Search Cancer Clinical Trials
Recruiting
This is an open-label, multi-center Phase 1 study of LY3410738, an oral, covalent IDH inhibitor, in patients with IDH1 and/or IDH2-mutant advanced hematologic malignancies who have received standard therapy
- Acute Myeloid Leukemia (AML)
- Myelodysplastic Syndrome (MDS)
- Chronic Myelomonocytic Leukemia (CMML)
- Myeloproliferative Neoplasms (MPNs)
- LY3410738
Phase 1
Interventional
Primary Outcome:
- To determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D)
- To assess the activity of LY3410738 as measured by the overall response rate (ORR) per the investigator assessment
Secondary Outcome:
- To determine the safety profile and tolerability of LY3410738 including acute and chronic toxicities by collecting and evaluating adverse events and treatment emergent adverse events
- To characterize the pharmacokinetics (PK) properties of LY3410738 by collecting and evaluating serum at protocol specified time points
- To characterize the pharmacodynamic properties of LY3410738 as expressed by change in 2-HG oncometabolite levels in plasma
- To assess the activity of LY3410738 as measured by the overall response rate (ORR) per investigator assessment
- To assess the activity of LY3410738 as measured by Best Overall Response per investigator assessment
- To assess the activity of LY3410738 by Complete Response Rate plus partial hematologic recovery (AML patients)
- To assess the activity of LY3410738 by Duration of Response
- To assess the activity of LY3410738 by Hematologic improvement in patients with MDS
- To determine the safety profile and tolerability of LY3410738 including acute and chronic toxicities by collecting and evaluating Adverse events and treatment emergent adverse events
- To characterize the pharmacokinetics (PK) properties of LY3410738 by collecting and evaluating serum at protocol specified time points
- To characterize the pharmacodynamic properties of LY3410738 as expressed by change in 2-HG oncometabolite levels in plasma.
220
December 1, 2020
- Gender: All
- Minimum age: 18 Years
- Maximum age: N/A
- Healthy volunteers: No
Eli Lilly and Company
Eli Lilly and Company
A Phase 1 Study of Oral LY3410738 in Patients With Advanced Hematologic Malignancies With IDH1 or IDH2 Mutations
NCT04603001
Source: Clinicaltrials.gov. Through our founding membership in the Dana-Farber/Harvard Cancer Center, an NCI-designated Comprehensive Cancer Center, these clinical trials are conducted at the Massachusetts General Hospital Cancer Center and may be available at other partner institutions.