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CLINICAL TRIALS PROFILE FOR IDHIFA

All Clinical Trials for IDHIFA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01915498 ↗	Phase 1/2 Study of Enasidenib (AG-221) in Adults With Advanced Hematologic Malignancies With an Isocitrate Dehydrogenase Isoform 2 (IDH2) Mutation	Active, not recruiting	Agios Pharmaceuticals, Inc.	Phase 1/Phase 2	2013-09-20	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.
NCT01915498 ↗	Phase 1/2 Study of Enasidenib (AG-221) in Adults With Advanced Hematologic Malignancies With an Isocitrate Dehydrogenase Isoform 2 (IDH2) Mutation	Active, not recruiting	Celgene	Phase 1/Phase 2	2013-09-20	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.
NCT01915498 ↗	Phase 1/2 Study of Enasidenib (AG-221) in Adults With Advanced Hematologic Malignancies With an Isocitrate Dehydrogenase Isoform 2 (IDH2) Mutation	Active, not recruiting	Celgene Corporation	Phase 1/Phase 2	2013-09-20	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 Conditions for IDHIFA

Condition Name

Condition Name for IDHIFA
Intervention	Trials
Recurrent Acute Myeloid Leukemia	5
IDH2 Gene Mutation	5
Acute Myeloid Leukemia	4

Condition MeSH

Condition MeSH for IDHIFA
Intervention	Trials
Leukemia, Myeloid	8
Leukemia	8
Leukemia, Myeloid, Acute	8

Clinical Trial Locations for IDHIFA

Trials by Country

Trials by Country for IDHIFA
Location	Trials
United States	49
Canada	3
France	1

Trials by US State

Trials by US State for IDHIFA
Location	Trials
California	6
Tennessee	4
Florida	4
Texas	3
Ohio	3

Clinical Trial Progress for IDHIFA

Clinical Trial Phase

Clinical Trial Phase for IDHIFA
Clinical Trial Phase	Trials
Phase 2	3
Phase 1/Phase 2	2
Phase 1	7

Clinical Trial Status

Clinical Trial Status for IDHIFA
Clinical Trial Phase	Trials
Recruiting	5
Not yet recruiting	3
Active, not recruiting	2

Clinical Trial Sponsors for IDHIFA

Sponsor Name

Sponsor Name for IDHIFA
Sponsor	Trials
National Cancer Institute (NCI)	6
Celgene	4
City of Hope Medical Center	3

Sponsor Type

Sponsor Type for IDHIFA
Sponsor	Trials
Industry	9
Other	9
NIH	6