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)

NCT01558739

Phase 4 Completed 48 enrolled Novartis Pharmaceuticals
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

EvaluationDrugModalityDoseRoute
Subject Ruxolitinib Small molecule 15 mg Oral
Subject Ruxolitinib Small molecule 20 mg Oral