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<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>>
This is a study to assess the antitumor activity of zolbetuximab, an Immunoglobulin (IgG1)
chimeric monoclonal antibody directed against CLDN18.2, in subjects with recurrent locally
advanced or metastatic gastric or gastroesophageal junction adenocarcinoma and locoregional
gastric or GEJ adenocarcinoma whose tumors are CLDN18.2 positive. For each cohort, the study
consists of the following periods: pre-screening; screening; treatment; and follow-up for
disease progression (or post-treatment follow-up for disease recurrence, which will be
conducted for Cohort 5). In addition, there will be a survival follow-up period for Cohorts
1A, 4B, and 5 participants only. Tolerability of zolbetuximab in combination with
pembrolizumab in Japanese participant(s) will be evaluated in Cohort 3A DLT assessment.
Tolerability of zolbetuximab in combination with mFOLFOX6 and nivolumab in Japanese
subject(s) will be evaluated in Cohort 4B, if Japanese subjects are not enrolled in the
Cohort 4A DLT assessment.
[/INST]
The purpose of this study is to determine the Objective Response Rate (ORR) of zolbetuzimab
as a single agent as assessed by an independent central reader. This study will also assess
the ORR and Progression Free Survival (PFS) of zolbetuximab in combination with mFOLFOX6
(with or without Nivolumab) and in combination with pembrolizumab, assess the safety and
tolerability, assess the effects on CLDN18.2 expression and assess the immunogenicity and
immunomodulatory effects of zolbetuximab as a single agent and in combination with mFOLFOX6
(with or without Nivolumab) and in combination with pembrolizumab and in combination with
fluorouracil, leucovorin or folinic acid, oxaliplatin and docetaxel (FLOT). This study will
also evaluate the pharmacokinetics (PK) of zolbetuximab as a single agent and in combination
with mFOLFOX6 (with or without Nivolumab) and in combination with pembrolizumab and in
combination with fluorouracil, leucovorin or folinic acid, oxaliplatin and docetaxel (FLOT)
and PK of oxaliplatin, fluorouracil (5-FU), and pembrolizumab in combination with
zolbetuximab, evaluate health-Related Quality of Life (HRQoL), evaluate the Disease Control
Rate (DCR), Duration of Response (DOR), PFS of zolbetuximab as a single agent, in combination
with mFOLFOX6 (with or without Nivolumab) and in combination with pembrolizumab based on both
investigator and independent central reader assessment, assess Overall Survival (OS) of
zolbetuximab as a single agent and in combination with mFOLFOX6 and nivolumab and in
combination with FLOT.
</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 - INSIGHT 2[/INST]
This study will assess the antitumor activity, safety, tolerability, and pharmacokinetics
(PK) of the Mesenchymal-epithelial Transition Factor (MET) inhibitor tepotinib combined with
the 3rd generation EGFR inhibitor osimertinib in participants with advanced or metastatic
non-small cell lung cancer (NSCLC).
</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 - Advanced Cancers[/INST]
This is a Phase 1, open-label, multi-center, first time in human study of AMP-224 in adult
patients with cancer that is not responding to standard therapy. This study will be conducted
in two stages consisting of a Dose-Escalation stage and an Expansion Stage.
</s> |
<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>>
A Randomized, Double-Blind, Parallel-Group, 52-Week, Chronic-Dosing, Multi-Center Study to
Assess the Safety and Tolerability of PT010, PT009 and PT003 in Subjects with Moderate to
Very Severe Chronic Obstructive Pulmonary Disease
[/INST]
Study to Assess the Safety and Tolerability of PT010, PT009 and PT003 in Subjects with
Moderate to Very Severe Chronic Obstructive Pulmonary Disease
</s> |
<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>>
JAVELIN Ovarian PARP 100 (B9991030) is an open-label, international, multi-center, randomized
study designed to evaluate the efficacy and safety of avelumab in combination with
chemotherapy followed by maintenance therapy of avelumab in combination with talazoparib
versus an active comparator in treatment-naïve patients with locally advanced or metastatic
ovarian cancer (Stage III or Stage IV). The primary endpoint is progression-free survival
(PFS) as determined based on blinded independent central review (BICR) assessment per RECIST
v1.1.
On March 19, 2019, Sponsors alliance announced the discontinuation of the ongoing Phase III
JAVELIN Ovarian PARP 100 study. The alliance has notified health authorities and trial
investigators of the decision to discontinue the trial. The decision was based on several
emerging factors since the trial's initiation, including the previously announced interim
results from JAVELIN Ovarian 100 study (B9991010), which was stopped due to futility of
efficacy at a planned interim analysis on 21 December 2018. The alliance determined that the
degree of benefit observed with avelumab in frontline ovarian cancer in that study does not
support continuation of the JAVELIN Ovarian PARP 100 trial in an unselected patient
population and emphasizes the need to better understand the role of immunotherapy in ovarian
cancer. Additional factors include the rapidly changing treatment landscape and the approval
of a PARP inhibitor in the frontline maintenance setting. The decision to discontinue the
JAVELIN Ovarian PARP 100 trial was not made for safety reasons.
Patients who remain in the study will continue receiving investigational products according
to their randomized treatment assignment and will be monitored for appropriate safety
assessments until treatment discontinuation.
[/INST]
JAVELIN Ovarian PARP 100 (B9991030) is an open-label, randomized study designed to evaluate
the efficacy and safety of avelumab in combination with chemotherapy followed by maintenance
therapy of avelumab in combination with talazoparib versus an active comparator in
treatment-naïve patients with locally advanced or metastatic ovarian cancer (Stage III or
Stage IV). On March 19, 2019, Sponsors alliance announced the discontinuation of the ongoing
Phase III study, and the decision was based on several factors, including previous announced
interim results from JAVELIN Ovarian 100 study (B9991010). Patients who remain in B9991030
study will continue receiving their randomized treatment assigned and will be monitored for
appropriate safety assessments until treatment discontinuation.
</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 - Multiple Dosing Regimens (NIAID)[/INST]
The goal of this Phase 2 trial is to evaluate the immune response to and safety profile of
various doses/formulations/and schedules of administration of PXVX0317 in healthy adults.
Primary Objective:
To assess the immune response to the vaccine
Secondary Objectives:
To assess the kinetics of the immune response to different doses/formulations/schedules To
assess the persistence of immune responses to different doses/formulations/schedules To
assess the effect of a booster dose of the vaccine
Safety Objective:
To assess local and systemic reactions to the vaccine and to describe the safety profile of
the vaccine
</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 - NP39596 (w/Meropenem)[/INST]
This is a non-randomized, open-label, one-treatment, one group study in participants with
complicated urinary tract infection (cUTI) including pyelonephritis to characterize the
pharmacokinetics of RO7079901 co-administered with meropenem.
</s> |
<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>>
In the single-blind run-in (RI) period, rilonacept 320 mg (or 4.4 mg/kg in pediatric
participants ≥12 and <18 years old) subcutaneous (SC), followed by 160 mg (or 2.2 mg/kg in
pediatric participants ≥12 and <18 years old) injections once weekly.
During the Randomized-Withdrawal (RW) period, eligible participants are randomized 1:1 to
double-blinded administration of study drug:
- Rilonacept 160 mg (or 2.2 mg/kg in pediatric participants ≥12 and <18 years old) SC
injections once weekly
- Matching placebo SC injections once weekly.
Participants with pericarditis recurrence who meet the protocol criteria for bailout
rilonacept (report at least 1 day with pericarditis pain ≥4 on the 11-point numerical rating
scale (NRS) and have 1 C-reactive protein (CRP) value ≥ 1 mg/dL [either on the same day or
separated by no more than 7 days]) receive bailout rilonacept (2 open-label injections of 160
mg rilonacept [or 4.4 mg/kg for pediatric subjects]) irrespective of randomized treatment
assignment and as soon as at least 5 days have passed since the last study drug injection.
Upon completion of the RW period (i.e., when the prespecified number of primary efficacy
endpoints [clinical events committee-confirmed pericarditis recurrence] events have
occurred), all participants who did not discontinue study drug have an option to continue
treatment with open-label rilonacept in the Long-Term Extension (LTE) or to withdraw from the
study. Participants still in the RI period at the time that the RW period has ended and the
LTE is opened will have the option to enter the LTE directly when they have completed the RI
period and have met the definition of clinical response or to withdraw from the study.
[/INST]
The primary objective of this study was to assess the efficacy of rilonacept treatment in
participants with recurrent pericarditis.
</s> |
<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>>
Phase 1, double-blind, randomized, placebo-controlled clinical trial in healthy and HCV
genotype 1 infected adults to evaluate safety, tolerability, antiviral activity and
pharmacokinetics of ABT-333.
[/INST]
The purpose of this study is to assess the safety, tolerability, pharmacokinetics of ABT-333
in healthy volunteers and the antiviral activity in HCV infected subjects.
</s> |
<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase I/II[/INST]
This trial will test the safety and efficacy of CF102 in patients with advanced liver cancer.
Successive groups of patients will be given higher doses of CF102 by mouth on a twice-daily
basis. Treatment will be assessed for adverse effects and for effects on the tumor.
</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[/INST]
ICT-107 consists of dendritic cells, prepared from autologous mononuclear cells that are
pulsed with six synthetic peptides that were derived from tumor associated antigens (TAA)
present on glioblastoma tumor cells. This is a Phase 3 study to evaluate ICT-107 in patients
with newly diagnosed glioblastoma. Subjects will be randomized to receive standard of care
chemoradiation (temozolomide (TMZ) with either ICT-107 or a blinded control. Reinfusion with
the pulsed dendritic cells should stimulate cytotoxic T cells to specifically target
glioblastoma tumour cells.
</s> |
<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase III - IT-R-006[/INST]
The purpose of this study is to evaluate the safety profile and the treatment effect of
Isolagen TherapyTM compared with placebo when administered to bilateral nasolabial fold
wrinkles.
</s> |
<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>>
Emerging evidence shows that many breast cancers with triple negative and basal like features
have infiltration by mononuclear cells and lymphocytes. Irrespective of the entity of tumor
infiltration by mononuclear cells, expression of immune regulatory checkpoints such as PD-1
and its ligand B7-H1 (or PD-L1) negatively affect the results of treatments. These data
suggest that a subset of patients have an ongoing immune response within the tumor
micro-environment, and that PD-L1 expression is an adaptive method of tumor resistance to
tumor infiltrating lymphocytes, which in turn are needed for response to chemotherapy.
Overall, the data suggests a role for immune regulation of response to chemotherapy, and
support the concept that blockade of immune check-points may favor the achievement of durable
response by immune mechanisms themselves, and in combination with classical chemotherapy.
MPDL3280A (atezolizumab) is a human monoclonal antibody containing an engineered Fc-domain to
optimize efficacy and safety that targets PD-L1 and blocks binding of its receptors,
including PD-1 and B7.1. Based on these considerations, we plan to conduct a study of the
combination of abraxane and carboplatin with or without PDL1-directed antibody in women with
locally advanced breast cancer suitable for neoadjuvant therapy with the aim to improve
event-free survival
[/INST]
This study that aims to evaluate the addition of MPDL3280A (atezolizumab) to carboplatin and
nab-paclitaxel in patients with early high-risk and locally advanced triple negative breast
cancer. compared to the control arm of carboplatin and abraxane. Half of participants will
receive MPDL3280A in combination with carboplatin and abraxane, while the other half will
receive only carboplatin and abraxane.
