chufangao/CTO huggingface dataset:
Clinical trial NCT04584034: Bronchodilators for Wheeze in Young Children Presenting to Primary Care: a Randomised, Placebo-controlled, Multicentre, Parallel Group Trial
Official title: Bronchodilators for Wheeze in Young Children Presenting to Primary Care: a Randomised, Placebo-controlled, Multicentre, Parallel Group Trial
Acronym: KIWI
Sponsor: UMC Utrecht (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: Premature ending of the study due to impossibility of obtaining a suitable placebo-inhaler
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-09-30
Primary completion date: 2023-04-30
Completion date: 2023-04-30
Plan to share individual participant data: YES
IPD sharing description: We will make our data accessable for verification and future research (other researchers / spin-off projects), yet these will be shared under restrictions. Data cannot be reused without consulting the research team.
IPD time frame: Data will only be accessable after publication of trial results. Data will be stored for at least 25 years.
IPD access criteria: On request, after approval of principle investigator.
Clinical trial NCT03904251: CPX-351 and Gemtuzumab Ozogamicin in Treating Patients With Relapsed Acute Myeloid Leukemia
Official title: A Phase Ib Trial With Dose Expansion Evaluating CPX-351 Plus Gemtuzumab Ozogamicin for Relapsed Acute Myelogenous Leukemia
Sponsor: Jonsson Comprehensive Cancer Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: slow accrual
Enrollment: 13.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-07-18
Primary completion date: 2023-10-25
Completion date: 2023-10-25
Clinical trial NCT02673398: Neratinib in Treating Older Patients With Stage IV HER2-Positive Breast Cancer
Official title: Phase II Study of Neratinib in Patients 60 and Older With HER2 Positive Metastatic Breast Cancer
Sponsor: City of Hope Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 25.0 (ACTUAL)
Number of arms: 1.0
Start date: 2016-12-02
Primary completion date: 2020-03-12
Completion date: 2022-09-22
Clinical trial NCT05211284: Saroglitazar Magnesium 4 mg for NAFLD in People Living With HIV in the US
Official title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial of Saroglitazar Magnesium for the Treatment of Nonalcoholic Fatty Liver Disease (NAFLD) in People Living With Human Immunodeficiency Virus (HIV) in the US
Acronym: SARONAPLUS
Sponsor: Zydus Therapeutics Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Sponsor Decision
Enrollment: 4.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-12-08
Primary completion date: 2023-10-02
Completion date: 2023-10-02
Clinical trial NCT02994953: A Phase Ib Study to Evaluate the Safety, Tolerability, and Pharmacokinetics (PK) of Avelumab in Combination With M9241(NHS-IL12) (JAVELIN IL-12)
Official title: A Phase Ib Open-Label, Dose-Finding Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of Avelumab in Combination With M9241(NHS-IL12) in Subjects With Locally Advanced, Unresectable, or Metastatic Solid Tumors
Acronym: COMBO
Sponsor: EMD Serono (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: The study was terminated due to pre-specified futility criteria met.
Enrollment: 52.0 (ACTUAL)
Number of arms: 6.0
Start date: 2017-01-31
Primary completion date: 2020-10-08
Completion date: 2020-10-08
Limitations and caveats: The study was terminated due to pre-specified futility criteria met.
Plan to share individual participant data: NO
IPD sharing description: We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and the European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21
Clinical trial NCT03549871: A Study of Fitusiran in Severe Hemophilia A and B Patients Previously Receiving Factor or Bypassing Agent Prophylaxis
Official title: ATLAS-PPX: an Open-label, Multinational, Switching Study to Describe the Efficacy and Safety of Fitusiran Prophylaxis in Patients With Hemophilia A and B Previously Receiving Factor or Bypassing Agent Prophylaxis.
Acronym: ATLAS-PPX
Sponsor: Sanofi (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 80.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-07-25
Primary completion date: 2022-01-20
Completion date: 2022-03-25
Baseline population: Baseline analysis population included all completed participants from BPA/factor prophylaxis period + 2 participants from Cohort A subgroup who directly enrolled to fitusiran treatment period.
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 NCT03927573: Study With Bispecific Antibody Engaging T-cells, in Patients With Progressive Cancer Diseases With Positive PSCA Marker
Official title: A Multicenter, Open-label, Dose-escalating, Phase I Trial With GEM3PSCA, a PSCA Targeted Bispecific Antibody Engaging T-cells, in Patients With Progressive Disease After Standard Systemic Therapy in Cancers With Positive PSCA Marker
Sponsor: AvenCell Europe GmbH (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: business decision by sponsor
Enrollment: 23.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-04-15
Primary completion date: 2023-06-28
Completion date: 2023-06-28
Plan to share individual participant data: NO
Clinical trial NCT03313180: A Trial to Evaluate the Safety of Long Term Treatment With Nintedanib in Patients With Scleroderma Related Lung Fibrosis
Official title: An Open-label Extension Trial of the Long Term Safety of Nintedanib in Patients With 'Systemic Sclerosis Associated Interstitial Lung Disease' (SSc-ILD)
Sponsor: Boehringer Ingelheim (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 444.0 (ACTUAL)
Number of arms: 1.0
Start date: 2017-11-27
Primary completion date: 2023-01-25
Completion date: 2023-01-25
Baseline population: Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication
Plan to share individual participant data: YES
IPD sharing description: After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed Document Sharing Agreement.~Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.~The data shared are the raw clinical study data sets.
