chufangao/CTO huggingface dataset:
Clinical trial NCT02432209: Improving Reproductive Fitness Through Pretreatment With Lifestyle Modification in Obese Women With Unexplained Infertility
Official title: Improving Reproductive Fitness Through Pretreatment With Lifestyle Modification in Obese Women With Unexplained Infertility
Acronym: FIT-PLESE
Sponsor: Yale University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 379.0 (ACTUAL)
Number of arms: 2.0
Start date: 2015-08-31
Primary completion date: 2019-11-30
Completion date: 2020-05-31
Plan to share individual participant data: YES
IPD sharing description: IPD will be shared with other researchers through the NICHD DASH system. It will be available 6 months after publication of the primary results.
Clinical trial NCT04845321: VNRX-9945 Safety and Pharmacokinetics in Healthy Adult Volunteers
Official title: Phase 1 Study to Evaluate the Safety and Pharmacokinetics of Single and Multiple Ascending Doses of VNRX-9945 in Healthy Adult Volunteers
Sponsor: Venatorx Pharmaceuticals, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Part 2 terminated, unrelated to safety.
Enrollment: 32.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-06-23
Primary completion date: 2021-10-31
Completion date: 2021-10-31
Clinical trial NCT03829657: Phase 3 Clinical Effect Durability of TD-9855 for Treating Symptomatic nOH in Subjects With Primary Autonomic Failure
Official title: A Phase 3, 22-week, Multi-center, Randomized Withdrawal Study of TD-9855 in Treating Symptomatic Neurogenic Orthostatic Hypotension in Subjects With Primary Autonomic Failure
Acronym: REDWOOD
Sponsor: Theravance Biopharma (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Stopped early due to company decision. Company decision based on analysis results in TD-9855-0169.
Enrollment: 203.0 (ACTUAL)
Number of arms: 3.0
Start date: 2019-02-22
Primary completion date: 2021-11-10
Completion date: 2021-11-10
Baseline population: OL Treatment Period Safety Analysis Set: all enrolled participants who received at least 1 dose of ampreloxetine during the OL period.
Limitations and caveats: De Novo participants in the OL treatment period had limited follow-up due to early termination of the study.
Plan to share individual participant data: NO
IPD sharing description: Theravance Biopharma, Inc. will not be sharing individual de-identified participant data or other relevant study documents.
Clinical trial NCT04371666: Phase 3 Trial of Pamrevlumab or Placebo With Systemic Corticosteroids in Participants With Non-ambulatory Duchenne Muscular Dystrophy (DMD)
Official title: A Phase 3, Randomized, Double-Blind Trial of Pamrevlumab (FG-3019) or Placebo in Combination With Systemic Corticosteroids in Subjects With Non-ambulatory Duchenne Muscular Dystrophy (DMD)
Acronym: LELANTOS-1
Sponsor: FibroGen (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Study did not meet its primary endpoint.
Enrollment: 98.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-08-10
Primary completion date: 2023-02-13
Completion date: 2023-08-17
Baseline population: The intent-to-treat (ITT) set included all randomized participants.
Plan to share individual participant data: UNDECIDED
Clinical trial NCT04768881: Safety and Efficacy of Selinexor in Combination With Pembrolizumab in Recurrent Advanced Melanoma
Official title: A Phase 2 Open-Label Multicenter Study to Evaluate the Safety and Efficacy of Selinexor in Combination With Pembrolizumab in Recurrent Advanced Melanoma
Sponsor: Karyopharm Therapeutics Inc (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: The trial was terminated due to a lack of sufficient anti-melanoma tumor signal for the combination of selinexor + pembrolizumab.
Enrollment: 15.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-05-12
Primary completion date: 2023-09-22
Completion date: 2023-09-22
Baseline population: Modified intent-to-treat (mITT) population consisted of all participants who received at least one dose of any study treatment.
Limitations and caveats: This study was stopped prematurely due to a lack of sufficient anti-tumor signal for the selinexor/pembrolizumab combination treatment in participants with advanced or metastatic melanoma.
