Trials / Completed
CompletedNCT01558739
Exploratory Phase II Study of INC424 Patients With Primary Myelofibrosis (PMF) or Post Polycythaemia Myelofibrosis (PPV MF) or Post Essential Thrombocythaemia Myelofibrosis (PET-MF)
A UK Open-label, Multicentre, Exploratory Phase II Study of INC424 for Patients With Primary Myelofibrosis (PMF) or Post Polycythaemia Myelofibrosis (PPV MF) or Post Essential Thrombocythaemia Myelofibrosis (PET-MF)
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 48 (actual)
- Sponsor
- Novartis Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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).
Conditions
- Primary Myelofibrosis (PMF)
- Post Polycythaemia Myelofibrosis (PPV MF)
- Post Essential Thrombocythaemia Myelofibrosis (PET-MF)
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | INC424 | Ruxolitinib was provided in 5 mg tablets, packaged in bottles. 15 - 20 mg (dose based on Baseline platelet count) twice daily. |
Timeline
- Start date
- 2012-05-01
- Primary completion
- 2014-01-01
- Completion
- 2014-01-01
- First posted
- 2012-03-20
- Last updated
- 2015-03-03
- Results posted
- 2015-03-03
Locations
10 sites across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT01558739. Inclusion in this directory is not an endorsement.