Trial to evaluate different starting doses (strengths) of ponatinib
Research type
Research Study
Full title
A Randomized, Open-label, Phase 2 Trial of Ponatinib in Patients with Resistant Chronic Phase Chronic Myeloid Leukemia to Characterize the Efficacy and Safety of a Range of Doses
IRAS ID
183464
Contact name
Jane Apperley
Contact email
Sponsor organisation
ARIAD Pharmaceuticals, Inc.
Eudract number
2014-001617-12
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
IND Number, 78,375
Duration of Study in the UK
4 years, 1 months, 30 days
Research summary
An experimental drug called ponatinib is being studied as a possible cancer treatment for participants with chronic myeloid leukaemia (CML) and Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) who are no longer benefitting from their current treatment.
The purpose of the trial is to evaluate different starting doses (strengths) of ponatinib to determine which dose provides the best control of disease and the least amount of side effects.
Participants will be randomly assigned to receive one of three starting doses of ponatinib, which means being assigned by chance, like the flip of a coin.
Participants and the Study Doctor will know which ponatinib dose they are receiving.
Duration of participation will be 24 months. Screening tests will be performed for up to 3 weeks prior to treatment to determine if participants meet the criteria to take part in this trial. The length of time participants will take ponatinib will depend on cancer status (if there is benefit from treatment) and how well ponatinib is tolerated.REC name
London - Westminster Research Ethics Committee
REC reference
15/LO/1192
Date of REC Opinion
21 Sep 2015
REC opinion
Further Information Favourable Opinion