EUCTR2004-001860-27-FI
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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Patients with Gastrointestinal Stromal Tumor who are Refractory to Standard Therapy and May Derive Benefit for Treatment with SU011248
- Sponsor
- Pfizer Oy
- Enrollment
- 1500
- 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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