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NCT02492737
Study of Orally Administered AG-881 in Patients With Advanced Hematologic Malignancies With an IDH1 and/or IDH2 Mutation
Phase 1 trial testing AG881 in Acute Myeloid Leukemia (AML) in 46 participants. Completed in 21 March 2018.
21 March 2018
Quick facts
| Lead sponsor | Agios Pharmaceuticals, Inc. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 46 |
| Start date | 7 August 2015 |
| Primary completion | 21 March 2018 |
| Estimated completion | 21 March 2018 |
| Sites | 6 locations across France, United States |
Drugs / interventions tested
- AG881 — full drug profile →
Conditions studied
- Acute Myeloid Leukemia (AML) — all drugs for Acute Myeloid Leukemia (AML) →
- Myelodysplastic Syndrome — all drugs for Myelodysplastic Syndrome →
- Hematologic Malignancies — all drugs for Hematologic Malignancies →
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):
-
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 -
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 -
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 -
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 -
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 -
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 -
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 -
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:
- PubMed search for NCT02492737
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of AG881
Trials testing the same drug.
- NCT04145128 — A Study to Evaluate AG-881 in Healthy Japanese and Non-Asian Participants · Phase 1 · completed
- NCT03343197 — Study of AG-120 and AG-881 in Subjects With Low Grade Glioma · Phase 1 · completed
Other recruiting trials for Acute Myeloid Leukemia (AML)
Currently open trials in the same condition.
- NCT07463651 — MRD-guided Maintenance Post-HCT: Gilteritini vs Sorafenib · Phase 3 · recruiting
- NCT07500441 — Digital PCR of CHIP and MR for MRD Monitoring After Allo-HSCT in AML · recruiting
- NCT07410494 — Biomarker-Guided Allogeneic Single-Target or Dual-Target CAR-NK Cell Therapy for Advanced Solid Tumors · Phase 1, PHASE2 · recruiting
- NCT06707493 — Ivosidenib as Post-HSCT Maintenance for AML · Phase 2 · recruiting
- NCT07458542 — Effectiveness and Safety of ONUREG (Oral Azacitidine) in Chinese Patients With Acute Myeloid Leukemia · active not recruiting
Other Agios Pharmaceuticals, Inc. trials
Trials by the same sponsor.
- NCT07075640 — A Study to Determine the Safety and Tolerability of AG-236 and How it is Absorbed, Broken Down, and Eliminated From the · Phase 1 · recruiting
- NCT06745271 — A Study to Determine How Tebapivat is Absorbed, Broken Down, and Removed From the Body and the Extent to Which Tebapivat · Phase 1 · completed
- NCT06648824 — Study of How Mitapivat Affects Midazolam Blood Levels in Healthy Participants · Phase 1 · completed
- NCT06286033 — Single and Multiple Ascending Dose Study and Food Effect Study for AG181 · Phase 1 · completed
- NCT05610657 — A Pharmacokinetic Study of Mitapivat in Participants With Moderate Hepatic Impairment Compared to Matched Healthy Contro · Phase 1 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02492737 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Agios Pharmaceuticals, Inc.
- Last refreshed: 8 March 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02492737.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing