drugset / Trial / NCT01558739
Exploratory Phase II Study of INC424 Patients With Primary Myelofibrosis (PMF) or Post Polycythaemia Myelofibrosis (PPV MF) or Post Essential Thrombocythaemia Myelofibrosis (PET-MF)
NaSingle-groupOpen-labelTreatment
Summary
The primary objective of this study is to evaluate the efficacy of INC424 in patients with PMF, PPV MF, or PET-MF using a composite measure of either an objective endpoint (\> 50% reduction in splenomegaly using palpitation at 48 weeks) and/or a subjective endpoint (\>50% reduction in total symptom score at 48 weeks).
Timeline
- Start
- 2012-05
- Primary completion
- 2014-01
- Completion
- 2014-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ruxolitinib | Small molecule | 15 mg | Oral |
| Subject | Ruxolitinib | Small molecule | 20 mg | Oral |