</s> |
<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>>
In each arm, patients underwent three monthly loading doses (at Baseline, Week 4, and Week
8). From Week 8, after the patient had received their third injection of study treatment, the
visit intervals were determined by the patient's disease activity. If any of the
protocol-specified signs of disease activity were present in the study eye, the subsequent
injection visit interval was kept at 4 weeks. If none of the signs were present, the
subsequent injection interval was extended by 2-week increments up until a maximum of
12-weekly intervals was reached. If there were any signs of disease activity in the study
eye, the treatment interval was reduced as specified in the protocol. The planned individual
duration of study participation was 24 months.
[/INST]
The purpose of this study was to compare the development of new geographic atrophy in
patients with wet Age-related Macular Degeneration (AMD) when treated with either ranibizumab
or aflibercept over 24 months. Geographic atrophy is an advanced form of AMD that can result
in the progressive and irreversible loss of visual function over time.
</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 - BOLERO-4 (ER+; w/letrozole)[/INST]
The purpose of this study was to assess the efficacy and safety of first-line treatment with
everolimus plus letrozole in postmenopausal women with estrogen receptor-positive (ER+),
human epidermal growth factor receptor 2 negative (HER2-) locally advanced or metastatic
breast cancer.
Moreover, the study also aimed to investigate the efficacy and safety of second line
treatment with everolumus plus examestane in participants whose disease progressed during
everolimus plus letrozole therapy.
</s> |
<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>>
The SUNRISE study is a prospective, multi-center, double-blind, randomized,
placebo-controlled trial in subjects aged 12.0 to <41.0 years diagnosed with T1D, as defined
by American Diabetes Association (ADA) criteria, and within 5 years of diagnosis. Time of
diagnosis is defined as the first day of insulin administration. Subjects will be stratified
by duration (zero up to 1 year and 1 year up to five years) to ensure balance of disease
duration across treatment and placebo groups in each strata. For analytical purposes, all
subjects12-<41 will be considered cohort A, subjects aged 12-<18 will considered cohort B and
subjects aged 18-<41 will be considered cohort C. For subjects aged 12-<18 (Cohort B), dosing
will be staggered with an initial 6 subjects aged 14-<18 being enrolled with the last subject
a having a minimum of 2 injections with at least 1 week follow-up after the 2nd injection.
Safety data from this cohort will be evaluated before opening the study to subjects 12 and
older. Subjects should be randomized no sooner than 6 weeks after diagnosis, unless glycemic
range is adequately controlled as confirmed by time in glycemic range (70-180 mg/dL) >55% by
CGM recording over 3 or more consecutive or non-consecutive days. Screening assessments will
include a physical examination, a fundoscopic photograph, chemistry and hematology safety
labs, urinalysis, 24-hour urine protein and creatinine, HbA1c, presence of T1D antibodies,
and a 4-hour MMTT. Approximately 99 qualified subjects who meet all selection criteria will
be randomized in a 2:1 ratio to treatment with TOL-3021 or placebo and treated for 52 weeks.
Study drug treatments will be administered via an IM injection into a large muscle every week
for 52 weeks. Continuous glucose monitoring (CGM) will be initiated within 5 days prior to
the screening MMTT visit and continued through Week 52. Subjects will agree to diabetes
management during the study with the goal of maintaining HbA1c levels of approximately 7.0%
without frequent episodes of hypoglycemia.
[/INST]
The study is a prospective, randomized, 52-week double-blind, placebo-controlled, multicenter
trial in subjects with T1D followed by a 2-year safety follow-up.
</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 - Study 105 (SPARTA-II)[/INST]
Part A Primary Objective To determine the safety of six months of PRTX-100 administration.
Part B Primary Objective To obtain antisera from normal volunteers that have developed
anti-PRTX-100 antibodies.
Secondary Objective(s) To assess rheumatoid arthritis activity during the period of PRTX-100
treatment To evaluate the development of anti-PRTX-100 antibodies To explore feasibility of
joint evaluations with ultrasound To explore feasibility of biomarkers as disease markers
</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 - EPOCH 2 (Herniorrhaphy)[/INST]
This is a Phase 3, randomized, double-blind, saline placebo- and active-controlled,
multicenter study to evaluate the analgesic efficacy and safety of HTX 011 administered via
local administration into the surgical site in subjects undergoing unilateral open inguinal
herniorrhaphy.
</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 - Adults[/INST]
The study will consist of a Screening period (up to 14 days), a Treatment period, and a
Follow-Up period. Sixteen subjects will be enrolled into two sequential dose cohorts - 10 or
30 mg (or matching placebo) across four study centers.
</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 - POLARIS-3[/INST]
The primary objective of this study is to evaluate the efficacy, safety, and tolerability of
treatment with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed-dose combination (FDC)
for 8 weeks and of treatment with sofosbuvir/velpatasvir (SOF/VEL) FDC for 12 weeks in
participants naive to direct-acting antivirals (DAA) with chronic genotype 3 hepatitis C
virus (HCV) infection and cirrhosis.
</s> |
<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>>
The primary objective is to determine the noninferiority in the early clinical response rate
of 6 day oral TR-701 FA compared with that of 10-day oral linezolid treatment at the 48-72
Hour Visit in the ITT analysis set in patients with ABSSSI.
[/INST]
This is a randomized, double-blind, double dummy, multicenter Phase 3 study of oral TR-701 FA
200 mg once daily for 6 days versus oral Zyvox® (linezolid) 600 mg every 12 hours for 10 days
for the treatment of ABSSSI in adults.
Approximately 75 to 100 sites globally will participate in this study. Patients with an
ABSSSI caused by suspected or documented gram positive pathogen(s) at baseline will be
randomized 1:1 to study treatment
</s> |
<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>>
The master screening protocol is MK-3475-U01 (KEYMAKER-U01) - NCT04165798
[/INST]
The purpose of this study is to assess the efficacy and safety of pembrolizumab (MK-3475) in
combination with boserolimab (MK-5890), MK-4830, MK-0482 in participants with advanced
squamous or non-squamous NSCLC that have been previously treated with anti-PD-L1 therapy.
This study is one of three pembrolizumab substudies being conducted under one pembrolizumab
umbrella master protocol (MK-3475-U01/KEYMAKER-U01).
</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 - SPARC[/INST]
This is a prospective, randomized, open-label, phase II trial of cabozantinib in subjects
with untreated, high risk prostate cancer undergoing radical prostatectomy. This multicenter
study will enroll 30 subjects. Duke is the lead site for this trial. There will be a second
site selected TBD.
Patients will be assigned (first 9 subjects only) or randomized 2:1 to either: (1)
cabozantinib 40 mg by mouth daily for 4 weeks, followed by a 2 week drug washout period
before prostatectomy (n = 20), or (2) immediate prostatectomy within 12 weeks of registration
(n = 10). The first 9 subjects (6 subjects assigned to cabozantinib treatment, 3 subjects
assigned to immediate prostatectomy) will constitute the Safety Lead-In Cohort, which will be
only accrued at Duke. After six subjects have received cabozantinib and completed the 57-85
day safety visit without triggering a stopping rule, subjects may be accrued at the ex-Duke
site.
The primary goal is to compare pathologic apoptotic indices (cleaved caspase-3) in
prostatectomy specimens from patients who undergo immediate prostatectomy (controls) versus
those who receive with cabozantinib followed by prostatectomy. The secondary objective is to
conduct immune phenotypic profiling on the peripheral blood and tumor microenvironment in
prostatectomy specimens from both groups. A statistical analysis will be used to compare the
apoptotic indices between the two 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 III - COACT-2[/INST]
This is a phase 3, randomized, controlled, blinded, multicenter study conducted in 3 parallel
cohorts of diabetic patients with at least 1 infected foot ulcer. Patients will be randomized
to receive 1 of 3 study treatments; systemic antibiotic therapy and standard ulcer care with
either (A) daily application of a gentamicin-sponge, (B) daily application of a
placebo-sponge or (C) no-sponge, in the ratio 2:1:1. Patients will be treated for
approximately 28 days and return to the clinic weekly for safety and efficacy assessments.
After completing treatment, patients will return to the clinic for scheduled follow-up visits
approximately 10, 30, 60 and 90 days after treatment is stopped.
</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 - X052171[/INST]
The study will evaluate the long-term safety of gevokizumab in treating active PG ulcers
</s> |
<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>>
This primary objective of this Phase 1/2 study is to evaluate the DLT and MTD of escalating
oral doses of ABT-751 given BID (twice daily) on Day 1 of each cycle for 7 days in
combination with carboplatin given on a 21-day schedule. The carboplatin dose is fixed at AUC
6 and will be administered on Day 4 during the first cycle to facilitate the pharmacokinetic
analysis. During the subsequent cycles both agents will be administered on Day 1. ABT-751 is
administered at the following dose levels using the Simon rapid dose escalation model: 100,
mg, 125 mg, 150 mg, 175 mg and 200 mg BID.
Initially, 1 patient will be enrolled in dose level 1. If the patient experiences a Grade 2
toxicity, an additional 2 patients will be enrolled at the same dose level. If 1 of the 3
patients experiences a Grade 3 (or higher toxicity), the cohort will be expanded to 6
patients. However, if 1 patient completes one cycle at the assigned dose regimen without
experiencing a Grade 2 toxicity, enrollment in the next cohort (dose level 2) can begin. This
rapid dose escalation scheme will apply to cohorts 1 through 3.
Initially, in the 4th cohort (dose level 4), a minimum of three patients will be enrolled. If
1 of the 3 patients experiences a Grade 3 (or higher toxicity), the cohort will be expanded
to 6 patients. However, if 3 patients complete one cycle at the assigned dose regimen without
experiencing a Grade 3 (or higher toxicity), enrollment in the next cohort (dose level 5) can
begin. This scheme will apply to cohorts 4, 5, and 6 MTD is defined as the highest dose of
ABT-751 given in combination with carboplatin at which fewer than 33% of patients experience
DLT. MTD will be evaluated at the end of the first cycle (21 days). Toxicities will be
determined also at the end of cycle 2 to evaluate the safety of combining both agents on day
1. If the MTD has not been determined after completion of the 6th cohort (dose level 6),
based on an overall review of toxicity at each cohort, the Investigator may select a dose
thought to be the recommended dose for Phase 2 studies. Six patients treated at MTD will
undergo PK (pharmacokinetic) and PD (pharmacodynamic) evaluation. An additional cohort of
14-20 patients will be enrolled at either the MTD or at the recommended Phase 2 dose level
administering both drugs on day 1. During this portion of the study patients will be
withdrawn from the study if any of the following occur:
• Patient or patient's legally acceptable representative decides to withdraw consent.
• Patient's response to therapy is unsatisfactory, as evidenced by progression of disease as
defined by RECIST Criteria for Tumor Response (within 2 cycles)
• The patient experiences toxicities deemed possibly or probably related to drug that have
not resolved to at least Grade 2 or lower within three weeks.
• The patient requires more than one dose reduction because of toxicities attributable to
ABT-751.
