腸胃道基質瘤

經imatinib mesylate治療後復發,或無法耐受此藥物且不適合參加SU011248其他計畫的腸胃道基質瘤病患的治療計畫

膠囊劑

SUNITINIB MALATE

130

12.5mg/ 25mg/ 50mg

- Safety profile of SU011248
- Overall survival (OS)
- Time-to-progression (TTP)
- Objective response rate (ORR)

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, major/equal to Grade 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
minor/equal to 1.
7. 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
8. 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.
9. Willingness and ability to comply with scheduled visits, treatment plans and
laboratory tests and other study procedures.

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