chufangao/CTO huggingface dataset:
Clinical trial NCT03639324: Rituximab, Idelalisib, and Venetoclax in Relapsed/Refractory CLL/SLL
Official title: Phase 1 Trial of Rituximab, Idelalisib, and Venetoclax in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia (RIVe-CLL/SLL)
Acronym: RIVe-CLL/SLL
Sponsor: Virginia Commonwealth University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: Slow Accrual
Enrollment: 0.0 (ACTUAL)
Number of arms: 6.0
Start date: 2020-10-02
Primary completion date: 2021-10-18
Completion date: 2021-10-18
Plan to share individual participant data: NO
Clinical trial NCT04484935: Evaluate the Safety and Tolerability, for Nirsevimab in Immunocompromised Children
Official title: A Phase 2, Open-label, Uncontrolled, Single-dose Study to Evaluate the Safety and Tolerability, Pharmacokinetics, and Occurrence of Antidrug Antibody for Nirsevimab in Immunocompromised Children ≤ 24 Months of Age
Acronym: MUSIC
Sponsor: AstraZeneca (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 100.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-08-19
Primary completion date: 2023-02-17
Completion date: 2023-02-17
Baseline population: The As-treated population consisted of all participants who were enrolled and received any dose of nirsevimab.
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 AstraZeneca (AZ) disclosure commitment:~https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AstraZeneca (AZ) are accepting requests for Individual Participant Data (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 European Federation of Pharmaceutical Industries and Associations (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 deidentified 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 NCT04746131: Safety and Pharmacokinetic Study of IMM0306 in Patients With Refractory or Relapsed CD20-positive B-cell Non-Hodgkin's Lymphoma (B-NHL)
Official title: Safety and Pharmacokinetic Study of IMM0306 in Patients With Refractory or Relapsed CD20-positive B-cell Non-Hodgkin's Lymphoma (B-NHL)
Sponsor: ImmuneOnco Biopharmaceuticals (Shanghai) Inc. (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: SUSPENDED 
Why stopped: Due to the product development strategy change, without any safety concerns, we (the sponsor of the trial) have decided to request to place the IND (#151570) on inactive status.
Enrollment: 90.0 (ESTIMATED)
Number of arms: 1.0
Start date: 2021-01-15
Primary completion date: 2024-04-11
Completion date: 2024-04-11
Clinical trial NCT03068468: Study of BIIB092 in Participants With Progressive Supranuclear Palsy
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Intravenously Administered BIIB092 in Participants With Progressive Supranuclear Palsy
Acronym: PASSPORT
Sponsor: Biogen (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: 251PP301(PASSPORT) primary endpoint was not met;Biogen decision to close the study early. There were no safety concerns with the PASSPORT study.
Enrollment: 490.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-06-01
Primary completion date: 2019-09-06
Completion date: 2020-02-07
Baseline population: Intent-to-treat (ITT) population included randomized participants who had received at least 1 dose of blinded study treatment (BIIB092 or Placebo).
Limitations and caveats: Study got terminated as the primary endpoint was not met. PC period was completed at the time of termination. The study was not terminated due to a safety concern.