• The patient requires during the study period alternate antineoplastin agent, concurrent
radiotherapy or surgery of the only measurable site(s) of disease.
• The patient becomes pregnant or begins to breast-feed.
• The investigator believes it is in the best interest of the patient to discontinue study
drug administration.
If grade 3 or higher toxicities develop in 2 or more out of the first 6 patients who receive
both drugs on day 1 on a dose level at which no such toxicities were noted on the ABT-751 day
1/carboplatin day 4 schedule, the additional patients for the second portion of the study
will receive the latter schedule.
If toxicities characteristic of carboplatin (myelosuppression and others) are observed at the
AUC 6 dose, carboplatin dose will be lowered to AUC 4.5 and the following dose escalation
schema will be employed, beginning at the same ABT-751 dose as the one at which the toxicity
developed:
All patients should receive antiemetics prior to carboplatin. A regimen of dexamethasone 10
mg and dolasetron 100 mg IV prior to carboplatin infusion may be used.
The study enrollment will be limited to patients with advanced NSCLC. Treatment will continue
until progression of disease, unacceptable toxicities or withdrawal of informed consent. Male
and female cancer patients will be selected to participate in the study according to the
selection criteria.
[/INST]
Primary Objectives:
The primary objectives of this study are as follows:
• To determine the dose limiting toxicity (DLT) and the maximum tolerated dose (MTD) of
escalating ABT-751 in combination with fixed dose carboplatin in patients with advanced non
small cell lung cancer (NSCLC).
• To evaluate the efficacy of the combination with ABT-751 and carboplatin in patients with
advanced NSCLC
• To determine the median survival in the study population
Secondary Objectives
The secondary objectives are:
• To characterize the pharmacokinetic profile of ABT-751 given in combination with
carboplatin in a subset of patients, treated at the MTD or recommended doses for Phase 2.
• To determine the pharmacodynamics of ABT-751 as a single agent and the combination of
ABT-751 and carboplatin as evaluated by cell cycle analysis of buccal mucosa cells.
</s> |
<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>>
JTX-4014 is a fully human IgG4 monoclonal antibody designed to specifically bind to PD-1 and
block its interaction with its ligands, PD-L1 and PD-L2, to augment anti-tumor T cell
activity. Vopratelimab is an agonist monoclonal antibody that specifically binds to the
Inducible CO-Stimulator of T cells (ICOS) to generate an anti-tumor immune response. This is
a Phase 2, open label study to evaluate the efficacy, safety, tolerability of JTX-4014 alone
and in combination with vopratelimab in biomarker-selected adult subjects with metastatic
NSCLC who are PD-1/PD-L1 inhibitor naïve and have progressed on a platinum based chemotherapy
regimen
[/INST]
This is a Phase 2, open-label study to evaluate PD-1 inhibitor JTX-4014 alone and in
combination with vopratelimab, an ICOS agonist, in biomarker-selected adult subjects with
metastatic NSCLC who are PD-1/PD-L1 inhibitor naïve and have progressed on a platinum based
chemotherapy regimen.
</s> |
<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase Ib - China[/INST]
The purpose of this study is to assess the safety, pharmacokinetic profile of APG-2575 single
agent and in combination with HHT/AZA in patients with relapsed/refractory AML and related
myeloid malignancies.
</s> |
<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>>
This is a bridging study to support China registration. An estimation strategy rather than a
formal hypothesis testing was pursued. Twenty subjects were enrolled into the study.
Treatment with eltrombopag started at 25 mg/day and increased by 25 mg/day every 2 weeks
according to the platelet count, up to 150 mg/day. Hematological response rate was assessed
at 3, 6 months and 1 year (Week 13, 26 and 52) after starting the study treatment. Subjects
in whom the treatment was found to be effective at 6 months continued to receive the
treatment. Eltrombopag was discontinued if the treatment was ineffective at 6 months.
Subjects were to discontinue eltrombopag before 6 months if any of the treatment
discontinuation criteria were met.
Analysis set for the primary endpoint is Full Analysis Set (FAS) and subjects who discontinue
from the study before Week 26 were treated as non-responders in the response analysis.
Eltrombopag treatment was provided to subjects who were considered to require continued
treatment at Week 26. After Week 26, if all of the hematologic response criteria (i.e.,
platelet count > 50×109/L, hemoglobin level > 100 g/L without transfusion, and neutrophil
count > 1.0×109/L) remained fulfilled for more than 8 weeks, the dose of eltrombopag was
decreased by half. If the response continued for further 8 weeks even at the decreased dose,
the treatment was discontinued. If a decrease in any of the hematologic values (i.e.,
platelet count < 30×109/L, hemoglobin < 90 g/L, or neutrophil count < 0.5×109/L) was found
after dose reduction, the dose was increased to the previous level. Furthermore, after
treatment interruption, the treatment was restarted if any of the hematologic values
decreased to the above-mentioned levels. The response assessment and safety evaluation were
performed at Week 52.
The Extension part of this study started 1 year (Week 52) after the initiation of study
treatment. This part was included in the study with an ethical consideration for subjects who
required continued treatment. The continued treatment was provided up to the launch of
eltrombopag after approval. Follow-up visit was performed 30 days after the discontinuation
of eltrombopag treatment.
To better understand the PK characteristics of eltrombopag in Chinese SAA patient population,
intensive PK blood samples was collected only in the initial 12 Chinese subjects receiving 25
mg/day dose after reaching steady-state to provide evaluable full PK profiles. Steady-state
trough concentrations were collected at other dose levels and in other subjects.
[/INST]
This is a non-randomized, open-label, phase II study to assess the efficacy and safety of
eltrombopag in Chinese subjects with refractory or relapsed severe aplastic anemia (SAA).
Treatment with eltrombopag will be started at 25 mg/day and increased by 25 mg/day every 2
weeks according to the platelet count up to 150 mg/day. The hematological response rate will
be assessed at 3, 6 months and 1 year after starting the study treatment (Week 13, 26 and
52).
</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 - D15-11094[/INST]
This study will evaluate the safety, antitumor activity and preliminary pharmacokinetics of
an investigational drug product, DTRMWXHS-12, in patients with chronic lymphocytic leukemia
or other B-cell lymphomas. DTRMWXHS-12 will be evaluated as a single agent, and in
combination.
This study will be conducted in two parts: phase Ia and Ib. Both parts will explore
escalating doses of DTRMWXHS-12. The phase Ia study will evaluate DTRMWXHS-12 monotherapy.
The phase Ib study will evaluate DTRMWXHS-12 combinations.
</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 - E103[/INST]
DS-1093a is an inhibitor of hypoxia-inducible factor prolyl hydroxylases, and is expected to
produce transient dose / exposure dependent increases in erythropoietin levels in subjects
with chronic kidney disease (CKD). This study will be conducted in 2 parts. Part A will
involve subjects with stage 3b or 4 CKD, and will be an open, non-controlled parallel group
investigation of three single doses of DS-1093a (6 subjects/dose), in which allocation to
dose will be randomised. On completion of this part of the study an optional fourth dose may
be tested to gain a more complete understanding of the PK/PD behaviour of DS-1093a. Part B
will be an open, non-controlled investigation of a single dose of DS-1093a in CKD subjects
(n=6) receiving haemodialysis. The dose for Part B will be determined based on the data from
Part A.
</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 - BREATH-1[/INST]
The symptoms associated with COPD include overproduction of mucus and inflammation in the
lungs. Overproduction of mucus results in impaired lung function and it encourages bacterial
growth and associated COPD exacerbations. Therefore, a treatment that inhibits mucus
overproduction or blocks inflammation could benefit COPD patients. The drug under evaluation
in this study, BIO-11006 Inhalation Solution, is a new drug that may inhibit overproduction
of mucus and may have important anti-inflammatory properties.
</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 Finding (Ext.)[/INST]
This is an open-label extension study for patients who participated in the BPS-MR-PAH-201
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 - w/Trametinib (Belgium)[/INST]
Patients with BRAF V600 mutant advanced melanoma benefit from treatment with a BRAF-inhibitor
(e.g. dabrafenib, vemurafenib) and from combination of a BRAF- and MEK-inhibitor (e.g.
dabrafenib and trametinib). Following initial tumor regression, progression is diagnosed in a
majority of patients treated with BRAF-inhibitor mono-therapy within the first 12-months of
therapy. Various molecular mechanisms that underlie the development of resistance to
treatment with a BRAF-inhibitor have been reported. These mechanisms do not include secondary
mutations in the BRAF-gene and therefore resistance to BRAF-inhibition could potentially be
reversible when selective pressure by BRAF-inhibition is withheld for a sufficient period of
time of melanoma progression. This clinical trial protocol addresses the potential renewed
anti-tumor activity of combined BRAF- and MEK inhibition with the combination of dabrafenib
and trametinib in patients with unresectable AJCC stage III or - IV BRAF V600 mutant melanoma
who are documented with progression of disease at least 12 weeks following the last day of
dosing of a BRAFinhibitor containing treatment regimen.
</s> |
<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase I/II - w/Nivolumab[/INST]
The purpose of this study is to determine whether BMS-986258 both monotherapy and in
combination with Nivolumab is safe and tolerable in the treatment of advanced malignant
tumors.
</s> |
<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase II - Safety in Adults w/AMI[/INST]
The goal of this study is to find out how fast a drug called selatogrel (ACT-246475) can
prevent platelets from binding together. This study will also help to find out more about the
safety of this new drug. The drug selatogrel (ACT-246475) will be used in 2 different doses
(8 mg or 16 mg) and will be administered in the thigh.
</s> |
<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>>
The Synovate Study is a global, randomized, double-blind, placebo-controlled, phase 3 study
in patients with unresectable, locally-advanced or metastatic New York esophageal squamous
cell carcinoma 1 (NY-ESO-1) positive synovial sarcoma following first-line systemic
anti-cancer therapy.
[/INST]
To assess if the CMB305 vaccine regimen may help the body's immune system to slow or stop the
growth of synovial sarcoma tumor and improve survival.
</s> |
<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>>
This is a Phase I Study to Compare Pharmacokinetics and Safety between CT-P13 SC Pre-filled
Syringe and CT-P13 SC Auto-injector in Healthy Subjects. A total of 218 healthy subjects will
be enrolled.
[/INST]
This study compares two administration methods of CT-P13. Half of participants will receive
CT-P13 by pre-filled syringe while the other half will receive CT-P13 by auto-injector.
</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 - CONNEX-1[/INST]
This study is open to adults with schizophrenia. Schizophrenia can affect the way a person
thinks, their memory and their mental functioning. Examples include struggling to remember
things, or to read a book or pay attention to a movie. Some people have difficulty
calculating the right change or planning a trip so that they arrive on time. The purpose of
this study is to find out whether a medicine called Iclepertin improves learning and memory
in people with schizophrenia.
Participants are put into two groups randomly, which means by chance. One group takes
Iclepertin tablets and the other group takes placebo tablets. Placebo tablets look like
Iclepertin tablets but do not contain any medicine. Participants take a tablet once a day for
26 weeks. In addition, all participants take their normal medication for schizophrenia.
During this time, doctors regularly test learning and memory of the participants by use of
questionnaires, interviews, and computer tests. The results of the mental ability tests are
compared between the groups.
