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 range
18 Years
Sex
ALL
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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