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: Not specified

Target Recruitment: 1500

Inclusion Criteria

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 SU0011248 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, major/equal to 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
minor/equal to 1.
8. Adequate organ function as defined by the following criteria:
- Total serum bilirubin minor/equal to 2 x ULN (patients with Gilbert’s disease
exempt)
- Serum transaminases <5 x ULN
- Absolute neutrophil count (ANC): major/equal to 1000/mL
- Platelets: major/equal75,000/mL
- Hemoglobin major/equal 8.0 g/dL
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:
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 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

Related Trials