Clinical trial NCT04731051: The Potential Use of Inhaled Hydroxychloroquine for the Treatment of COVID-19 in Cancer Patients
Official title: A Pilot, Randomized, Open-label Trial to Determine the Feasibility, Safety, Efficacy, and Pharmacokinetics of Nebulized HCQ01 for the Treatment of Patients With COVID-19 and Cancer
Sponsor: King Hussein Cancer Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: WITHDRAWN 
Why stopped: the study was terminated as no more COVID cases were treated at the center
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-10-31
Primary completion date: 2022-11-30
Completion date: 2022-12-31
Clinical trial NCT04658849: Insulin Resistance Following ADT for Prostate CA
Official title: Insulin Resistance Following Androgen Deprivation Therapy in Men With Prostate Cancer
Sponsor: St. Louis University (OTHER)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: WITHDRAWN 
Why stopped: End of grant funding
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-12-02
Primary completion date: 2023-03-29
Completion date: 2023-03-29
Plan to share individual participant data: NO
Clinical trial NCT05629364: A Multi-Centre, Randomised, Controlled, Masked Phase 2 Study of the Safety and Efficacy of KIO-101 Ophthalmic Solution, Versus Vehicle Control in the Treatment of Dry Eye Disease in Patients With Autoimmune Disease
Official title: A Multi-Centre, Randomised, Controlled, Masked Phase 2 Study of the Safety and Efficacy of KIO-101 Ophthalmic Solution, Versus Vehicle Control in the Treatment of Dry Eye Disease in Patients With Autoimmune Disease
Sponsor: Kiora Pharmaceuticals, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Study halted prematurely but potentially will resume
Enrollment: 4.0 (ACTUAL)
Number of arms: 3.0
Start date: 2023-03-15
Primary completion date: 2024-01-09
Completion date: 2024-01-09
Clinical trial NCT04246619: Efficacy of Pregabalin and Duloxetine in Patients With PDPN: the Effect of Pain on Cognitive Function, Sleep and Quality of Life
Official title: Efficacy of Pregabalin and Duloxetine in Patients With Painful Diabetic Peripheral Neuropathy (PDPN): the Effect of Pain on Cognitive Function, Sleep and Quality of Life (BLOSSOM)
Acronym: BLOSSOM
Sponsor: KRKA (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: The statistical analysis will still provide relevant results with the same statistical power as initially planned.COVID-19 pandemic prolonged the recruiting period and consequently affected the costs of the clinical trial.
Enrollment: 254.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-11-12
Primary completion date: 2021-12-21
Completion date: 2021-12-21
Plan to share individual participant data: NO
Clinical trial NCT00995150: A Study of a Levonorgestrel-Releasing Intrauterine System for Long-Term, Reversible Contraception
Official title: A Phase 3, Multi-Center, Open-Label Study of a Levonorgestrel-Releasing Intrauterine System for Long-Term, Reversible Contraception
Sponsor: Medicines360 (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: The data cutoff date of 05 April 2021 was chosen as it coincides with all subjects completing through Year 8 of use (intended duration of use for the product).
Enrollment: 1910.0 (ACTUAL)
Number of arms: 3.0
Start date: 2009-11-30
Primary completion date: 2021-10-12
Completion date: 2021-10-12
Plan to share individual participant data: NO
Clinical trial NCT04347135: Evaluating Endometriosis With 16α-(18)F-fluoro-17β-estradiol ([F-18] FES) PET/MRI
Official title: Pilot Study Evaluating Endometriosis With 16α-(18)F-fluoro-17β-estradiol ([F-18] FES) PET/MRI
Sponsor: Mayo Clinic (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: WITHDRAWN 
Why stopped: No Enrollment
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2022-10-07
Primary completion date: 2024-04-30
Completion date: 2024-04-30
Plan to share individual participant data: NO
Clinical trial NCT03795428: Long-Term, Open Label Extension Study of Pemziviptadil (PB1046) in PAH Subjects Following Completion of Study PB1046-PT-CL-0004
Official title: A Long-Term, Open Label Extension Study of Pemziviptadil (PB1046) Subcutaneous Injections in Pulmonary Arterial Hypertension Subjects Following Completion of Study PB1046-PT-CL-0004
Acronym: VIP Extend
Sponsor: PhaseBio Pharmaceuticals Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Terminated: Study drug resupply delayed (Covid-19)
Enrollment: 25.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-04-10
Primary completion date: 2022-01-11
Completion date: 2022-01-11
Plan to share individual participant data: NO
Clinical trial NCT05193318: KAP for Depression in Abstinent Opioid Users
Official title: Ketamine-assisted Psychotherapy for the Treatment of Persistent Depression in Abstinent Opioid Users
Acronym: KReDO
Sponsor: Medical University of South Carolina (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Primary Investigator leaving institution
Enrollment: 5.0 (ACTUAL)
Number of arms: 1.0
Start date: 2022-01-13
Primary completion date: 2023-03-20
Completion date: 2023-03-20
Clinical trial NCT03052361: Triage Administration of Ondansetron for Gastroenteritis in Children
Official title: Triage Administration of Ondansetron for Gastroenteritis in Children; a Randomized Controlled Trial
Sponsor: St. Justine's Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: TERMINATED 
Why stopped: The recruitment was much slower than expected and the COVID pandemic added new barriers to recruitment.
