chufangao/CTO huggingface dataset:
Clinical trial NCT03275740: A First in HumanTrial to Evaluate The Safety, Tolerability, And Pharmacokinetics Of PF-06755347
Official title: A PHASE 1, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO -CONTROLLED, FIRST-IN-HUMAN TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF PF 06755347 AFTER SINGLE ASCENDING INTRAVENOUS AND SUBCUTANEOUS DOSING IN HEALTHY ADULT MALE PARTICIPANTS AND OPEN-LABEL AFTER SINGLE SUBCUTANEOUS DOSING IN MALE AND FEMALE PARTICIPANTS WITH PERSISTENT OR CHRONIC PRIMARY IMMUNE THROMBOCYTOPENIA
Sponsor: Pfizer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: The Sponsor has decided to terminate the above referenced clinical study for business reasons. There were no safety concerns that led to this decision and there was no impact to participant safety.
Enrollment: 58.0 (ACTUAL)
Number of arms: 5.0
Start date: 2017-07-17
Primary completion date: 2023-01-06
Completion date: 2023-01-06
Limitations and caveats: The study was terminated due to sponsor's business decision.
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 NCT01335399: Phase III Study of Lenalidomide and Dexamethasone With or Without Elotuzumab to Treat Newly Diagnosed, Previously Untreated Multiple Myeloma
Official title: A Phase 3, Randomized, Open Label Trial of Lenalidomide/Dexamethasone With or Without Elotuzumab in Subjects With Previously Untreated Multiple Myeloma
Acronym: ELOQUENT - 1
Sponsor: Bristol-Myers Squibb (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 748.0 (ACTUAL)
Number of arms: 2.0
Start date: 2011-08-04
Primary completion date: 2019-10-01
Completion date: 2021-09-03
Baseline population: All randomized participants
Clinical trial NCT03538041: A Study of INCB050465 in Participants With Autoimmune Hemolytic Anemia
Official title: A Phase 2, Open-Label Study of INCB050465 in Participants With Autoimmune Hemolytic Anemia
Sponsor: Incyte Corporation (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 25.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-11-21
Primary completion date: 2021-08-05
Completion date: 2024-04-02
Plan to share individual participant data: NO
Clinical trial NCT03248297: Antibiotic Prophlaxis for High-risk Laboring Women in Low Income Countries
Official title: Azithromycin With or Without Amoxicillin to Prevent Peripartum Infection and Sepsis in Laboring High-risk Women: 3-Arm RCT
Sponsor: University of Alabama at Birmingham (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 756.0 (ACTUAL)
Number of arms: 3.0
Start date: 2018-01-12
Primary completion date: 2020-05-15
Completion date: 2020-10-01
Plan to share individual participant data: NO
Clinical trial NCT01850303: Maintenance After Induction Chemotherapy in Elderly Patients With Advanced Non-small Cell Lung Cancer
Official title: Phase III Study Comparing Maintenance With Pemetrexed or Gemcitabine to a Surveillance in Elderly Patients (70 Years Old and More) With a Advanced Non Small Cell Lung Cancer Controlled by Induction Chemotherapy.
Acronym: MODEL
Sponsor: Intergroupe Francophone de Cancerologie Thoracique (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 632.0 (ACTUAL)
Number of arms: 2.0
Start date: 2013-05-16
Primary completion date: 2018-08-20
Completion date: 2020-01-31
Clinical trial NCT03216356: Effect of D-cycloserine on a Short Imagery Rescripting Intervention for Subclinical PTSD
Official title: Effect of D-cycloserine on a Short Imagery Rescripting Intervention for Subclinical PTSD
Sponsor: Boston University Charles River Campus (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: WITHDRAWN 
Enrollment: 0.0 (ACTUAL)
Number of arms: 3.0
Start date: 2016-09-30
Primary completion date: 2023-12-31
Completion date: 2024-12-31
Plan to share individual participant data: UNDECIDED
Clinical trial NCT04480879: Evaluation of AZD8154 Concentrations in Blood
Official title: A Randomised, 3 Period, Single Dose, Open-label Crossover Study to Evaluate the Systemic Exposure of AZD8154 While Administered Via Inhalation Using a Nebuliser Formulation and a Monodose Dry Powder Inhaler (DPI) Formulation in Healthy Subjects
Sponsor: AstraZeneca (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Need for evaluation of emerging pre-clinical toxicology findings
Enrollment: 10.0 (ACTUAL)
Number of arms: 3.0
Start date: 2020-07-17
Primary completion date: 2020-09-02
Completion date: 2020-09-02
Plan to share individual participant data: YES
IPD sharing description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment:~https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
IPD time frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
IPD access criteria: When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Clinical trial NCT04331717: Bariatric Arterial Embolization for Men Starting Hormones for Prostate Cancer
Official title: BASH-PC: Bariatric Arterial Embolization for Men Starting Hormones for Prostate Cancer
Acronym: BASH-PC
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: accrual on hold
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-11-16
Primary completion date: 2023-08-31
Completion date: 2023-12-31
Clinical trial NCT04071041: Effect of Albumin Administration in Hypoalbuminemic Hospitalized Patients With Community-acquired Pneumonia.
