Study of the JAK Inhibitor Ruxolitinib Administered Orally to Patients With Primary Myelofibrosis (PMF), Post-Polycythemia Vera-Myelofibrosis (PPV-MF) or Post-Essential Thrombocythemia-Myelofibrosis (PET-MF)
Status and phase
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Treatments
Study type
Funder types
Identifiers
Details and patient eligibility
About
This is a Phase IB, open-label, dose-finding study of the JAK 1 and 2 inhibitor ruxolitinib in patients with myelofibrosis (MF). The study consists of two periods: the core study period, comprising the dose escalation stage and the safety extension phase up to Week 24, then the extension study period beyond Week 24 and up to 3 years, to further characterize the safety and efficacy of ruxolitinib in this patient population. The dose escalation phase will enroll successive cohorts of patients who receive increasing doses of ruxolitinib until the maximum safe starting dose (MSSD) is determined. In the safety expansion phase, additional patients will be treated with ruxolitinib at the MSSD defined during dose escalation. The primary objective is to establish the MSSD of ruxolitinib in patients with MF and starting platelet counts < 100 x 10 ^9/L
Enrollment
Sex
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Volunteers
Inclusion criteria
- Require treatment for MF and classified at least as intermediate risk level 1 defined by the International Working Group.
- Platelet count < 100x10 ^9/L at screening or at Study Day 1.
Exclusion criteria
- Received platelet transfusion within 14 days prior to Screening evaluations.
Trial design
Primary purpose
Allocation
Interventional model
Masking
69 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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