Study of Oral LY3410738 in Patients With Advanced Hematologic Malignancies With IDH1 or IDH2 Muta… (NCT04603001) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Study of Oral LY3410738 in Patients With Advanced Hematologic Malignancies With IDH1 or IDH2 Mutations
United States260 participantsStarted 2020-11-19
Plain-language summary
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
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Advanced IDH mutant hematologic malignancy including:
\-- For Dose Escalation Arm C and Dose Expansion Cohort 5:
* Patients with newly diagnosed AML who are 75 years or older or have comorbidities that preclude the use of intensive chemotherapy
* Patients with R/R AML (US only)
* Patients must have received prior therapy
* Blasts at least 5% in bone marrow.
* Patients must have a qualifying IDH1 R132, IDH2 R140 or IDH2 R172 mutation
* Eastern Cooperative Oncology Group (ECOG) 0 to 2
* Adequate organ function
* Ability to swallow capsules or tablets
* Ability to comply with outpatient treatment, laboratory monitoring, and required clinic visits for the duration of study participation
* Willingness of men and women of reproductive potential to observe conventional and effective birth control for the duration of treatment and for 3 months following the last dose of study treatment.
Exclusion Criteria:
* Investigational agent or anticancer therapy within 2 weeks or 5 half-lives, whichever is shorter; or investigational monoclonal antibody within 4 weeks prior to planned start of LY3410738
* For Dose Escalation Arm C and Dose Expansion Cohort 5:
* Prior venetoclax treatment is not allowed.
* Patients are allowed to receive up to 1 cycle of single agent azacitidine or azacitidine plus venetoclax while waiting for results of locally obtained molecular profiling, including IDH1/IDH2 mutational status, prior to starting on study.
* Major surgery wi…
What they're measuring
1
To determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D)
Timeframe: Up to 30 months
2
To assess the activity of LY3410738 as measured by the overall response rate (ORR) per the Investigator assessment