chufangao/CTO huggingface dataset:
Clinical trial NCT05249569: Study of Bavituximab, Axitinib, and Avelumab in Advanced Hepatocellular Carcinoma
Official title: Multi-center Phase II Open-label Study of Bavituximab, Axitinib, and Avelumab in Advanced Hepatocellular Carcinoma
Sponsor: University of Texas Southwestern Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Sponsor pulled support for one of the study drugs.
Enrollment: 1.0 (ACTUAL)
Number of arms: 1.0
Start date: 2022-11-04
Primary completion date: 2022-12-30
Completion date: 2022-12-30
Baseline population: One patient signed consent and was enrolled on study. However, the sponsor that was planning to provide one of the study drugs decided they no longer wanted to supply the drug for this project. The participant that was enrolled on the study did not receive treatment before the study was terminated.
Plan to share individual participant data: NO
Clinical trial NCT02225275: Lenalidomide and Obinutuzumab in Treating Patients With Recurrent or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Official title: Combination of Lenalidomide and Obinutuzumab (GA101) in Patients With Recurrent Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)
Sponsor: M.D. Anderson Cancer Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Due to slow accrual
Enrollment: 9.0 (ACTUAL)
Number of arms: 1.0
Start date: 2016-03-31
Primary completion date: 2021-05-19
Completion date: 2021-05-19
Clinical trial NCT04822298: Study of AMG 160 in Subjects With Non-Small Cell Lung Cancer
Official title: A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 160 in Subjects With Non-Small Cell Lung Cancer
Sponsor: Amgen (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Amgen made a business decision to discontinue AMG 160 20180273
Enrollment: 3.0 (ACTUAL)
Number of arms: 3.0
Start date: 2021-08-31
Primary completion date: 2021-12-08
Completion date: 2022-01-26
Baseline population: Safety analysis set: defined as all participants that were enrolled and receive at least 1 dose of AMG 160.
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 NCT02657889: Niraparib in Combination With Pembrolizumab in Patients With Triple-negative Breast Cancer or Ovarian Cancer
Official title: Phase 1/2 Clinical Study of Niraparib in Combination With Pembrolizumab (MK-3475) in Patients With Advanced or Metastatic Triple-Negative Breast Cancer and in Patients With Recurrent Ovarian Cancer
Acronym: TOPACIO
Sponsor: Tesaro, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: COMPLETED 
Enrollment: 122.0 (ACTUAL)
Number of arms: 1.0
Start date: 2016-04-15
Primary completion date: 2018-05-14
Completion date: 2021-09-17
Baseline population: The Baseline analysis Population consisted of all participants who received at least one dose of study medication.
Plan to share individual participant data: NO
Clinical trial NCT04212169: Efficacy and Safety of MEDI3506 in Adult Subjects With Atopic Dermatitis
Official title: A Phase 2 Randomized, Double-blinded, Placebo-controlled Study to Evaluate the Efficacy and Safety of MEDI3506 in Adult Subjects With Moderate-to-severe Atopic Dermatitis
Sponsor: AstraZeneca (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 148.0 (ACTUAL)
Number of arms: 4.0
Start date: 2019-12-09
Primary completion date: 2022-07-21
Completion date: 2022-09-20
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 NCT03871153: Chemoradiation Plus Durvalumab Followed by Surgery Followed by Adjuvant Durvalumab in Patients With Surgically Resectable Stage III (N2) Non-Small Cell Lung Cancer
Official title: A Phase II Study of Concurrent Chemoradiation Plus Durvalumab (MEDI4736) Followed by Surgery Followed by Adjuvant Durvalumab (MEDI4736) in Medically Operable Patients With Surgically Resectable Stage III (N2) Non-Small Cell Lung Cancer
Sponsor: Hoosier Cancer Research Network (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Investigator decided to halt study due to low accrual.
Enrollment: 7.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-08-02
Primary completion date: 2021-10-30
Completion date: 2022-03-09
Plan to share individual participant data: NO
Clinical trial NCT00062868: LMP-specific T-cells for Patients With Relapsed EBV-positive Lymphoma
Official title: Administration of LMP-Specific Cytotoxic T-Lymphocytes to Patients With Relapsed EBV-Positive Lymphoma (ALCI) / Previously Known as: Administration of Neomycin Resistance Gene Marked LMP2A-Specific Cytotoxic T-Lymphocytes to Patents With Relapsed EBV-Positive Lymphoma (ALASCAR)
Acronym: ALCI
Sponsor: Baylor College of Medicine (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 74.0 (ACTUAL)
Number of arms: 9.0
Start date: 2003-09-30
Primary completion date: 2014-04-30
Completion date: 2020-04-30
Baseline population: The number of participants analyzed is zero if there were no participants treated in the arm/group/dose.
