chufangao/CTO huggingface dataset:
Clinical trial NCT03354611: Contrast-Enhanced Cone Beam Breast CT for Diagnostic Breast Imaging
Official title: Contrast-Enhanced Cone Beam Breast CT for Diagnostic Breast Imaging
Sponsor: Koning Corporation (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: TERMINATED 
Why stopped: The study progress doesn't meet the sponsor's requirement
Enrollment: 21.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-09-10
Primary completion date: 2021-09-01
Completion date: 2021-09-01
Plan to share individual participant data: NO
Clinical trial NCT04334629: LIBERATE Trial in COVID-19
Official title: Lipid Ibuprofen Versus Standard of Care for Acute Hypoxemic Respiratory Failure Due to COVID-19: a Multicentre, Randomised, Controlled Trial
Acronym: LIBERATE
Sponsor: King's College London (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: Study withdrawn.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-05-26
Primary completion date: 2021-05-25
Completion date: 2021-09-25
Plan to share individual participant data: UNDECIDED
Clinical trial NCT03310593: Cannabidiol as an Adjunctive Treatment for Bipolar Depression
Official title: A Double-blind, Randomized, Placebo-controlled Clinical Trial of Adjunctive Cannabidiol for Bipolar Depression
Acronym: CBDBD
Sponsor: Hospital de Clinicas de Porto Alegre (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: TERMINATED 
Why stopped: It was interrupted due to the coronavirus pandemic outbreak.
Enrollment: 36.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-11-01
Primary completion date: 2020-02-24
Completion date: 2020-03-24
Plan to share individual participant data: NO
Clinical trial NCT04425733: MK-5475 in Participants With Hypoxemia Due to COVID-19 Pneumonia (MK-5475-009)
Official title: A Study to Assess the Safety, Tolerability, and Pharmacodynamics of Multiple Dose MK-5475 in Participants With Hypoxemia Due to COVID-19 Pneumonia
Sponsor: Merck Sharp & Dohme LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: Business reasons
Enrollment: 0.0 (ACTUAL)
Number of arms: 6.0
Start date: 2020-07-07
Primary completion date: 2020-11-10
Completion date: 2020-11-10
Plan to share individual participant data: YES
IPD sharing description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Clinical trial NCT02644525: Efficacy and Microfilaricidal Kinetics of Imatinib for the Treatment of Loa Loa
Official title: A Double-blinded, Randomized, Placebo-Controlled Dose Escalation Study to Examine the Efficacy and Microfilaricidal Kinetics and Safety of Imatinib for the Treatment of Loa Loa (A Pilot Study)
Sponsor: National Institutes of Health Clinical Center (CC) (NIH)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Planned interim analysis demonstrated futility of intervention
Enrollment: 20.0 (ACTUAL)
Number of arms: 4.0
Start date: 2019-09-16
Primary completion date: 2020-12-31
Completion date: 2021-03-19
Clinical trial NCT03274440: Effects of Marijuana on Symptoms of OCD
Official title: Effects of Marijuana on Symptoms of Obsessive-Compulsive Disorder
Acronym: ECOS
Sponsor: New York State Psychiatric Institute (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: COMPLETED 
Enrollment: 14.0 (ACTUAL)
Number of arms: 3.0
Start date: 2017-10-01
Primary completion date: 2019-03-01
Completion date: 2020-10-29
Baseline population: Baseline characteristics for all study completers
Plan to share individual participant data: NO
Clinical trial NCT05109650: Assessment of Safety and Preliminary Efficacy With BAT6026 in Solid Tumour Patients
Official title: A Phase 1, Multi-Center, Open-Label Study to Assess Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of BAT6026 as Monotherapy and in Combination With BAT1308 in Patients With Advanced Solid Tumours
Sponsor: Bio-Thera Solutions (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Considering that the high budget will affect the subsequent development, it is decided to terminate the test voluntarily
Enrollment: 13.0 (ACTUAL)
Number of arms: 6.0
Start date: 2021-11-15
Primary completion date: 2023-03-23
Completion date: 2023-03-23
Plan to share individual participant data: NO
IPD sharing description: no plan to share IPD
Clinical trial NCT05651711: A Study Assessing Rocatinlimab (AMG 451) Monotherapy in Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-Horizon)
Official title: A Phase 3, Randomized, 24-week, Placebo-controlled, Double-blind Study to Assess the Efficacy, Safety and Tolerability of Rocatinlimab (AMG 451) Monotherapy in Adult Subjects With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-Horizon)
Acronym: ROCKET-Horizon
Sponsor: Amgen (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 726.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-12-14
Primary completion date: 2024-06-05
Completion date: 2024-08-23
Plan to share individual participant data: YES
IPD sharing description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
IPD time frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
IPD access criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
Clinical trial NCT05434091: A First-In-Human Study of the Study Medicine, Called PF-07291177, in Healthy Adult Participants
Official title: A PHASE 1, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO CONTROLLED, 4-PERIOD, CROSSOVER, FIRST-IN-HUMAN STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF SINGLE ASCENDING ORAL DOSES OF PF 07291177 ADMINISTERED TO HEALTHY ADULT PARTICIPANTS
Sponsor: Pfizer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: Study stopped due to change in strategy.
