Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00075218 | A Study To Assess The Safety And Efficacy Of SU11248 In Patients With Gastrointestinal Stromal Tumor(GIST) | PHASE3 | COMPLETED | 361 | — | — | Dec 1, 2003 | May 1, 2008 | Sep 28, 2009 | 61 | United States, Australia +9 |
Time from randomization to first documentation of objective tumor progression based on the assessment of an independent, third-party imaging laboratory using RECIST (Response Evaluation Criteria in Solid Tumors).
Time from randomization to first documentation of objective tumor progression based on the assessment of an independent, third-party imaging laboratory using RECIST (Response Evaluation Criteria in Solid Tumors).
| Arm | Type | Description |
|---|---|---|
| B | PLACEBO_COMPARATOR | - |
| A | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | 50 mg taken orally once a day. 6 week treatment cycle (Schedule 4/2) 4 weeks on study drug/2 weeks off study drug. |
| SU011248 | DRUG | 50 mg taken orally once a day. 6 week treatment cycle (Schedule 4/2) 4 weeks on study drug/2 weeks off study drug. |
Key Inclusion Criteria: * Histologically-proven diagnosis of malignant GIST not amenable to surgery, radiation or combined modality treatment with curative intent * Failed Gleevec treatment or intolerant to Gleevec therapy Key Exclusion Criteria: * Treatment with any chemotherapy, chemoembolizati...