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 SA0 sites338 target enrollmentDecember 1, 2005

Overview

No summary available.

Registry

who.int

Start Date

December 1, 2005

End Date

TBD

Last Updated

13 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•1\. Histopathologically proven diagnosis of malignant GIST that is not amenable to standard therapy with curative intent.
•2\. Must have undergone screening and found to be ineligible for participation in ongoing SU011248 clinical studies such as the A6181004 Phase 3 trial.
•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 3\.0\) at any dose (attempt to dose reduce or rechallenge not required) or
•·Unacceptable toxicity induced by a moderate dose (eg, 400 mg/day). Specifically, ³Grade 2 toxicity that is unacceptable to the patient (such as nausea) that persists despite standard countermeasures
•5\. Male or female, 18 years of age or older.
•6\. Resolution of all acute toxic effects of prior systemic therapy (including imatinib mesylate), radiotherapy or surgical procedure to NCI CTCAE Version 3\.0 grade £1\.
•7\. Adequate organ function as defined by the following criteria:
•·Total serum bilirubin £2 x ULN (patients with Gilbert’s disease exempt)

•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 judgment of the investigator, would make the patient inappropriate for entry into this study