Official title: Effect of Albumin Administration on Outcomes in Hypoalbuminemic Patients Hospitalized With Community-acquired Pneumonia (ALBUCAP): a Prospective, Randomized, Phase III Clinical Controlled Trial.
Acronym: ALBUCAP
Sponsor: Hospital Universitari de Bellvitge (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Low recruitment
Enrollment: 39.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-10-31
Primary completion date: 2021-10-31
Completion date: 2021-10-31
Plan to share individual participant data: NO
Clinical trial NCT02675231: A Study of Abemaciclib (LY2835219) in Women With HR+, HER2+ Locally Advanced or Metastatic Breast Cancer
Official title: monarcHER: A Phase 2, Randomized, Multicenter, 3-Arm, Open-Label Study to Compare the Efficacy of Abemaciclib Plus Trastuzumab With or Without Fulvestrant to Standard-of-Care Chemotherapy of Physician's Choice Plus Trastuzumab in Women With HR+, HER2+ Locally Advanced or Metastatic Breast Cancer
Acronym: monarcHER
Sponsor: Eli Lilly and Company (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 237.0 (ACTUAL)
Number of arms: 3.0
Start date: 2016-05-23
Primary completion date: 2019-04-08
Completion date: 2023-11-09
Baseline population: All enrolled 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 NCT03560908: Dasatinib Combined With Chemotherapy in Relapsed t(8;21) Acute Myeloid Leukemia With KIT D816 Mutation
Official title: Dasatinib Combined With Multi-agents Chemotherapy in Relapsed t(8;21) Acute Myeloid Leukemia With KIT D816 Mutation
Sponsor: Institute of Hematology & Blood Diseases Hospital, China (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: No enough eligable participants enrolled
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-07-01
Primary completion date: 2020-12-31
Completion date: 2021-12-31
Plan to share individual participant data: UNDECIDED
Clinical trial NCT04443192: A Single Ascending and Repeated Dose Study of Oral ZF874 in Healthy Volunteers and PiXZ Subjects
Official title: A Double-blind, Randomised, Placebo-controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single Ascending and Repeated Doses of Orally Administered ZF874 in Healthy Volunteers and PiXZ Subjects
Sponsor: Z Factor Limited (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Based on the results observed to date, the Sponsor concluded that ZF874 was unlikely to achieve the desired target product profile.
Enrollment: 69.0 (ACTUAL)
Number of arms: 14.0
Start date: 2020-08-03
Primary completion date: 2022-09-12
Completion date: 2022-09-12
Plan to share individual participant data: NO
Clinical trial NCT04621331: Investigating the Efficacy, Safety and PK of Roxadustat (FG-4592) for Treatment of Anemia in Pediatric Patients With CKD
Official title: An Open-label, Multicenter Study Investigating the Efficacy, Safety and Pharmacokinetics of Roxadustat (FG-4592) for Treatment of Anemia in Pediatric Patients With Chronic Kidney Disease
Sponsor: FibroGen (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Why stopped: Sponsor's decision
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2022-05-23
Primary completion date: 2022-05-23
Completion date: 2022-05-23
Plan to share individual participant data: NO
Clinical trial NCT04609865: Impact of Intravenous Lidocaine on Clinical Outcomes of Patients With ARDS During COVID-19 Pandemia
Official title: Impact of Intravenous Lidocaine on Clinical Outcomes of Patients With ARDS During COVID-19 Pandemia
Acronym: LidoCovid
Sponsor: University Hospital, Strasbourg, France (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: departure of the principal investigator and inclusion difficulties
Enrollment: 14.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-11-04
Primary completion date: 2022-03-17
Completion date: 2022-03-17
Clinical trial NCT03876925: A Single Arm, Open-label,Phase Ib Study of CT053PTSA in Preciously Treated Patients With Advanced and Metastatic RCC
Official title: A Single Arm, Open-label,Phase Ib Study of CT053PTSA in Preciously Treated Patients With Advanced and Metastatic Renal Cell Cancer
Sponsor: Sunshine Lake Pharma Co., Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: The effect of CT053PTSA in preciously treated patients with advanced and metastatic RCC is not as good as pre-expected
Enrollment: 10.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-06-25
Primary completion date: 2020-03-01
Completion date: 2020-05-12
Plan to share individual participant data: NO
Clinical trial NCT03956550: A Study to Examine the Efficacy and Safety of REGN5069 in Patients With Pain Due to Osteoarthritis of the Knee
Official title: A Randomized, Double-Blind, Multi-Dose, Placebo-Controlled Study to Evaluate the Efficacy and Safety of REGN5069 in Patients With Pain Due to Osteoarthritis of the Knee
Sponsor: Regeneron Pharmaceuticals (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Regeneron has discontinued further clinical development of REGN5069, an antibody to GFRα3, which was previously being studied in osteoarthritis pain of the knee
Enrollment: 259.0 (ACTUAL)
Number of arms: 3.0
Start date: 2019-05-21
Primary completion date: 2020-05-01
Completion date: 2020-10-29
Plan to share individual participant data: YES
IPD sharing description: All IPD that underlie publicly available results will be considered for sharing
IPD time frame: Individual anonymized participant data will be considered for sharing once the indication has been approved by a regulatory body, if there is legal authority to share the data and there is not a reasonable likelihood of participant re-identification.
IPD access criteria: Qualified researchers may request access to anonymized patient level data or aggregate study data when Regeneron has received marketing authorization from major health authorities (e.g., FDA, EMA, PMDA, etc) for the product and indication, has the legal authority to share the data, and has made the study results publicly available (eg, scientific publication, scientific conference, clinical trial registry).
Clinical trial NCT04322773: Anti-il6 Treatment of Serious COVID-19 Disease With Threatening Respiratory Failure
Official title: Effectiveness of Interleukin-6 Receptor Inhibitors in the Management of Patients With Severe SARS-CoV-2 Pneumonia: An Open-Label, Multicenter Sequential and Cluster Randomized Trial
Acronym: TOCIVID
Sponsor: Frederiksberg University Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: The study has been terminated due to changed clinical conditions and too few patients available
Enrollment: 20.0 (ACTUAL)
Number of arms: 4.0
Start date: 2020-04-05
Primary completion date: 2020-10-08
Completion date: 2020-10-08
Plan to share individual participant data: YES
Clinical trial NCT03718507: Study on the Effects of Different Premedication for LISA on Stress and Cerebral Tissue Oxygenation in Preterm Infants
Official title: A Single-centre, Randomized Pilot Study on the Effects of Different Premedication Treatments for Less Invasive Surfactant Administration (LISA) on Pain, Cerebral Tissue Oxygenation and Cortisol Levels in Preterm Infants
Acronym: SAFE LISA
Sponsor: ASST Fatebenefratelli Sacco (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: no recrutiment started
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-05-20
Primary completion date: 2019-12-20
Completion date: 2020-02-20
Plan to share individual participant data: NO
Clinical trial NCT02601157: Harmonizing Optimal Strategy for Treatment of Coronary Artery Stenosis - Coronary Intervention With Next Generation Drug-Eluting Stent Platforms and Abbreviated Dual Antiplatelet Therapy (HOST-IDEA) Trial
Official title: Harmonizing Optimal Strategy for Treatment of Coronary Artery Stenosis - Coronary Intervention With Next Generation Drug-Eluting Stent Platforms and Abbreviated Dual Antiplatelet Therapy (HOST-IDEA) Trial
Acronym: HOST-IDEA
Sponsor: Seoul National University Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 2173.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-01-18
Primary completion date: 2021-08-14
Completion date: 2022-08-14
Clinical trial NCT04442230: NasoVAX in Patients With Early Coronavirus Infectious Disease 2019 (COVID-19)
Official title: Phase 2, Double-blind, Randomized, Placebo-controlled Study of NasoVAX in the Prevention of Clinical Worsening in Patients With Early Coronavirus Infectious Disease 2019 (COVID-19)
Sponsor: Altimmune, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Enrollment
Enrollment: 48.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-10-10
Primary completion date: 2021-02-15
Completion date: 2021-02-15
Baseline population: Safety Population
Plan to share individual participant data: NO
Clinical trial NCT02501278: A Phase II Clinical Trial of Chemo-radiotherapy in Combination With INO-3112 in Patients With Locally Advanced Cervical Cancer
Official title: A Phase II Clinical Trial of Chemo-radiotherapy in Combination With INO-3112 in Patients With Locally Advanced Cervical Cancer
Sponsor: European Organisation for Research and Treatment of Cancer - EORTC (NETWORK)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: company (Inovio) is no longer able to support the study
Enrollment: 0.0 (ACTUAL)
Number of arms: 3.0
Start date: 2016-05-31
Primary completion date: 2019-05-31
Completion date: 2021-05-31
Clinical trial NCT03591380: CAMPath and BELimumab for Transplant Tolerance in Sensitized Kidney Transplant Recipients
Official title: CAMPath and BELimumab for the Induction of Donor Specific Humoral Transplant Tolerance in Sensitized Kidney Transplant Recipients To Improve Long-Term Allograft Survival
Acronym: CAMPBEL
Sponsor: University of Wisconsin, Madison (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Recruitment complications due to COVID-19
Enrollment: 3.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-05-14
Primary completion date: 2021-12-03
Completion date: 2021-12-03
Plan to share individual participant data: NO
Clinical trial NCT03651804: Radiofrequency Ablation: Treatment for Posterior Element Pain From Vertebral Compression Fractures
Official title: Radiofrequency Ablation of the Medial Branch Nerve as a Novel Treatment for Posterior Element Pain From Vertebral Compression Fractures
Sponsor: University of California, Davis (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Difficulty recruiting members
Enrollment: 5.0 (ACTUAL)
Number of arms: 3.0
Start date: 2019-04-10
Primary completion date: 2023-12-19
Completion date: 2023-12-19
Plan to share individual participant data: UNDECIDED
Clinical trial NCT04002011: DOAC Versus VKA After Cardiac Surgery
Official title: Oral Anticoagulation After Cardiac Surgery in the Era of Direct Oral Anticoagulants: is Large Use of Vitamin K Antagonists Still Justified?