Participants are in the study for about 8 months and visit the study site about 14 times.
During this time, doctors regularly check participants' health and take note of any unwanted
effects.
</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 - H35136[/INST]
Patients enrolled on this study will have received a stem cell transplant. After a
transplant, while the immune system grows back the patient is at risk for infection. Some
viruses can stay in the body for life, and if the immune system is weakened (like after a
transplant), they can cause life-threatening infections.
Adenovirus (AdV) is a virus that just causes symptoms of a common cold normally, but which
can cause serious life-threatening infections in patients who have weak immune systems. It
usually affects the lungs and can cause a very serious pneumonia, but it can also affect the
gut, the liver, the pancreas and the eyes.
Investigators want to see if they can use a kind of white blood cell called T cells to treat
adenovirus infections that occur after a transplant. Investigators have observed in other
studies that treatment with specially trained T cells has been successful when the cells are
made from the transplant donor. However as it takes 1-2 months to make the cells, that
approach is not practical when a patient already has an infection.
Investigators have now generated AdV-specific T cells from the blood of healthy donors and
created a bank of these cells. Investigators have previously successfully used frozen
virus-specific T cell lines generated from healthy donors to treat virus infections after
bone marrow transplant, and have now improved the production method and customized the bank
of lines to specifically and exclusively target AdV.
In this study, investigators want to find out if the banked AdV-specific T cells derived from
healthy donors are safe and can help to treat adenoviral infection.
The AdV-specific T cells (Viralym-A) are an investigational product not approved by the Food
and Drug Administration (FDA).
Funding source - FDA OOPD
</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 - Non-Ambulatory DMD[/INST]
This is a Phase 2, open-label, single arm trial of pamrevlumab (FG-3019) to estimate
pamrevlumab's safety and efficacy in non-ambulatory participants with DMD.
</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 - RAPID-C OLE (China)[/INST]
This study will continue to evaluate the safety & efficacy of Certolizumab Pegol (CZP) for 6
months in Chinese subjects with active Rheumatoid Arthritis who participated in RA0044.
</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 - CHRYSALIS[/INST]
The purpose of study is to evaluate the safety, pharmacokinetics, and preliminary efficacy of
Amivantamab as a monotherapy and in combination with lazertinib, and to determine the
recommended Phase 2 dose (RP2D) (monotherapy), recommended Phase 2 combination dose (RP2CD)
(combination therapy), and to determine recommended Phase 2 Dose (RP2q3W) with combination
chemotherapy (Amivantamab in combination with standard of care carboplatin and pemetrexed) in
21 day treatment cycle for participants with advanced non-small cell lung cancer (NSCLC).
</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 - Maintenance[/INST]
To determine the response rate of the administration of HyperAcute-Lung Cancer Vaccine for
subjects with stage IIIB or stage IV non-small cell lung cancer who have been treated with
first line platinum-doublet therapy and have responded or are considered to have stable
disease.
</s> |
<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>>
The primary purpose of the phase Ib part of this study is to determine the maximum tolerated
dose(s) (MTD(s)) and/or recommended phase II dose (RP2D) of LEE011 + everolimus + exemestane
in patients with ER+ Her2- advanced breast cancer. This part of the study will also assess
safety, tolerability, and PK of the LEE011 + exemestane, LEE011 + everolimus + exemestane
combinations.
The Dose Expansion part of the study will evaluate the triple combination of LEE011 +
everolimus + exemestane and the double combination of LEE011 + exemestane for safety and
tolerability.
[/INST]
Dose Escalation part of the study: To estimate the MTD(s) and/ or RP2D of LEE011 in
combination with everolimus + exemestane, and LEE011 in combination with exemestane, and to
characterize the safety and tolerability of the combinations of everolimus + exemestane +
LEE011 and LEE011 + exemestane in patients with ER+ HER2- advanced breast cancer
Dose Expansion part of the study: To characterize the safety and tolerability of the triplet
combination of LEE011 + everolimus + exemestane in patients naïve or refractory to CDK4/6
inhibitor based therapy, and the safety and tolerability of the doublet combination of LEE011
+ exemestane in patients refractory to CDK4/6 inhibitor based therapy (except patients
treated with prior LEE011 are not allowed in Group 3).
</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/Methotrexate[/INST]
A multicenter, randomized, parallel assignment, double blind, placebo-controlled,
safety/efficacy phase II study of two different dosages of subcutaneous F8IL10 in patients
with active rheumatoid arthritis receiving MTX.
</s> |
<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>>
This was a randomized, SoC-controlled, open-label, multi-center study in patients with TAM
after hematopoietic precursor cell transplantation (HPCT). Study consisted of up to 28 days
of screening period, 16 weeks treatment period that can be extended to 45 weeks, 36 weeks
follow up, and end of study visit (EOS) at week 52. Duration of follow up depended on
duration of treatment. Patients who are treated for more than 41 weeks will proceed directly
to EOS visit.
Approximately 40 patients was to be randomized to receive SoC or LFG316 plus SoC. Patients
was included in the study if they have diagnosis of TAM and poor prognostic markers.
Patients showing worsening of disease after two weeks of treatment or showing no response at
week 4 or any time after will be considered failures and can be switched to receive the
alternative treatment (SoC or LFG316). Patients can only switch treatment arms once.
[/INST]
This was a randomized, SoC-controlled, open-label, multi-center study in patients with TAM
after hematopoietic precursor cell transplantation (HPCT) .
Study consisted of up to 28 days of screening period, 16 weeks treatment period that can be
extended to 45 weeks.Approximately 40 patients was to be randomized to receive SoC or LFG316
plus SoC. Patients was included in the study if they have diagnosis of TAM and poor
prognostic markers. This trial was terminated: LFG316, a monoclonal antibody inhibitor of
complement factor 5 (C5), had been studied in seven patients with transplantation-associated
microangiopathy (TAM). Due to low confidence of clinical benefit, this study was closed
</s> |
<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase I - Japan[/INST]
This was a Phase 1, open-label, dose-escalation trial of avelumab (antibody targeting
programmed death ligand 1 [anti PD-L1]) in Japanese participants with metastatic or locally
advanced solid tumors, followed by a consecutive expansion part in Asian participants with
gastric cancer.
</s> |
<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>>
PRIMARY OBJECTIVES:
I. To determine the objective response rate of patients with malignant mesothelioma treated
with pembrolizumab in A) an unselected patient population, as well as B) in a programmed cell
death ligand 1 (PD-L1) positive population (should the trial proceed to Part B, and PD-L1
expression correlate with improved efficacy).
II. To determine the optimal threshold for PD-L1 expression using the 22C3 antibody based
immunohistochemistry (IHC) assay in correlation to tumor response.
SECONDARY OBJECTIVES:
I. To determine the progression-free survival of patients with malignant mesothelioma in A)
an unselected patient population and B) a PD-L1 positive population when treated with
pembrolizumab.
II. To determine the overall survival of patients with malignant mesothelioma in A) an
unselected patient population and B) a PD-L1 positive population when treated with
pembrolizumab.
III. To determine the disease control rate (complete response [CR] + partial response [PR] +
stable disease [SD]) of patients with malignant mesothelioma who are treated with
pembrolizumab in A) an unselected patient population and B) a PD-L1 positive population.
IV. To determine toxicity in patients with malignant mesothelioma who are treated with
pembrolizumab.
V. To determine percentage of patients with mesothelioma who have PD-L1 tumor expression, and
the distribution of PD-L1 expression (percent positivity of tumor cells/stroma staining).
TERTIARY OBJECTIVES:
I. To characterize the T-cell inflamed phenotype in mesothelioma patients via presence of
cluster of differentiation (CD)8 tumor infiltrating lymphocytes (TILs) and/or use of a gene
expression signature (Nanostring).
II. To evaluate other immune escape mechanisms including indoleamine-pyrrole 2,3-dioxygenase
(IDO) expression, regulatory T cells (Tregs) (forkhead box P3 [FOXP3] expression),
myeloid-derived suppressor cells (MDSCs) and other checkpoints by immunohistochemistry (or
other methods e.g. flow cytometry).
III. To determine PD-L1 expression by mass spectrometry and correlate with tumor response,
PD-L1 expression by IHC, and the T-cell inflamed phenotype.
IV. To determine the immune cell populations present in fresh tumor (when available), via
tumor digests and mass spectrometry-based flow cytometric analysis (e.g. using CyTOF) in a
multiplex fashion in patients with fresh tumor tissue.
V. To characterize the T-cell receptor repertoire of TILs compared to circulating T-cells in
mesothelioma patients with available fresh frozen tissue (spectrotyping, T-cell repertoire
sequencing [e.g. using the Adaptive platform]).
OUTLINE:
Patients receive pembrolizumab intravenously (IV) over 30 minutes on day 1. Treatment repeats
every 21 days for up to 24 months in the absence of disease progression or unacceptable
toxicity. Patients may be eligible for up to 1 year of additional pembrolizumab therapy if
they progress after stopping pembrolizumab.
After completion of study treatment, patients are followed up for 30 days (up to 90 days for
serious adverse events), every 8 weeks until patient experiences confirmed disease
progression or starts a new anti-cancer therapy, and then every 12 weeks for 3 years.
[/INST]
This phase II trial studies how well pembrolizumab works in treating patients with malignant
mesothelioma, a cancer of the linings around the lungs (pleura) or abdomen (peritoneum).
Monoclonal antibodies, such as pembrolizumab, work by blocking a protein called programmed
cell death 1 (PD-1) which may stimulate an immune response and kill tumor cells.
</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, double-blind (neither the researchers nor the participants know what
treatment the participant is receiving), randomized (study medication assigned to
participants by chance), placebo-controlled (an inactive substance; a pretend treatment [with
no drug in it] that is compared in a clinical trial with a drug to test if the drug has a
real effect), parallel group, multicenter (when more than one hospital work on a medical
research study) study, with a single-blind, long-term follow-up to Year 3. The study will be
split into 2 phases, a double-blind phase with screening (Day -12 to Day 1), Vaccination (Day
1) and Safety and Immunogenicity Follow-up (Day 1 up to Day 360), and a single-blind
long-term follow-up phase thereafter until Year 3 for participants in placebo and two ExPEC4V
dose groups selected based on the primary (Day 30) analysis. Participants will be stratified
in 2 age groups (>=18 to less than [<] 50 years and >=50 years) and in each dosing group in
each stratum randomized to a single vaccination with 1 of 5 doses of ExPEC4V or placebo. The
duration of the double-blind phase (from randomization/vaccination) will be approximately 360
days for placebo participants and participants in the dose group selected based on the
primary analysis, and approximately 180 days for the participants in the other groups. The
duration of the single-blind long-term follow-up phase will be approximately 2 years after
the double-blind phase for placebo participants and participants in the selected dose group.
Participants' safety will be monitored throughout the study.
[/INST]
The purpose of this study is to evaluate the safety, tolerability of different doses of
JNJ-63871860 (ExPEC4V) in participants greater than or equal to (>=)18 years of age and to
evaluate the dose-dependent immunogenicity of ExPEC as measured by enzyme-linked
immunosorbent assay (ELISA).