Enrollment: 81.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-07-15
Primary completion date: 2020-09-03
Completion date: 2020-10-03
Plan to share individual participant data: NO
Clinical trial NCT05136443: Loteprednol Etabonate 0.25% for Prevention of Cornea Transplant Rejection
Official title: Prospective Analysis of Loteprednol Etabonate Ophthalmic Suspension 0.25% for Prevention of Immunologic Rejection After Descemet Membrane Endothelial Keratoplasty
Sponsor: Price Vision Group (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 70.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-11-23
Primary completion date: 2023-09-05
Completion date: 2023-09-05
Plan to share individual participant data: NO
Clinical trial NCT03398837: Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis
Acronym: RESOLVE-1
Sponsor: Corbus Pharmaceuticals Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Sponsor terminated open-label extension
Enrollment: 365.0 (ACTUAL)
Number of arms: 3.0
Start date: 2017-12-18
Primary completion date: 2020-05-27
Completion date: 2020-12-21
Plan to share individual participant data: UNDECIDED
Clinical trial NCT02002819: Levetiracetam for Alzheimer's Disease-Associated Network Hyperexcitability
Official title: Phase 2a Levetiracetam Trial for AD-Associated Network Hyperexcitability
Acronym: LEV-AD
Sponsor: University of Minnesota (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 34.0 (ACTUAL)
Number of arms: 2.0
Start date: 2014-10-16
Primary completion date: 2020-07-21
Completion date: 2020-07-21
Clinical trial NCT04572217: Medications After Adolescent Bariatric Surgery
Official title: Medications After Adolescent Bariatric Surgery Protocol for Inadequate Weight Loss Following Sleeve Gastrectomy in Adolescents and Young Adults: A Pilot Feasibility Study
Acronym: MAABS Protocol
Sponsor: Stanford University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: No available funding
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-06-30
Primary completion date: 2022-06-30
Completion date: 2022-06-30
Plan to share individual participant data: NO
Clinical trial NCT04361253: Evaluation of SARS-CoV-2 (COVID-19) Antibody-containing Plasma thErapy
Official title: A Prospective, Randomized, Double-Masked, Placebo-Controlled Trial of High-Titer COVID-19 Convalescent Plasma (HT-CCP) for the Treatment of Hospitalized Patients With COVID-19 of Moderate Severity
Acronym: (ESCAPE)
Sponsor: Brigham and Women's Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Futility
Enrollment: 45.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-04-30
Primary completion date: 2021-04-01
Completion date: 2021-06-30
Plan to share individual participant data: YES
IPD sharing description: Deidentified data will be made available upon request to the principal investigator following the publication of the primary manuscript.
IPD time frame: Beginning 3 months after study publication. No end date.
IPD access criteria: Proposals should be submitted to rmkaufman@bwh.harvard.edu.
