Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years and Over|
Inclusion Criteria:1. Subject is at least 18 years of age at the time of signing the informed consent form (ICF) 2. Subject has an Eastern Cooperative Oncology Group (ECOG) Performance Score (PS) of 0, 1 or 2. 3. Subject has diagnosis of primary myelofibrosis (PMF) according to the 2016 World Health Organization (WHO) criteria, or diagnosis of post-ET or post-PV myelofibrosis according to the IWG-MRT 2007 criteria, confirmed by the most recent local pathology report. 4. Subject has a DIPSS Risk score of Intermediate-2 or High. 5. Subject has a measurable splenomegaly during the screening period as demonstrated by spleen volume of ≥ 450 cm3 by MRI or CT-scan and by palpable spleen measuring ≥ 5 cm below the left costal margin. 6. Subject has a measurable total symptoms score (≥ 1) as measured by the Myelofibrosis Symptom Assessment Form (MFSAF) 7. Subject has been previously exposed to ruxolitinib, and must meet at least one of the following criteria (a and/or b) 1. Treatment with ruxolitinib for ≥ 3 months with inadequate efficacy response (refractory) defined as < 10% spleen volume reduction by MRI or < 30% decrease from baseline in spleen size by palpation or regrowth (relapsed) to these parameters following an initial response. 2. Treatment with ruxolitinib for ≥ 28 days complicated by any of the following (intolerant):
- - Development of a red blood cell transfusion requirement (at least 2 units/month for 2 months) or.
- - Grade ≥ 3 AEs of thrombocytopenia, anemia, hematoma, and/or hemorrhage while on treatment with ruxolitinib.
Exclusion Criteria:1. Any of the following laboratory abnormalities: 1. Platelets < 50 x 109/L. 2. Absolute neutrophil count (ANC) < 1.0 x 109/L. 3. White blood count (WBC) > 100 x 109/L. 4. Myeloblasts ≥ 5 % in peripheral blood. 5. Estimated glomerular filtration rate < 30 mL/min/1.73 m2 (as per the Modification of Diet in Renal Disease [MDRD] formula) 6. Serum amylase or lipase > 1.5 x upper limit of normal (ULN) 7. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3 x upper limit of normal (ULN) 8. Total bilirubin > 1.5 x ULN, subject's total bilirubin between 1.5
- - 3.0 x ULN are eligible if the direct bilirubin fraction is < 25% of the total bilirubin.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Vishwanath Gharpure, MD|
|Principal Investigator Affiliation||Celgene Corporation|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
|Countries||Australia, Austria, Belgium, China, Czechia, France, Germany, Hungary, Ireland, Italy, Korea, Republic of, Netherlands, Poland, Russian Federation, Spain, United Kingdom|
The disease, disorder, syndrome, illness, or injury that is being studied.
|Primary Myelofibrosis, Post-Polycythemia Vera, Myelofibrosis|
This Phase 3, multicenter, randomized, two-arm, open-label study will include subjects with intermediate or high-risk (as per the DIPSS score) primary myelofibrosis (PMF), postpolycythemia vera myelofibrosis (post-PV MF), or post-essential thrombocythemia myelofibrosis (post-ET MF). This study will be conducted in compliance with International Council for Harmonisation (ICH) Good Clinical Practices (GCPs). Study design includes:
- - A 28-day Screening Period.
- - 2:1 Randomization to fedratinib or best available therapy (BAT) - Stratification at Randomization according to: - Spleen size by palpation: < 15 cm below left costal margin (LCM) versus ≥ 15 cm below LCM.
- - Platelets ≥ 50 to < 100 x 109/L versus platelets ≥ 100 x 109/L.
- - Refractory or relapsed to ruxolitinib treatment versus intolerant to ruxolitinib treatment.
- - Study Treatment Period (time on study drug plus 30 days after last dose) - Subjects are allowed to crossover from BAT to the fedratinib arm after the Cycle 6 response assessment or before the Cycle 6 response assessment in the event of a confirmed progression of splenomegaly by MRI/CT scan.
Experimental: Fedratinib 400mg/day
Will include up to 128 subjects receiving fedratinib 400 mg self-administered Investigational Product (IP) on an outpatient basis, once daily preferably together with food during an evening meal at the same time each day in consecutive 4-week (28-day) cycles.
Active Comparator: Best Available Therapy (BAT)
Best-available Investigator-selected therapy included a number of available compounds to treat MF and/or its symptoms and was chosen by the investigator for each subject. Therapy changed at different times during the treatment period. No investigational agents (e.g. not approved for the treatment of any indication) were allowed. BAT also included the choice of no treatment.
Drug: - FEDRATINIB
A potent and selective inhibitor of JAK2 kinase activity
Drug: - Best Available Therapy (BAT)
Best available therapy (BAT)
Contact a Trial Team
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