</s> |
<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>>
Siemens Molecular Imaging (SMI) is seeking to determine if [F-18]T807 might be useful as a
non-invasive assessment tool in the clinical evaluation of subjects with conditions
associated with tau protein aggregates, such as Alzheimer's disease. The information
collected under this exploratory study will not be used for diagnostic purposes, assessments
of the participant's response to therapy or for clinical management of the participants.
However, this exploratory study will provide baseline information on the safety,
biodistribution, and dosimetry of [F-18]T807. These data will aid in the design of future
studies of [F-18]T807 in patients with Alzheimer's disease. Overall, this study will provide
initial data that inform the development of [F-18]T807 as the first PET imaging agent for
human tau protein related pathology.
[/INST]
[F-18]T807 is being developed as a diagnostic radiopharmaceutical for PET imaging of the
human brain.
</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 - 0310 (Japan)[/INST]
The objective of this study is to evaluate the efficacy and safety of ASP1517 when converted
from recombinant human erythropoietin (rHuEPO) or darbepoetin alfa (DA), compared to DA in
the treatment of anemia in non-dialysis chronic kidney disease patients. Another uncontrolled
cohort will be included to evaluate the efficacy and safety of ASP1517 in patients converted
from epoetin beta pegol (CERA). This study will also assess the safety/efficacy of long term
treatment of ASP1517 (52 weeks).
</s> |
<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>>
Patients with a morphologically proven diagnosis AML and both the two following criteria:
- Age > 50 years and £ 70 years.
- Not previously treated for their disease.
Randomization will be centralized by phone :
Arm A chemotherapy with daunorubicin and Aracytine or Arm B Daunorubicin and Aracytine and
Mylotarg.
[/INST]
The main objective of this study is to compare conventional chemotherapy: daunorubicin and
the Aracytine and this chemotherapy in combination with the monoclonal antibody used Mylotarg
in divided doses.
</s> |
<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>>
Complement 5a and its receptor C5aR (CD88) is involved in the pathogenesis of anti-neutrophil
cytoplasmic antibody (ANCA)-associated vasculitis. This is a randomized, double-blind,
placebo-controlled Phase 2 study to evaluate the safety and efficacy of the C5aR inhibitor
CCX168 in subjects with ANCA-associated vasculitis. The aim of this trial is to test the
safety and efficacy of two dose regimens of the complement C5a receptor CCX168 in patients
with anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV).
[/INST]
The aim of this trial is to test the safety and efficacy of two dose regimens of the
complement C5a receptor CCX168 in patients with anti-neutrophil cytoplasmic antibody
(ANCA)-associated vasculitis (AAV).
Funding Source - FDA OOPD
</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/PDR001 (Solid/Hematologic)[/INST]
The purpose of this signal seeking study is to determine whether treatment with PDR001 and
LAG525 demonstrates sufficient efficacy in advanced malignancies to warrant further 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 - RESGEX (Europe)[/INST]
The aim of the study is to evaluate the efficacy of CetuGEX™ for the treatment of patients
with stage III/IV recurrent and/or metastatic SCCHN as compared to cetuximab (both in
combination with platinum-based chemotherapy) in terms of progression-free survival (PFS).
</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 - J306 (Japan)[/INST]
To examine antihypertensive effect and safety of administration of CS-3150 in combination
with ARB or ACE inhibitor in hypertensive patients with type 2 diabetes and albuminuria.
</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 - T-Force Green[/INST]
Phase 2, double-blind, placebo-controlled study to assess the safety and efficacy of
NBI-98854 administered once daily (qd) for a total of 6 weeks of treatment. This study will
enroll approximately 90 male and female pediatric subjects clinically diagnosed with Tourette
Syndrome.
</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/Docetaxel[/INST]
This study will test whether giving a combination of a vaccine together with docetaxel is
more effective against breast cancer than docetaxel alone. The Food and Drug Administration
has approved docetaxel to treat many cancers, including breast cancer. The vaccine consists
of three parts: 1) a "priming vaccine" called PANVAC (PAN (all) VAC (vaccine)) trademark
[TM]-V, which is made from vaccinia virus; 2) a "boosting vaccine" called PANVAC[TM]-F, made
from fowlpox virus; and 3) sargramostim, or granulocyte macrophage colony stimulating factor
(GM-CSF), a protein that may help boost the immune system. Human genes are inserted into the
vaccinia and fowlpox viruses to cause production of carcinoembryonic antigen (CEA) and mucin
1 (MUC-1)-two proteins that are often produced by cancer cells and can be used as a target
for the immune system to attack the cancer. Another type of deoxyribonucleic acid (DNA) is
inserted to cause production of other proteins that enhance immune activity.
Patients 18 years of age or older with metastatic breast cancer (disease that has spread
beyond the original site) and whose cancer produces CEA or mucin 1 (MUC-1) protein may be
eligible for this study. Patients must have antigen type human leukocyte antigen A2 (HLA-A2).
They may have received adjuvant docetaxel treatment at least 3 months before entering this
study, prior hormonal therapy and up to three chemotherapy regimens. Candidates are screened
with a medical history and physical examination, blood and urine tests, electrocardiogram,
and computerized tomography (CT) or magnetic resonance imaging scans.
Participants are randomly assigned to one of two treatment groups - docetaxel alone or
docetaxel plus vaccine - as follows:
Docetaxel Alone
All patients receive docetaxel. The drug is infused through a vein over 30 to 60 minutes once
a week for 3 consecutive weeks with 1 week off drug. Patients also take dexamethasone 12
hours and 1 hour before and 12 hours after the docetaxel to help prevent fluid retention
(edema) that docetaxel may cause.
Docetaxel Plus Vaccine
Participants receive the priming vaccination followed by monthly boosting vaccinations, along
with the weekly docetaxel therapy. With every vaccination, patients also receive an injection
of sargramostim to increase the number of immune cells at the vaccination site. Sargramostim
injections are given the day of vaccination and daily for the next 3 days. All vaccine and
sargramostim doses are given as injections under the skin, usually in the thigh. Patients are
observed in the clinic for 1 hour after each injection.
Patients have blood tests every four weeks to monitor drug side effects and before every
vaccination to check blood counts. A bone scan or CT scan (or both) is done every 2 to 3
months to check the response to treatment.
Patients may continue receiving treatment as long as their disease does not worsen and they
can tolerate the treatment without significant side effects. Patients assigned to receive
docetaxel alone whose disease progresses after 3 months on the drug may choose to receive the
vaccine or come off the study to receive other treatment options. Patients are monitored with
yearly telephone calls for up to 15 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 II - Hospitalized Patients[/INST]
The study assessed the efficacy and safety of Brilacidin for the treatment of COVID-19 in
hospitalized participants
</s> |
<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>>
At the completion of the Week-12 visit of the pivotal study (Baseline [Day 1] in this study),
all eligible subjects will be offered enrollment in the long-term extension study. Study
visits during the treatment period for all subjects will occur every 4 weeks (± 3 days). The
total duration of study participation will be approximately 44 weeks.
[/INST]
This is a long-term, open-label, multicenter, study to evaluate the safety and efficacy of
topical tapinarof cream, 1% in adults with plaque psoriasis. Subjects in this study completed
treatment in 1 of 2 Phase 3 pivotal efficacy and safety studies (Study DMVT-505-3001 or Study
DMVT-505-3002). This study will consist of up to 40 weeks of treatment and a 4-week safety
follow-up period.
</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 - CL023 (Moderate to Severe Crow's Feet)[/INST]
This study will evaluate the long-term safety of botulinum toxin type A for the treatment of
moderate to severe crow's feet lines after repeat application.
</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 - A04[/INST]
This study will evaluate the imaging characteristics of flortaucipir in subjects with a
previous flortaucipir scan in order to assess the rate of change of tau deposition over time.
</s> |
<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>>
The study is a two-arm (placebo, lanifibranor 800 mg/day), randomized (1:1), double-blind,
placebo-controlled, 24-week treatment study. Thirty four (n=34)patients with T2DM will be
randomized, allowing for a 10% drop-out rate. The diagnosis of NAFLD on imaging will be done
by measuring IHTG using the gold-standard magnetic resonance and spectroscopy (¹H-MRS)
technique. Ten non-diabetic subjects without NAFLD will also serve as a control group for the
metabolic and imaging procedures. The study will last 34-36 weeks (~6-8 weeks for run-in, 24
weeks of treatment and 4 weeks post-study follow-up), with an estimated recruitment period of
~9 months. Patients with uncontrolled T2DM and a diagnosis of "fatty liver" per history
(elevated AST/ALT and/or liver fat on liver ultrasound or ¹H-MRS and/or other appropriate
imaging technique - see below). Participants may be treated by diet only, or be on a stable
dose of metformin and/or a sulfonylurea and/or a DPP-IV inhibitor for ≥ 2 months prior to
enrollment. If the HbA1c is ≤8.0% on any of these diabetes medications, the dose of these
medications will be kept stable throughout the study and baseline studies performed as
outlined below. If the HbA1c is > 8.0% but ≤ 9.5%, metformin (minimum dose required: 1,000
mg/day for metformin) and/or a sulfonylurea (minimum dose required: glimepiride 2 mg once
daily) will be added, or doses maximized, during the first 2 weeks of the lead-in period.
Afterwards, patient's metformin or sulfonylurea dose will be maintained at the new dose
stable for 4 weeks before baseline metabolic and study-specific liver imaging.
After patients sign the informed consent and meet eligibility criteria, baseline imaging and
metabolic studies will be performed. These will include measurement of IHTG by 1H-MRS, liver
fibrosis by VCTE (Fibroscan) and MRE, and additional imaging by T1 MRI mapping. Metabolic
testing will be done with the patient being admitted to the CRC (clinical research unit) for
an overnight stay. Assessment of insulin sensitivity and DNL will be done with the
administration of stable isotopes of glucose (intravenously) and deuterium labeled water
(orally) to measure glucose and lipid turnover and substrate oxidation (with indirect
calorimetry) during a euglycemic hyperinsulinemic clamp.
After all baseline tests are completed, patients will be asked to take a therapeutic dose of
800 mg lanifibranor (QD), or placebo, for 24 weeks. They will be closely followed by study
staff every 4 weeks with visits to the CRC and interim phone calls. At 24 weeks, all baseline
tests will be repeated and treatment considered completed. There will be a final, off-drug,
safety follow-up visit 4 weeks after treatment at week 28. After this the participant will
have completed all study procedures.
Note: The investigators recalculated the sample size for the primary endpoint of change in
intrahepatic triglyceride (IHTG) measured by 1H-MRS with lanifibranor (800 mg/day) vs.
placebo based on the data from the population with diabetes from the Phase IIb NATIVE
(NCT03008070: NAsh Trial to Validate IVA337 Efficacy; liver histology results) and comparing
to prior studies by Dr. Cusi et al that had simultaneous liver histology and liver fat
measured by 1H-MRS (Belfort et al, NEJM 2006; Cusi et al, Annals Int Med 2016). From this
analysis, the required sample size per group calls for 15 patients in each arm (lanifibranor
vs. placebo) to complete treatment. Conservatively assuming that 10 % of the randomized
patients will not complete the trial (dropouts), the total number of patients to be
randomized is 33-34 patients.
[/INST]
The primary aim is to establish the safety, efficacy and mechanism of action of lanifibranor
in patients with type 2 diabetes (T2DM) and nonalcoholic fatty liver disease (NAFLD).
Specifically, to determine if lanifibranor decreases intrahepatic triglycerides (IHTG)
(primary endpoint), improves hepatic insulin sensitivity, endogenous (hepatic) glucose
production, de novo lipogenesis (DNL), HbA1c and lipid profiles. In addition, exploratory
analysis with surrogate plasma biomarkers and imaging on liver fibrosis changes on with
treatment will be performed.
</s> |
<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>>
The study consists of four phases: up to 9-day screening phase, main 4-week treatment phase,
up-to 8-week extension phase, and up-to 5-day post-treatment phase.
[/INST]
Primary Objective:
To evaluate safety (4 weeks)
Secondary Objectives:
- To evaluate the long-term safety (12 weeks)
- To evaluate the efficacy
- To characterize the pharmacokinetic profile
</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/Sorafenib[/INST]
Phase 1/2 dose escalation study to investigate the combination of RDEA119 and sorafenib in
advanced cancer patients.
</s> |
<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>>
Approximately 600 subjects diagnosed with opioid use disorder will be enrolled; approximately
300 subjects who completed the randomized,double-blind, placebo-controlled study NCT02357901
(RB-US-13-0001) ('roll-over' participants), and approximately 300 subjects who did not
participate in study RB-US-13-0001 ('de novo' participants). Following informed consent and
completion of screening procedures, all subjects will receive SUBOXONE sublingual film,
titrated to response.
After 4-14 days of SUBOXONE sublingual film treatment, subjects will be evaluated for
enrollment into the study. Eligible subjects will receive 300 mg RBP-6000 as an initial dose,
followed by monthly injections of 100 mg or 300 mg RBP-6000, based on the medical judgment of
the investigator.
Subjects who participated in study RB-US-13-0001 ('roll-over' participants) will receive
monthly injections for up to 6 months. Subjects who did not participate in study
RB-US-13-0001 ('de novo' participants) will receive monthly injections for up to12 months.
At all injection visits continuous electrocardiogram recordings and pulse oximetry will be
collected prior to injection and at least 4 hours after injection. Subjects will return to
the clinic every 1-4 weeks for laboratory tests, complete study questionnaires, adverse event
and injection site assessments.
[/INST]
A multi-center, open-label, long-term safety study in which approximately 600 subjects
diagnosed with opioid use disorder will be enrolled. Following a screening period, all
subjects will receive run in SUBOXONE sublingual film followed by an initial injection of
open-label high dose (300 mg) RBP-6000. The RBP-6000 monthly injection dose can be adjusted
to low dose (100 mg), and back to high dose, based on the medical judgment of the
Investigator. Subjects will participate in the study for either 6 or 12 months.
</s> |
<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase II - 116392[/INST]
GSK2245035 is a highly selective Toll-like receptor 7 (TLR7) agonist that stimulates
preferentially the induction of type I interferons. Intranasal (i.n.) administration of
GSK2245035 in humans causes immune changes in the upper airways milieu that may alter
bystander immune responsiveness to aeroallergens and contribute to reduction of allergic
reactivity in subjects with respiratory allergies. The purpose of this study is to examine
the safety and pharmacodynamics (PD) of repeat dosing with i.n. GSK2245035 in subjects with
respiratory allergies. The safety and pharmacodynamic response of four weekly administrations
of escalating doses of i.n. GSK2245035 will be investigated and the maximum tolerated dose
will be established. The study will be conducted in patients with symptomatic allergic
rhinitis and mild asthma. The overall duration of the study will be up to a maximum of
approximately 122 days considering 90 days screening period, 22 days treatment period and 10
days follow-up period.
</s> |
<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>>
In dose cohort 1, patients will be treated in cycles, which are defined by APG-1252
intravenous administration on Days 1, 4, 8, 11, 15, 18 and 22, over a 28-day cycle the start
dose is 10mg.
After dose escalation to 240mg twice weekly in dose cohort 1, dose cohort 2 will be performed
with dose cohort 1 parallelly, patients will be treated in the same 28-day-cycles, APG-1252
intravenous administration on Days 1, 8, 15, and 22, the start dose is 240mg.
In both dose cohorts' patients could continue to receive cycles of APG-1252 until disease
progress or unacceptable toxicity.
Study drug will be administered by intravenous infusion for 30 minutes at the investigational
site by site staff.
[/INST]
APG-1252 is a highly potent Bcl-2 family protein inhibitor, a promising drug candidate which
shown high binding affinities to Bcl-2, Bcl-xL and Bcl-w. The preclinical studies have shown
that APG-1252 alone achieves complete and persistent tumor regression in multiple tumor
xenograft models with a twice weekly or weekly dose-schedule, including SCLC, colon, breast
and acute lymphocytic leukemia (ALL) cancer xenografts; achieves strong synergy with the
chemotherapeutic agents, indicating that APG-1252 may have a broad therapeutic potential for
the treatment of human cancer as a single agent and in combination with other classes of
anticancer drugs. APG-1252 is intended for the treatment of patients with SCLC or other solid
tumors.
This is a multi-center, open-label, dose escalation Phase I study to determine the MTD and
DLTs of intravenously administered APG-1252. After dose escalation to 240mg twice weekly, 2
dose cohorts two different dosing schedules including weekly and twice weekly will be
assessed to evaluate for safety, tolerability, pharmacokinetics (PK) and preliminary
anti-tumor efficacy. Treatment with APG-1252 will be administered to 30-60 patients at
approximately 2 investigational sites in US.
</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 - Symptomatic GERD[/INST]
The objectives of this study are to evaluate the safety, efficacy, and dose-response
relationship of IW-3718 administered orally to participants who have GERD and continue to
experience GERD symptoms while receiving once-daily (QD), standard-dose proton pump
inhibitors (PPIs).
</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 - 001[/INST]
The objective of this study is to assess safety and efficacy of various doses of BTX 1503
liquid formulation in subjects with moderate to severe acne vulgaris of the face.
</s> |
<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase II/III - C-SALT (Child-Pugh-B Hepatic Insufficiency)[/INST]
This study is being done to evaluate the efficacy and safety of the drug combination
grazoprevir (GZR; MK-5172) + elbasvir (EBR; MK-8742) in participants with chronic hepatitis C
virus (HCV) genotype (GT) 1, 4, or 6 infection and who have cirrhosis and Child-Pugh (CP)
score 7-9 moderate hepatic insufficiency (CP-B). The primary hypothesis is that the
percentage of HCV-infected participants with hepatic insufficiency (the CP-B population)
achieving sustained viral response (SVR) 12 weeks after the end of all treatment (SVR12) will
be greater than 60%. Additionally, ten non-cirrhotic (NC) HCV-infected GT1 participants will
also be given GZR + EBR at the beginning of the study; this will be done for the purpose of
collecting plasma pharmacokinetic (PK) data in HCV GT1-infected participants who do not have
hepatic insufficiency.
</s> |
<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>>
The purpose of this Phase II study is to evaluate the safety, tolerability, antitumoural
activity and systemic exposure of repeated IT administrations of BO-112 percutaneously
injected into a hepatic metastatic lesion in combination with pembrolizumab administered
intravenously.
This is an open-label, non-comparative, 2-cohort study with a Simon's 2-stage design which
will include up to 69 evaluable adult subjects with un resectable liver metastasis suitable
for IT injection from CRC or GC/GEJ who are naive to anti-PD1/PDL1 therapy.
Cohort A will consist of up to 26 subjects with metastatic CRC who have received at least 2
prior standard of care systemic anticancer therapies for advanced/metastatic disease.
Bevacizumab may have been previously administrated. Prior Anti-EGFR drugs are mandatory if
applicable depending on the RAS status.
Cohort B will consist of up to 43 subjects with gastric or GC/GEJ who have received at least
1 prior standard of care systemic anticancer therapy for advanced/metastatic disease. Prior
Her2 blockade will be mandatory in those patients with Her2 positive tumors.
The aim of this study is to reverse the primary resistance that the subgroup of patients from
these 2 cohorts who present microsatellite stability (MSS), in which data from previous
clinical trials have demonstrate that the inhibition of PD-1 has no proven efficacy. For that
purpose, the MSI status will be determined in the pre-treatment biopsy, done on C1D1, before
the first BO-112 administration. Those patients with a MSI status will continue under study
treatment but will be replaced and will not be considered for the efficacy assessment, only
for the safety assessment. Those patients having a MSS status will be considered bot both
assessments.
The recommended dose for further clinical development of BO-112 is 1 mg administered in 1.7
mL volume, based on the data from the 112/2016-IT study, the fist-in-human trial with BO-112.
The planned dose of pembrolizumab for this study is 200 mg. Study treatment will consist of
BO-112 IT injections in combination with IV pembrolizumab infusions and will be administered
in 3-week cycles. For each cycle, BO-112 IT injections will be administered after the
pembrolizumab infusion, either the same day or within a period of up to 36 hours after the
pembrolizumab infusion (for organisational feasibility at the site). On the first cycle,
BO-112 will be administered on D1 and D8.
The BO-112 IT injections will be administered by an interventional radiologist under
ultrasound guidance, or occasional CT scan guidance, at the discretion of the interventional
radiologist.
Study treatment should continue as long as there is clinical benefit and it is tolerated, up
to a maximum of approx. 2 years (corresponding to 35 treatment cycles).
[/INST]
This is an open, single arm, multicenter phase 2 trial in which BO-112 will be administered
intratumorally in combination with intravenous pembrolizumab in patients with liver
metastasis from colorectal, gastric or gastroesophageal junction cancers. The objective is to
reverse the primary resistance that a subgroup of patients from these tumors having
microsatellite stability present to the PD-1 inhibitors. Treatment will be administered every
3 weeks, with the exception of the first cycle, in which BO-112 will be also administered on
D8, for up to 2 years.
The primary objective is overall response rate based on RECIST 1.1 and safety, specifically
referred to treatment emergent adverse events (TEAEs) with severity ≥ Grade 3 related to the
study treatment (NCI-CTCAE v 5.0). The secondary endpoints include other efficacy endpoints
(duration of response, disease control rate, progression-free survival, overall survival at 6
months, all based on RECIST 1.1, and overall response rate based on a specific tumor
assessment criteria to evaluate the response to immunotherapies, IRECIST) and safety, in this
case considering the number and proportion of subjects with treatment TEAEs (any grade) . In
addition, the changes in the tumor microenvironment induced by the injection of BO-112 will
be also evaluated as exploratory endpoints.
