Status:
COMPLETED
Safety Study of IPI-504 in Patients With Gastrointestinal Stromal Tumors (GIST) or Soft Tissue Sarcomas (STS)
Lead Sponsor:
Infinity Pharmaceuticals, Inc.
Conditions:
Gastrointestinal Stromal Tumors
Soft Tissue Sarcomas
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The primary objectives of the study are: * Determine the safety and maximum tolerated dose (MTD) of IPI-504 in GIST and STS patients who have failed prior therapies * Recommend a dose for subsequent ...
Detailed Description
IPI-504 is a novel, water-soluble analog of 17-AAG and a potent inhibitor of Hsp90. Hsp90's role in the cell is to control the proper folding, function, and viability of various "client" proteins. Man...
Eligibility Criteria
Inclusion
- Pathologically confirmed diagnosis of GIST or STS
- Failed prior therapies
- ECOG performance status of 0-2
- Ability to adhere to the study visit schedule and all protocol requirements
Exclusion
- Previous treatment with 17-AAG, DMAG, or other known Hsp90 inhibitor
- Participation in any investigational drug study or treatment with any other kinase inhibitor therapy within 2 weeks preceding start of treatment
- Concurrent radiation therapy is not permitted
- Concurrent treatment with any agent that alters CYP3A activity
- Concurrent treatment with any agent that may prolong the QTc interval
- Myocardial infarction or active ischemic heart disease within 6 months
- History of arrhythmia
- Baseline QTc \>450
- Grade 3 or greater peripheral neuropathy
- Renal insufficiency, serum creatinine \>1.5 x ULN
- Platelets \< 100,000 mm3
- AST and / or ALT \> 2.5 x ULN
- ANC \<1,500 cells/mm3
- Alkaline phosphatase \> 2.5 x ULN
- Amylase and lipase \> 1.5 x ULN
- Hemoglobin \< 9.0 g/dL
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT00276302
Start Date
December 1 2005
End Date
November 1 2010
Last Update
January 6 2011
Active Locations (5)
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1
Premiere Oncology
Scottsdale, Arizona, United States, 85260
2
Premiere Oncology
Santa Monica, California, United States, 90404
3
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
4
University of Michigan Hosptials
Ann Arbor, Michigan, United States, 48109