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Last Updated: June 26, 2022

CLINICAL TRIALS PROFILE FOR FEDRATINIB HYDROCHLORIDE


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All Clinical Trials for Fedratinib Hydrochloride

Trial ID Title Status Sponsor Phase Start Date Summary
NCT03165734 ↗ A Phase 3 Study of Pacritinib in Patients With Primary Myelofibrosis, Post Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis Recruiting Covance Phase 3 2017-06-26 This study (study ID PAC203 North America; PAC303 ex-North America) is evaluating 200 mg BID of pacritinib compared to physician's choice (P/C) therapy in patients with MF and severe thrombocytopenia (platelet count <50,000/μL). Approximately 348 patients in total will be enrolled, randomized 2:1 to either pacritinib (approximately 232 patients) or to P/C therapy (approximately 116 patients) Condition or disease: Primary Myelofibrosis/Post-Polycythemia Vera Myelofibrosis/ Post-essential Thrombocythemia Myelofibrosis Intervention/treatment: Drug-Pacritinib
NCT03165734 ↗ A Phase 3 Study of Pacritinib in Patients With Primary Myelofibrosis, Post Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis Recruiting PSI CRO Phase 3 2017-06-26 This study (study ID PAC203 North America; PAC303 ex-North America) is evaluating 200 mg BID of pacritinib compared to physician's choice (P/C) therapy in patients with MF and severe thrombocytopenia (platelet count <50,000/μL). Approximately 348 patients in total will be enrolled, randomized 2:1 to either pacritinib (approximately 232 patients) or to P/C therapy (approximately 116 patients) Condition or disease: Primary Myelofibrosis/Post-Polycythemia Vera Myelofibrosis/ Post-essential Thrombocythemia Myelofibrosis Intervention/treatment: Drug-Pacritinib
NCT03165734 ↗ A Phase 3 Study of Pacritinib in Patients With Primary Myelofibrosis, Post Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis Recruiting CTI BioPharma Phase 3 2017-06-26 This study (study ID PAC203 North America; PAC303 ex-North America) is evaluating 200 mg BID of pacritinib compared to physician's choice (P/C) therapy in patients with MF and severe thrombocytopenia (platelet count <50,000/μL). Approximately 348 patients in total will be enrolled, randomized 2:1 to either pacritinib (approximately 232 patients) or to P/C therapy (approximately 116 patients) Condition or disease: Primary Myelofibrosis/Post-Polycythemia Vera Myelofibrosis/ Post-essential Thrombocythemia Myelofibrosis Intervention/treatment: Drug-Pacritinib
NCT03755518 ↗ A Safety 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 With Concomitant Lusp Recruiting Impact Biomedicines, Inc., a wholly owned subsidiary of Celgene Corporation Phase 3 2019-03-27 This is Single-Arm, Open-Label Efficacy and Safety Trial of Fedratinib in 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) and Previously Treated with Ruxolitinib including a Sub-study with concomitant Luspatercept for subjects with anemia. The primary objective of the main study is to evaluate the percentage of subjects with at least a 35% reduction in spleen size and one of the secondary objectives is to evaluate the safety of fedratinib. The primary objective of the sub-study is to evaluate the safety and tolerability of Luspatercept when administered concomitantly with Fedratinib.
NCT03755518 ↗ A Safety 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 With Concomitant Lusp Recruiting Celgene Phase 3 2019-03-27 This is Single-Arm, Open-Label Efficacy and Safety Trial of Fedratinib in 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) and Previously Treated with Ruxolitinib including a Sub-study with concomitant Luspatercept for subjects with anemia. The primary objective of the main study is to evaluate the percentage of subjects with at least a 35% reduction in spleen size and one of the secondary objectives is to evaluate the safety of fedratinib. The primary objective of the sub-study is to evaluate the safety and tolerability of Luspatercept when administered concomitantly with Fedratinib.
NCT03952039 ↗ 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 Previousl Recruiting Impact Biomedicines, Inc., a wholly owned subsidiary of Celgene Corporation Phase 3 2019-09-09 A Phase 3, multicenter, open-label, randomized study to evaluate the efficacy and safety of fedratinib compared to best available therapy (BAT) in 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) and previously treated with ruxolitinib. The primary objective of the study is to evaluate the percentage of subjects with at least 35% spleen volume reduction in the fedratinib and the BAT arms.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Fedratinib Hydrochloride

Condition Name

Condition Name for Fedratinib Hydrochloride
Intervention Trials
Myelofibrosis 7
Primary Myelofibrosis 7
Healthy Volunteers 5
Myeloproliferative Neoplasm 4
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Condition MeSH

Condition MeSH for Fedratinib Hydrochloride
Intervention Trials
Primary Myelofibrosis 12
Polycythemia Vera 7
Polycythemia 7
Thrombocytosis 7
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Clinical Trial Locations for Fedratinib Hydrochloride

Trials by Country

Trials by Country for Fedratinib Hydrochloride
Location Trials
United States 73
Australia 10
Canada 9
Spain 5
Germany 5
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Trials by US State

Trials by US State for Fedratinib Hydrochloride
Location Trials
Texas 9
Florida 6
New Jersey 5
Washington 4
Tennessee 4
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Clinical Trial Progress for Fedratinib Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Fedratinib Hydrochloride
Clinical Trial Phase Trials
Phase 3 3
Phase 2 6
Phase 1/Phase 2 3
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Clinical Trial Status

Clinical Trial Status for Fedratinib Hydrochloride
Clinical Trial Phase Trials
Recruiting 14
Not yet recruiting 6
Completed 2
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Clinical Trial Sponsors for Fedratinib Hydrochloride

Sponsor Name

Sponsor Name for Fedratinib Hydrochloride
Sponsor Trials
Celgene 7
Impact Biomedicines, Inc., a wholly owned subsidiary of Celgene Corporation 6
Bristol-Myers Squibb 4
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Sponsor Type

Sponsor Type for Fedratinib Hydrochloride
Sponsor Trials
Industry 27
Other 7
NIH 2
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