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.

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 1098

Inclusion Criteria

Patients must meet all of the following inclusion criteria to be eligible for enrollment into the trial: 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). If there are no SU011248 protocols open at the institution, patients may be entered if meeting the study entry criteria. 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, ≥Grade 2 toxicity that is unacceptable to the patient (such as nausea) that persists despite standard countermeasures. 5. Administration of the last dose of imatinib mesylate ≥1-week prior to start of treatment. 6. Male or female, 18 years of age or older. 7. 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. 8. Adequate organ function as defined by the following criteria: ? Total serum bilirubin ≤2 x ULN (patients with Gilbert's disease exempt); ? Serum transaminases <5 x ULN; ? Absolute neutrophil count (ANC) ≥1000/μL; ? Platelets ≥75,000/μL; ? Hemoglobin ≥8.0 g/dL (may be supported with transfusion and/or growth factors). 9. Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all the pertinent aspects of the trial prior to enrollment. 10. Willingness and ability to comply with scheduled visits, treatment plans and laboratory tests and other study procedures.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Subjects presenting with any of the following will not be included in the trial: 1. Current treatment in another therapeutic 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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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