placebo, subjects will return to the clinical
research center on Day 19 and safety will be assessed. On Day 20, subjects will ingest a
high-fat morning meal over 30 minutes; thereafter, the subject will receive a single dose of
20 mg EPX- 100 or placebo at 30 minutes after the start of the meal. Blood samples will be
drawn at the following time points: 0, 0.5, 1, 2, 4, 6, 8, 12, 18, and 24 hours after the
administration of study drug to determine the PK of EPX-100 in the fed state. Once the 20 mg
dose level of EPX-100 is evaluated and the Safety Review Committee (SRC) determines it is
safe to escalate to the next dose level, subsequent groups of 8 subjects each will be
administered 40 mg (cohort 2) and 80 mg (cohort 3) (N=6 active drug, N=2 matching placebo)
EPX-100 and follow the same study procedures as the low-dose group (cohort 1).
Throughout the study period, subjects will undergo cardiac assessments, safety assessments,
and PK sampling.
[/INST]
This is a placebo-controlled, double-blind, 2-period study in 3 sequential groups of 8
healthy subjects each. The safety and pharmacokinetics of escalating single and multiple oral
doses of EPX-100 will be assessed in fasting healthy subjects and following a high-fat meal.
</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 - GRECO[/INST]
The purpose of the study is to assess functionality, performance, and reliability of an
single-use auto-injector (AI) with benralizumab administered subcutaneously (SC) in an
at-home setting reported by the patient or caregiver, and to confirm the safety and clinical
benefit of benralizumab administration in asthma patients with severe asthma
</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 - Healthy Elderly[/INST]
One dose of escalating strengths of an investigational influenza vaccine, VAX2012Q
(Quadrivalent Recombinant Hemagglutinin Seasonal Influenza Vaccine), will be evaluated for
safety and immunogenicity in healthy adults 65 to 75 years of age in this placebo-controlled
study.
</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 I/IIa study designed to evaluate ART4215, a new first-in-class
investigational medicinal product that is a potent and selective inhibitor of
deoxyribonucleic acid (DNA) polymerase (pol) theta. ART4215 is being developed as an oral
anti-cancer agent for monotherapy treatment of patients with cancers that harbor defects in
DNA repair and in combination with anticancer medicines that cause DNA damage.
[/INST]
This clinical trial is evaluating a drug called ART4215 in participants with advanced or
metastatic solid tumors. The main goals of this study are to:
- Find the recommended dose of ART4215 that can be given safely to participants alone and
in combination with talazoparib
- Learn more about the side effects of ART4215 alone and in combination with talazoparib
- Learn more about the effectiveness of ART4215 alone and in combination with talazoparib
- Learn more about the effectiveness of ART4215 alone and in combination with niraparib
</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 - CLI-037[/INST]
RATIONALE: Drugs used in chemotherapy, such as cytarabine and VNP40101M, work in different
ways to stop the growth of cancer cells, either by killing the cells or by stopping them from
dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.
PURPOSE: This randomized phase III trial is studying cytarabine and VNP40101M to see how well
they work compared to cytarabine alone in treating patients with relapsed acute myeloid
leukemia.
</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, three-arm, phase 1 dose escalation study and phase 2 study of BBI608
in combination with sorafenib, or BBI503 in combination with sorafenib. The study population
is adult patients with advanced hepatocellular carcinoma (HCC) who have not received systemic
chemotherapy.
The phase 1 portion will involve dose-escalation of BBI608 administered in combination with a
fixed starting dose of sorafenib (Arm 1), and dose escalation of BBI503 administered in
combination with a fixed starting dose of sorafenib (Arm 2). The fixed starting dose-level of
sorafenib for both arms will be 400 mg twice daily (800 mg total daily dose). Eligible
patients will be randomized to either Arm 1 or Arm 2.
The phase 2 portion will be an open-label, 3-arm, randomized trial of patients with advanced
HCC who have not received prior systemic treatment. Patients will be randomized to receive
either, Arm 1: sorafenib administered in combination with BBI608 (at the RP2D determined for
BBI608 plus sorafenib during the phase 1 portion); Arm 2: sorafenib in combination with
BBI503 (at the RP2D determined for BBI503 plus sorafenib during the phase 1 portion), or Arm
3: sorafenib alone at a starting dose of 400 mg twice daily. The starting dose for sorafenib
is the same for all study arms.
