26
Participants
Start Date
March 31, 2011
Primary Completion Date
April 30, 2013
Study Completion Date
July 31, 2014
AT13387 and Imatinib
"In part 1 pts will receive AT13387 in combination with imatinib. Up to 5 possible dose levels of AT13387 could be evaluated in combination with imatinib 400 mg daily: 120 mg/m2, 150 mg/m2, 180 mg/m2, 220 mg/m2 and 260 mg/m2. AT13387 IV (in the vein) on day 1, 8 and 15 of each 28 day cycle, until progression or unacceptable toxicity develops, in order to establish the recommended phase II combination dose, which will be used in part 2 and/or part 3 of the study.~In part 2 an additional 6-9pts will be treated.~In part 3, provided that sufficient evidence of anti-tumour effect was observed in part 2 (disease stabilisation or reduction in tumour dimensions by RECIST), then an additional 12pts will be treated with AT13387 in combination with imatinib. Alternatively, if combination treatment is found to have excellent efficacy the randomised phase of the study may start so that 12 pts receive AT13387 on its own (monotherapy) and 12 pts receive AT13387 in combination with imatinib."
Johns Hopkins University, Baltimore
Duke University Medical Center, Durham
Robert H. Lurie Cancer Center of Northwestern University, Chicago
Arizona Cancer Center at UMC North, Tucson
Oregon Health and Sciences University, Portland
Dana-Farber Cancer Institute, Boston
Fox Chase Cancer Center, Philadelphia
University of Texas MD Anderson Cancer Center, Houston
Lead Sponsor
Astex Pharmaceuticals, Inc.
INDUSTRY