Enrollment: 0.0 (ACTUAL)
Number of arms: 3.0
Start date: 2022-08-15
Primary completion date: 2023-03-29
Completion date: 2023-03-29
Plan to share individual participant data: NO
IPD sharing description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Clinical trial NCT05070754: Cold Atmospheric Plasma Device for Pediatric Molluscum and Verruca
Official title: Using a Cold Atmospheric Plasma Device to Treat Molluscum Contagiosum and Verruca Vulgaris in Pediatric Patients
Sponsor: Medical University of South Carolina (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 17.0 (ACTUAL)
Number of arms: 3.0
Start date: 2021-12-02
Primary completion date: 2022-12-31
Completion date: 2022-12-31
Limitations and caveats: Limitations:~* Study was adequately powered with the number of lesions, but a small number of patients enrolled~* Low enrollment of patients with skin of color~* Patients limited to only three treatments with the NTAP device~* Assessment of sustained treatment response was limited to 4 weeks after treatment \& may not represent long-term response~* Post-treatment sequelae were measured at the end of the study period. We are unable to determine whether they persisted or self-resolved.
Plan to share individual participant data: NO
Clinical trial NCT05127473: A Research Study of How a New Medicine NNC0365-3769 (Mim8) Works in the Body of Healthy People
Official title: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Subcutaneous Dose of Reformulated NNC0365-3769 (Mim8) in Healthy Male Participants
Sponsor: Novo Nordisk A/S (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 66.0 (ACTUAL)
Number of arms: 12.0
Start date: 2021-07-14
Primary completion date: 2022-05-14
Completion date: 2022-05-14
Plan to share individual participant data: YES
IPD sharing description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Clinical trial NCT03937791: Immunotherapy With E7 T Cell Receptor T Cells for Vulvar High-Grade Squamous Intraepithelial Lesions
Official title: A Phase II Study of Immunotherapy With E7 T Cell Receptor T Cells for Vulvar High-Grade Squamous Intraepithelial Lesions
Sponsor: National Institutes of Health Clinical Center (CC) (NIH)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: All analysis with identifiable specimens/data is complete or site has no identifiers linked to the specimens/data. The one enrolled pt has been taken off study
Enrollment: 1.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-10-09
Primary completion date: 2020-06-22
Completion date: 2020-06-22
Plan to share individual participant data: NO
Clinical trial NCT04405908: SCB-2019 as COVID-19 Vaccine
Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled, First-in-human Study to Evaluate the Safety and Immunogenicity of SCB 2019, a Recombinant SARS-CoV-2 Trimeric S Protein Subunit Vaccine for COVID-19 in Healthy Volunteers.
Sponsor: Clover Biopharmaceuticals AUS Pty Ltd (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 166.0 (ACTUAL)
Number of arms: 27.0
Start date: 2020-06-19
Primary completion date: 2021-10-20
Completion date: 2021-12-08
Clinical trial NCT04795466: Study of the Efficacy and Safety of Various Anti-inflammatory Agents in Participants With Mild Cognitive Impairment or Mild Alzheimer's Disease
Official title: Exploratory PLatform Trial on Anti-Inflammatory Agents in Alzheimer's Disease (EXPLAIN-AD): A Randomized, Placebo-controlled, Multicenter Platform Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of Various Anti-inflammatory Agents in Patients With Mild Cognitive Impairment Due to Alzheimer's Disease and Mild Alzheimer's Disease
Sponsor: Novartis (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Terminated by Novartis for strategic reasons.. Decision was not safety related.
Enrollment: 34.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-10-28
Primary completion date: 2024-03-07
Completion date: 2024-03-07
Plan to share individual participant data: YES
IPD sharing description: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on https://www.clinicalstudydatarequest.com/
Clinical trial NCT04061798: ACT Guided Heparinization During Open Abdominal Aortic Aneurysm Repair.
