A TREATMENT PROTOCOL FOR PATIENTS WITH GASTROINTESTINAL STROMAL TUMOR WHO ARE INELIGIBLE FOR PARTICIPATION IN OTHER SU011248 PROTOCOLS AND ARE REFRACTORY TO OR INTOLERANT OF IMATINIB MESYLATE

Pfizer Global Research Development0 sites1,500 target enrollmentSeptember 21, 2005

Overview

No summary available.

Registry

who.int

Start Date

September 21, 2005

End Date

TBD

Last Updated

13 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Pfizer Global Research Development

•1\. Histopathologically proven diagnosis of malignant GIST that is not amenable to
•standard therapy with curative intent.
•2\. Must be ineligible for participation in ongoing SU011248 clinical studies (if any Phase 1, 2, or 3 SU011248 protocols for patients having GIST are open to enrollment at the institution)
•3\. Judged to have the potential to derive clinical benefit from SU011248 treatment
•by the treating physician.
•4\. Failed prior treatment with imatinib mesylate, defined either by progression of
•disease, or by significant toxicity during treatment with imatinib mesylate that
•precluded further treatment. Intolerance to prior imatinib mesylate therapy will
•be defined as follows:
•\- Life\-threatening adverse events (ie, Grade 4 according to NCI CTCAE Version

•Subjects presenting with any of the following will not be included in the trial:
•1\. Current treatment in another clinical trial
•2\. Symptomatic CNS metastases
•3\. Symptomatic congestive heart failure, myocardial infarction or coronary artery
•bypass graft in the previous six months, ongoing severe or unstable angina or
•any unstable arrhythmia requiring medication
•4\. Pregnancy or breastfeeding (see Section 4\.4 for further details)
•5\. Other severe acute or chronic medical or psychiatric condition, or laboratory
•abnormality that would impart, in the judgment of the investigator, excess risk
•associated with study participation or study drug administration, or which, in the