Phase 1/2 Study of Enasidenib (AG-221) in Adults With Advanced Hematologic Malignancies With an Isocitrate Dehydrogenase Isoform 2 (IDH2) Mutation
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
Sponsor: Agios Pharmaceuticals, Inc.
A PHASE1/PHASE2 clinical study on Hematologic Neoplasms, this trial is completed. The trial is conducted by Agios Pharmaceuticals, Inc. and has accumulated 23 data snapshots since 2013. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.
Status Flow
Change History
23 versions recorded-
Sep 2025 — Present [monthly]
Completed PHASE1/PHASE2
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Nov 2024 — Sep 2025 [monthly]
Completed PHASE1/PHASE2
-
Sep 2024 — Nov 2024 [monthly]
Completed PHASE1/PHASE2
-
Jul 2024 — Sep 2024 [monthly]
Completed PHASE1/PHASE2
Phase: PHASE1_PHASE2 → PHASE1/PHASE2
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Mar 2024 — Jul 2024 [monthly]
Completed PHASE1_PHASE2
Status: Active Not Recruiting → Completed
▶ Show 18 earlier versions
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May 2023 — Mar 2024 [monthly]
Active Not Recruiting PHASE1_PHASE2
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Sep 2022 — May 2023 [monthly]
Active Not Recruiting PHASE1_PHASE2
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Jul 2022 — Sep 2022 [monthly]
Active Not Recruiting PHASE1_PHASE2
-
Jun 2022 — Jul 2022 [monthly]
Active Not Recruiting PHASE1_PHASE2
-
Mar 2022 — Jun 2022 [monthly]
Active Not Recruiting PHASE1_PHASE2
-
Jan 2022 — Mar 2022 [monthly]
Active Not Recruiting PHASE1_PHASE2
-
Jan 2021 — Jan 2022 [monthly]
Active Not Recruiting PHASE1_PHASE2
-
Nov 2020 — Jan 2021 [monthly]
Active Not Recruiting PHASE1_PHASE2
-
Nov 2019 — Nov 2020 [monthly]
Active Not Recruiting PHASE1_PHASE2
-
Sep 2019 — Nov 2019 [monthly]
Active Not Recruiting PHASE1_PHASE2
-
May 2019 — Sep 2019 [monthly]
Active Not Recruiting PHASE1_PHASE2
-
Mar 2019 — May 2019 [monthly]
Active Not Recruiting PHASE1_PHASE2
-
Jul 2018 — Mar 2019 [monthly]
Active Not Recruiting PHASE1_PHASE2
-
Jun 2018 — Jul 2018 [monthly]
Active Not Recruiting PHASE1_PHASE2
-
Aug 2017 — Jun 2018 [monthly]
Active Not Recruiting PHASE1_PHASE2
-
May 2017 — Aug 2017 [monthly]
Active Not Recruiting PHASE1_PHASE2
-
Feb 2017 — May 2017 [monthly]
Active Not Recruiting PHASE1_PHASE2
Phase: PHASE1 → PHASE1_PHASE2
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Jan 2017 — Feb 2017 [monthly]
Active Not Recruiting PHASE1
First recorded
Aug 2013
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Agios Pharmaceuticals, Inc.
- Celgene
For direct contact, visit the study record on ClinicalTrials.gov .