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NCT02492737

Study of Orally Administered AG-881 in Patients With Advanced Hematologic Malignancies With an IDH1 and/or IDH2 Mutation

Completed Phase 1 Last updated 8 March 2019
What this trial tests

Phase 1 trial testing AG881 in Acute Myeloid Leukemia (AML) in 46 participants. Completed in 21 March 2018.

Timeline
7 August 2015
Primary endpoint
21 March 2018
21 March 2018

Quick facts

Lead sponsorAgios Pharmaceuticals, Inc.
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment46
Start date7 August 2015
Primary completion21 March 2018
Estimated completion21 March 2018
Sites6 locations across France, United States

Drugs / interventions tested

Conditions studied

Sponsor

Agios Pharmaceuticals, Inc. — full company profile →

Who can join

18 and older, any sex, with Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this Phase I, multicenter study is to evaluate the safety, pharmacokinetics, pharmacodynamics and clinical activity of AG-881 in advanced hematologic malignancies that harbor an IDH1 and/or IDH2 mutation

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. The emerging role and targetability of the TCA cycle in cancer metabolism.
    Anderson NM, Mucka P, Kern JG, Feng H. · · 2018 · cited 404× · PMID 28748451 · DOI 10.1007/s13238-017-0451-1
  2. Tumor biomarkers for diagnosis, prognosis and targeted therapy.
    Zhou Y, Tao L, Qiu J, Xu J, et al · · 2024 · cited 379× · PMID 38763973 · DOI 10.1038/s41392-024-01823-2
  3. Isocitrate dehydrogenase mutations in myeloid malignancies.
    Medeiros BC, Fathi AT, DiNardo CD, Pollyea DA, et al · · 2017 · cited 257× · PMID 27721426 · DOI 10.1038/leu.2016.275
  4. Energy metabolism in health and diseases.
    Liu H, Wang S, Wang J, Guo X, et al · · 2025 · cited 178× · PMID 39966374 · DOI 10.1038/s41392-025-02141-x
  5. Mutant Isocitrate Dehydrogenase Inhibitors as Targeted Cancer Therapeutics.
    Golub D, Iyengar N, Dogra S, Wong T, et al · · 2019 · cited 176× · PMID 31165048 · DOI 10.3389/fonc.2019.00417
  6. Mitochondria in cancer.
    Grasso D, Zampieri LX, Capelôa T, Van de Velde JA, et al · · 2020 · cited 168× · PMID 32548570 · DOI 10.15698/cst2020.06.221
  7. IDH1 and IDH2 mutations as novel therapeutic targets: current perspectives.
    Mondesir J, Willekens C, Touat M, de Botton S. · · 2016 · cited 153× · PMID 27621679 · DOI 10.2147/jbm.s70716
  8. Cancer-associated mutation and beyond: The emerging biology of isocitrate dehydrogenases in human disease.
    Tommasini-Ghelfi S, Murnan K, Kouri FM, Mahajan AS, et al · · 2019 · cited 110× · PMID 31131326 · DOI 10.1126/sciadv.aaw4543

Verify or expand the search:

Other trials of AG881

Trials testing the same drug.

Other recruiting trials for Acute Myeloid Leukemia (AML)

Currently open trials in the same condition.

Other Agios Pharmaceuticals, Inc. trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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