Overview

Phase 1/2 Study of Enasidenib (AG-221) in Adults With Advanced Hematologic Malignancies With an Isocitrate Dehydrogenase Isoform 2 (IDH2) Mutation

Status:
Active, not recruiting

Trial end date:
2020-12-31

Target enrollment:

Participant gender:

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.

Phase:

Phase 1/Phase 2

Details

Lead Sponsor:

Celgene
Celgene Corporation

Collaborator:

Agios Pharmaceuticals, Inc.