Official title: ACTION-1: ACT Guided Heparinization During Open Abdominal Aortic Aneurysm Repair, a Randomised Trial.
Acronym: ACTION-1
Sponsor: Dijklander Ziekenhuis (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Futility
Enrollment: 294.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-03-02
Primary completion date: 2024-04-13
Completion date: 2024-04-29
Plan to share individual participant data: YES
IPD sharing description: under pre-defined conditions and contract
IPD time frame: after data lock, 07-2024
IPD access criteria: contract with pre-defined criteria according to government regulation concerning science research
Clinical trial NCT04075396: A Study of Lazertinib in Participants With Epidermal Growth Factor Receptor (EGFR) Mutation Positive Advanced Non-Small Cell Lung Cancer (NSCLC)
Official title: A Phase I/II, Open-Label, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-Tumor Activity of YH25448 in Patients With EGFR Mutation Positive Advanced Non-Small Cell Lung Cancer (NSCLC)
Sponsor: Janssen Research & Development, LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: COMPLETED 
Enrollment: 29.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-10-16
Primary completion date: 2021-01-08
Completion date: 2022-11-14
Baseline population: The safety analysis population included all participants who received at least 1 dose of investigational product (IP).
Limitations and caveats: Study Parts A, B, and C were sponsored by Yuhan Corporation under protocol identifier (ID) YH25448-201 and Part D was sponsored by Janssen Research and Development, LLC under protocol ID 73841937NSC2001. Therefore, only Part D results are reported.
Plan to share individual participant data: YES
IPD sharing description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency.~As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Clinical trial NCT03637868: Eribulin in Brain Metastases From HER2-negative Breast Cancer
Official title: A Phase II Study of Eribulin in Brain Metastases From HER2-negative Breast Cancer Pre-treated With Anthracyclines and Taxanes
Acronym: ERIBRAIN
Sponsor: Institut Paoli-Calmettes (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: no enrollment
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-02-26
Primary completion date: 2020-04-14
Completion date: 2020-04-14
Plan to share individual participant data: NO
Clinical trial NCT05191862: Bioequivalence Study of Once Daily PMR Compared to Twice Daily Cilostazol IR Tablets in Healthy Volunteers
Official title: An Open-Label, Randomized, Two-Treatment, Two-Sequence, Four-Period, Fully Replicated Crossover Bioequivalence Study of Once Daily PMR Compared to Twice Daily Cilostazol IR Tablets in Healthy Volunteers
Sponsor: Genovate Biotechnology Co., Ltd., (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Randomization Error
Enrollment: 19.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-04-23
Primary completion date: 2022-05-04
Completion date: 2022-05-07
Clinical trial NCT03807063: Rivogenlecleucel Donor Lymphocyte Immunotherapy in Treating Patients With Recurrent Blood Cancers After Stem Cell Transplant
Official title: Phase I Trial With Off-The-Shelf Third-Party BPX-501 Donor Lymphocyte Immunotherapy to Treat Persistence or Relapse of Hematologic Malignancies After Allogeneic Stem Cell Transplantation
Sponsor: Fred Hutchinson Cancer Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: Insufficient funding
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-01-02
Primary completion date: 2020-12-31
Completion date: 2021-12-31
Plan to share individual participant data: NO
Clinical trial NCT02697201: Dynamics of Muscle Mitochondria in Type 2 Diabetes (DYNAMMO T2D)
Official title: Dynamics of Muscle Mitochondria in Type 2 Diabetes (DYNAMMO-T2D)
Acronym: DYNAMMO-T2D
Sponsor: Pennington Biomedical Research Center (OTHER)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: COMPLETED 
Enrollment: 25.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-07-31
Primary completion date: 2021-05-31
Completion date: 2021-05-31
Plan to share individual participant data: NO
Clinical trial NCT01896531: A Study of Ipatasertib (GDC-0068) in Combination With Fluoropyrimidine Plus Oxaliplatin in Participants With Advanced or Metastatic Gastric or Gastroesophageal Junction Cancer
Official title: A Randomized, Phase II, Placebo-controlled Study of Ipatasertib (GDC-0068), an Inhibitor to Akt, in Combination With Fluoropyrimidine Plus Oxaliplatin in Patients With Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
Sponsor: Genentech, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 153.0 (ACTUAL)
Number of arms: 2.0
Start date: 2013-08-14
Primary completion date: 2015-06-03
Completion date: 2021-01-26
