chufangao/CTO huggingface dataset:
Clinical trial NCT02392637: Gemcitabine Hydrochloride, Cisplatin, and Nab-Paclitaxel in Treating Patients With Advanced or Metastatic Biliary Cancers
Official title: A Phase II Study of Gemcitabine, Cisplatin, and Abraxane in Advanced Biliary Cancers
Sponsor: M.D. Anderson Cancer Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 62.0 (ACTUAL)
Number of arms: 1.0
Start date: 2015-04-02
Primary completion date: 2020-08-13
Completion date: 2020-08-13
Baseline population: Intent to treat participants
Clinical trial NCT03780166: A Study of the Safety and Tolerability of INCB050465 in Pemphigus Vulgaris
Official title: A Phase 2 Dose-Escalation Study of the Safety and Tolerability of INCB050465 in Participants With Pemphigus Vulgaris
Sponsor: Incyte Corporation (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: The study was withdrawn due to insufficient interest in study participation due to recent approval in this rare condition.
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-03-31
Primary completion date: 2020-11-30
Completion date: 2020-11-30
Plan to share individual participant data: NO
Clinical trial NCT05461209: A Study of Comparing Talquetamab to Belantamab Mafodotin in Participants With Relapsed/Refractory Multiple Myeloma
Official title: A Phase 3 Study Comparing Talquetamab to Belantamab Mafodotin in Participants With Relapsed/Refractory Multiple Myeloma Who Have Received at Least 4 Prior Therapies Including an Immunomodulatory Drug, a Proteasome Inhibitor, and an Anti-CD38 Antibody
Acronym: MonumenTAL-5
Sponsor: Janssen Research & Development, LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Why stopped: Business Decision
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-10-20
Primary completion date: 2022-11-15
Completion date: 2022-11-15
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 NCT03841604: Effect of Safinamide on Parkinson's Disease Related Chronic Pain
Official title: A Randomised, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Safinamide 100mg Once Daily, as add-on Therapy, in Idiopathic Parkinson's Disease (PD) Patients With Motor Fluctuations and PD Related Chronic Pain
Sponsor: Zambon SpA (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 94.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-04-09
Primary completion date: 2021-04-30
Completion date: 2021-05-03
Baseline population: Safety Set: all randomised subjects assigned to study intervention and who took at least 1 dose of study intervention.
Plan to share individual participant data: NO
Clinical trial NCT05169008: A Study to Evaluate the Safety and Immunogenicity of Ad5-nCoV and Ad5-nCoV-IH in CoronaVac Immunized Children and Adolescents
Official title: A Multicenter, Randomized, and Open-label Clinical Trial to Evaluate the Safety and Immunogenicity of Intramuscular and Inhaled COVID-19 Vaccine in Children Aged 6-12 Years and Adolescents Aged 13-17 Years Who Have Been Immunized With Two Doses of CoronaVac
Sponsor: CanSino Biologics Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Difficulty recruiting subjects, so the study was terminated.
Enrollment: 91.0 (ACTUAL)
Number of arms: 1.0
Start date: 2022-02-25
Primary completion date: 2023-01-13
Completion date: 2023-01-13
Plan to share individual participant data: NO
Clinical trial NCT04292899: Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734™) in Participants With Severe Coronavirus Disease (COVID-19)
Official title: A Phase 3 Randomized Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734™) in Participants With Severe COVID-19
Sponsor: Gilead Sciences (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 4891.0 (ACTUAL)
Number of arms: 4.0
Start date: 2020-03-06
Primary completion date: 2020-04-09
Completion date: 2020-06-30
Baseline population: Part A: Safety Analysis Set included participants who were randomized into part A of the study and received at least 1 dose of study treatment.~Part B: Expanded RDV-Treated Analysis Set included participants who were enrolled into part B of the study and received at least 1 dose of study treatment.
Plan to share individual participant data: YES
IPD sharing description: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy.
IPD time frame: 18 months after study completion
IPD access criteria: A secured external environment with username, password, and RSA code.
Clinical trial NCT05442788: A Study of HB0017 in Patients With Moderate to Severe Plaque Psoriasis
Official title: A Phase Ib, Randomized, Double-blind, Placebo-controlled, Dose-escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HB0017 Following Multiple Dose in Patients With Moderate to Severe Plaque Psoriasis
Sponsor: Huabo Biopharm Co., Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 30.0 (ACTUAL)
Number of arms: 3.0
Start date: 2021-09-02
Primary completion date: 2022-05-31
Completion date: 2022-05-31
Plan to share individual participant data: NO
Clinical trial NCT04596267: Pitolisant Effects on Alcohol Self-Administration in Heavy Drinkers
Official title: The Effects of the Histamine-3 Receptor Inverse Agonist Pitolisant on Alcohol Self-Administration in Heavy Drinkers
Sponsor: Boston Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Study funding was exhausted prior to reaching the recruitment goal due to pandemic related delays
Enrollment: 9.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-09-13
Primary completion date: 2023-02-03
Completion date: 2023-02-03
Limitations and caveats: Recruitment was impacted by COVID-19 restrictions on human subject research, leading to a smaller number of subjects analyzed than planned. This study start date was also delayed due to problems securing the medication supply.
