Fedratinib
Sponsors
Bristol-Myers Squibb Services Unlimited Company, Celgene Corp., Celgene, University of Washington, Bristol-Myers Squibb
Conditions
Acute Myeloid LeukemiaBlood CancerDIPSS-Intermediate or High Risk MyelofibrosisEssential ThrombocythemiaHealthy VolunteersHepatic ImpairmentIDH MutationIDH1 Mutation
Phase 1
Effect of Rifampin and Efavirenz on the Pharmacokinetics of Fedratinib in Healthy Adult Subjects
CompletedNCT03983239
Start: 2019-06-21End: 2019-11-06Updated: 2020-08-21
A Pharmacokinetics and Tolerability Study of Fedratinib in Subjects With Moderate and Severe Hepatic Impairment
CompletedNCT03983161
Start: 2019-09-04End: 2023-01-05Updated: 2023-03-17
Influence of Fedratinib on the Pharmacokinetics of the Transporter Probe Substrates Digoxin, Rosuvastatin, and Metformin
CompletedNCT04231435
Start: 2019-12-18End: 2020-02-21Updated: 2020-05-21
A Study of Fedratinib in Japanese Subjects With DIPSS (Dynamic International Prognostic Scoring System)- Intermediate or High-risk Primary Myelofibrosis (PMF), Post-polycythemia Vera Myelofibrosis (Post-PV MF), or Post-essential Thrombocythemia Myelofibrosis (Post-ET MF)
Active, not recruitingNCT04446650
Start: 2020-10-12End: 2026-11-30Updated: 2025-10-21
A Study to Evaluate the Effect of a Dual CYP2C19 and CYP3A4 Inhibitor, Fluconazole, on the Pharmacokinetics of Fedratinib in Healthy Adult Subjects
CompletedNCT04702464
Start: 2021-01-12End: 2021-05-13Updated: 2021-11-29
A Study to Assess the Safety and Tolerability of BMS-986158 Alone and in Combination With Either Ruxolitinib or Fedratinib in Participants With Blood Cancer (Myelofibrosis)
Active, not recruitingNCT04817007
Start: 2021-03-22End: 2026-05-31Target: 216Updated: 2025-09-10
A Study of Fedratinib With IDH Inhibition in Advanced-Phase, IDH-Mutated Ph-Negative Myeloproliferative Neoplasms
WithdrawnNCT04955938
Start: 2021-10-29End: 2023-06-07Updated: 2024-07-31
A Study to Evaluate the Bioavailability of Fedratinib When Administered in Different Ways to Healthy Adult Participants
CompletedNCT05051553
Start: 2021-09-21End: 2022-04-08Updated: 2022-06-27
A Phase 1b/2 Study of BMS-986158 Monotherapy and in Combination with Either Ruxolitinib or Fedratinib in Participants with DIPSS-Intermediate or High Risk Myelofibrosis
Active, not recruitingCTIS2023-509635-89-00
Start: 2021-06-01Target: 132Updated: 2026-01-12
Phase 2
Phase 3
A Trial of Fedratinib in Subjects With DIPSS, Intermediate or High-Risk Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis and Previously Treated With Ruxolitinib
TerminatedNCT03755518
Start: 2019-03-27End: 2023-11-08Updated: 2024-12-12
An Efficacy and Safety Study of Fedratinib Compared to Best Available Therapy in Subjects With DIPSS-intermediate or High-risk Primary Myelofibrosis, Post-polycythemia Vera Myelofibrosis, or Post-essential Thrombocythemia Myelofibrosis and Previously Treated With Ruxolitinib
CompletedNCT03952039
Start: 2019-09-09End: 2025-07-28Updated: 2025-08-28
A Phase 3, multicenter, open-label, randomized study to evaluate the efficacy and safety of fedratinib compared to best available therapy in subjects with DIPSS - intermediate or high-risk primary myelofibrosis, post-polycythemia vera myelofibrosis, or post-essential thrombocythemia myelofibrosis and previously treated with ruxolitinib
CompletedCTIS2024-511972-33-00
Start: 2019-08-05End: 2025-07-23Target: 144Updated: 2025-03-26
Unknown Phase
Real World Evidence of Fedratinib Effectiveness in MF
RecruitingNCT05883904
Start: 2024-01-29End: 2026-01-31Target: 93Updated: 2024-02-08
A Post-Marketing Surveillance Study to Assess the Safety of Fedratinib in Korean Patients With Myelofibrosis
RecruitingNCT06073847
Start: 2023-06-13End: 2027-12-20Target: 137Updated: 2024-11-06
Related Papers
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