Clinical trial NCT02999854: Safety and Efficacy of ATIR101 as Adjunctive Treatment to Blood Stem Cell Transplantation From a Haploidentical Family Donor Compared to Post-transplant Cyclophosphamide in Patients With Blood Cancer
Official title: A Phase III, Multicenter, Randomized Controlled Study to Compare Safety and Efficacy of a Haploidentical HSCT and Adjunctive Treatment With ATIR101, a T-lymphocyte Enriched Leukocyte Preparation Depleted ex Vivo of Host Alloreactive T-cells, Versus a Haploidentical HSCT With Post-transplant Cyclophosphamide in Patients With a Hematologic Malignancy
Acronym: HATCY
Sponsor: Kiadis Pharma (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Insufficient efficacy, terminated by Sponsor
Enrollment: 63.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-11-29
Primary completion date: 2021-11-09
Completion date: 2021-12-17
Plan to share individual participant data: NO
Clinical trial NCT03254732: Study ADI-PEG 20 Plus Pembrolizumab in Advanced Solid Cancers
Official title: Phase 1B Study of ADI-PEG 20 Plus Pembrolizumab in Advanced Solid Cancers
Sponsor: Polaris Group (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Changing Corporate Priorities
Enrollment: 33.0 (ACTUAL)
Number of arms: 1.0
Start date: 2017-07-14
Primary completion date: 2019-05-07
Completion date: 2020-02-25
Clinical trial NCT03724084: Pinometostat With Standard Chemotherapy in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia and MLL Gene Rearrangement
Official title: A Phase 1b/2 Study of Pinometostat in Combination With Standard Induction Chemotherapy in Newly Diagnosed Acute Myeloid Leukemia With MLL Rearrangement
Sponsor: National Cancer Institute (NCI) (NIH)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Other - Study agent no longer available
Enrollment: 6.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-04-10
Primary completion date: 2022-11-14
Completion date: 2022-11-14
Limitations and caveats: Study terminated early due to investigational product not being available
Plan to share individual participant data: YES
IPD sharing description: NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page
Clinical trial NCT03592264: A Phase I/II Study of OBI-3424 in Subjects with Advanced Solid Tumors
Official title: A Phase I/II Study of OBI-3424 in Subjects with Advanced Solid Tumors
Sponsor: OBI Pharma, Inc (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Little evidence of clinical activity in tumor types enrolled
Enrollment: 68.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-07-02
Primary completion date: 2024-02-13
Completion date: 2024-03-21
Plan to share individual participant data: UNDECIDED
Clinical trial NCT03924154: A Study of RVT-1201 in Patients With Pulmonary Arterial Hypertension (ELEVATE 1)
Official title: A Phase 2a, Double-Blind, Placebo-Controlled Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Effects of RVT-1201 in Patients With Pulmonary Arterial Hypertension
Sponsor: Altavant Sciences GmbH (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Inability to enroll
Enrollment: 3.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-08-01
Primary completion date: 2020-02-24
Completion date: 2020-02-24
Plan to share individual participant data: NO
Clinical trial NCT02118584: Study for Participants With Ulcerative Colitis Previously Enrolled in Etrolizumab Phase II/III Studies
Official title: An Open-Label Extension and Safety Monitoring Study of Moderate to Severe Ulcerative Colitis Patients Previously Enrolled in Etrolizumab Phase II/III Studies
Acronym: COTTONWOOD
Sponsor: Hoffmann-La Roche (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: The study was terminated due to program discontinuation, based on mixed efficacy results in the parent studies. There were no safety concerns.
Enrollment: 1822.0 (ACTUAL)
Number of arms: 2.0
Start date: 2014-09-15
Primary completion date: 2023-10-05
Completion date: 2023-10-05
Clinical trial NCT02807454: A Study to Determine the Safety and Efficacy for the Combination of Durvalumab and Daratumumab in Relapsed and Refractory Multiple Myeloma
Official title: A Phase 2, Multicenter, Open-label, Study to Determine the Safety and Efficacy for the Combination of Durvalumab (DURVA) and Daratumumab (DARA) (D2) in Subjects With Relapsed and Refractory Multiple Myeloma (RRMM)
Acronym: FUSIONMM-003
Sponsor: Celgene (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Health Authority request due to class effect
Enrollment: 37.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-07-07
Primary completion date: 2022-01-03
Completion date: 2022-01-03
Limitations and caveats: This study stopped enrolling participants on 05-Sep-2017 and was terminated earlier than planned on 03-Jan-2022. This results disclosure report provides outputs from the Simon Stage 1: D2 and PD3 arms. Simon Stage 2: D2 did not enroll any participants.