[/INST]
This is an open label, three-arm, phase 1 dose escalation study and phase 2 study of BBI608
in combination with sorafenib, or BBI503 in combination with sorafenib. The study population
is adult patients with advanced hepatocellular carcinoma who have not received systemic
chemotherapy.
</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 - w/Tocilizumab[/INST]
This is a two cohort, open-label, pilot study to describe the efficacy of administration
timing of tocilizumab on CART19 (CTL019) associated cytokine release syndrome safety events
in pediatric patients with CD19 expressing relapsed and refractory B-cell acute lymphoblastic
leukemia with high versus low pre-infusion tumor burden following redirected autologous T
cells transduced with the anti-CD19 lentiviral vector (CART19/CTL019).
</s> |
<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>>
This Phase 4, 12-week, single-arm, open-label, multi-center investigational efficacy and
safety study was conducted in subjects with severe inflammatory acne. Subjects who met the
inclusion criteria and none of the exclusion criteria at the Screening visit returned to the
clinic for baseline measures (Week 0) and to start treatment, which continued for up to 12
weeks.
Treatment consisted of 2 investigational study drugs:
- A/BPO 0.3%/2.5% gel applied to dry skin as directed by study staff once daily for 12
weeks, at night after washing.
- Doxycycline hyclate 200 mg: each subject was to take 2 50-mg tablets of doxycycline
hyclate in the morning and 2 at night, for a total of 4 tablets (a total of 200 mg)
daily for 12 weeks.
[/INST]
Demonstrate that a daily treatment regimen of adapalene 0.3%/benzoyl peroxide 2.5% gel + oral
Doxycycline 200 mg is effective and safe in severe inflammatory acne with 3 or fewer nodules
or cysts (non-nodulocystic) during a 12-week treatment period.
</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 (all the people know the identity of the intervention), single arm
(study will be conducted in a single group) clinical study, to evaluate the safety,
tolerability and efficacy of TMC435 along with pegylated interferon alpha-2a (PegIFNα-2a) and
ribavirin (RBV) triple therapy in adult chronic hepatitis C (CHC) genotype-1 infected
patients who are co-infected with human immunodeficiency virus-type 1 (HIV-1). The study
consists of 3 phases, screening phase (Week -6), treatment phase, and a follow-up phase (up
to 24 weeks). In the treatment phase, patients will be classified based on their experience
with previous hepatitis C virus (HCV) treatment as follows: 1) HCV treatment-naive (patients
who never received medication for the treatment of HCV); 2) prior HCV relapsers (patients who
received at least 24 weeks of a PegIFNα-2a and RBV-based therapy and relapsed within 1 year
after the last medication intake); and 3) prior HCV non-responders (can be further classified
as, null responders: patients having at least 1 prior documented course of PegIFNα-2a and RBV
therapy for at least 12 consecutive weeks; or partial responders: patients having at least 20
consecutive weeks which has not been discontinued due to intolerability to PegIFNα-2a and RBV
therapy). All patients will receive TMC435 once daily along with PegIFNα-2a and RBV for 12
weeks. Patients who are continuing treatment only with PegIFNα-2a and RBV will follow until
24 or 48 weeks. Pharmacokinetics will be measured after collection of blood samples. Safety
evaluations for adverse events, clinical laboratory tests, electrocardiogram, vital signs,
physical examinations, and specific toxicities will be performed throughout the study. The
total duration of treatment is approximately of 24 weeks.
[/INST]
The purpose of this study is to evaluate the safety and tolerability of TMC435 along with
pegylated interferon alpha-2a (PegIFNα-2a) and ribavirin (RBV) triple therapy in hepatitis C
virus genotype-1 infected subjects, co-infected with human immunodeficiency virus-type 1, and
to evaluate the number of patients with sustained virologic response (SVR) at 12 weeks after
the planned end of treatment.
</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, safety study designed to assess the multiple-dose pharmacokinetics and
potential for adrenal suppression following topical treatment with halobetasol propionate
0.05% spray applied twice-daily in adult patients with moderate to severe atopic dermatitis.
At least 40 eligible patients with atopic dermatitis that satisfy all eligibility criteria
will be enrolled into the study. Patients must be overall in good health and should have a
current diagnosis of moderate to severe atopic dermatitis with Investigator Global Assessment
(IGA) score of at least 3 or 4. Patients will be stratified by age with:
Cohort 1: At least 20 patients 18 years of age and older with ≥ 25% BSA affected.