Clinical trial NCT04990219: A Study of Lu AG06466 for the Treatment of Spasticity in Participants With Multiple Sclerosis
Official title: Interventional, Randomized, Double-blind, Placebo-controlled, Parallel-group, Phase 1B Study Investigating the Effects of Lu AG06466 for the Treatment of Spasticity in Patients With Multiple Sclerosis
Sponsor: H. Lundbeck A/S (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: The study was terminated for strategic reasons
Enrollment: 37.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-09-27
Primary completion date: 2023-01-19
Completion date: 2023-01-31
Clinical trial NCT00487305: Vaccination for the Treatment of Previously Untreated or Relapsed Follicular Lymphoma
Official title: A Phase I Trial of Vaccination With Lethally Irradiated Lymphoma Cells Admixed With Granulocyte-Macrophage Colony Stimulating Factor Secreting K562 Cells for the Treatment of Previously Untreated or Relapses Follicular Lymphoma
Sponsor: Dana-Farber Cancer Institute (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 24.0 (ACTUAL)
Number of arms: 1.0
Start date: 2007-06-30
Primary completion date: 2023-07-25
Completion date: 2023-07-25
Clinical trial NCT02403323: Open-Label Extension and Safety Study for Participants With Crohn's Disease Previously Enrolled in the Etrolizumab Phase III Study GA29144
Official title: An Open-Label Extension and Safety Monitoring Study of Patients With Moderately to Severely Active Crohn's Disease Previously Enrolled in the Etrolizumab Phase III Protocol GA29144
Acronym: JUNIPER
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: 900.0 (ESTIMATED)
Number of arms: 2.0
Start date: 2015-06-08
Primary completion date: 2023-10-09
Completion date: 2023-10-09
Clinical trial NCT05664100: First in Human Safety Study of FX-345 in Adults With Sensorineural Hearing Loss
Official title: A Phase 1b, Prospective, Randomized, Single-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety of FX-345 Administered as a Single Intratympanic Injection in Adults With Acquired Adult-Onset Sensorineural Hearing Loss
Sponsor: Frequency Therapeutics (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Business reasons
Enrollment: 6.0 (ACTUAL)
Number of arms: 4.0
Start date: 2022-12-15
Primary completion date: 2023-04-12
Completion date: 2023-04-12
Clinical trial NCT04465734: A Clinical Study to Compare the Efficacy and Safety of HLX10 in Combination With HLX04 Versus Sorafenib as the First-line Treatment in Patients With Locally Advanced or Metastatic HCC
Official title: A Randomized, Open-Label, Controlled, Multicenter, Phase III Clinical Study to Compare the Efficacy and Safety of HLX10 (Anti-PD-1 Antibody) in Combination With HLX04 (Anti-VEGF Antibody) Versus Sorafenib as the First-line Treatment in Patients With Locally Advanced or Metastatic Hepatocellular Carcinoma (HCC)
Sponsor: Shanghai Henlius Biotech (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Why stopped: The trial used sorafenib as a control drug. It's not suitable now(after the A+T has been approved).The sponsor terminated the trial.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-11-15
Primary completion date: 2023-10-15
Completion date: 2024-03-15
Plan to share individual participant data: NO
Clinical trial NCT03478956: A Phase I Study Of Etrolizumab Followed By Open-Label Extension And Safety Monitoring In Pediatric Patients With Moderate To Severe Ulcerative Colitis Or Moderate To Severe Crohn's Disease
Official title: A Phase I, Open-Label, Randomized, Pharmacokinetic, Pharmacodynamic, And Safety Study Of Etrolizumab Followed By Open-Label Extension And Safety Monitoring In Pediatric Patients From 4 Years To Less Than 18 Years Of Age With Moderate To Severe Ulcerative Colitis Or Moderate To Severe Crohn's Disease
Acronym: FENNEL
Sponsor: Hoffmann-La Roche (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: The study was terminated due to program discontinuation, based on mixed efficacy results in the adult ulcerative colitis and Crohn's disease studies. There were no safety concerns.
Enrollment: 24.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-03-27
Primary completion date: 2019-12-02
Completion date: 2023-09-27
Clinical trial NCT03743246: A Study to Evaluate the Safety and Efficacy of JCAR017 in Pediatric Subjects With Relapsed/Refractory (r/r) B-cell Acute Lymphoblastic Leukemia (B-ALL) and B-cell Non-Hodgkin Lymphoma (B-NHL)
Official title: A Phase 1/2, Open-label, Single Arm, Multicohort, Multicenter Trial to Evaluate the Safety and Efficacy of JCAR017 in Pediatric Subjects With Relapsed/Refractory (r/r) B-cell Acute Lymphoblastic Leukemia (B-ALL) and B-cell Non-Hodgkin Lymphoma (B-NHL).
