At a glance
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A Phase 1/2, Multicenter, Open-Label, Dose-Escalation and Expansion, Safety, Pharmacokinetic, Pharmacodynamic, and Clinical Activity Study of Orally Administered AG-221 in Subjects With Advanced Hematologic Malignancies With an IDH2 Mutation
In Brief
A Phase 2 clinical trial evaluating Enasidenib for Hematologic Neoplasms. Completed, enrolled 345 participants across 24 sites in 2 countries.
Detailed Summary
The primary objectives of Phase 1 Dose Escalation/Part 1 Expansion are: * To assess the safety and tolerability of treatment with enasidenib administered continuously as a single agent dosed orally on Days 1 to 28 of a 28-day cycle in participants with advanced hematologic malignancies. * To determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) and/or the recommended Phase 2 dose (RP2D) of enasidenib in participants with advanced hematologic malignancies. The primary objective of Phase 2 is: • To assess the efficacy of enasidenib as treatment for participants with relapsed or refractory (R/R) acute myelogenous leukemia (AML) with an IDH2 mutation.
Study Details
Timeline
Interventions
Enasidenib tablets administered orally every day of 28-day treatment cycles until disease progression or unacceptable toxicities.