A Study to Investigate the Safety and Efficacy of AT13387, Alone or in Combination With Imatinib, in Patients With GIST

PHASE2CompletedINTERVENTIONAL
Enrollment

26

Participants

Timeline

Start Date

March 31, 2011

Primary Completion Date

April 30, 2013

Study Completion Date

July 31, 2014

Conditions
Gastrointestinal Stromal Tumor (GIST)
Interventions
DRUG

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."

Trial Locations (8)

21231

Johns Hopkins University, Baltimore

27710

Duke University Medical Center, Durham

60611

Robert H. Lurie Cancer Center of Northwestern University, Chicago

85719

Arizona Cancer Center at UMC North, Tucson

97239

Oregon Health and Sciences University, Portland

02459

Dana-Farber Cancer Institute, Boston

19111-2412

Fox Chase Cancer Center, Philadelphia

77230-1402

University of Texas MD Anderson Cancer Center, Houston

Sponsors
All Listed Sponsors
lead

Astex Pharmaceuticals, Inc.

INDUSTRY