Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as AMN107
AMN107, STI571 · 3 trials · 2 indications
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 | 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...
AMN107 is an investigational small molecule studied in gastrointestinal stromal tumors and chronic myeloid leukemia. It has been evaluated in patients whose disease failed prior imatinib and sunitinib therapy for GIST, and in adults with chronic myelogenous leukemia resistant or intolerant to imatinib mesylate. It is not approved and remains in clinical development.
AMN107 is being developed by Novartis AG, which trades under the ticker NVS. Novartis sponsored the clinical trials evaluating AMN107 in gastrointestinal stromal tumors and chronic myeloid leukemia. The drug is an investigational small molecule and has not received regulatory approval.
AMN107 is in Phase 2 development. Two completed Phase 2 trials evaluated the drug in gastrointestinal stromal tumors and chronic myeloid leukemia, and one completed Phase 1 trial studied AMN107 with imatinib in GIST. No active trials are ongoing, and the drug is not approved.
AMN107 has been studied in three completed trials. NCT00718562 was a Phase 2 trial in Japan in GIST patients who failed imatinib and sunitinib. NCT00264160 was a Phase 2 trial in Israel in chronic myelogenous leukemia patients resistant or intolerant to imatinib. NCT00135005 was a Phase 1 trial of AMN107 with imatinib in GIST across the United States, France, Germany, and Italy.
AMN107 is also known as AMN107, and STI571 is a separate designation. AMN107 is the investigational compound developed by Novartis, while STI571 refers to imatinib mesylate, which is used as a comparator or prior therapy in the AMN107 trials. They are distinct agents.