A Treatment Protocol for Patients With Gastrointestinal Stromal Tumor (GIST) Who May Derive Benefit From Treatment With SU011248

• Status: Approved for marketing
• Trial end date: 2011-10-01
• Target enrollment: 0
• Participant gender: All

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 in ongoing clinical studies such as A6181004; AND b) patients have GIST which standard treatments have not been able to control with acceptable toxicity AND c) patients have the potential to derive clinical benefit from treatment with SU011248.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Sunitinib

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.