Patients with Gastrointestinal Stromal Tumor who are Refractory to Standard Therapy and May Derive Benefit for Treatment with SU011248 MedDRA version: 7.1 Level: LLY Classification code 10062427
Conditions
Interventions
Trade Name: SUTENT
Product Name: SUTENT
Product Code: SU011248 L-Malate Salt
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: NA
Sponsors
Pfizer Limited
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to provide access to SU011248 treatment for patients with GIST given the following conditions: a) patients have received treatment with imatinib mesylate and have developed resistance or intolerance, and b) patients have, in the judgment of the investigator, the potential to derive clinical benefit from treatment with SU011248, and c) patients are ineligible for participating 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). ; Secondary Objective: The following clinical endpoints will be evaluated: - Safety profile of SU011248 - Overall survival (OS) - Time-to-progression - Objective response rate (ORR) ; Primary end point(s): This is an open-label “treatment use” protocol for patients with GIST given the following conditions: a) patients have received treatment with imatinib mesylate and have developed resistance or intolerance, and b) patients have, in the judgment of the investigator, the potential to derive clinical benefit from treatment with SU011248, and c) patients are ineligible for participating 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). Disease assessments for tumor response and progression will be done as per standard of care for GIST. Minimal disease evaluation data (best response and date of progression) will be collected within this protocol. | — |
Countries
Austria, Denmark, Finland, Greece, Hungary, Italy, Slovakia, Spain, Sweden, United Kingdom
Outcome results
None listed