Plan to share individual participant data: NO
IPD sharing description: Deidentified data from this study will be submitted to the NIAAA Data archive (https://nda.nih.gov/).
Clinical trial NCT03986086: MPH966 for Prevention of Graft-versus-host Disease After Allogeneic Hematopoietic Stem Cell Transplantation
Official title: A Phase 1/2 Study of MPH966, an Oral Neutrophil Elastase Inhibitor, for Prevention of Graft-versus-host Disease After Allogeneic Hematopoietic Stem Cell Transplantation
Sponsor: Duke University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: WITHDRAWN 
Why stopped: Lack of Funding
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-09-30
Primary completion date: 2022-12-31
Completion date: 2023-12-31
Plan to share individual participant data: NO
Clinical trial NCT03077412: Study to Evaluate the Efficacy and Safety of Filgotinib in the Treatment of Perianal Fistulizing Crohn's Disease
Official title: A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of Filgotinib in the Treatment of Perianal Fistulizing Crohn's Disease
Acronym: Divergence2
Sponsor: Gilead Sciences (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 57.0 (ACTUAL)
Number of arms: 3.0
Start date: 2017-04-06
Primary completion date: 2021-01-20
Completion date: 2021-02-17
Plan to share individual participant data: NO
Clinical trial NCT03682770: Study in Pediatric Subjects With Peanut Allergy to Evaluate Efficacy and Safety of Dupilumab as Adjunct to AR101 (Peanut Oral Immunotherapy)
Official title: A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Study in Pediatric Subjects With Peanut Allergy to Evaluate the Efficacy and Safety of Dupilumab as Adjunct to AR101 (Peanut Oral Immunotherapy)
Sponsor: Regeneron Pharmaceuticals (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 148.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-10-03
Primary completion date: 2020-10-16
Completion date: 2021-07-23
Baseline population: Full analysis set (FAS) included all randomized participants
Clinical trial NCT05021978: A Clinical Trial of PRAX-944 in Participants With Essential Tremor
Official title: A Phase 2 Clinical Trial Evaluating the Efficacy, Safety, Tolerability, and Pharmacokinetics of PRAX-944 in Adults With Essential Tremor
Sponsor: Praxis Precision Medicines (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 24.0 (ACTUAL)
Number of arms: 3.0
Start date: 2020-03-03
Primary completion date: 2022-03-24
Completion date: 2022-03-24
Limitations and caveats: Due to repeated mistakes during the eligibility review process, a Corrective and Preventative Actions (CAPA) report was issued and enrollment at one site was suspended.
Clinical trial NCT02435992: Safety and Efficacy Trial of RPC1063 for Moderate to Severe Ulcerative Colitis
Official title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Oral RPC1063 as Induction and Maintenance Therapy for Moderate to Severe Ulcerative Colitis
Sponsor: Celgene (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 1012.0 (ACTUAL)
Number of arms: 2.0
Start date: 2015-06-17
Primary completion date: 2020-03-27
Completion date: 2020-06-17
Clinical trial NCT04045028: A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD), and Preliminary Activity of Tiragolumab in Participants With Relapsed or Refractory Multiple Myeloma or With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma
Official title: A Phase Ia/Ib Open-Label, Multicenter Study Evaluating the Safety and Pharmacokinetics of Tiragolumab as a Single Agent and in Combination With Atezolizumab and/or Daratumumab in Patients With Relapsed or Refractory Multiple Myeloma, and as a Single Agent and in Combination With Rituximab in Patients With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma
Sponsor: Genentech, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Slow recruitment
Enrollment: 41.0 (ACTUAL)
Number of arms: 5.0
Start date: 2019-07-22
Primary completion date: 2023-03-28
Completion date: 2023-03-28
Plan to share individual participant data: YES
IPD sharing description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).
