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NCT03245424
Ivosidenib Expanded Access Program in Relapsed/Refractory AML With an IDH1 Mutation
APPROVED FOR MARKETING
Last updated 24 July 2018
What this trial tests
trial testing ivosidenib (AG-120) in Acute Myeloid Leukemia. Approved for marketing.
Quick facts
| Lead sponsor | Agios Pharmaceuticals, Inc. |
|---|---|
| Status | APPROVED FOR MARKETING |
| Study type | EXPANDED_ACCESS |
Drugs / interventions tested
- ivosidenib (AG-120) — full drug profile →
Conditions studied
- Acute Myeloid Leukemia — all drugs for Acute Myeloid Leukemia →
- Relapsed Adult AML — all drugs for Relapsed Adult AML →
- Relapsed Pediatric AML — all drugs for Relapsed Pediatric AML →
Sponsor
Agios Pharmaceuticals, Inc. — full company profile →
Who can join
12 and older, any sex, with Acute Myeloid Leukemia or Relapsed Adult AML. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
To provide access to ivosidenib monotherapy to patients with relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase 1 (IDH1) mutation.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Altered metabolism in cancer: insights into energy pathways and therapeutic targets.
Tufail M, Jiang CH, Li N. · · 2024 · cited 265× · PMID 39294640 · DOI 10.1186/s12943-024-02119-3 -
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 -
Ivosidenib: First Global Approval.
Dhillon S. · · 2018 · cited 112× · PMID 30209701 · DOI 10.1007/s40265-018-0978-3 -
Epigenetic regulation in hematopoiesis and its implications in the targeted therapy of hematologic malignancies.
Zhao A, Zhou H, Yang J, Li M, et al · · 2023 · cited 81× · PMID 36797244 · DOI 10.1038/s41392-023-01342-6 -
Molecular Approaches to Treating Pediatric Leukemias.
Kuhlen M, Klusmann JH, Hoell JI. · · 2019 · cited 33× · PMID 31555628 · DOI 10.3389/fped.2019.00368 -
The Time Has Come for Targeted Therapies for AML: Lights and Shadows.
Fiorentini A, Capelli D, Saraceni F, Menotti D, et al · · 2020 · cited 32× · PMID 32700072 · DOI 10.1007/s40487-019-00108-x -
<i>IDH1</i>-mutated relapsed or refractory AML: current challenges and future prospects.
Megías-Vericat JE, Ballesta-López O, Barragán E, Montesinos P. · · 2019 · cited 28× · PMID 31413655 · DOI 10.2147/blctt.s177913 -
MR-detectable metabolic biomarkers of response to mutant IDH inhibition in low-grade glioma.
Molloy AR, Najac C, Viswanath P, Lakhani A, et al · · 2020 · cited 24× · PMID 32754276 · DOI 10.7150/thno.47317
Verify or expand the search:
- PubMed search for NCT03245424
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of ivosidenib (AG-120)
Trials testing the same drug.
- NCT03071770 — Japanese Bridging Study of Ivosidenib (AG-120) in Healthy Subjects · Phase 1 · completed
Other recruiting trials for Acute Myeloid Leukemia
Currently open trials in the same condition.
- NCT07020533 — A Vaccine (CMV-MVA Triplex Vaccine) for the Enhancement of CMV-Specific Immunity and the Prevention of CMV Viremia in Pa · Phase 1 · recruiting
- NCT06782542 — Olutasidenib, Venetoclax, and Azacitidine in IDH1 Mutated Newly Diagnosed Acute Myeloid Leukemia Patients Eligible for I · Phase 2 · recruiting
- NCT07177079 — High-dose Ascorbate (HDA) in Combination With Standard of Care Azacitidine and Venetoclax in Acute Myeloid Leukemia (AML · Phase 1 · recruiting
- NCT07384715 — First-in-human (FIH) Trial of GEN3018 in Relapsed or Refractory (R/R) Acute Myeloid Leukemia (AML) or Higher-risk Myelod · Phase 1 · recruiting
- NCT07107126 — Safety and Proof-of-Concept Study of RPT1G in Adults With Acute Myeloid Leukemia and High-Risk Myelodysplastic Syndromes · Phase 1 · 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)
Data sources for this page
- Trial protocol + status: ClinicalTrials.gov NCT03245424 (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: 24 July 2018
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/NCT03245424.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing