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.
- Conditions
- Gastrointestinal stromal tumorClassification code 10038415
- Registration Number
- EUCTR2004-001860-27-ES
- Lead Sponsor
- Pfizer SA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 338
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, ³Grade 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 £1.
7. 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) ³1000/mL
·Platelets ³75,000/mL
·Hemoglobin ³8.0 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.
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
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 Main Objective: The primary objective is to provide access to SU011248 treatment for patients with GIST given the following conditions: a) patients who undergo screening, but are ineligible for participation in ongoing SU011248 clinical studies (such as A6181004), and b) patients have received treatment with imatinib mesylate and have developed resistance or intolerance, and c) patients have, in the judgment of the investigator, the potential to derive clinical benefit from treatment with SU011248. ;Secondary Objective: In addition, the following clinical endpoints will be evaluated.<br>Safety profile of SU011248<br> Overall survival (OS)<br>Time-to-progression (TTP)<br> Objective response rate (ORR);Primary end point(s): The primary objective is to provide access to SU011248 treatment for patients with GIST according to conditions described in the protocol without formal hypothesis testing.
- Secondary Outcome Measures
Name Time Method