CLINICAL TRIALS PROFILE FOR FEDRATINIB HYDROCHLORIDE

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.
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	Celgene	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.

Clinical Trial Conditions for FEDRATINIB HYDROCHLORIDE

Condition Name

Condition Name for FEDRATINIB HYDROCHLORIDE
Intervention	Trials
Myelofibrosis	7
Primary Myelofibrosis	7
Myeloproliferative Neoplasm	5
Healthy Volunteers	5

Condition MeSH

Condition MeSH for FEDRATINIB HYDROCHLORIDE
Intervention	Trials
Primary Myelofibrosis	12
Thrombocytosis	7
Myeloproliferative Disorders	7
Polycythemia Vera	7

Clinical Trial Locations for FEDRATINIB HYDROCHLORIDE

Trials by Country

Trials by Country for FEDRATINIB HYDROCHLORIDE
Location	Trials
United States	74
Australia	10
Canada	9
Germany	5
Italy	5

Trials by US State

Trials by US State for FEDRATINIB HYDROCHLORIDE
Location	Trials
Texas	9
Florida	6
New Jersey	5
Washington	4
Tennessee	4

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

Clinical Trial Status

Clinical Trial Status for FEDRATINIB HYDROCHLORIDE
Clinical Trial Phase	Trials
Recruiting	15
Not yet recruiting	6
Completed	2

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	5

Sponsor Type

Sponsor Type for FEDRATINIB HYDROCHLORIDE
Sponsor	Trials
Industry	28
Other	8
NIH	2