IPD time frame: After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
IPD access criteria: For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.
Clinical trial NCT04050852: Pulmonary Function Test Changes and Respiratory Muscle Strength Trends in Spinal Muscular Atrophy Patients Receiving Nusinersen Treatments
Official title: Pulmonary Function Test Changes and Respiratory Muscle Strength Trends in Spinal Muscular Atrophy Patients Receiving Nusinersen Treatments
Sponsor: NYU Langone Health (OTHER)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: WITHDRAWN 
Why stopped: no enrolled prospects
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-07-17
Primary completion date: 2021-04-01
Completion date: 2021-04-01
Clinical trial NCT03144661: An Open-Label Safety and Tolerability Study of INCB062079 in Subjects With Advanced Hepatocellular Carcinoma and Other Malignancies
Official title: A Phase 1, Open-Label, Dose-Escalation and Expansion, Safety and Tolerability Study of INCB062079 in Subjects With Advanced Hepatocellular Carcinoma and Other Malignancies
Sponsor: Incyte Corporation (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Strategic Business Decision
Enrollment: 25.0 (ACTUAL)
Number of arms: 4.0
Start date: 2017-05-25
Primary completion date: 2020-06-10
Completion date: 2020-06-10
Plan to share individual participant data: UNDECIDED
Clinical trial NCT03858972: Tesetaxel Plus Reduced Dose of Capecitabine in Patients With HER2 Negative, HR Positive, LA/MBC
Official title: Multinational, Multicenter, Phase 2 Study of Tesetaxel Plus a Reduced Dose of Capecitabine in Patients With HER2 Negative, Hormone Receptor Positive, Locally Advanced or Metastatic Breast Cancer Who Have Not Previously Received a Taxane
Acronym: CONTESSA 2
Sponsor: Odonate Therapeutics, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: The Sponsor has discontinued the development of tesetaxel
Enrollment: 152.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-02-05
Primary completion date: 2021-06-11
Completion date: 2021-06-11
Clinical trial NCT03275597: Phase Ib Study of Stereotactic Body Radiotherapy (SBRT) in Oligometastatic Non-small Lung Cancer (NSCLC) With Dual Immune Checkpoint Inhibition
Official title: Comprehensive Stereotactic Body Radiotherapy (SBRT) to All Sites of Oligometastatic Non-small Cell Lung Cancer (NSCLC) Combined With Durvalumab (MEDI4736) and Tremelimumab Dual Immune Checkpoint Inhibition.
Sponsor: University of Wisconsin, Madison (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: slow accrual
Enrollment: 17.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-02-20
Primary completion date: 2020-07-01
Completion date: 2020-07-01
Clinical trial NCT03395405: NNITS-Nitazoxanide for Norovirus in Transplant Patients Study
Official title: A Phase 2 Multi-Center, Prospective, Randomized, Double-Blind Study to Assess the Clinical and Antiviral Efficacy and Safety of Nitazoxanide for the Treatment of Norovirus in Hematopoietic Stem Cell and Solid Organ Transplant Recipients
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 31.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-10-15
Primary completion date: 2021-08-24
Completion date: 2021-08-24
Clinical trial NCT04189952: Acalabrutinib in Combination With R-ICE For Relapsed or Refractory Lymphoma
Official title: A Phase 2, Open-Label Study of Acalabrutinib in Combination With R-ICE For Relapsed or Refractory Non-Germinal Center Diffuse Large B Cell Lymphoma, Transformed Chronic Lymphocytic Leukemia/Small Lymphocytic Leukemia or Transformed Marginal Zone Lymphoma
Sponsor: University of Miami (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Investigator Decision
Enrollment: 2.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-09-22
Primary completion date: 2021-06-30
Completion date: 2022-03-01
Limitations and caveats: To protect participant privacy and maintain confidentiality, results will not be reported.
