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AMN107, STI571 · 2 trials · 1 indication
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...
AMN107 is an investigational small molecule being studied for the treatment of chronic myeloid leukemia and gastrointestinal stromal tumors (GIST). It has been evaluated in clinical trials for patients with chronic myelogenous leukemia resistant or intolerant to imatinib mesylate therapy, and for GIST patients who have failed both imatinib and sunitinib.
AMN107 is being developed by Novartis AG (ticker: NVS). The company has sponsored clinical trials investigating the drug in oncology indications, including chronic myeloid leukemia and gastrointestinal stromal tumors.
AMN107 has completed Phase 2 clinical trials. The drug is investigational and remains in clinical development, with no approval status indicated. Two Phase 2 studies and one Phase 1 study have been completed, involving a total of 94 participants.
AMN107 has been studied in three completed trials: NCT00135005, a Phase 1 study of AMN107 with imatinib in gastrointestinal stromal tumors (GIST) with 59 participants; NCT00264160, a Phase 2 study in chronic myelogenous leukemia with 36 participants; and NCT00718562, a Phase 2 study in GIST patients who failed imatinib and sunitinib with 35 participants.
AMN107 is a small molecule developed for oncology. Its specific molecular target has not been disclosed in the available clinical trial information, so its mechanism of action is not detailed here.
AMN107 is not identified as nilotinib in the available data. The drug is referred to only as AMN107 in the clinical trial records, with no alternative names provided.