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The purpose of this study is to evaluate the safety, tolerability and potential efficacy of IDH305 with standard treatments for newly diagnosed IDH1R132 mutant acute myeloid leukemia (AML).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: Medically fit for induction | Experimental | IDH305 + Standard of care for patients that are medically fit for induction. |
|
| Arm 2 Medically unfit for induction | Experimental | IDH305 + Standard of care for patients that are medically unfit for induction. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IDH305 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose Limiting toxicities | (escalation only) | 10 months |
| Number of patients with adverse events (AEs) | 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under Curve (AUC) | To characterize the PK profile of IDH305 with SOC medications (each Arm) | 36 months |
| Maximum Plasma Concentration (Cmax) | To characterize the PK profile of IDH305 with SOC medications (each Arm) |
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Inclusion Criteria:
-- Previously untreated AML. Patients with untreated, high or very high risk MDS (according to rIPSS or equivalent) are also permitted in Arm 2.
Exclusion Criteria:
Other protocol-defined Inclusion/Exclusion may apply
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
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| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| 36 months |
| Time taken to reach maximum plasma concentration (Tmax) | To characterize the PK profile of IDH305 with SOC medications (each Arm) | 36 months |
| Complete remission rate (CRR) | To characterize preliminary anti-tumor activity for each arm of the study. (Arm 1 and Arm 2) | 36 months |
| Overall response rate (ORR) | To characterize preliminary anti-tumor activity for each arm of the study. (Arm 1 and Arm 2) | 36 months |
| Event free survival (EFS) | To characterize preliminary anti-tumor activity for each arm of the study. (Arm 1 and Arm 2) | 36 months |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |