Ruxolitinib (INC424) and BKM120 in patients with myelofibrosis
Research type
Research Study
Full title
A phase Ib, open-label, multi-center, two-arm, dose-finding study to assess the safety and efficacy of the oral combination of Ruxolitinib (INC424) and BKM120 in patients with primary myelofibrosis (PMF), postpolycythemia vera-myelofibrosis (PPV-MF), or postessential thrombocythemia-myelofibrosis (PET-MF).
IRAS ID
116110
Contact name
Donata Scossa
Contact email
Sponsor organisation
Novartis Pharma Services AG
Eudract number
2012-003385-41
Duration of Study in the UK
2 years, 5 months, 22 days
Research summary
This study is a phase Ib, open-label, multi-centre, two-arm, dose-finding study to assess the safety and efficacy of the oral combination of Ruxolitinib (INC424) and BKM120 in patients with primary myelofibrosis (PMF), postpolycythemia vera-myelofibrosis (PPV-MF), or postessential thrombocythemia-myelofibrosis (PET-MF). The primary purpose of this study is to find the highest starting dose of INC424 in combination with BKM120 that can be safely given to myelofibrosis patients, and to learn about any of the side effects that might occur during or following treatment.
INC424 has been approved for use in Europe but BKM120 is not yet approved. It is hoped that 62 patients will join this study at 14 centres in 8 countries.REC name
South Central - Oxford C Research Ethics Committee
REC reference
12/SC/0668
Date of REC Opinion
28 Dec 2012
REC opinion
Further Information Favourable Opinion