Ph1b study PIM447 with INC424 + LEE011 in patients with myelofibrosis
Research type
Research Study
Full title
A phase Ib, multi-center, open-label, dose-escalation study of PIM447 in combination with ruxolitinib (INC424) and LEE011 administered orally in patients with myelofibrosis
IRAS ID
172250
Contact name
Marc Credi
Contact email
Sponsor organisation
Novartis Institutes for BioMedical Research, Inc.
Eudract number
2014-003801-14
Duration of Study in the UK
2 years, 1 months, 12 days
Research summary
This study is a Phase 1b dose escalation and dose expansion study.
The purpose of this open label dose escalation study is to determine the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE) of PIM447 and/or LEE011 when administered in combination with Ruxolitinib (INC424) in patients with myelofibrosis.
A group of patients (3 - 6 patients) will be given PIM447 and/or LEE011 + Ruxolitinib combinations at a predefined safe dose and closely monitored and any adverse events will be reported and taken into consideration during the dose escalation meeting (DEM). At the DEM if the decision is to dose escalate then further groups of patients will receive higher doses of PIM447 and/or LEE011 + Ruxolitinib until the MTD and/or RDE is determined for the combinations. At this point the dose expansion part of the study will open.
The purpose of the dose expansion study is to gain further safety and tolerability information of the MTD and/or RDE for PIM447 and/or LEE011 when administered in combination with Ruxolitinib (INC424) and to assess the anti-myelofibrosis effects of the combinations.
REC name
London - West London & GTAC Research Ethics Committee
REC reference
15/LO/0317
Date of REC Opinion
21 Apr 2015
REC opinion
Further Information Favourable Opinion