Plan to share individual participant data: UNDECIDED
Clinical trial NCT03338205: The Role of Ketamine as an Adjuvant Therapy for Children With Acute Status Asthmaticus
Official title: The Role of Ketamine as an Adjuvant Therapy for Children With Acute Status Asthmaticus in Pediatric Emergency Medicine Patients: A Pilot Study
Sponsor: Augusta University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Why stopped: Unable to enroll patients
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-01-31
Primary completion date: 2021-12-31
Completion date: 2022-01-31
Clinical trial NCT02178358: A Study of LY2157299 in Participants With Advanced Hepatocellular Carcinoma
Official title: A Randomized Phase 2 Study of LY2157299 Versus LY2157299 - Sorafenib Combination Versus Sorafenib in Patients With Advanced Hepatocellular Carcinoma
Sponsor: Eli Lilly and Company (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 132.0 (ACTUAL)
Number of arms: 3.0
Start date: 2014-08-08
Primary completion date: 2017-06-30
Completion date: 2021-02-18
Baseline population: All randomized participants.
Plan to share individual participant data: YES
IPD sharing description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
IPD time frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and european union (EU), whichever is later. Data will be indefinitely available for requesting.
IPD access criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Clinical trial NCT04109742: Curcumin for Pediatric Nonalcoholic Fatty Liver Disease
Official title: Curcumin for Pediatric Nonalcoholic Fatty Liver Disease: A Pilot Randomized Controlled Trial
Sponsor: Columbia University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Lack of funding
Enrollment: 0.0 (ACTUAL)
Number of arms: 3.0
Start date: 2019-12-09
Primary completion date: 2020-04-22
Completion date: 2020-04-22
Plan to share individual participant data: NO
Clinical trial NCT01905592: A Phase III Trial of Niraparib Versus Physician's Choice in HER2 Negative, Germline BRCA Mutation-positive Breast Cancer Patients
Official title: A Phase III, Randomized, Open Label, Multicenter, Controlled Trial of Niraparib Versus Physician's Choice in Previously-treated, HER2 Negative, Germline BRCA Mutation-positive Breast Cancer Patients
Acronym: BRAVO
Sponsor: Tesaro, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: The study was terminated due to futility.
Enrollment: 216.0 (ACTUAL)
Number of arms: 2.0
Start date: 2014-02-25
Primary completion date: 2018-05-23
Completion date: 2021-10-26
Baseline population: The centrally-confirmed intent-to-treat population is defined as all randomized participants with a central confirmation of germline BRCA mutation.
Limitations and caveats: IDMC interim analysis concluded that concerns with the quantity and quality of data in the control arm precluded meaningful comparative analyses and generation of a clinically useful endpoint, therefore enrollment was ended prematurely.
Plan to share individual participant data: NO
Clinical trial NCT03901469: A Study of ZEN003694 and Talazoparib in Patients With Triple Negative Breast Cancer
Official title: A Phase 2b Study of ZEN003694 in Combination With Talazoparib in Patients With Triple-Negative Breast Cancer
Acronym: TNBC
Sponsor: Zenith Epigenetics (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Parts 1 and 2 and Expansion Cohort C were completed. Expansion Cohorts A and B were discontinued based on results from an interim futility analysis and not due to safety concerns.
Enrollment: 115.0 (ACTUAL)
Number of arms: 4.0
Start date: 2019-06-26
Primary completion date: 2024-03-07
Completion date: 2024-03-07
Plan to share individual participant data: NO
Clinical trial NCT02873195: Capecitabine and Bevacizumab With or Without Atezolizumab in Treating Patients With Refractory Metastatic Colorectal Cancer
Official title: BACCI: A Phase II Randomized, Double-Blind, Placebo-Controlled Study of Capecitabine Bevacizumab Plus Atezolizumab Versus Capecitabine Bevacizumab Plus Placebo in Patients With Refractory Metastatic Colorectal Cancer
Sponsor: Academic and Community Cancer Research United (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 133.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-07-07
Primary completion date: 2023-03-06
Completion date: 2023-12-01
Clinical trial NCT04163991: A Study to Evaluate the Safety and Efficacy of VIB4920 in Participants With Rheumatoid Arthritis
Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Mechanistic Insight and Dosage Optimization Study of the Efficacy and Safety of VIB4920 in Patients With Rheumatoid Arthritis (RA)
Acronym: MIDORA
Sponsor: Viela Bio (acquired by Horizon Therapeutics) (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 78.0 (ACTUAL)
Number of arms: 5.0
Start date: 2019-12-09
Primary completion date: 2021-12-28
Completion date: 2021-12-28
Baseline population: Full Analysis Set: all randomized participants who received any dose of study drug, analyzed according to the treatment randomized.
