Fedratinib

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Information
Drug Name
Fedratinib
Description
Entry(CIViC)
1
CIViC
Disease Mutation EL ET ED CS VO TR Pubmed Links
polycythemia vera JAK2 p.Val617Phe (p.V617F)
( ENST00000381652.4 ) JAK2 p.Val617Phe (p.V617F)
( ENST00000381652.4 ) 		D Predictive Supports Sensitivity/Response Somatic 3 18394554 Detail
Annotation
Description Associated Genes Associated Variants Sensitivity Supported Source Links
TG101348 effectively inhibits STAT5 signaling in J... JAK2 JAK2 p.Val617Phe (p.V617F)
( ENST00000381652.4 ) JAK2 p.Val617Phe (p.V617F)
( ENST00000381652.4 ) 		Sensitivity true CIViC Evidence detail
NCT ID Status Phase Summary Start date Completion date
NCT04817007 Active, not recruiting Phase 1/Phase 2 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) March 22, 2021 May 31, 2026
NCT04446650 Active, not recruiting Phase 1/Phase 2 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) October 12, 2020 June 30, 2025
NCT03952039 Active, not recruiting Phase 3 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 September 16, 2019 June 23, 2025
NCT04231435 Completed Phase 1 Influence of Fedratinib on the Pharmacokinetics of the Transporter Probe Substrates Digoxin, Rosuvastatin, and Metformin December 18, 2019 February 21, 2020
NCT04702464 Completed Phase 1 A Study to Evaluate the Effect of a Dual CYP2C19 and CYP3A4 Inhibitor, Fluconazole, on the Pharmacokinetics of Fedratinib in Healthy Adult Subjects January 12, 2021 May 13, 2021
NCT03755518 Completed 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 March 27, 2019 November 8, 2023
NCT03983161 Completed Phase 1 A Pharmacokinetics and Tolerability Study of Fedratinib in Subjects With Moderate and Severe Hepatic Impairment September 4, 2019 January 5, 2023
NCT03983239 Completed Phase 1 Effect of Rifampin and Efavirenz on the Pharmacokinetics of Fedratinib in Healthy Adult Subjects June 21, 2019 November 6, 2019
NCT05051553 Completed Phase 1 A Study to Evaluate the Bioavailability of Fedratinib When Administered in Different Ways to Healthy Adult Participants September 21, 2021 April 8, 2022
NCT04955938 Recruiting Phase 1 A Study of Fedratinib With IDH Inhibition in Advanced-Phase, IDH-Mutated Ph-Negative Myeloproliferative Neoplasms October 29, 2021 October 1, 2025
NCT06073847 Recruiting A Post-Marketing Surveillance Study to Assess the Safety of Fedratinib in Korean Patients With Myelofibrosis July 13, 2023 December 20, 2027
NCT05883904 Recruiting Real World Evidence of Fedratinib Effectiveness in MF January 29, 2024 January 2026
NCT04282187 Recruiting Phase 2 Decitabine With Ruxolitinib, Fedratinib or Pacritinib for the Treatment of Accelerated/Blast Phase Myeloproliferative Neoplasms March 24, 2020 November 11, 2026