➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

McKinsey
Baxter
McKesson
Medtronic
Boehringer Ingelheim
Harvard Business School

Last Updated: August 9, 2020

DrugPatentWatch Database Preview

CLINICAL TRIALS PROFILE FOR FEDRATINIB HYDROCHLORIDE

➤ Get the DrugPatentWatch Daily Briefing
» See Plans and Pricing

« Back to Dashboard

All Clinical Trials for Fedratinib Hydrochloride

Trial ID Title Status Sponsor Phase Start Date Summary
NCT03755518 An Efficacy and 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 Not yet recruiting Celgene Phase 3 2018-12-22 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. The primary objective of the study is to evaluate the percentage of subjects with at least a 35% reduction of spleen volume and one of the secondary objectives is to evaluate the safety of 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 Not yet recruiting Impact Biomedicines, Inc., a wholly owned subsidiary of Celgene Corporation Phase 3 2019-08-23 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 Not yet recruiting Celgene Phase 3 2019-08-23 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.
NCT03983161 A Pharmacokinetics and Tolerability Study of Fedratinib in Subjects With Moderate and Severe Hepatic Impairment Not yet recruiting Impact Biomedicines, Inc., a wholly owned subsidiary of Celgene Corporation Phase 1 2019-12-15 This is a Phase 1, multicenter, nonrandomized, open-label, single oral dose study to assess the PK of fedratinib in subjects with moderate and severe hepatic impairment, and in matched subjects with normal hepatic function. Degrees of hepatic impairment will be determined during screening by the subject's score according to Pugh's Modification of Child's Classification of Severity of Liver Disease.
NCT03983161 A Pharmacokinetics and Tolerability Study of Fedratinib in Subjects With Moderate and Severe Hepatic Impairment Not yet recruiting Celgene Phase 1 2019-12-15 This is a Phase 1, multicenter, nonrandomized, open-label, single oral dose study to assess the PK of fedratinib in subjects with moderate and severe hepatic impairment, and in matched subjects with normal hepatic function. Degrees of hepatic impairment will be determined during screening by the subject's score according to Pugh's Modification of Child's Classification of Severity of Liver Disease.
NCT03983239 Study to Evaluate the Effect of Rifampin and Rifabutin With Fedratinib in Healthy Adult Subjects Not yet recruiting Impact Biomedicines, Inc., a wholly owned subsidiary of Celgene Corporation Phase 1 2019-12-15 This is a 2-part study to evaluate the effect of multiple doses of rifampin or rifabutin on the PK, safety, and tolerability of single doses of fedratinib in healthy subjects. Each study part will consist of a nonrandomized, fixed-sequence, open-label design. The study parts can be run in any order or in parallel. Subjects may participate in one part only. For each part, subjects will participate as follows: - Screening - Treatment period (includes baseline) - Follow-up telephone call (4 days [± 2 days] after discharge) During the study, blood samples will be collected at prespecified times for PK. Subject safety will be monitored throughout the study.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Fedratinib Hydrochloride

Condition Name

Condition Name for Fedratinib Hydrochloride
Intervention Trials
Primary Myelofibrosis 4
Healthy Volunteers 3
Polycythemia Vera 2
Thrombocytosis 2
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Condition MeSH

Condition MeSH for Fedratinib Hydrochloride
Intervention Trials
Primary Myelofibrosis 6
Thrombocytosis 4
Thrombocythemia, Essential 4
Polycythemia Vera 4
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Clinical Trial Locations for Fedratinib Hydrochloride

Trials by Country

Trials by Country for Fedratinib Hydrochloride
Location Trials
United States 5
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Trials by US State

Trials by US State for Fedratinib Hydrochloride
Location Trials
Texas 2
Washington 1
Tennessee 1
Florida 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Clinical Trial Progress for Fedratinib Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Fedratinib Hydrochloride
Clinical Trial Phase Trials
Phase 3 2
Phase 2 1
Phase 1/Phase 2 2
[disabled in preview] 4
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Clinical Trial Status

Clinical Trial Status for Fedratinib Hydrochloride
Clinical Trial Phase Trials
Not yet recruiting 8
Recruiting 1
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Clinical Trial Sponsors for Fedratinib Hydrochloride

Sponsor Name

Sponsor Name for Fedratinib Hydrochloride
Sponsor Trials
Celgene 6
Impact Biomedicines, Inc., a wholly owned subsidiary of Celgene Corporation 4
University of Washington 1
[disabled in preview] 3
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Sponsor Type

Sponsor Type for Fedratinib Hydrochloride
Sponsor Trials
Industry 8
Other 5
NIH 1
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Colorcon
Medtronic
AstraZeneca
McKinsey
Moodys

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.