Safety Study of IPI-504 in Patients With Gastrointestinal Stromal Tumors (GIST) or Soft Tissue Sa… (NCT00276302) | Clinical Trial Compass
CompletedPhase 1
Safety Study of IPI-504 in Patients With Gastrointestinal Stromal Tumors (GIST) or Soft Tissue Sarcomas (STS)
United States, Canada63 participantsStarted 2005-12
Plain-language 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 studies of IPI-504
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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
What they're measuring
1
To determine the safety and maximum tolerated dose (MTD) of IPI-504 in GIST and STS patients who have failed prior therapies
Timeframe: 18 months
2
To recommend a dose for subsequent studies of IPI-504