Plan to share individual participant data: NO
Clinical trial NCT02460692: Trial of Dronabinol and Vaporized Cannabis in Chronic Low Back Pain
Official title: A Randomized Controlled Trial of Dronabinol and Vaporized Cannabis in Chronic Low Back Pain
Sponsor: University of California, San Diego (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 131.0 (ACTUAL)
Number of arms: 3.0
Start date: 2016-12-31
Primary completion date: 2020-03-25
Completion date: 2020-03-25
Plan to share individual participant data: UNDECIDED
Clinical trial NCT03006770: Efficacy, Tolerability and Safety of Intramuscular Injections of PLX PAD for the Treatment of Subjects With Critical Limb Ischemia (CLI) With Minor Tissue Loss Who Are Unsuitable for Revascularization
Official title: Efficacy, Tolerability and Safety of Intramuscular Injections of PLX PAD for the Treatment of Subjects With Critical Limb Ischemia (CLI) With Minor Tissue Loss Who Are Unsuitable for Revascularization
Sponsor: Pluristem Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 213.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-05-22
Primary completion date: 2021-03-03
Completion date: 2022-04-20
Clinical trial NCT04072601: Statins for Prevention of Disease Progression and Hospitalization in Liver Cirrhosis
Official title: Statins for Prevention of Disease Progression and Hospitalization in Liver Cirrhosis: A Multi-center, Randomized, Double Blind, Placebo-controlled Trial. The STATLiver Trial
Acronym: STATLiver
Sponsor: Copenhagen University Hospital, Hvidovre (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Study part one completed
Enrollment: 78.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-11-08
Primary completion date: 2022-07-31
Completion date: 2023-01-10
Plan to share individual participant data: YES
IPD sharing description: IPD and supporting information are planned to be shared via data repository sites, such as UCPH data repository or other public data repository.
IPD time frame: Data will be stored for up to 10 years after completion of the trial, depending on approval from Danish Health Authorities, Scientific Ethics Comittee and the Danish Data Protection Regulation.
IPD access criteria: upon request
Clinical trial NCT03870880: Study to Evaluate the Efficacy and Safety of Risperidone ISM® in Patients With Acute Schizophrenia: Open Label Extension
Official title: Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Intramuscular Injections of Risperidone ISM® in Patients With Acute Exacerbation of Schizophrenia: Open Label Extension (PRISMA-3_OLE)
Acronym: PRISMA-3_OLE
Sponsor: Rovi Pharmaceuticals Laboratories (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 215.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-08-25
Primary completion date: 2020-01-08
Completion date: 2020-01-08
Baseline population: All analyses were undertaken on the population of patients who received at least one dose of study drug during the OLE study.
Plan to share individual participant data: NO
Clinical trial NCT03950414: A Dose-Escalation Study Evaluating Safety and Tolerability of Viral-Specific T Cells Against CMV in Adult Solid Organ Transplant Recipients
Official title: A Phase I Dose-Escalation Study Evaluating Safety and Tolerability of Viral-Specific T Cells Against CMV in Adult Solid Organ Transplant Recipients
Sponsor: University of Wisconsin, Madison (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Insufficient Patient Population
Enrollment: 2.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-09-27
Primary completion date: 2022-07-11
Completion date: 2022-07-11
Plan to share individual participant data: NO
Clinical trial NCT04108468: GOLimumab and Methotrexate Versus Methotrexate in Very Early PsA (GOLMEPsA)
Official title: An Investigator-initiated Double-blind, Parallel-group Randomised Controlled Trial of GOLimumab and Methotrexate Versus Methotrexate in Very Early PsA Using Clinical and Whole Body MRI Outcomes: the GOLMePsA Study.
Acronym: GOLMePsA
Sponsor: The Leeds Teaching Hospitals NHS Trust (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 84.0 (ACTUAL)
Number of arms: 2.0
Start date: 2015-10-27
Primary completion date: 2023-07-31
Completion date: 2023-07-31
Plan to share individual participant data: NO
Clinical trial NCT03926117: Trial to Evaluate Reduction in Inflammation in Patients With Advanced Chronic Renal Disease Utilizing Antibody Mediated IL-6 Inhibition
Official title: A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate Reduction in Inflammation in Patients With Advanced Chronic Renal Disease Utilizing Antibody Mediated IL-6 Inhibition
Acronym: RESCUE
Sponsor: Novo Nordisk A/S (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 264.0 (ACTUAL)
Number of arms: 4.0
Start date: 2019-06-03
Primary completion date: 2020-06-26
Completion date: 2020-06-26
Baseline population: Intent-to-treat (ITT) analysis population included all randomized participants.
Plan to share individual participant data: YES
IPD sharing description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Clinical trial NCT03222973: Efficacy and Safety of BIIB033 (Opicinumab) as an Add-on Therapy to Disease-Modifying Therapies (DMTs) in Relapsing Multiple Sclerosis (MS)
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study With Optional Open-Label Extension in Subjects With Relapsing Multiple Sclerosis to Evaluate the Efficacy and Safety of BIIB033 as an Add-On Therapy to Anti-Inflammatory Disease-Modifying Therapies
Acronym: AFFINITY
Sponsor: Biogen (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: The top-line results from the Part 1 did not meet the pre-specified primary endpoint nor the key secondary endpoints. The decision to discontinue study 215MS202 Part 2 was not based on safety concerns.
