deltatrials
Completed PHASE1/PHASE2 INTERVENTIONAL 1-arm NCT01915498

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.

Interventions Enasidenib
Updated 23 times since 2017 Last updated: Sep 26, 2024 Started: Aug 27, 2013 Primary completion: Jul 25, 2019 Completion: Oct 31, 2023
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

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

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshot~Feb 2017 – ~May 2017 · 3 months · monthly snapshot~May 2017 – ~Aug 2017 · 3 months · monthly snapshot~Aug 2017 – ~Jun 2018 · 10 months · monthly snapshot~Jun 2018 – ~Jul 2018 · 30 days · monthly snapshot~Jul 2018 – ~Mar 2019 · 8 months · monthly snapshot~Mar 2019 – ~May 2019 · 2 months · monthly snapshot~May 2019 – ~Sep 2019 · 4 months · monthly snapshot~Sep 2019 – ~Nov 2019 · 2 months · monthly snapshot~Nov 2019 – ~Nov 2020 · 12 months · monthly snapshot~Nov 2020 – ~Jan 2021 · 2 months · monthly snapshot~Jan 2021 – ~Jan 2022 · 12 months · monthly snapshot~Jan 2022 – ~Mar 2022 · 59 days · monthly snapshot~Mar 2022 – ~Jun 2022 · 3 months · monthly snapshot~Jun 2022 – ~Jul 2022 · 30 days · monthly snapshot~Jul 2022 – ~Sep 2022 · 2 months · monthly snapshot~Sep 2022 – ~May 2023 · 8 months · monthly snapshot~May 2023 – ~Mar 2024 · 10 months · monthly snapshot~Mar 2024 – ~Jul 2024 · 4 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Nov 2024 · 2 months · monthly snapshot~Nov 2024 – ~Sep 2025 · 10 months · monthly snapshot~Sep 2025 – present · 11 months · monthly snapshot

Change History

23 versions recorded
  1. Sep 2025 — Present [monthly]

    Completed PHASE1/PHASE2

  2. Nov 2024 — Sep 2025 [monthly]

    Completed PHASE1/PHASE2

  3. Sep 2024 — Nov 2024 [monthly]

    Completed PHASE1/PHASE2

  4. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE1/PHASE2

    Phase: PHASE1_PHASE2PHASE1/PHASE2

  5. Mar 2024 — Jul 2024 [monthly]

    Completed PHASE1_PHASE2

    Status: Active Not RecruitingCompleted

Show 18 earlier versions
  1. May 2023 — Mar 2024 [monthly]

    Active Not Recruiting PHASE1_PHASE2

  2. Sep 2022 — May 2023 [monthly]

    Active Not Recruiting PHASE1_PHASE2

  3. Jul 2022 — Sep 2022 [monthly]

    Active Not Recruiting PHASE1_PHASE2

  4. Jun 2022 — Jul 2022 [monthly]

    Active Not Recruiting PHASE1_PHASE2

  5. Mar 2022 — Jun 2022 [monthly]

    Active Not Recruiting PHASE1_PHASE2

  6. Jan 2022 — Mar 2022 [monthly]

    Active Not Recruiting PHASE1_PHASE2

  7. Jan 2021 — Jan 2022 [monthly]

    Active Not Recruiting PHASE1_PHASE2

  8. Nov 2020 — Jan 2021 [monthly]

    Active Not Recruiting PHASE1_PHASE2

  9. Nov 2019 — Nov 2020 [monthly]

    Active Not Recruiting PHASE1_PHASE2

  10. Sep 2019 — Nov 2019 [monthly]

    Active Not Recruiting PHASE1_PHASE2

  11. May 2019 — Sep 2019 [monthly]

    Active Not Recruiting PHASE1_PHASE2

  12. Mar 2019 — May 2019 [monthly]

    Active Not Recruiting PHASE1_PHASE2

  13. Jul 2018 — Mar 2019 [monthly]

    Active Not Recruiting PHASE1_PHASE2

  14. Jun 2018 — Jul 2018 [monthly]

    Active Not Recruiting PHASE1_PHASE2

  15. Aug 2017 — Jun 2018 [monthly]

    Active Not Recruiting PHASE1_PHASE2

  16. May 2017 — Aug 2017 [monthly]

    Active Not Recruiting PHASE1_PHASE2

  17. Feb 2017 — May 2017 [monthly]

    Active Not Recruiting PHASE1_PHASE2

    Phase: PHASE1PHASE1_PHASE2

  18. 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

Sponsor contact:
  • Agios Pharmaceuticals, Inc.
  • Celgene
Data source: Celgene

For direct contact, visit the study record on ClinicalTrials.gov .