Plan to share individual participant data: NO
Clinical trial NCT02105636: Trial of Nivolumab vs Therapy of Investigator's Choice in Recurrent or Metastatic Head and Neck Carcinoma (CheckMate 141)
Official title: An Open Label, Randomized Phase 3 Clinical Trial of Nivolumab vs Therapy of Investigator's Choice in Recurrent or Metastatic Platinum-refractory Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Sponsor: Bristol-Myers Squibb (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 361.0 (ACTUAL)
Number of arms: 2.0
Start date: 2014-05-29
Primary completion date: 2015-11-06
Completion date: 2021-09-10
Clinical trial NCT05352815: A Research Study to See How Well the New Weekly Medicine IcoSema, Which is a Combination of Insulin Icodec and Semaglutide, Controls Blood Sugar Level in People With Type 2 Diabetes Compared to Weekly Insulin Icodec
Official title: A 52 Week Study Comparing the Efficacy and Safety of Once Weekly IcoSema and Once Weekly Insulin Icodec, Both Treatment Arms With or Without Oral Anti Diabetic Drugs, in Participants With Type 2 Diabetes Inadequately Controlled With Daily Basal Insulin.
Acronym: COMBINE 1
Sponsor: Novo Nordisk A/S (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 1291.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-06-01
Primary completion date: 2024-03-18
Completion date: 2024-04-23
Plan to share individual participant data: YES
IPD sharing description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Clinical trial NCT05643729: Zofin to Treat Chronic Obstructive Pulmonary Disease (COPD)
Official title: A Phase I/II Randomized, Double Blinded, Placebo Trial to Evaluate the Safety and Potential Efficacy of Intravenous Infusion (IV) of ZofinTM for the Treatment of Chronic Obstructive Pulmonary Disease (COPD)
Sponsor: ZEO ScientifiX, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: SUSPENDED 
Why stopped: Study is on hold
Enrollment: 20.0 (ESTIMATED)
Number of arms: 2.0
Start date: 2023-11-15
Primary completion date: 2024-05-30
Completion date: 2024-08-31
Plan to share individual participant data: NO
Clinical trial NCT04762771: Colchicine for the Treatment of Cardiac Injury in Hospitalized Patients With COVID-19 (COLHEART-19)
Official title: Open-label (Unblinded) Randomization to Treatment of Colchicine Plus Current Care Per Institution Treating Physicians vs. Current Care Per Institution Treating Physicians (Control Arm)
Acronym: Colheart-19
Sponsor: Baptist Health South Florida (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Recovery Trial showed no convincing evidence that further recruitment would provide conclusive proof of worthwhile benefit for the evaluation of Colchicine in patients with Covid-19.
Enrollment: 2.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-12-23
Primary completion date: 2021-05-12
Completion date: 2021-09-20
Limitations and caveats: The rapid decline in COVID patients and other competing trials did not allowed enrollment of additional subjects. Given the small sample size, the study was terminated.
Clinical trial NCT05012397: Milademetan in Advanced/Metastatic Solid Tumors
Official title: A Phase 2 Basket Study of Milademetan in Advanced/Metastatic Solid Tumors (MANTRA-2)
Sponsor: Rain Oncology Inc (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Sponsor Decision
Enrollment: 40.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-11-01
Primary completion date: 2023-10-15
Completion date: 2023-10-15
Plan to share individual participant data: NO
Clinical trial NCT04888858: Effect of Epidural Analgesia During Labor on Force of Maternal Push
Official title: Effect of Epidural Analgesia During Labor on Force of Maternal Push
Sponsor: Henry Ford Health System (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: The PI, Dr. Younger, left Henry Ford Health.
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-11-02
Primary completion date: 2022-07-02
Completion date: 2022-07-02
Plan to share individual participant data: NO
IPD sharing description: There is not a plan to share individual participant data with other researchers.
