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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00718562 | Efficacy and Safety of AMN107 in Patients With GastroIntestinal Stromal Tumors (GIST) Who Have Failed Both Imatinib and Sunitinib | PHASE2 | COMPLETED | 35 | — | — | Sep 1, 2008 | Jul 1, 2013 | Feb 23, 2017 | 8 | Japan |
| NCT00135005 | Study of AMN107 With Imatinib in Gastrointestinal Stromal Tumors (GIST) | PHASE1 | COMPLETED | 59 | — | — | Aug 1, 2005 | Nov 1, 2006 | Dec 8, 2020 | 5 | United States, France +2 |
MTD is defined to be the highest dose of AMN in combination with imatinib given for at least 21 days in the first treatment cycle
| Arm | Type | Description |
|---|---|---|
| Nilotinib | EXPERIMENTAL | - |
| AMN107 + STI571 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| AMN107 | DRUG | - |
| AMN107, STI571 | DRUG | - |
Inclusion Criteria: * Documented disease progression during imatinib and sunitinib therapy OR intolerance to imatinib and/or sunitinib * At least one measurable site of disease on CT/MRI scan * PS≤2 * Normal organ, electrolyte, and bone marrow function Exclusion Criteria: * Previous treatment wit...