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: | Active, not recruiting |
|---|---|
| Conditions: | Hematology |
| Therapuetic Areas: | Hematology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 12/8/2018 |
| Start Date: | March 2011 |
| End Date: | September 2020 |
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
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
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.
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