18 completed, 5 terminated, 3 recruiting, 1 active not recruiting. 17 Phase 1, 12 Phase 2, 3 Phase 3.
Follow fedratinib: new trials by email Literature Review of fedratinib trials Research Report on fedratinib
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Revumenib in Patients With Myelofibrosis Revumenib, Ruxolitinib, FEDRATINIB - Myelofibrosis, Post-polycythemia Vera Myelofibrosis | Phase 1 / Phase 2 | Not yet recruiting | John Mascarenhas | 32 | 2026-12-01 | 2026-07-29 |
| Real World Evidence of Fedratinib Effectiveness in MF Fedratinib - Primary Myelofibrosis, Post-polycythemia Vera Myelofibrosis | Unknown | Gruppo Italiano Malattie EMatologiche dell'Adulto | 93 | 2024-01-29 | 2024-02-08 | |
| A Post-Marketing Surveillance Study to Assess the Safety of Fedratinib in Korean Patients With Myelofibrosis Fedratinib - Primary Myelofibrosis, Post-polycythemia Vera Myelofibrosis | Recruiting | Bristol-Myers Squibb | 137 | 2023-06-13 | 2024-11-06 | |
| Fedratinib in Combination With Nivolumab Fedratinib Oral Capsule [Inrebic], Nivolumab - Primary Myelofibrosis, Secondary Myelofibrosis | Phase 2 | Completed | Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest | 30 | 2022-06-14 | 2026-04-08 |
| Maintenance Fedratinib to Prevent Post-Transplant Relapse in Myeloproliferative Neoplasms Fedratinib Pill - Myeloproliferative Neoplasm | Phase 1 | Terminated | H. Lee Moffitt Cancer Center and Research Institute | 12 | 2022-03-14 | 2025-12-04 |
| Fedratinib in Myelodysplastic /Myeloproliferative Neoplasms (MDS/MPNs) and Chronic Neutrophilic Leukemia (CNL) Fedratinib Pill - Myeloproliferative Neoplasm, Chronic Neutrophilic Leukemia | Phase 2 | Completed | H. Lee Moffitt Cancer Center and Research Institute | 25 | 2022-03-01 | 2026-06-09 |
| Combination of Fedratinib and Decitabine for Myeloproliferative Neoplasms (MPN)- Accelerated Phase (AP)/Blast Phase (BP) Fedratinib Oral Capsule 300 mg, Decitabine 20 mg/m2, Fedratinib Oral Capsule 400 mg - Myeloproliferative Neoplasm | Phase 1 | Terminated | Joseph Jurcic | 2 | 2022-01-28 | 2024-04-23 |
| A Study of Fedratinib With IDH Inhibition in Advanced-Phase, IDH-Mutated Ph-Negative Myeloproliferative Neoplasms Ivosidenib, Enasidenib, Fedratinib - IDH Mutation, IDH1 Mutation | Phase 1 | Withdrawn | University of Chicago | 2021-10-29 | 2024-07-31 | |
| A Study to Evaluate the Bioavailability of Fedratinib When Administered in Different Ways to Healthy Adult Participants Fedratinib - Healthy Volunteers | Phase 1 | Completed | Bristol-Myers Squibb | 58 | 2021-09-21 | 2022-06-27 |
| 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) BMS-986158, Ruxolitinib, Fedratinib - Myelofibrosis | Phase 1 / Phase 2 | Active not recruiting | Bristol-Myers Squibb | 216 | 2021-03-22 | 2026-05-08 |
| Reduced Intensity Haploidentical Transplantation for the Treatment of Primary or Secondary Myelofibrosis Cyclophosphamide, JAK Inhibitor, Fludarabine - Primary Myelofibrosis, Secondary Myelofibrosis | Phase 2 | Recruiting | Fred Hutchinson Cancer Center | 20 | 2021-02-09 | 2026-07-20 |
| A Study to Evaluate the Effect of a Dual CYP2C19 and CYP3A4 Inhibitor, Fluconazole, on the Pharmacokinetics of Fedratinib in Healthy Adult Subjects Fedratinib, Fluconazole - Healthy Volunteers | Phase 1 | Completed | Celgene | 29 | 2021-01-12 | 2021-11-29 |
| 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) Fedratinib - Primary Myelofibrosis | Phase 1 / Phase 2 | Completed | Bristol-Myers Squibb | 31 | 2020-10-12 | 2026-11-12 |
| Decitabine With Ruxolitinib, Fedratinib or Pacritinib for the Treatment of Accelerated/Blast Phase Myeloproliferative Neoplasms Decitabine, Ruxolitinib, Fedratinib - Acute Myeloid Leukemia, Essential Thrombocythemia | Phase 2 | Recruiting | University of Washington | 25 | 2020-03-24 | 2026-09-17 |
| Influence of Fedratinib on the Pharmacokinetics of the Transporter Probe Substrates Digoxin, Rosuvastatin, and Metformin Fedratinib, Digoxin, Rosuvastatin - Healthy Volunteers | Phase 1 | Completed | Celgene | 24 | 2019-12-18 | 2020-05-21 |
| 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 FEDRATINIB, Best Available Therapy (BAT) - Primary Myelofibrosis, Post-Polycythemia Vera | Phase 3 | Completed | Celgene | 202 | 2019-09-09 | 2025-08-28 |
| A Pharmacokinetics and Tolerability Study of Fedratinib in Subjects With Moderate and Severe Hepatic Impairment Fedratinib - Healthy Volunteers, Hepatic Impairment | Phase 1 | Completed | Celgene | 39 | 2019-09-04 | 2023-03-17 |
| Effect of Rifampin and Efavirenz on the Pharmacokinetics of Fedratinib in Healthy Adult Subjects Fedratinib, Rifampin, Efavirenz - Healthy Volunteers | Phase 1 | Completed | Celgene | 32 | 2019-06-21 | 2020-08-21 |
| 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 FEDRATINIB - Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis | Phase 3 | Terminated | Celgene | 38 | 2019-03-27 | 2024-12-12 |
| Effect of SAR302503 on ECG Activity in Patients With Solid Tumors SAR302503 (TG101348), Placebo SAR302503, Panolosetron - Neoplasm Malignant | Phase 1 | Completed | Bristol-Myers Squibb | 60 | 2013-05-01 | 2025-03-05 |
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Primary Myelofibrosis (14) · Myeloproliferative Disorders (7) · Hematologic Neoplasms (5) · Blast Crisis (1) · Leukemia (1) · Leukemia, Monocytic, Acute (1) · Leukemia, Myeloid, Acute (1) · Leukemia, Neutrophilic, Chronic (1) · Myelodysplastic Syndromes (1) · Myelodysplastic-Myeloproliferative Diseases (1) · Neoplasms (1) · Polycythemia Vera (1) · Renal Insufficiency (1) · Thrombocythemia, Essential (1)
Bristol-Myers Squibb (14) · Celgene (7) · H. Lee Moffitt Cancer Center and Research Institute (2) · Fred Hutchinson Cancer Center (1) · Gruppo Italiano Malattie EMatologiche dell'Adulto (1) · Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest (1) · John Mascarenhas (1) · Joseph Jurcic (1) · TargeGen (1) · University of Chicago (1) · University of Washington (1)
United States (25) · Germany (6) · Italy (6) · France (5) · South Korea (5) · Spain (5) · Australia (4) · Belgium (4) · Canada (4) · United Kingdom (4) · Austria (3) · Poland (3) · Hungary (2) · Ireland (2) · Israel (2)
Ayalew Tefferi, MD (2) · Andrew Kuykendall, MD (1) · Anna Halpern (1) · Anthony M Hunter, MD (1) · John Mascarenhas, MD (1) · Joseph Jurcic, MD (1) · Leon Carayannopolous, M.D. (1) · Leon Carayannopoulos, MD (1) · Olatoyosi Odenike, MD (1) · Rachel B. Salit (1) · Salah-Eddin Al-Batran, Prof. Dr. (1) · Taiga Nishihori, MD (1)
PMID 26181658, PMID 28602585, PMID 32673446, PMID 34019108, PMID 34477937, PMID 36001108, PMID 37955741, PMID 38838026, PMID 38967662, PMID 39265613
2018 (2), 2023 (1), P01CA108671 (1)