Cohort 2: At least 20 patients 12-16 years and 11 months of age with ≥ 25% BSA affected.
Cohort 2 will initiate enrollment once all enrolled patients in Cohort 1 have completed the
study and a safety analysis has been reviewed by the Medical Monitor and approved by the
Novum Independent Institutional Review Board (NIIRB). Sites will not begin enrollment of
patients in Cohort 2 until the site is notified by email that the safety analysis for Cohort
1 has been reviewed and approved. Each cohort will be enrolled based on the availability of
patients. Each cohort will be reviewed for the potential of HPA axis suppression. The Medical
Monitor or NIIRB may discontinue the study at any time if safety concerns are found. If 6 or
more patients in Cohort 1 experience HPA axis suppression, then enrollment for Cohort 1 will
be stopped. Cohort 2 will not be initiated if 6 or more patients enrolled in Cohort 1
experience HPA axis suppression or 30% or more of the final enrolled number of patients in
Cohort 1 experience HPA axis suppression. If 6 or more patients in Cohort 2 experience HPA
axis suppression, then enrollment for Cohort 2 will be stopped. If the study is stopped at
any time, patients currently enrolled will be contacted via phone and instructed to
discontinue study product immediately. Patients will be instructed to return for their next
scheduled visit for cortisol response testing. Sites will follow up with patients and monitor
for HPA axis suppression. All patients will be followed until cortisol levels are normal, as
defined in study protocol. Patients enrolled in the study will apply the study product twice
daily onto the affected skin areas for 14 days (Days 1-14), according to provided
instructions. .Patients will be instructed not to rub over the affected area after
application of spray. Each patient is expected to receive 28 doses of study product. All
patients will attend the clinic for the following 8 scheduled visits. Patients will apply the
morning dose of the study product in the clinic at each clinic visit (and evening dose on Day
4) and at home during non-clinic visits. A phone call will be made approximately 14 days
after the patient has completed dosing to follow-up on any new adverse events that may have
occurred. All patients will have a cortisol response test performed at screening and on Day
17 (at least 48 hours after last dose of study product).
The safety profile of the test product will be evaluated by analysis of reported adverse
events.
[/INST]
This is an open-label, safety study designed to assess the multiple-dose pharmacokinetics and
potential for adrenal suppression following topical treatment with halobetasol propionate
0.05% spray applied twice-daily in adult patients with moderate to severe atopic dermatitis.
At least 40 eligible patients with atopic dermatitis that satisfy all eligibility criteria
will be enrolled into the study
</s> |
<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>>
Multinational, randomized, multicenter, open-label, Phase III study of 1093 participants (age
≥ 18 years) with histologically- or cytologically-confirmed, stage IV squamous-cell NSCLC,
who have received no prior therapy for metastatic disease, will be randomized on a 1:1 basis
to receive first-line necitumumab plus chemotherapy consisting of gemcitabine and cisplatin
in study Arm A, or gemcitabine-cisplatin chemotherapy alone in study Arm B. Baseline
radiographic assessment of disease will be performed within 21 days prior to randomization
(first treatment will be administered within 7 days following randomization). Participants
will undergo radiographic assessment of disease status (computed tomography or magnetic
resonance imaging) every 6 weeks (± 3 days), until there is radiographic documentation of
progressive disease (PD). Chemotherapy will continue for a maximum of six cycles in each arm
(or until there is radiographic documentation of PD, toxicity requiring cessation, protocol
noncompliance or withdrawal of consent); participants in Arm A only will continue to receive
necitumumab until there is radiographic documentation of PD, toxicity requiring cessation,
protocol noncompliance, or withdrawal of consent.
After the end-of-study-visit (following PD), follow-up information regarding further
anticancer treatment and survival will be collected every 2 months (± 7 days). For
participants who discontinue study for reasons other than PD (eg, symptomatic deterioration),
information on disease progression will also be collected until PD is documented. Follow-up
will continue as long as the participant is alive, or until the end of the trial.
[/INST]
The research study is testing the investigational drug necitumumab (IMC-11F8) in the
treatment of advanced non-small cell lung cancer. The aim of this study is to determine if
necitumumab, given together with a standard chemotherapy combination consisting of cisplatin
and gemcitabine will be more effective in improving participant disease than the standard
chemotherapy combination alone.
</s> |