Clinical trial NCT05201313: Efficacy and Safety of the Application of Local Anaesthetic in Spray to Repair of 1st- 2nd Perineal Lacerations
Official title: Randomised Controlled Trial to Evaluate the Efficacy of Local Anaesthetic Application in Spray for the Repair of 1st- 2nd Perineal Lacerations Following Vaginal Delivery
Acronym: LISPRAY
Sponsor: Azienda Sanitaria-Universitaria Integrata di Udine (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 136.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-01-20
Primary completion date: 2022-07-08
Completion date: 2022-08-08
Plan to share individual participant data: NO
Clinical trial NCT04134208: An Investigational Scan (18F-Fluciclovine PET-CT) for the Measurement of Therapeutic Response in Patients With Metastatic Prostate Cancer
Official title: 18F-Fluciclovine PET CT as an Indicator of Therapeutic Response in Metastatic Prostate Carcinoma (M1PCa)
Sponsor: M.D. Anderson Cancer Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Slow accrual
Enrollment: 2.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-09-19
Primary completion date: 2022-06-28
Completion date: 2022-06-28
Clinical trial NCT02904954: Durvalumab (MEDI4736) With or Without SBRT in Clinical Stage I, II and IIIA Non-small Cell Lung Cancer
Official title: A Randomized Phase 2 Trial of Durvalumab (MEDI4736) With or Without SBRT in Clinical Stage I, II, and IIIA Non-small Cell Lung Cancer (NSCLC)
Sponsor: Weill Medical College of Cornell University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 60.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-12-02
Primary completion date: 2020-09-16
Completion date: 2022-10-04
Plan to share individual participant data: NO
Clinical trial NCT05264922: Stromal Vascular Fraction (SVF) Cells for Non-Operative Treatment of Small Rotator Cuff Tears
Official title: Stromal Vascular Fraction (SVF) Cells for Non-Operative Treatment of Small Rotator Cuff Tears
Acronym: SVF
Sponsor: AdventHealth (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Study never started. PI left institution.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-01-09
Primary completion date: 2022-07-22
Completion date: 2022-07-22
Plan to share individual participant data: NO
Clinical trial NCT05330286: Study to Compare the Pharmacokinetics, Safety and Tolerability of the Pediatric and Adult Branaplam Formulation in Healthy Adults and the Effect of Food on the Latter.
Official title: Randomized, Single-dose, Open-label, Two-part, Two-period, Cross-over Study to Compare the Pharmacokinetics, Safety and Tolerability of the Pediatric With an Adult Formulation of Branaplam and to Investigate the Adult Formulation in Fed and Fasted State in Healthy Participants
Sponsor: Novartis (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: The compound is no longer suitable for further clinical development due to a safety finding in a later phase program.
Enrollment: 9.0 (ACTUAL)
Number of arms: 4.0
Start date: 2022-04-13
Primary completion date: 2022-08-19
Completion date: 2022-08-19
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 NCT04523207: A Study of Apalutamide (Adjuvant Treatment) and Androgen Deprivation Therapy (ADT) in Participants Who Have Undergone Radical Prostatectomy (RP) for Non-metastatic Prostate Cancer and Who Are at High Risk for Metastases
Official title: A Multi-center, Open-label, Single-arm Phase 2 Study of the Adjuvant Treatment of Apalutamide and Androgen Deprivation Therapy (ADT) in Treatment-naïve Participants Who Have Undergone Radical Prostatectomy (RP) for Non-metastatic Prostate Cancer and Who Are at High Risk for Metastases
Sponsor: Janssen Research & Development, LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 108.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-08-19
Primary completion date: 2023-10-23
Completion date: 2023-10-25
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 NCT02704325: Gene Transfer Clinical Trial for Duchenne Muscular Dystrophy Using rAAVrh74.MCK.GALGT2
Official title: Phase I Gene Transfer Clinical Trial for Duchenne Muscular Dystrophy Using rAAVrh74.MCK.GALGT2
Sponsor: Nationwide Children's Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: WITHDRAWN 
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-04-30
Primary completion date: 2018-07-31
Completion date: 2020-02-29
Clinical trial NCT04393454: Study to Evaluate the Efficacy and Safety of Sirolimus in Subjects With Metastatic, Mismatch Repair Deficient Solid Tumors After Immunotherapy
Official title: Phase II Study to Evaluate the Efficacy and Safety of Sirolimus in Subjects With Metastatic, Mismatch Repair Deficient Solid Tumors After Immunotherapy
Sponsor: Albert Einstein College of Medicine (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Following discussion with the Cancer Center the PI elected to terminate the study.
Enrollment: 6.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-11-16
Primary completion date: 2023-05-16
Completion date: 2023-05-16
Baseline population: 6 baseline participants
Plan to share individual participant data: NO
Clinical trial NCT02951377: Mechanical Diagnosis and Treatment and/or Steroid Injections for Lumbar Radiculopathy
Official title: Mechanical Diagnosis and Treatment and/or Transforaminal Epidural Steroid Injections Versus Usual Care for Chronic Lumbar Radiculopathy: A Pilot Study.
