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Protocol # 20-560

Status

Recruiting

Description

This is an open-label, multi-center Phase 1 study of LY3410738, an oral, covalent isocitrate dehydrogenase (IDH) inhibitor, in patients with IDH1 and/or IDH2-mutant advanced hematologic malignancies who may have received standard therapy

Condition

  • Acute Myeloid Leukemia (AML)
  • Myelodysplastic Syndrome (MDS)
  • Chronic Myelomonocytic Leukemia (CMML)
  • Myeloproliferative Neoplasms (MPNs)

Interventions

  • LY3410738
  • Venetoclax
  • Azacitidine

Phase

Phase 1

Study Type

Interventional

Further Study Details

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 (BOR) per Investigator assessment
  • To assess the activity of LY3410738 by Complete Remission (CR) Rate (CRR) 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.

Enrollment

260

Study Start Date

December 1, 2020

Eligibility

  • Gender:     All
  • Minimum age:     18 Years
  • Maximum age:     N/A
  • Healthy volunteers:     No

Sponsors

Eli Lilly and Company

Source

Eli Lilly and Company

Official title

A Phase 1 Study of Oral LY3410738 in Patients With Advanced Hematologic Malignancies With IDH1 or IDH2 Mutations

Clinicaltrials.gov Identifier

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.