Clinical trial NCT04169360: Safety and Preliminary Efficacy of ANS-6637 to Reduce Drug Craving and Harm in People With Opioid Use Disorder
Official title: Safety and Preliminary Efficacy of ANS-6637 to Reduce Drug Craving and Harm in People With Opioid Use Disorder
Acronym: SEARCH
Sponsor: University of Maryland, Baltimore (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: The FDA determined that there is not adequate safety information to continue clinical investigations using ANS-6637 and Amygdala Neurosciences, the product company of ANS-6637, is no longer pursuing research with this compound.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-01-31
Primary completion date: 2021-01-12
Completion date: 2021-01-12
Plan to share individual participant data: YES
IPD sharing description: The investigator will share de-identified data with approved outside collaborators under appropriate agreements, at the time of publication or shortly thereafter.
IPD time frame: Data will be available at the time of publication or shortly thereafter, and will be kept indefinitely.
IPD access criteria: Will be determined by Principal Investigator
Clinical trial NCT04807829: Adjunctive CB1 Agonist Nabilone in Inpatients With Active Suicidal Ideation
Official title: A Randomized-Controlled Trial With the Adjunctive CB1 Agonist Nabilone in Inpatients With Active Suicidal Ideation
Sponsor: The University of Texas Health Science Center, Houston (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: The study was stopped due to drug unavailability. The drug is unavailable because production was discontinued in the US.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-04-30
Primary completion date: 2022-04-30
Completion date: 2022-04-30
Clinical trial NCT04798703: Study of ONCOFID-P-B™ (PACLITAXEL-HYALURONIC ACID)
Official title: Phase I Exploratory Study of ONCOFID-P-B™ (PACLITAXEL-HYALURONIC ACID) Administered for 12 Consecutive Weeks Followed by Maintenance Therapy in BCG Unresponsive/ Intolerant Patients With Bladder Carcinoma in Situ (CIS)
Sponsor: Fidia Farmaceutici s.p.a. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 20.0 (ACTUAL)
Number of arms: 1.0
Start date: 2017-05-24
Primary completion date: 2020-05-04
Completion date: 2020-11-18
Clinical trial NCT04746430: COVID-19 Primary Care Platform for Early Treatment and Recovery (COPPER) Study
Official title: COVID-19 Primary Care Platform for Early Treatment and Recovery (COPPER) Study: an Open-label Randomized Controlled Trial
Acronym: COPPER
Sponsor: General Practitioners Research Institute (NETWORK)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Too few patients
Enrollment: 17.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-02-16
Primary completion date: 2021-04-23
Completion date: 2021-04-23
Plan to share individual participant data: UNDECIDED
Clinical trial NCT03115567: A Study of Topical Steroids as Preemptive Therapy for EGFR Inhibitor-Induced Papulopustular Eruption
Official title: A Randomized Phase II Study of Topical Steroids as Preemptive Therapy for Epidermal Growth Factor Receptor Inhibitor-Induced Papulopustular Eruption
Sponsor: Northwestern University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Low enrollment accrual
Enrollment: 14.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-02-16
Primary completion date: 2020-04-24
Completion date: 2022-09-02
Plan to share individual participant data: NO
Clinical trial NCT04428021: Standard or Convalescent Plasma in Patients With Recent Onset of COVID-19 Respiratory Failure
Official title: Effectiveness of Adding Standard Plasma or COVID-19 Convalescent Plasma to Standard Treatment, Versus Standard Treatment Alone, in Patients With Recent Onset of COVID-19 Respiratory Failure. A Randomized, Three-arms, Phase 2 Trial
Acronym: PLACO-COVID
Sponsor: A.O.U. Città della Salute e della Scienza (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 180.0 (ACTUAL)
Number of arms: 3.0
Start date: 2020-06-15
Primary completion date: 2021-03-31
Completion date: 2021-10-31
Plan to share individual participant data: YES
IPD sharing description: All Individual Participant Data requests should be submitted to the corresponding author for consideration. Access to deidentified participant data may be granted following review, after the publication of major results
IPD time frame: Data will be available after 12 months from study ending and for the following 5 years
IPD access criteria: Data requests should be submitted to the corresponding author for consideration.
Clinical trial NCT02115464: Advanced Lung Cancer Treatment With Metformin and Chemo-Radiotherapy
Official title: A Phase II Study to Investigate a Combination of Metformin With Chemo-Radiotherapy in Patients With Locally Advanced Non-Small Cell Lung Cancer
Acronym: ALMERA
Sponsor: Ontario Clinical Oncology Group (OCOG) (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: The accrual rate was not high enough to reach the target sample size.
