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Study of Orally Administered AG-120 in Subjects With Advanced Hematologic Malignancies With an IDH1 Mutation

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary and study completion dates: Mar 2026 to Dec 31, 2026v50
  2. Primary completion date: Feb 2025 to Mar 2026 Completion date: Aug 2025 to Mar 2026 · Start date: Mar 2014 to Mar 1, 2014v49 Show 2 more changesShow less
    • Completion date: Aug 2025 to Mar 2026
    • Start date: Mar 2014 to Mar 1, 2014
  3. Study sites: 29 to 30v48
  4. Publications: 7 to 8v47 See this version in full on ClinicalTrials.gov ↗
  5. Study sites: 28 to 29v46
Show 44 earlier versionsHide 44 earlier versions
  1. Site details revised at 2 of 28 sitesv45
  2. Site details revised at 1 of 28 sitesv44
  3. Study sites: 27 to 28v43
  4. Site details revised at 1 of 27 sitesv42
  5. Site details revised at 3 of 27 sitesv41
  6. Site details revised at 2 of 27 sitesv40
  7. Site details revised at 1 of 27 sitesv39
  8. Study sites revised (27)v38 See this version in full on ClinicalTrials.gov ↗
  9. Re-verified, no change to tracked fieldsv37
  10. Lead sponsor: Agios Pharmaceuticals, Inc. to Institut de Recherches Internationales Servierv36
  11. Primary completion date: Dec 2020 to Feb 2025 Study sites: 24 to 27 · Completion date: Jun 2021 to Aug 2025v35 Show 2 more changesShow less
    • Study sites: 24 to 27
    • Completion date: Jun 2021 to Aug 2025
  12. Study sites revised (24)v34 See this version in full on ClinicalTrials.gov ↗
  13. Trial status: Active, Not Recruiting to Recruiting Primary completion date: May 2020 to Dec 2020 · Primary endpoints: 3 to 5 · Enrollment target: 266 to 291 · 3 morev33 Show 6 more changesShow less
    • Primary completion date: May 2020 to Dec 2020
    • Primary endpoints: 3 to 5
    • Enrollment target: 266 to 291
    • Study sites: 22 to 24
    • Completion date: May 2021 to Jun 2021
    • Secondary endpoints: 4 to 8

    See this version in full on ClinicalTrials.gov ↗

  14. Study sites: 21 to 22v32
  15. Study sites: 23 to 21v31
  16. Primary completion date: Sep 2017 to May 2020 Completion date: Sep 2018 to May 2021v30 Show 1 more changeShow less
    • Completion date: Sep 2018 to May 2021
  17. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 236 to confirmed 266 · Study sites revised (23)v29 Show 2 more changesShow less
    • Enrollment target: estimated 236 to confirmed 266
    • Study sites revised (23)

    See this version in full on ClinicalTrials.gov ↗

  18. Re-verified, no change to tracked fieldsv28
  19. Study sites revised (23)v27 See this version in full on ClinicalTrials.gov ↗
  20. Study sites: 21 to 23v26
  21. Re-verified, no change to tracked fieldsv25
  22. Study sites revised (21)v24 See this version in full on ClinicalTrials.gov ↗
  23. Study sites revised (21)v23 See this version in full on ClinicalTrials.gov ↗
  24. Study sites revised (21)v22 See this version in full on ClinicalTrials.gov ↗
  25. Study sites revised (21)v21 See this version in full on ClinicalTrials.gov ↗
  26. Study sites revised (21)v20 See this version in full on ClinicalTrials.gov ↗
  27. Re-verified, no change to tracked fieldsv19
  28. Primary completion date: Aug 2016 to Sep 2017 Enrollment target: 211 to 236 · Study sites: 20 to 21 · Completion date: Aug 2016 to Sep 2018 · 1 morev18 Show 4 more changesShow less
    • Enrollment target: 211 to 236
    • Study sites: 20 to 21
    • Completion date: Aug 2016 to Sep 2018
    • Eligibility criteria expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  29. Study sites revised (20)v17 See this version in full on ClinicalTrials.gov ↗
  30. Study sites: 19 to 20v16
  31. Study sites revised (19)v15 See this version in full on ClinicalTrials.gov ↗
  32. Enrollment target: 51 to 211 Primary endpoints: 2 to 3 · Study sites: 12 to 19 · Primary and study completion dates: Mar 2016 to Aug 2016 · 2 morev14 Show 5 more changesShow less
    • Primary endpoints: 2 to 3
    • Study sites: 12 to 19
    • Primary and study completion dates: Mar 2016 to Aug 2016
    • Eligibility criteria shortened, about 209 words
    • Secondary endpoints revised (4)

    See this version in full on ClinicalTrials.gov ↗

  33. Study sites revised (12)v13 See this version in full on ClinicalTrials.gov ↗
  34. Study sites revised (12)v12 See this version in full on ClinicalTrials.gov ↗
  35. Study sites: 9 to 12v11
  36. Study sites revised (9)v10 See this version in full on ClinicalTrials.gov ↗
  37. Study sites revised (9)v9 See this version in full on ClinicalTrials.gov ↗
  38. Study sites: 10 to 9v8
  39. Primary endpoints revised (2) Eligibility criteria expanded, about 49 words · Secondary endpoints revised (4)v7 Show 2 more changesShow less
    • Eligibility criteria expanded, about 49 words
    • Secondary endpoints revised (4)

    See this version in full on ClinicalTrials.gov ↗

  40. Study sites revised (10)v6 See this version in full on ClinicalTrials.gov ↗
  41. Study sites: 9 to 10v5
  42. Study sites revised (9)v4 See this version in full on ClinicalTrials.gov ↗
  43. Study sites: 8 to 9v3
  44. Trial status: Not Yet Recruiting to Recruiting Start date: Feb 2014 to Mar 2014 · Study sites revised (8)v2 Show 2 more changesShow less
    • Start date: Feb 2014 to Mar 2014
    • Study sites revised (8)

    See this version in full on ClinicalTrials.gov ↗

  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The purpose of this Phase I, multicenter study is to evaluate the safety, pharmacokinetics, pharmacodynamics and clinical activity of AG-120 in advanced hematologic malignancies that harbor an IDH1 mutation. The first portion of the study is a dose escalation phase where cohorts of patients will receive ascending oral doses of AG-120 to determine maximum tolerated dose (MTD) and/or the recommended Phase II dose. The second portion of the study is a dose expansion phase where four cohorts of patients will receive AG-120 to further evaluate the safety, tolerability, and clinical activity of the recommended Phase II dose. Additionally, the study includes a substudy evaluating the safety and tolerability, clinical activity, pharmacokinetics, and pharmacodynamics of AG-120 in subjects with relapsed or refractory myelodysplastic syndrome with an IDH1 mutation. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.
Trial Details
NCT Number NCT02074839
Lead Sponsor Institut de Recherches Internationales Servier
Conditions Relapsed or Refractory Acute Myeloid Leukemia (AML), Untreated AML, Other IDH1-mutated Positive Hematologic Malignancies, Myelodysplastic Syndromes
Enrollment 291 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov