EUCTR2004-001860-27-GR
Active, not recruiting
Not Applicable
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 Hellas A.E.0 sites500 target enrollmentJuly 11, 2006
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Pfizer Hellas A.E.
- Enrollment
- 500
- Status
- Active, not recruiting
- Last Updated
- 13 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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:
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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