Acronym: DOAC/VKA
Sponsor: Laval University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Submission process abandoned. No patient enrolled.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-03-09
Primary completion date: 2023-01-01
Completion date: 2023-03-09
Clinical trial NCT04338958: Ruxolitinib in Covid-19 Patients With Defined Hyperinflammation
Official title: A Phase-II Clinical Trial for First Line Treatment of Stage II/III Covid-19 Patients to Treat Hyperinflammation
Acronym: RuxCoFlam
Sponsor: University of Jena (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 193.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-04-22
Primary completion date: 2021-07-15
Completion date: 2021-07-15
Plan to share individual participant data: NO
Clinical trial NCT02264990: Study Comparing Veliparib Plus Carboplatin and Paclitaxel Versus Investigator's Choice of Standard Chemotherapy in Adults Receiving First Cytotoxic Chemotherapy for Metastatic or Advanced Non-Squamous Non-Small Cell Lung Cancer (NSCLC) and Who Are Current or Former Smokers
Official title: A Randomized, Open-Label, Multicenter, Phase 3 Trial Comparing Veliparib Plus Carboplatin and Paclitaxel Versus Investigator's Choice of Standard Chemotherapy in Subjects Receiving First Cytotoxic Chemotherapy for Metastatic or Advanced Non-Squamous Non-Small Cell Lung Cancer (NSCLC) and Who Are Current or Former Smokers
Sponsor: AbbVie (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 595.0 (ACTUAL)
Number of arms: 2.0
Start date: 2014-09-30
Primary completion date: 2019-11-14
Completion date: 2020-02-21
Baseline population: The intention-to-treat (ITT) population included all randomized participants.
Plan to share individual participant data: YES
IPD sharing description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
IPD time frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
IPD access criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
Clinical trial NCT02823028: Twitter-enabled Mobile Messaging for Smoking Relapse Prevention (Tweet2Quit)
Official title: Social Media Technology for Treating Tobacco Addiction
Acronym: Tweet2Quit
Sponsor: University of California, Irvine (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 960.0 (ACTUAL)
Number of arms: 3.0
Start date: 2016-10-31
Primary completion date: 2022-09-30
Completion date: 2022-09-30
Plan to share individual participant data: NO
Clinical trial NCT03251417: Apatinib and Irinotecan Combination Treatment in Unresectable or Metastatic Esophageal Squamous Cell Carcinoma
Official title: Apatinib and Irinotecan Combination Treatment in Unresectable or Metastatic Esophageal Squamous Cell Carcinoma Patients Failed in First-line Chemotherapy: A Phase II Study
Sponsor: Peking University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Because PD-1 antibodies had been proved to be a standard second-line treatment in esophageal cancer, the potential benefit of present intervention is under re-evaluation.
Enrollment: 11.0 (ACTUAL)
Number of arms: 1.0
Start date: 2017-09-10
Primary completion date: 2021-04-25
Completion date: 2021-04-25
Plan to share individual participant data: UNDECIDED
Clinical trial NCT03504410: Efficacy/Safety of CPI-613 in Combination With HD Cyt. and Mito. vs HD Cyt. and Mito. in Older Patients With R/R AML
Official title: Phase 3 Multicenter Randomized Trial to Evaluate Efficacy and Safety of CPI-613 in Combination With HD Cyt. and Mito. vs HD Cyt. and Mito. Therapy and Control Sub-groups in Older Patients With R/R AML
Sponsor: Cornerstone Pharmaceuticals (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Futile
Enrollment: 200.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-11-12
Primary completion date: 2021-10-25
Completion date: 2022-01-19
Baseline population: All subjects randomized were included in the analysis. Post interim analysis, the study was discontinued and no additional data was collected and analyzed.
Plan to share individual participant data: NO