Enrollment: 54.0 (ACTUAL)
Number of arms: 2.0
Start date: 2014-12-17
Primary completion date: 2020-03-09
Completion date: 2020-04-21
Clinical trial NCT04153188: Pulsed Dye Laser Treatment and Oxymetazoline Hydrochloride (HCL) 1% Cream for Erythematotelangiectatic Rosacea
Official title: Pilot Study to Evaluate Vbeam® Prima Pulsed Dye Laser (PDL) Treatment and RHOFADE® (Oxymetazoline HCL, 1% Cream) for Erythematotelangiectatic Rosacea
Sponsor: Candela Corporation (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 34.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-01-15
Primary completion date: 2020-11-13
Completion date: 2021-01-05
Limitations and caveats: Small sample size for randomization
Plan to share individual participant data: NO
Clinical trial NCT02427841: Nab-paclitaxel and Gemcitabine Hydrochloride Followed by Radiation Therapy Before Surgery in Treating Patients With Pancreatic Cancer That Can Be Removed by Surgery
Official title: Phase 2 Study of Preoperative Chemotherapy With Abraxane and Gemcitabine Followed by Chemoradiation for Borderline Resectable or Node-Positive Pancreatic Cancer
Sponsor: OHSU Knight Cancer Institute (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 20.0 (ACTUAL)
Number of arms: 1.0
Start date: 2016-01-21
Primary completion date: 2019-11-12
Completion date: 2022-12-12
Limitations and caveats: Study closed early due to lack of enrollment. Study was expected to enrolled 44 evaluable patients to achieve 83% power using the 2-sided binomial test at 10% significance. Study enrolled only 19 evaluable patients, meaning the study was underpowered at \< 62%. Study completed stage 1 of Simon's 2-stage minimax design and achieved the required goal of 8 R0 resections.
Clinical trial NCT04435808: Efficacy of Hydroxychloroquine Prophylaxis for Health Care Workers at High Risk for COVID-19
Official title: Off Label Study to Evaluate the Efficacy of Hydroxychloroquine as Prophylaxis to Prevent Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection Among Health Care Workers at High Risk of Occupational Exposure to SARS-CoV-2
Sponsor: University of New Mexico (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Stopped for futility by DSMB
Enrollment: 1.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-04-14
Primary completion date: 2020-07-15
Completion date: 2020-07-15
Baseline population: DSMB stopped the study
Plan to share individual participant data: NO
Clinical trial NCT02737475: An Investigational Immuno-Therapy Study of Experimental Medication BMS-986178 by Itself or in Combination With Nivolumab and/or Ipilimumab in Participants With Solid Cancers That Are Advanced or Have Spread
Official title: A Phase 1/2a Study of BMS-986178 Administered Alone or in Combination With Nivolumab and/or Ipilimumab in Subjects With Advanced Solid Tumors
Sponsor: Bristol-Myers Squibb (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: COMPLETED 
Enrollment: 166.0 (ACTUAL)
Number of arms: 9.0
Start date: 2016-06-17
Primary completion date: 2020-11-02
Completion date: 2020-11-02
Clinical trial NCT03782363: Study of Adoptive Immunotherapy in Relapsed and Non-resectable Sarcomas After Multimodal Treatment.
Official title: A Phase I Study of Adoptive Immunotherapy With Cytokine-Induced Killer Cells in Relapsed and Non-resectable Sarcomas After Multimodal Treatment.
Acronym: CAST
Sponsor: Italian Sarcoma Group (NETWORK)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: Initial version of the protocol not submitted and new version approved has a new sponsor and it has been added into Clinicaltrials by the new sponsor
Enrollment: 0.0 (ACTUAL)
Number of arms: 4.0
Start date: 2020-12-18
Primary completion date: 2023-04-01
Completion date: 2023-04-01
Plan to share individual participant data: NO
Clinical trial NCT03428100: A Long-term Study of Baricitinib (LY3009104) With Topical Corticosteroids in Adults With Moderate to Severe Atopic Dermatitis That Are Not Controlled With Cyclosporine or for Those Who Cannot Take Oral Cyclosporine Because it is Not Medically Advisable
Official title: A Phase 3, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Safety and Efficacy of Baricitinib in Combination With Topical Corticosteroids in Adult Patients With Moderate-to-Severe Atopic Dermatitis Who Have Experienced Failure to Cyclosporine or Are Intolerant to, or Have Contraindication to, Cyclosporine
Acronym: BREEZE-AD4
Sponsor: Eli Lilly and Company (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 463.0 (ACTUAL)
Number of arms: 19.0
Start date: 2018-05-15
Primary completion date: 2019-11-25
Completion date: 2023-04-20
Baseline population: All randomized 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 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 NCT04370236: INB03 for the Treatment of Pulmonary Complications From COVID-19
Official title: A Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial of INB03 in the Treatment of Participants With Pulmonary Complications From Coronavirus Disease (COVID-19)
Sponsor: Inmune Bio, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: TERMINATED 
Why stopped: Futility
Enrollment: 79.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-10-21
Primary completion date: 2021-10-13
Completion date: 2021-11-18
Plan to share individual participant data: NO
Clinical trial NCT03713684: Efficacy and Safety of Efpeglenatide Versus Placebo in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Basal Insulin Alone or in Combination With Oral Antidiabetic Drug(s)
Official title: A 56-week, Multicenter, Double-blind, Placebo-controlled, Randomized Study to Evaluate the Efficacy and Safety of Efpeglenatide Once Weekly in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Basal Insulin Alone or in Combination With Oral Antidiabetic Drug(s)
Acronym: AMPLITUDE-L
Sponsor: Sanofi (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Sponsor decision to cancel TRIAL, not related to safety concern
Enrollment: 370.0 (ACTUAL)
Number of arms: 4.0
Start date: 2018-11-09
Primary completion date: 2020-11-20
Completion date: 2021-01-04
Baseline population: Analysis was performed on Intent-to-treat (ITT) population which included all participants randomized irrespective of compliance with the study protocol and procedures analyzed, according to the treatment group allocated by randomization.
