FREEDOM 2- A study to evaluate the safety and efficacy of Fedratinib
Research type
Research Study
Full title
A Phase 3, multicenter, open-label, randomized study to evaluate the efficacy and safety 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
IRAS ID
258456
Contact name
Claire Harrison
Contact email
Sponsor organisation
Impact Biomedicines, Inc., a Wholly Owned Subsidiary of Celgene Corporation
Eudract number
2018-003411-21
Clinicaltrials.gov Identifier
078286, IND Number
Duration of Study in the UK
5 years, 0 months, 0 days
Research summary
This study is designed to evaluate the efficacy and safety of an investigational drug, Fedratinab (that is not approved for patients use for this indication) compared to best available therapy for patients with Myeloproliferative neoplasm (MPN) Associated Myelofibrosis who previously were treated with Ruxolitinib. This disease is found in the bone marrow(soft tissue inside the bones that makes blood cells)and is causing problems with the blood cells production, being a serious and life-threating disease. Patients in this study will receive by chance either Fedratinib or best available therapy. The study doctor will decide which is best available therapy most beneficial for each patient.
About 190 patients worldwide will take part in this study for approximately 2 years.REC name
London - Surrey Borders Research Ethics Committee
REC reference
19/LO/0787
Date of REC Opinion
12 Aug 2019
REC opinion
Further Information Favourable Opinion