SAR302503

DRUG8 trials

Conditions

Hematopoietic NeoplasmHepatic ImpairmentMyelofibrosisRenal ImpairmentSolid Tumor

Phase 1

Drug Interaction Study of SAR302503 in Patients With Solid Tumor

CompletedNCT01585623

Bristol-Myers SquibbSolid Tumor

Start: 2012-06-30End: 2013-03-31Updated: 2025-03-05

Open Label Pharmacokinetic Study of SAR302503 in Subjects With Hepatic Impairment

CompletedNCT01762462

Bristol-Myers SquibbHepatic Impairment

Start: 2012-12-31End: 2013-03-31Updated: 2025-03-05

Open Label Pharmacokinetic Study of SAR302503 in Subjects With Renal Impairment

CompletedNCT01763190

Bristol-Myers SquibbRenal Impairment

Start: 2012-11-30End: 2013-07-31Updated: 2025-03-05

Phase 2

Phase 2 Study of SAR302503 in Patients With Myelofibrosis

CompletedNCT01420770

Bristol-Myers SquibbHematopoietic Neoplasm

Start: 2011-08-31End: 2014-04-30Updated: 2025-03-05

Study With SAR302503 in Patients With Polycythemia Vera or Essential Thrombocythemia

CompletedNCT01420783

Bristol-Myers SquibbHematopoietic Neoplasm

Start: 2011-10-31End: 2014-05-31Updated: 2025-03-05

Phase II, Open Label, Single Arm Study of SAR302503 In Myelofibrosis Patients Previously Treated With Ruxolitinib

CompletedNCT01523171

Bristol-Myers SquibbHematopoietic Neoplasm

Start: 2012-04-30End: 2014-04-30Updated: 2025-03-05

Phase 2 Study in Japanese Patients With Intermediate-2 or High Risk Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, Post-Essential Thrombocythemia Myelofibrosis With Splenomegaly

CompletedNCT01692366

Bristol-Myers SquibbMyelofibrosis

Start: 2012-11-30End: 2014-03-31Updated: 2025-03-05

Phase 3

Phase III Study of SAR302503 in Intermediate-2 and High Risk Patients With Myelofibrosis

CompletedNCT01437787

Bristol-Myers SquibbHematopoietic Neoplasm

Start: 2011-12-31End: 2014-06-30Updated: 2025-03-05

Blood2024-11-051 citations

JAK2 Inhibitors & Myelofibrosis

Oncology Times2023-12-05

Matching-adjusted indirect comparison of the pelabresib-ruxolitinib combination vs JAKi monotherapy in myelofibrosis

Blood Advances2023-08-027 citations

Indirect treatment comparison (ITC) of momelotinib (MMB) vs fedratinib (FED) safety in patients (pts) with myelofibrosis (MF).

Journal of Clinical Oncology2023-06-013 citations

Safety and Efficacy of Fedratinib in Patients with Primary (P), Post-Polycythemia Vera (Post-PV), and Post-Essential Thrombocythemia (Post-ET) Myelofibrosis (MF) Previously Treated with Ruxolitinib: Primary Analysis of the FREEDOM Trial

Blood2022-11-1513 citations

Determinants of Survival and Retrospective Comparisons in 183 Clinical Trial Patients with Myelofibrosis Treated with Ruxolitinib, Fedratinib, Momelotinib, or BMS-911543 JAK2 Inhibitor between 2007 and 2013

Blood2022-11-152 citations

Effect of fluconazole on the pharmacokinetics of a single dose of fedratinib in healthy adults.

2022-08-244 citations

P1041: IMPACT OF FEDRATINIB ON SPLEEN VOLUME AND MYELOFIBROSIS SYMPTOMS IN PATIENTS WITH SUBSTANTIAL SPLENOMEGALY: POST HOC ANALYSES FROM THE JAKARTA AND JAKARTA2 TRIALS

HemaSphere2022-06-011 citations

P1059: COMPARATIVE EFFICACY OF FEDRATINIB AND PACRITINIB FOR THE TREATMENT OF MYELOFIBROSIS IN PATIENTS WITH LOW PLATELET COUNTS: A SIMULATED TREATMENT COMPARISON STUDY

HemaSphere2022-06-01

P1061: INDIRECT TREATMENT COMPARISONS OF FEDRATINIB VERSUS NAVITOCLAX PLUS RUXOLITINIB: EFFECT ON SPLEEN VOLUME AND SYMPTOMS IN RUXOLITINIB-EXPOSED MYELOFIBROSIS PATIENTS

HemaSphere2022-06-01

Comparative Effectiveness of Fedratinib and Pacritinib for the Treatment of Myelofibrosis in Patients with Low Platelet Counts: A Simulated Treatment Comparison Study

Blood2021-11-05

Indirect Treatment Comparisons of the Effect of Fedratinib Versus Navitoclax Plus Ruxolitinib on Spleen Volume and Symptoms in Patients with Myelofibrosis and Prior Ruxolitinib Treatment

Blood2021-11-05

Fedratinib (FEDR) in myelofibrosis (MF) patients previously treated with ruxolitinib (RUX): A reanalysis of the JAKARTA-2 study.

Journal of Clinical Oncology2019-05-2010 citations

Janus kinase-2 inhibitor fedratinib in patients with myelofibrosis previously treated with ruxolitinib (JAKARTA-2): a single-arm, open-label, non-randomised, phase 2, multicentre study.

2017-06-08248 citations

Safety and Efficacy of Fedratinib in Patients With Primary or Secondary Myelofibrosis

JAMA Oncology2015-06-18454 citations

Results Of a Randomized, Double-Blind, Placebo-Controlled Phase III Study (JAKARTA) Of The JAK2-Selective Inhibitor Fedratinib (SAR302503) In Patients With Myelofibrosis (MF)

Blood2013-11-1531 citations

Efficacy and Safety Of Fedratinib (SAR302503/TG101348) In Patients With Intermediate- Or High-Risk Myelofibrosis (MF), Post-Polycythemia Vera (PV) MF, Or Post-Essential Thrombocythemia (ET) MF Previously Treated With Ruxolitinib: Interim Results From a Phase II Study (JAKARTA-2)

Blood2013-11-1516 citations

Effect Of Treatment With The JAK2-Selective Inhibitor Fedratinib (SAR302503) On Bone Marrow Histology In Patients With Myeloproliferative Neoplasms With Myelofibrosis

Blood2013-11-157 citations

Long-Term Follow Up Of a Randomized Phase II Study Of The JAK2-Selective Inhibitor Fedratinib (SAR302503) In Patients With Myelofibrosis (MF)

Blood2013-11-156 citations

Symptom Burden and Health-Related Quality Of Life (HRQoL) In Patients With Myelofibrosis (MF) Treated With Fedratinib (SAR302503) In a Phase III Study (JAKARTA)

Blood2013-11-153 citations

SAR302503

Sponsors

Conditions

Phase 1

Phase 2

Phase 3

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