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Clinical Trial 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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT01915498
Study type Interventional
Source Celgene
Contact
Status Completed
Phase Phase 1/Phase 2
Start date August 27, 2013
Completion date October 31, 2023

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