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

Part of paid clinical trials in Duarte, California.

Sponsor
Eli Lilly and Company
Study ID
NCT04603001
Phase
PHASE1
Status
Active Not Recruiting

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • LY3410738 — DRUG
    Oral LY3410738
  • Venetoclax — DRUG
    Oral venetoclax
  • Azacitidine — DRUG
    Subcutaneous or intravenous azacitidine

Study Details

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

Key Dates

Start date
Nov 19, 2020
Status verified
Jun 2025
Primary completion
Jul 3, 2023
Completion
May 31, 2026

Study Design

Enrollment
260 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Escalation Arm A (Monotherapy)
    Patients not requiring a strong cytochrome P450 3A4 (CYP3A4) inhibitor.
  • Experimental: Dose Escalation Arm B (Monotherapy)
    Patients requiring a strong CYP3A4 inhibitor for active management or prevention of a lifethreatening condition, such as an azole administered to prevent invasive fungal infection.
  • Experimental: Dose Escalation Arm C (LY3410738, Venetoclax, and Azacitidine)
    Patients with no prior venetoclax therapy and not requiring a strong CYP3A4 inhibitor for active treatment within 7 days of starting LY3410738.
  • Experimental: Cohort 1
    Patients with relapsed/refractory (R/R) AML harboring an IDH1 R132 mutation who have received a prior IDH inhibitor.
  • Experimental: Cohort 2
    Patients with R/R AML harboring an IDH1 R132 mutation who have not received a prior IDH inhibitor.
  • Experimental: Cohort 3
    Patients with R/R MDS, chronic myelomonocytic leukemia (CMML) or other advanced hematologic malignancy harboring an IDH1 R132 mutation.
  • Experimental: Cohort 4
    Patients with R/R AML, MDS, CMML or other advanced hematologic malignancy harboring IDH2 mutations.
  • Experimental: Cohort 5
    Patients with newly diagnosed AML, R/R AML, or other advanced hematologic malignancy harboring IDH1 and/or IDH2 mutations with no prior venetoclax therapy. Strong CYP3A4 inhibitor allowed but not required.

Primary Outcome Measure

To determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) [ Time Frame: Up to 30 months ]

Locations (12)

FacilityCityStateZIPSite coordinators
City of Hope National Medical CenterDuarteCalifornia91010-
UCLA Medical CenterLos AngelesCalifornia90095-
University of California, Davis - Health SystemsSacramentoCalifornia95817-
H Lee Moffitt Cancer CenterTampaFlorida33612-9497-
Northwestern UniversityChicagoIllinois60611-
University of Chicago HospitalChicagoIllinois60637-
Massachusetts General HospitalBostonMassachusetts02114-
Roswell Park Cancer InstituteBuffaloNew York14263-0002-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
University of North Carolina at Chapel HillChapel HillNorth Carolina27514-
Vanderbilt University Medical CenterNashvilleTennessee37232-
University of Texas MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Duarte, CA

By research site
City of Hope National Medical Center· Duarte, CAUCLA Medical Center· Los Angeles, CAUniversity of California, Davis - Health Systems· Sacramento, CAH Lee Moffitt Cancer Center· Tampa, FLNorthwestern University· Chicago, ILUniversity of Chicago Hospital· Chicago, IL

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