Clinical trial NCT03725722: Dose-ranging Trial to Evaluate Delgocitinib Cream 1, 3, 8, and 20 mg/g Compared to Delgocitinib Cream Vehicle Over an 8-week Treatment Period in Adult Subjects With Atopic Dermatitis.
Official title: A Phase 2b, Double-blind, Randomised, 5-arm, Vehicle-controlled, Dose Ranging Trial to Evaluate the Efficacy and Safety of Twice Daily Topical Applications of Delgocitinib Cream 1, 3, 8, 20 mg/g for 8 Weeks in Adult Subjects With Mild to Severe Atopic Dermatitis.
Sponsor: LEO Pharma (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 251.0 (ACTUAL)
Number of arms: 5.0
Start date: 2018-12-28
Primary completion date: 2020-05-19
Completion date: 2020-05-19
Baseline population: Number of subjects randomized
Plan to share individual participant data: YES
IPD access criteria: De-identified Individual Participant Data can be made available to researchers and is subject to approved scientifically sound research proposal and signed data-sharing agreement.
Clinical trial NCT03523728: A Medical Research Study Designed to Determine if Venglustat Can be a Future Treatment for ADPKD Patients
Official title: Multicenter, Randomized, Double-blind, Placebo-controlled Two Stage Study to Characterize the Efficacy, Safety, Tolerability and Pharmacokinetics of GZ/SAR402671 in Patients at Risk of Rapidly Progressive Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Acronym: STAGED-PKD
Sponsor: Sanofi (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: TERMINATED 
Why stopped: Interim analysis for futility of the Stage 1 of the EFC15392 study met the protocol specified stopping rule based on the primary endpoint. EFC15392 study was stopped for futility based on prespecified criteria and recommendation from DMC
Enrollment: 478.0 (ACTUAL)
Number of arms: 5.0
Start date: 2018-10-04
Primary completion date: 2021-08-03
Completion date: 2021-08-03
Baseline population: Analysis was performed on all participants randomized in the study.
Limitations and caveats: Following decision to discontinue EFC15392 based on the futility analysis, the two-steps analysis initially planned were not applicable, therefore only the final analysis of all safety endpoints (laboratory, vital sign, ECG, physical examination, BDI-II, and lens opacity) were performed on extended combined Stage 1 and Stage 2 safety population only.
Plan to share individual participant data: YES
IPD sharing description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Clinical trial NCT03823404: GAIN Trial: Phase 2/3 Study of COR388 in Subjects With Alzheimer's Disease
Official title: GAIN Trial: A Randomized, Double-Blind, Placebo-Controlled Study of COR388 in Subjects With Alzheimer's Disease
Sponsor: Cortexyme Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: COMPLETED 
Enrollment: 643.0 (ACTUAL)
Number of arms: 3.0
Start date: 2019-03-28
Primary completion date: 2022-01-01
Completion date: 2022-01-01
Baseline population: Safety Population
Plan to share individual participant data: NO
Clinical trial NCT03231397: Predictors of AAA Expansion and/or Rupture
Official title: Noninvasive Assessment of Abdominal Aortic Aneurysm (AAA) Wall Structural Integrity and Inflammation as Predictors of Expansion and/or Rupture
Sponsor: Washington University School of Medicine (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: We were unable to recruit more subjects who met the inclusion/exclusion criteria and we have closed the study.
Enrollment: 2.0 (ACTUAL)
Number of arms: 4.0
Start date: 2017-08-01
Primary completion date: 2020-04-30
Completion date: 2020-04-30
Baseline population: We were unable to enroll subjects in the control group and the AAA's undergoing treatment who met the inclusion/exclusion criteria.
Plan to share individual participant data: NO
Clinical trial NCT04114656: Effects of Intravenous GSK3858279 on a Battery of Evoked Pain Tests in Healthy Volunteers
Official title: A Randomized, Double-blind, Placebo-controlled, Three-period Two-treatment Incomplete-block Crossover Study to Investigate the Effects of Intravenous GSK3858279 on a Battery of Evoked Pain Tests in Healthy Participants
Sponsor: GlaxoSmithKline (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: This study was terminated due to meeting protocol defined futility.