Sponsor: University of Alberta (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Recruitment
Enrollment: 27.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-10-01
Primary completion date: 2020-01-31
Completion date: 2020-01-31
Clinical trial NCT03585764: MOv19-BBz CAR T Cells in aFR Expressing Recurrent High Grade Serous Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Official title: Phase I Clinical Trial of Adoptive Transfer of Autologous Folate Receptor - Alpha Redirected T Cells for Recurrent High Grade Serous Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Sponsor: University of Pennsylvania (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: This study was halted prematurely due to recruitment barriers
Enrollment: 46.0 (ACTUAL)
Number of arms: 4.0
Start date: 2018-10-24
Primary completion date: 2024-03-26
Completion date: 2024-03-26
Plan to share individual participant data: NO
Clinical trial NCT05156034: A Multiple Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of SRK-001 in Healthy Participants
Official title: A Randomized, Placebo-Controlled, Double-blind, Multiple Dose, Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics Following Intravenous Administration of SRK-001 in Healthy Participants
Sponsor: Sarkana Pharma Inc (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Due to occurrence of eye related adverse events.
Enrollment: 16.0 (ACTUAL)
Number of arms: 4.0
Start date: 2021-12-21
Primary completion date: 2022-09-05
Completion date: 2022-09-05
Clinical trial NCT04591808: Efficacy and Safety of Atorvastatin + Perindopril Fixed-Dose Combination S05167 in Adult Patients With Arterial Hypertension and Dyslipidemia
Official title: Efficacy and Safety of Atorvastatin + Perindopril Fixed-Dose Combination S05167 in Adult Patients With Arterial Hypertension and Dyslipidemia, 8 Weeks, Phase 3, Randomized, Double-blind, Active-control, Multinational, Multi-center, Parallel Study
Sponsor: Servier (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: for strategic reasons
Enrollment: 146.0 (ACTUAL)
Number of arms: 3.0
Start date: 2021-09-09
Primary completion date: 2022-04-08
Completion date: 2022-04-08
Plan to share individual participant data: YES
IPD sharing description: Qualified scientific and medical researchers can request access to anonymized patient-level and study-level clinical trial data.~Access can be requested for all interventional clinical studies:~* used for Marketing Authorization (MA) of medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US).~* where Servier is the Marketing Authorization Holder (MAH). The date of the first MA of the new medicine (or the new indication) in one of the EEA Member States will be considered for this scope.~In addition, access can be requested for all interventional clinical studies in patients:~* sponsored by Servier~* with a first patient enrolled as of 1 January 2004 onwards~* for New Chemical Entity or New Biological Entity (new pharmaceutical form excluded) for which development has been terminated before any Marketing authorization (MA) approval.
IPD time frame: After Marketing Authorisation in EEA or US if the study is used for the approval.
IPD access criteria: Researchers should register on Servier Data Portal and fill in the research proposal form. This form in four parts should be fully documented. The Research Proposal Form will not be reviewed until all mandatory fields are completed.
Clinical trial NCT02958917: Study of Efficacy and Safety of Pirfenidone in Patients With Fibrotic Hypersensitivity Pneumonitis
Official title: A Randomized, Double-Blind, Placebo-Controlled, Study of Efficacy and Safety of Pirfenidone in Patients With Fibrotic Hypersensitivity Pneumonitis
Sponsor: National Jewish Health (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: covid-19 pandemic
Enrollment: 40.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-06-05
Primary completion date: 2021-03-02
Completion date: 2021-03-02
Plan to share individual participant data: NO
Clinical trial NCT03422094: Neoantigen-based Personalized Vaccine Combined With Immune Checkpoint Blockade Therapy in Patients With Newly Diagnosed, Unmethylated Glioblastoma
Official title: A Pilot Study to Assess the Safety, Feasibility, and Immunogenicity of a Neoantigen-based Personalized Vaccine Combined With Immune Checkpoint Blockade Therapy in Patients With Newly Diagnosed, Unmethylated Glioblastoma
Sponsor: Washington University School of Medicine (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Manufacturer changed focus to cell therapy
Enrollment: 3.0 (ACTUAL)
Number of arms: 5.0
Start date: 2018-10-31
Primary completion date: 2020-04-26
Completion date: 2020-12-31
Plan to share individual participant data: NO
Clinical trial NCT02083354: Study to Investigate the Objective Response Rate of Dabrafenib in Combination With Trametinib in Subjects With BRAF V600 Mutation-Positive Melanoma
Official title: An Open-Label, Multi-Center Study to Investigate the Objective Response Rate of Dabrafenib in Combination With Trametinib in Subjects With BRAF V600 Mutation-Positive Melanoma
Sponsor: Novartis (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 77.0 (ACTUAL)
Number of arms: 1.0
Start date: 2014-03-18
Primary completion date: 2018-02-23
Completion date: 2021-04-19
Plan to share individual participant data: UNDECIDED
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 www.clinicalstudydatarequest.com