Sponsor: Celgene (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Absence of significant therapeutic benefit over existing therapies
Enrollment: 21.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-10-17
Primary completion date: 2024-01-26
Completion date: 2024-01-26
Limitations and caveats: The study was terminated and hence participants were not enrolled in Phase 2 cohorts (r/r B-ALL; MRD+ B-ALL; r/r B-NHL).
Clinical trial NCT03749590: Magnesium Sulfate in the Prevention of Post-ERCP Pancreatitis.
Official title: Prospective Randomized Controlled Phase III Trial to Investigate the Efficacy of Magnesium Sulfate in the Prevention of Post-ERCP Pancreatitis.
Acronym: MagPEP
Sponsor: University Medicine Greifswald (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: The design of the MagPEP trial is no longer in compliance with the current state of science.
Enrollment: 327.0 (ACTUAL)
Number of arms: 2.0
Start date: 2012-08-27
Primary completion date: 2020-07-31
Completion date: 2020-08-31
Clinical trial NCT03417492: Cerebrovascular Reactivity in American Football Players
Official title: Cerebrovascular Reactivity Assessed With Functional Near-infrared Spectroscopy and Magnetic Resonance Imaging as a Biomarker of Traumatic Microvascular Injury in American Football Players
Sponsor: University of Pennsylvania (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Difficulty enrolling participants due to COVID emergency, and planned start of new study to address this question in a more rigorous fashion.
Enrollment: 7.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-03-01
Primary completion date: 2022-06-30
Completion date: 2022-06-30
Clinical trial NCT03582618: CVM-1118 and Sorafenib Combination in Subjects With Advanced Hepatocellular Carcinoma
Official title: A Phase 2, Open-Label Study With Orally Administered CVM-1118 and Sorafenib in Subjects With Advanced Hepatocellular Carcinoma
Sponsor: TaiRx, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: The study has been terminated due to slow enrollment
Enrollment: 12.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-07-12
Primary completion date: 2021-11-16
Completion date: 2022-12-30
Clinical trial NCT02263508: Pembrolizumab With Talimogene Laherparepvec or Placebo in Unresected Melanoma
Official title: A Phase 1b/3, Multicenter, Trial of Talimogene Laherparepvec in Combination With Pembrolizumab (MK-3475) for Treatment of Unresectable Stage IIIB to IVM1c Melanoma (MASTERKEY-265)
Acronym: MASTERKEY-265
Sponsor: Amgen (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Enrollment: 713.0 (ACTUAL)
Number of arms: 3.0
Start date: 2014-12-08
Primary completion date: 2021-03-11
Completion date: 2021-03-11
Baseline population: All enrolled participants
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 (or other new use) 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, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. 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 link below.
Clinical trial NCT03011645: Gene-by-Stress Interactions in Intervention Studies Significance
Official title: Gene-by-Stress Interactions in Intervention Studies Significance
Sponsor: Duke University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Lack of participants
Enrollment: 7.0 (ACTUAL)
Number of arms: 3.0
Start date: 2018-05-24
Primary completion date: 2020-01-28
Completion date: 2020-01-28
Plan to share individual participant data: NO
Clinical trial NCT03663166: Radiation and Chemotherapy With Ipilimumab Followed by Nivolumab for Patients With Stage III Unresectable Non-Small Cell Lung Cancer (NSCLC)
Official title: Radiation and Chemotherapy With Ipilimumab Followed by Nivolumab for Patients With Stage III Unresectable NSCLC
Sponsor: H. Lee Moffitt Cancer Center and Research Institute (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Increased SAE occurrence per PI
Enrollment: 19.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-11-20
Primary completion date: 2021-10-22
Completion date: 2021-10-22