Enrollment: 21.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-10-15
Primary completion date: 2021-09-16
Completion date: 2021-09-16
Plan to share individual participant data: YES
IPD sharing description: IPD for this study will be made available via the Clinical Study Data Request site.
IPD time frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.
IPD access criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
Clinical trial NCT04712721: Study of [68Ga]-FF58 in Patients With Selected Solid Tumors Expected to Overexpress αvβ3 and αvβ5 Integrins.
Official title: Phase I, Open-label, Multicenter Study to Evaluate the Imaging Performance, Safety, Biodistribution and Dosimetry of [68Ga]-FF58 in Adult Patients With Selected Solid Tumors Expected to Overexpress αvβ3 and αvβ5 Integrins.
Sponsor: Novartis (INDUSTRY)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: TERMINATED 
Why stopped: Business reasons
Enrollment: 14.0 (ACTUAL)
Number of arms: 4.0
Start date: 2021-10-14
Primary completion date: 2024-06-18
Completion date: 2024-07-01
Plan to share individual participant data: NO
Clinical trial NCT03170271: A Study of the Safety and Effectiveness of Benralizumab to Treat Patients With Severe Uncontrolled Asthma.
Official title: A Multicenter, Randomized, Double-blind, Parallel Group, Placebo Controlled, Phase 3b Study to Evaluate the Safety and Efficacy of Benralizumab 30 mg sc in Patients With Severe Asthma Uncontrolled on Standard of Care Treatment
Acronym: ANDHI
Sponsor: AstraZeneca (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 660.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-07-07
Primary completion date: 2019-09-25
Completion date: 2020-10-21
Baseline population: All patients in the full analysis set (FAS) who received any investigational product (IP) were included in the baseline analysis.
Plan to share individual participant data: YES
Clinical trial NCT03043651: Open-label Extension of Oral Treprostinil in Subjects With PH Associated With HFpEF
Official title: An Open-label Extension Study of Oral Treprostinil in Subjects With Pulmonary Hypertension (PH) Associated With Heart Failure With Preserved Ejection Fraction (HFpEF) - A Long-term Follow-up to Study TDE-HF-301
Sponsor: United Therapeutics (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Terminated by Sponsor
Enrollment: 48.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-01-30
Primary completion date: 2020-03-02
Completion date: 2020-03-02
Baseline population: All Subjects
Plan to share individual participant data: NO
Clinical trial NCT03762681: A Study of RO7239958 to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Healthy Volunteers and Participants With Chronic Hepatitis B Virus Infection
Official title: A Randomized, Placebo-controlled,Observer-blinded Study, to Evaluate Safety,Tolerability, Pharmacokinetics and Pharmacodynamics of RO7239958 in Healthy Volunteers and Patients With Chronic Hepatitis B Virus Infection
Sponsor: Hoffmann-La Roche (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: The study was terminated due to program discontinuation.
Enrollment: 55.0 (ACTUAL)
Number of arms: 3.0
Start date: 2018-12-14
Primary completion date: 2020-04-06
Completion date: 2020-04-06
Baseline population: Safety population included all study participants who received at least one dose of RO7239958 or placebo.
Plan to share individual participant data: YES
IPD sharing description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).
Clinical trial NCT04854434: A Study to Evaluate the Safety and Efficacy of Selinexor With or Without Pembrolizumab Versus Standard of Care in Previously Treated Metastatic Colorectal Cancer With RAS Mutations
Official title: A Phase 2 Open-Label Multicenter Study to Evaluate the Safety and Efficacy of Selinexor With or Without Pembrolizumab Versus Standard of Care in Previously Treated Metastatic Colorectal Cancer With RAS Mutations
Sponsor: Karyopharm Therapeutics Inc (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Sponsor decision
Enrollment: 13.0 (ACTUAL)
Number of arms: 3.0
Start date: 2021-06-29
Primary completion date: 2022-06-24
Completion date: 2022-06-24
Limitations and caveats: Prior to study completion, the signal was assessed by sponsor to be uncompetitive in the current treatment landscape and thus CRC program was closed. Thereby some of the protocol planned analysis were not performed and thus no data was reported for those outcome measures.
Plan to share individual participant data: UNDECIDED