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

APPROVED_FOR_MARKETING

Conditions studied: Gastrointestinal Neoplasm

In brief

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.

Key facts

Study ID

NCT00094029

Run by

Pfizer

Starts

2004-09-01

Expected to finish

2011-10-01

Last updated by the study team

2012-03-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Pfizer Investigational Site — Pasadena, California, United States
• Pfizer Investigational Site — San Francisco, California, United States
• Pfizer Investigational Site — Santa Monica, California, United States
• Pfizer Investigational Site — Washington D.C., District of Columbia, United States
• Pfizer Investigational Site — Gainesville, Florida, United States
• Pfizer Investigational Site — Gainsville, Florida, United States
• Pfizer Investigational Site — Miami, Florida, United States
• Pfizer Investigational Site — Tampa, Florida, United States
• Pfizer Investigational Site — Niles, Illinois, United States
• Pfizer Investigational Site — Park Ridge, Illinois, United States
• Pfizer Investigational Site — Boston, Massachusetts, United States
• Pfizer Investigational Site — New Bedford, Massachusetts, United States
• Pfizer Investigational Site — Detroit, Michigan, United States
• Pfizer Investigational Site — Detroit, Michigan, United States
• Pfizer Investigational Site — Farmington Hills, Michigan, United States
• Pfizer Investigational Site — Minneapolis, Minnesota, United States
• Pfizer Investigational Site — Rochester, Minnesota, United States
• Pfizer Investigational Site — Creve Coeur, Missouri, United States
• Pfizer Investigational Site — St Louis, Missouri, United States
• Pfizer Investigational Site — St Louis, Missouri, United States
• Pfizer Investigational Site — Buffalo, New York, United States
• Pfizer Investigational Site — New York, New York, United States
• Pfizer Investigational Site — New York, New York, United States
• Pfizer Investigational Site — The Bronx, New York, United States
• Pfizer Investigational Site — Duarte, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.