Enrollment: 263.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-11-15
Primary completion date: 2021-02-12
Completion date: 2021-02-12
Baseline population: Intent-to-treat (ITT) population included all randomized participants who received at least 1 dose of study treatment. Participants were analyzed according to their treatment assignment regardless of actual treatment received.
Limitations and caveats: The top-line results from the Part 1 did not meet the pre-specified primary endpoint nor the key secondary endpoints. The decision to discontinue study 215MS202 Part 2 was not based on safety concerns.
Clinical trial NCT04504331: Study of Infigratinib in Combination With Tamoxifen in Hormone Receptor Positive, HER2 Negative, FGFR Altered Advanced Breast Cancer
Official title: A Phase 1B Study of Infigratinib in Combination With Tamoxifen in Hormone Receptor Positive, HER2 Negative, FGFR Altered Advanced Breast Cancer
Sponsor: Stanford University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Drug manufacturer decision to terminate development.
Enrollment: 4.0 (ACTUAL)
Number of arms: 3.0
Start date: 2020-10-13
Primary completion date: 2021-10-22
Completion date: 2021-10-22
Plan to share individual participant data: NO
Clinical trial NCT00114140: Temozolomide and Radiation Therapy in Treating Patients With Gliomas
Official title: A Phase II Study of a Temozolomide-Based Chemoradiotherapy Regimen for High-Risk Low-Grade Gliomas
Sponsor: Radiation Therapy Oncology Group (NETWORK)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 136.0 (ACTUAL)
Number of arms: 1.0
Start date: 2005-01-31
Primary completion date: 2013-02-28
Completion date: 2022-05-20
Baseline population: Eligible patients
Limitations and caveats: Quality of life endpoint was added via an amendment while study was in progress.
Clinical trial NCT03992131: A Study to Evaluate Rucaparib in Combination With Other Anticancer Agents in Participants With a Solid Tumor (SEASTAR)
Official title: SEASTAR: A Phase 1b/2, Open-label, Parallel Arm Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Oral Rucaparib in Combination With Other Anticancer Agents in Patients With a Solid Tumor
Sponsor: pharmaand GmbH (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Due to a change in development priorities, no further clinical development of the lucitanib plus rucaparib or lucitanib plus sacituzumab govitecan combinations is planned at this time.
Enrollment: 25.0 (ACTUAL)
Number of arms: 3.0
Start date: 2019-06-28
Primary completion date: 2022-03-08
Completion date: 2022-04-22
Baseline population: Safety population included all participants who have received at least 1 dose of study drug.
Limitations and caveats: The study was terminated due to Sponsor's decision to discontinue development of the combination of rucaparib and sacituzumab govitecan.
Clinical trial NCT04725240: Open-Label Study of Setmelanotide in Hypothalamic Obesity
Official title: A Phase 2, Open-Label 20-Week Study to Evaluate the Safety and Efficacy of Setmelanotide in Subjects With Hypothalamic Obesity
Sponsor: Rhythm Pharmaceuticals, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 18.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-06-07
Primary completion date: 2022-06-28
Completion date: 2022-06-28
Baseline population: The Full Analysis Set included all participants who received at least 1 dose of setmelanotide and had baseline data.
Plan to share individual participant data: NO
Clinical trial NCT03984370: Dasiglucagon in the Treatment of Postprandial Hypoglycaemia After Roux-en-Y Gastric Bypass
Official title: Dasiglucagon in the Treatment of Postprandial Hypoglycaemia After Roux-en-Y Gastric Bypass
Sponsor: University Hospital, Gentofte, Copenhagen (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 10.0 (ACTUAL)
Number of arms: 3.0
Start date: 2019-09-18
Primary completion date: 2020-02-26
Completion date: 2020-02-26
Plan to share individual participant data: NO
Clinical trial NCT04165031: A Study of LY3499446 in Participants With Advanced Solid Tumors With KRAS G12C Mutation
Official title: A Phase 1/2 Study of LY3499446 Administered to Patients With Advanced Solid Tumors With KRAS G12C Mutation
Sponsor: Eli Lilly and Company (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: The study was terminated due to an unexpected toxicity finding.
Enrollment: 5.0 (ACTUAL)
Number of arms: 6.0
Start date: 2019-11-28
Primary completion date: 2020-10-30
Completion date: 2020-10-30
Baseline population: All participants who received at least one dose of study drug
Limitations and caveats: The study was terminated due to an unexpected toxicity finding.
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 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.