Limitations and caveats: The study was terminated early by the Sponsor on 09 September 2020. Due to early termination of the study, few efficacy evaluations originally planned in the protocol were no longer considered to be relevant and were not performed. Primary, and secondary efficacy data were descriptively summarized and data were carefully considered given that the study was terminated early.
Plan to share individual participant data: NO
IPD sharing description: No plan to share individual participant data (IPD) by SANOFI: Product rights transferred to Hanmi Pharmaceutical.
Clinical trial NCT04644029: Oral ISL QM as PrEP in Cisgender Women at High Risk for HIV-1 Infection (MK-8591-022)
Official title: A Phase 3, Randomized, Active-Controlled, Double-blind Clinical Study to Evaluate the Efficacy and Safety of Oral Islatravir Once-Monthly as Preexposure Prophylaxis in Cisgender Women at High Risk for HIV-1 Infection
Acronym: Impower-022
Sponsor: Merck Sharp & Dohme LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Voluntarily terminated due to benefit/risk assessment
Enrollment: 730.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-02-24
Primary completion date: 2023-07-18
Completion date: 2024-06-11
Baseline population: The baseline characteristics population includes all randomized participants who received study drug.
Plan to share individual participant data: YES
IPD sharing description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Clinical trial NCT02501811: Combination of Mesenchymal and C-kit+ Cardiac Stem Cells as Regenerative Therapy for Heart Failure
Official title: A Phase II, Randomized, Placebo-Controlled Study of the Safety, Feasibility, & Efficacy of Autologous Mesenchymal Stem Cells & C-kit+ Cardiac Stem Cells, Alone or in Combination, Administered Transendocardially in Subjects With Ischemic HF
Acronym: CONCERT-HF
Sponsor: The University of Texas Health Science Center, Houston (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 125.0 (ACTUAL)
Number of arms: 4.0
Start date: 2015-10-31
Primary completion date: 2020-06-25
Completion date: 2020-07-22
Baseline population: Denominators are of those reporting
Limitations and caveats: Relatively small group sizes overall. Relatively long interval between harvest visit and study product injection (approx. 14wks) resulting in patient attrition. Failure of cells to grow from tissue of some patients, resulting in some patients crossing over into other treatment groups.
Clinical trial NCT03654989: Iontophoresis of Treprostinil to Enhance Wound Healing in Diabetic Foot Skin Ulcers
Official title: Iontophoresis of Treprostinil to Enhance Wound Healing in Diabetic Foot Skin Ulcers
Acronym: InTREPiD
Sponsor: University Hospital, Grenoble (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: recruitment difficulties
Enrollment: 4.0 (ACTUAL)
Number of arms: 3.0
Start date: 2020-01-28
Primary completion date: 2021-12-07
Completion date: 2021-12-07
Plan to share individual participant data: UNDECIDED
Clinical trial NCT04702464: A Study to Evaluate the Effect of a Dual CYP2C19 and CYP3A4 Inhibitor, Fluconazole, on the Pharmacokinetics of Fedratinib in Healthy Adult Subjects
Official title: A Phase 1, Open-label Study to Evaluate the Effect of a Dual CYP2C19 and CYP3A4 Inhibitor, Fluconazole, on the Pharmacokinetics of Fedratinib in Healthy Adult Subjects
Sponsor: Celgene (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 29.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-01-12
Primary completion date: 2021-05-09
Completion date: 2021-05-13
Plan to share individual participant data: YES
IPD sharing description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link:~https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/
IPD time frame: See Plan Description
IPD access criteria: See Plan Description