A phase I study of oral ABL001 in patients with CML or Ph+ ALL
Research type
Research Study
Full title
A phase I, multicenter, open-label study of oral ABL001 in patients with chronic myelogenous leukemia or Philadelphia Chromosome-positive acute lymphoblastic leukemia
IRAS ID
206527
Contact name
Oliver Ottmann
Contact email
Sponsor organisation
Novartis Pharma AG
Eudract number
2013-004491-36
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 0 months, 8 days
Research summary
This is a multicentre, open-label, phase I study which will enroll adult patients with cytogenetically confirmed, previously diagnosed Philadelphia Chromosome-positive Chronic Myeloid Leukemia (Ph+ CML) and Philadelphia Chromosome-positive acute lymphoblastic leukemia (Ph+ ALL).
This study consists of two parts: dose escalation and dose expansion.
The purpose of the dose escalation study is to define the Maximum Tolerated Dose (MTD)/Recommended Dose for Expansion (RDE(s)), safety, tolerability, Pharmacokinetics (PK) and to provide preliminary evidence of efficacy of ABL001 given as single agent or in combination with either nilotinib or imatinib or dasatinib.
ABL001 will be given as single agent in patients with Chronic Phase (CP) and Accelerated Phase (AP) Chronic Myeloid Leukemia (CML), and in patients with Blast Phase (BP) Chronic Myeloid Leukemia (CML) and Philadelphia Chromosome-positive acute lymphoblastic leukemia (Ph+ALL).
ABL001 will be given in combination with either nilotinib or imatinib or dasatinib in patients with Chronic Phase (CP) and Accelerated Phase (AP) Chronic Myeloid Leukemia (CML).
The purpose of the dose expansion study is to gain further safety and tolerability information of the Maximum Tolerated Dose (MTD)/Recommended Dose for Expansion (RDE(s)) of ABL001 given as single agent or in combination with either nilotinib or imatinib or dasatinib.
REC name
South Central - Oxford A Research Ethics Committee
REC reference
16/SC/0401
Date of REC Opinion
26 Aug 2016
REC opinion
Further Information Favourable Opinion