</s> |
<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase I - 200207[/INST]
The proposed study, 200207 is a double blind, placebo controlled, single and repeat dose
escalation study to investigate the safety, tolerability and PK of GSK2838232 alone and when
co-administered with RTV 100 milligram (mg) Once daily (QD). This study will enable future
clinical development of GSK2838232 in healthy subjects and in a Phase IIa proof of concept
study in Human Immunodeficiency Virus (HIV) infected patients. This study is a single and
repeat dose escalation study and will be conducted as two Parts. Part A will evaluate
GSK2838232 20 mg and 50 mg administered QD for 8 days and Part B will evaluate GSK2838232 10
mg, 20 mg, and 50 mg, co-administered with RTV 100 mg, QD for 11 days. The extended period of
dosing is to account for the longer terminal phase half-life of GSK2838232 when given with
RTV. Dose cohorts will be enrolled sequentially; enrollment into a cohort will commence
following review of interim PK and safety data from at least 4 subjects in the preceding
cohort. Subjects in both parts will have a screening visit within 30 days prior to first dose
and a follow-up visit 7-14 days after the last dose. Maximum duration of study participation
will be approximately 7 weeks. Approximately 40 healthy subjects will be enrolled, 8
subjects/cohort. Subjects will be randomized 3:1 to receive GSK2838232 or 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 - TOLEDO[/INST]
The primary objective of the trial was to investigate the efficacy of apomorphine continuous
subcutaneous infusion compared to placebo in Parkinson's Disease patients with motor
fluctuations not well controlled on medical treatment.
The secondary objective of the study was to investigate the safety and tolerability of
apomorphine continuous subcutaneous 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 IIb - 2MD-7H-2B[/INST]
The goal of this study is to test a new vitamin D compound for its ability to reduce
parathyroid hormone levels in patients who are on hemodialysis.
</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 - SIRROUND-M (Japan)[/INST]
The purpose of this study is to evaluate the safety and efficacy of sirukumab as a single
therapy in Japanese patients with moderately to severely active rheumatoid arthritis (RA) who
have not responded to treatment with methotrexate (MTX) or sulfasalazine (SSZ).
</s> |
<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>>
The dose-finding phase will determine recommended dose (RD) for durvalumab in combination
with lenalidomide (LEN) with and without dexamethasone (dex) in a 28-day treatment cycle.
Three treatment Cohorts (A, B, and C) will be enrolled in parallel:
- Cohort A: durvalumab + LEN + dex in high risk transplant non-eligible (TNE) newly
diagnosed multiple myeloma (NDMM) participants;
- Cohort B: durvalumab + LEN + dex (dex for up to 12 cycles) in ≥ 65 years old TNE NDMM
participants who are not high risk;
- Cohort C: durvalumab + LEN as maintenance in post-transplant high risk NDMM
participants.
Based on experience with durvalumab for other indications, the initial dose of durvalumab
will be 1500 mg for each treatment cohort. The dose of durvalumab might be de-escalated to
750 mg level.
The dose of LEN will be 25 mg (adjustable per the creatinine clearance [CrCl] value) on Days
1 to 21 of each 28-day treatment cycle for participants in Cohort A and B. The dose of LEN
will be 10 mg on Days 1 to 21 of each 28-day treatment cycle for participants in Cohort C.
The dose of dex will be 40 mg/day (for participants ≤ 75 years old) or 20 mg/day (for
participants > 75 years old) on Days 1, 8, 15, and 22 of a 28-day cycle for Cohort A and
Cohort B (for up to 12 cycles).
Initially, 6 participants will be enrolled into each cohort and each will receive 1500 mg
durvalumab.
The dose-limiting toxicity (DLT) evaluation period will be the first treatment cycle.
- If ≤ 1 of the 6 initial participants experience a DLT within the first cycle, then the
dose expansion phase may be initiated with durvalumab 1500 mg as the recommended dose
(RD);
- If 2 or more of the 6 initial participants experience a DLT within the first cycle, then
the maximum tolerated dose (MTD) has been exceeded and de-escalation to durvalumab 750
mg level after review of safety and pharmacokinetic/pharmacodynamic (PK/Pd) of the
initial 6 participants by the Dose Review Team (DRT).
Any of the cohorts may be removed from the study based on emerging PK, Pd, efficacy or safety
data.
Dose de-escalation will only occur after review of safety (DLT) and possibly PK/Pd data by
the Dose Review Team ( DRT).
Note: In the US, two treatment arms (A and B) will be enrolled in parallel. Cohort C will
enroll upon completion of at least 4 cycles of follow-up for safety assessment of Cohorts A
and B.
[/INST]
This is a multicenter, open-label, Phase 1/2 study to determine the recommended dose and
regimen of durvalumab in combination with lenalidomide (LEN) with and without dexamethasone
(dex) in adults with newly diagnosed multiple myeloma (NDMM).
The study will consist of a dose-finding phase as well as a parallel dose-expansion phase to
determine the optimal regimen.
******************************************************************************
The study was placed on full clinical hold by the United States (US) Food and Drug
Administration (FDA) on 05 Sep 2017. The decision by the FDA was based on data from
non-Celgene-sponsored studies related to risks of anti-programmed cell death 1 (PD-1),
pembrolizumab, in combination with immunomodulatory agents. As the result, the study was
closed for further enrollment, and all subjects were discontinued from all study treatments
(durvalumab, lenalidomide and dexamethasone). All subjects are being followed for second
primary malignancies (SPMs), every 6 months for 5 years after the last subject has been
enrolled as per protocol. After stopping data collection in the clinical database, any SPM
events will continue to be recorded in the subject's source documents, and reported to
Celgene Drug Safety.
</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 - 3-Month Efficacy Study (ERC-231)[/INST]
The purpose of this Phase III trial is to confirm the efficacy of intravaginal
dehydroepiandrosterone (DHEA) in postmenopausal women with vaginal atrophy.
</s> |
<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>>
According to the World Health Organization (WHO), epilepsy afflicts more than 50 million
people worldwide. Despite the ongoing use of older antiepileptic drugs (AEDs) and the
development of newer treatments that are better tolerated, approximately 30% of patients,
particularly those with partial seizures, are not well controlled even on newer treatments,
or experience significant side effects from treatment. RWJ-333369 is a drug with
anticonvulsant activity that is being investigated for the treatment of epilepsy. This is a
randomized (patients are assigned different treatments based on chance), double-blind study
(neither the patient nor the physician knows whether drug or placebo is being taken, or at
what dosage ) in males and females who have partial onset seizures that have had an
inadequate response to at least one AED. The study consists of 3 phases: pretreatment (a
screening visit and a 56-day baseline period), double-blind treatment (12 weeks of treatment
with either 200 mg per day of RWJ-333369, 400 mg per day of RWJ-333369, or placebo), and
posttreatment (a posttreatment visit that occurs 7 to 14 days after the last dose of
double-blind study drug). The posttreatment phase is only for patients not continuing in the
open-label extension study. The open-label extension study is offered after completion of the
double-blind treatment phase if the study doctor judges that the patient may benefit from
continued treatment with RWJ-333369. The open-label extension study lasts until RWJ-333369
becomes available by prescription or its development is stopped by the sponsor. The efficacy
of the RWJ-333369 will be based on a change in the frequency and severity of seizures. Safety
assessments include adverse events (side effects) reporting, collecting blood tests and
Electrocardiograms and performing physical exams, including vitals signs. The study
hypothesis is that 400 mg per day of RWJ-333369 is better than placebo as add-on treatment of
partial onset seizures, as measured by the percent reduction from baseline in the monthly
partial onset seizure frequency. 200 mg per day RWJ-333369, 400 mg per day RWJ-333369, or
placebo, given twice daily with or without food approximately 12 hours apart; study drug
should be swallowed whole and not be chewed, divided, crushed, or dissolved.
[/INST]
The purpose of this study is to demonstrate that RWJ-333369 is safe and effective as add-on
treatment of partial onset seizures.
</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 - TMS Effects[/INST]
The XEN1101 Phase 1 clinical trial is a randomized, double-blind, placebo-controlled study
that will eventuate the safety, tolerability, pharmacokinetics (PK) and effects on
transcranial magnetic stimulation (TMS) of oral doses of XEN1101 in healthy male subjects.The
TMS procedure is designed to demonstrate delivery of XEN1101 into the central nervous system
and to observe a change in cortical excitability as measured by EEG and/or EMG activity. It
is estimated there will be approximately 15 subjects in the planned 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 - BEBYP (Italy)[/INST]
RATIONALE: Drugs used in chemotherapy, such as irinotecan, oxaliplatin, leucovorin, and
fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the
cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can
block tumor growth in different ways. Some block the ability of tumor cells to grow and
spread. Others find tumor cells and help kill them or carry tumor-killing substances to them.
It is not yet known whether combination chemotherapy is more effective with or without
bevacizumab in treating metastatic colorectal cancer.
PURPOSE: This randomized phase III trial is studying second-line combination chemotherapy to
see how well it works compared with or without bevacizumab in treating patients with
metastatic colorectal cancer who have received first-line chemotherapy and bevacizumab.
</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 - KEYNOTE-032 (Chinese Patients)[/INST]
The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK) and
efficacy of three doses of pembrolizumab (MK-3475) in adult Chinese participants with locally
advanced or metastatic non-small-cell lung cancer (NSCLC).
Cycle 1 is 28 days long; subsequent cycles are 21 days long.
</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 - Three-Part Safety Study[/INST]
Parts 1 and 2:
Subjects take 1 dose of various formulations of the study product, and provide samples for
pharmacokinetic (PK) analysis after each, with at least 7 days between doses.
Part 3:
Subjects take 2-4 doses of study product or placebo for 6 days, plus 1 additional dose, and
provides samples for PK analysis.
</s> |
<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>>
A peripheral stem cell transplant may be able to replace blood-forming cells that were
destroyed by chemotherapy. Currently filgrastim (G-CSF), a colony stimulating factor, is used
to cause the growth and mobilization of stem cells from bone marrow to peripheral blood,
which can then be collected from the peripheral blood by a process called apheresis.
Plerixafor aids in the release of the stem cells from the bone marrow into the peripheral
blood, possibly allowing for a more rapid collection of a larger number of stem cells from
the peripheral blood. Larger stem cell doses for transplantation correlate to faster recovery
times after high dose chemotherapy followed with stem cell transplantation. This study is
intended to determine whether the combination of plerixafor with filgrastim (G-CSF)is better
than filgrastim (G-CSF) alone in helping multiple myeloma patients collect at least 6 million
stem cells in two or less apheresis sessions.
This study was previously posted by AnorMED, Inc. In November 2006, AnorMED, Inc. was
acquired by Genzyme Corporation. Genzyme Corporation is the sponsor of the trial.
[/INST]
The purpose of this study is to determine whether the combination of AMD3100 (plerixafor) and
granulocyte colony-stimulating factor (G-CSF, generic name of filgrastim) is better than
G-CSF alone to mobilize and collect the optimal number of stem cells in multiple myeloma
patients for autologous transplantation.
</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 - Karolinska and Uppsala University Hospitals[/INST]
This is a Phase II open, randomized, active comparator-controlled multi center study in
patients with severe type-1 diabetes. This is a two-armed study where patients are randomized
in a 2:1 ratio between IBsolvMIR and heparin. Eighteen patients are planned to be included.
The study consists of up to 8 visits; screening, transplantation surgery with bolus
administration of study drug or active comparator, IBsolvMIR doses on day 1, 3 and 6 after
surgery, follow up visits on day 7 and 14, and follow-up phone call on day 44.
The primary endpoint is to study AEs up to 44 days following study drug administration. The
secondary endpoints are to evaluate changes in TAT, C-peptide, C3a and HGF at baseline and
during the first 24 hours after study drug administration, as well as evaluate a change in
levels of C-peptide-glucose-creatinine ratio on day 14 compared to baseline.
