Status:
APPROVED_FOR_MARKETING
A Treatment Protocol for Patients With Gastrointestinal Stromal Tumor (GIST) Who May Derive Benefit From Treatment With SU011248
Lead Sponsor:
Pfizer
Conditions:
Gastrointestinal Neoplasm
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this study is to permit access to SU011248 for treatment use by patients with GIST given the following conditions: a) patients undergo screening, but are not eligible for participation ...
Detailed Description
Given that an Expanded Access study does not meet the definition of a controlled clinical investigation, and as such, is not considered an applicable drug clinical trial per NIH, Basic Results for suc...
Eligibility Criteria
Inclusion
- Histologically proven Gastrointestinal Stomal Tumor (GIST) that is not amenable to standard therapy
- Undergone screening and found to be ineligible for participation in ongoing SU011248 clinical studies
- Patient judged to have potential to derive clinical benefit from SU011248 treatment by the treating physician
- Failed prior treatment with imatinib mesylate, defined as either progression of disease or significant toxicity during treatment with imatinib mesylate that precluded further treatment
- Male or Female, 18 years or older
- Resolution of all acute toxicities of prior therapies
- Adequate organ function
Exclusion
- Symptomatic congestive heart failure, myocardial infarction, or coronary artery bypass graft in the last 6 months, or ongoing severe or unstable angina or any unstable arrhythmia requiring medication
- Symptomatic central nervous system metastases
- Serious acute or chronic illness
- Current treatment on another clinical trial
- Pregnant or breastfeeding.
Key Trial Info
Start Date :
September 1 2004
Trial Type :
EXPANDED_ACCESS
End Date :
October 1 2011
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00094029
Start Date
September 1 2004
End Date
October 1 2011
Last Update
March 9 2012
Active Locations (118)
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1
Pfizer Investigational Site
Duarte, California, United States, 91010
2
Pfizer Investigational Site
Pasadena, California, United States, 91105
3
Pfizer Investigational Site
San Francisco, California, United States, 94115-1705
4
Pfizer Investigational Site
Santa Monica, California, United States, 90404