</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 - Renaissance 4 (Fixed Dose)[/INST]
The purpose of this study is to determine if TC-5214 or placebo (a tablet that looks like
medicine tablet or capsule, but contains no active medicine) is safe and effective when taken
together with another antidepressant.
</s> |
<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>>
In this study, all patients will receive open-label (all people involved know the identity of
the intervention) telaprevir in addition to Peg IFN-alfa and RBV for treatment of hepatitis C
virus (HCV) and protocol permissible treatments for HIV. Chronic hepatitis C infection causes
inflammation of the liver which can potentially cause long-term complications of the current
liver disease (fibrosis or cirrhosis). Therefore it is important the patient is treated for
this infection. Telaprevir is an experimental medication that has been tested for the
treatment of hepatitis C infections in several previous studies in more than 2500 patients.
Telaprevir is a member of a new class of drugs being developed for chronic hepatitis C:
Direct Acting Antiviral (DAA) agents. Unlike pegylated interferon (Peg-IFN) and ribavirin
(RBV), DAA agents act directly on the hepatitis C virus (HCV) replication cycle. The aim of
the telaprevir treatment is to eradicate the Hepatitis C virus out of the patient's body.
This can be measured by testing the amount of a certain part of this Hepatitis C virus,
called the Ribonucleic acid (RNA [HCV RNA]) in their blood. It is possible that the patient
will not respond to the therapy and the levels of HCV RNA in their blood will not decrease or
even increase. Based on these results it might be decided the patient will not benefit from
treatment and he/she need to stop the telaprevir only or all medication for their hepatitis C
infection. The doctor will keep them informed about the patient's reaction to the treatment
and will take the necessary measurements as prescribed by the study protocol and routine
medical practice. During the study the patient will simultaneously be treated with the
therapy that the doctor would normally prescribe for treatment of their chronic hepatitis C
infection: "ribavirin (RBV)" and "pegylated interferon alfa (PEG-INF-alfa)". Telaprevir is
always administered in combination with RBV and PEG-IFN-alfa. In function of the patient's
specific HIV status, the doctor has prescribed, or not, a specific treatment that the patient
will continue to take during the study. This treatment could be: (a) efavirenz, tenofovir
disoproxil fumarate (TDF), plus either emtricitabine or lamivudine, (b) efavirenz, abacavir,
plus either emtricitabine or lamivudine, (c) ritonavir-boosted atazanavir, TDF, plus either
emtricitabine or lamivudine, (d) ritonavir-boosted atazanavir, abacavir, plus either
emtricitabine or lamivudine, (e) raltegravir, TDF, plus either emtricitabine or lamivudine,
(f) raltegravir, abacavir, plus either emtricitabine or lamivudine or (g) etravirine, TDF,
plus either emtricitabine or lamivudin, (h) etravirine, abacavir, plus either emtricitabine
or lamivudine, (i) rilpivirine, TDF, plus either emtricitabine or lamivudine, (j)
rilpivirine, abacavir, plus either emtricitabine or lamivudine, (k) no treatment. In an
interim analysis of a Phase 2a study, human immunodeficiency virus (HIV)-1/HCV genotype 1
coinfected patients currently receiving HIV therapy who had telaprevir added to Peg
IFN-alfa-2a and RBV regimen for treatment of their HCV genotype 1 infection had a higher HCV
RNA response (undetectable HCV RNA) at Weeks 4 and 12 than those who received only the
Peg-IFN-alfa-2a and RBV regimen. These responses were sustained through Week 24, with 73.7%
of patients who had telaprevir added to the Peg-IFN-alfa-2a and RBV regimen and 54.5% of
patients who received only the Peg-IFN-alfa-2a and RBV regimen also achieving undetectable
HCV RNA at Week 24. Patients with severe fibrosis or cirrhosis have a lower likelihood of
sustained virologic response (SVR) and also have the greatest risk of liver failure,
hepatocellular carcinoma (HCC), and death. Administering telaprevir in this difficult to
treat population may reduce the risk of long-term complications associated with HCV in
patients with HIV/HCV genotype 1 coinfection. All patients eligible to enter the study will
receive telaprevir (750 or 1,125 mg every 8 hours based on their Highly Active Antiretroviral
Therapy (HAART) regimen) during the first 12 weeks of the study in combination with Peg IFN
alfa/RBV. Patients will subsequently be treated with Peg-IFN-alfa/RBV for an additional 36
weeks. The total duration of Peg-IFN-alfa/RBV will be 48 weeks. HCV RNA levels should be
measured at Weeks 4, 12, 24 and 48. All patients should have a posttreatment follow-up visit,
including measurement of plasma HCV RNA levels, performed 24 weeks after the last
administered dose of treatment. Note that in certain countries, an additional main objective
of the study is to provide Early Access to telaprevir in this population.
[/INST]
The purpose of this study is to collect safety and tolerability data on telaprevir treatment
in combination with Peg-IFN-alfa and RBV in patients with HIV/genotype 1 chronic HCV
coinfection with severe fibrosis or compensated cirrhosis who are not eligible for enrollment
into an ongoing clinical study of telaprevir.
</s> |
<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>>
Cabozantinib (XL184) is an inhibitor of multiple receptor tyrosine kinases and was approved
by the U.S. Food and Drug Administration (FDA) on 29 November 2012 for the treatment of
patients with progressive, metastatic medullary thyroid cancer. It is commercially available
as COMETRIQ™ in the United States.
During the Pre Treatment Period, participants are consented and qualified (screened) for the
study. Treatment will be administered on an outpatient basis.
Each treatment cycle lasts 28 days, during which time the participant will be taking the
study drug, cabozantinib, once daily. The participant will be given a study drug-dosing diary
for each treatment cycle. The diary will also include special instructions for taking the
study drug.
- Participants will be followed for 8 weeks after removal from study or until death,
whichever occurs first. Participants removed from study for unacceptable adverse events will
be followed until resolution or stabilization of the adverse event.
[/INST]
This is an open-label, non-randomized, phase 2 study to assess the feasibility of using
cabozantinib in recurrent/metastatic Merkel Cell Carcinoma patients that progressed after
platinum-based 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 III - PINETREE (Outpatient Population)[/INST]
The primary objectives of this study are to evaluate the efficacy of remdesivir (RDV) in
reducing the rate of of coronavirus disease 2019 (COVID-19) related hospitalization or
all-cause death in non-hospitalized participants with early stage COVID-19 and to evaluate
the safety of RDV administered in an outpatient setting.
</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 - Dose-Ranging[/INST]
A Phase 2, Double-Blind (DB), Randomized, Placebo-Controlled Study Followed by an Open-Label
Extension Period to Evaluate the Activity of Seladelpar in Subjects with Nonalcoholic
Steatohepatitis (NASH)
OLE phase was not analyzed due to the early termination of 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 II - Primary Aldosteronism[/INST]
The purpose of the present phase II study is to determine whether DP13 displays the clinical
safety and efficacy profile to support further development in patients with primary
aldosteronism.
</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 - Vektis[/INST]
The objective of this study is to compare the efficacy of two different dosing regimen of
NOVA22007 (1mg/ml ciclosporin/cyclosporine) eye drops, emulsion versus placebo (vehicle of
the formulation) administered four times a day in patients with severe vernal
keratoconjunctivitis after 4 months of 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 III - FHA101[/INST]
This is an open-label study to provide metreleptin for the treatment of diabetes mellitus
and/or hypertriglyceridemia associated with lipodystrophy. This study intends to provide
guidance to investigators with respect to identification of appropriate subjects for
metreleptin treatment, guidance on metreleptin dosing, and collection of safety and efficacy
data following metreleptin treatment in this 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 III - Chronic Stable Plaque Psoriasis[/INST]
This study will compare the efficacy and safety of DFD-06 Cream to Vehicle Cream for topical
treatment of moderate to severe plaque psoriasis after 3, 7, and 14 days of 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 I - MTD (Japan)[/INST]
To determine the maximum tolerated dose (MTD) of OPB-51602
</s> |
<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>>
This is an open-label, multi-center Phase I/IIa two-part study with a sequential dose
escalation part, followed by three parallel Extension cohorts (BRAF-mutated melanoma,
BRAF-mutated non-melanoma solid tumors, and BRAF-mutated classical hairy cell leukemia). Up
to approximately 42 patients may be enrolled in the dose escalation phase of the study,
depending on the number of cohorts required, number of patients per cohort needed, and the
need for replacement patients. Approximately 130 patients are planned to be enrolled in the
BRAF-mutated tumor Extension cohorts, with the goal of enrolling approximately 50 patients
with BRAF/MEK/ERK inhibitor-naïve melanoma, approximately 10-15 patients with BRAF/MEK/ERK
inhibitor-pretreated melanoma, approximately 50 patients with non-melanoma solid tumors, and
approximately 10-15 patients with hairy cell leukemia. The trial was intended to be a Phase
1/2 trial, but the trial never moved forward to Phase 2.
[/INST]
The study objective is to evaluate the safety, pharmacokinetics (PK), and pharmacodynamics
(PD) of orally administered PLX8394 in patients with advanced solid tumors. An additional
objective is to identify a Recommended Phase 2 (RP2D) for further evaluation in the Extension
Cohorts (Phase IIa portion).
The study objective of the Extension Cohorts (PART 2 portion) is to assess the objective
tumor response and the PK, PD, and safety of PLX8394 when the RP2D is used in patients with
advanced BRAF-mutated cancers.
</s> |
<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>>
The aim of this single-arm, multicentre, open-label Phase II study is to evaluate the
Lenalidomide (LEN) combined with Tafasitamab (MOR00208) in adult participants with DLBCL who
had relapsed after or were refractory to at least one, but no more than three previous
systemic regimens administered for the treatment of their DLBCL and who were not candidates
for high-dose chemotherapy and subsequent Autologous stem cell transplants and were thus
considered to have exhausted their therapeutic options. One prior therapy line had to include
an anti-CD20 targeted therapy (e.g., rituximab [RTX]).
MOR00208 and LEN were administered for up to 12 cycles (28 days each), followed by MOR00208
monotherapy until progression, in participants with at least stable disease or a better
response.
[/INST]
This is a Phase II, Single-Arm, Open-Label, Multicentre Study to Evaluate the Safety and
Efficacy of Lenalidomide Combined with MOR00208 in Participants with Relapsed or Refractory
Diffuse Large B-Cell Lymphoma (R-R DLBCL).
</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 - Drug Interaction (Solids)[/INST]
Primary Objective:
- To assess the effect of 15-day repeated oral doses of 500 mg SAR302503 on the cytochrome
P450 activity using a CYP probe cocktail (2C19, 2D6 and 3A4).
- To document pharmacokinetics of SAR302503 after repeated 500 mg oral daily doses.
Secondary Objectives:
- To assess the safety profile of 15-day repeated oral doses of 500 mg SAR302503 in
Segment 1
- To characterize the safety and tolerability of 28-day consecutive doses of 500 mg
SAR302503 in Segment 2
- To determine antitumor activity in Segment 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 II - CL007 (Albuminuria)[/INST]
The purpose of this study is to evaluate the effect of treatment with CCX140-B on urinary
albumin excretion in subjects with type 2 diabetes mellitus and albuminuria, as well as to
study the safety and efficacy of the medication in this patient population.
</s> |
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