Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

ACTIVE NOT RECRUITING Phase 3

Study of AG-120 (Ivosidenib) vs. Placebo in Combination With Azacitidine in Participants With Previously Untreated Acute Myeloid Leukemia With an IDH1 Mutation

NCT03173248 · View on ClinicalTrials.gov ↗

Study Summary

Study AG120-C-009 is a global, Phase 3, multicenter, double-blind, randomized, placebo-controlled clinical trial to evaluate the efficacy and safety of AG-120 (ivosidenib) + azacitidine vs placebo + azacitidine in adult participants with previously untreated IDH1m AML who are considered appropriate candidates for non-intensive therapy. The primary endpoint is event-free survival (EFS). The key secondary efficacy endpoints are overall survival (OS), rate of complete remission (CR), rate of CR and complete remission with partial hematologic recovery (CRh), and overall response rate (ORR). Participants eligible for study treatment based on Screening assessments will be randomized 1:1 to receive oral AG-120 or matched placebo, both administered in combination with subcutaneous (SC) or intravenous (IV) azacitidine. An estimated 200 participants will take part in the study.

Interventions

  • DRUG Placebo
  • DRUG Azacitidine
  • DRUG AG-120

Study Locations (20)

Other

  • Salzburger Landeskliniken — Salzburg
  • Krankenhaus Hietzing mit Neurologischem Zentrum Rosenhugel — Vienna
  • Instituto Nacional de Cancer — Rio de Janeiro
  • Hospital Sirio Libanes — São Paulo
  • Hospital Sao Jose — São Paulo
  • Hospital Santa Marcelina — São Paulo
  • Peking Union Medical College Hospital — Beijing
  • Guangdong Provincial People's Hospital — Guangzhou
  • The First Affiliated Hospital, College of Medicine, Zhejiang University — Hangzhou

South Australia

  • Royal Adelaide Hospital — Adelaide
  • Flinders Medical Centre — Bedford Park

São Paulo

  • Unicamp Universidade Estadual de Campinas — Campinas
  • Hospital Amaral Carvalho — Jaú

Kentucky

  • Norton Cancer Institute - Suburban — Louisville

Massachusetts

  • Massachusetts General Hospital — Boston

New South Wales

  • Royal Prince Alfred Hospital — Camperdown

Manitoba

  • Cancer Care Manitoba — Winnipeg

Ontario

  • University Health Network — Toronto

Trial Details

FieldValue
Enrollment Target 146 participants
Start Date 2017-06-26
Est. Completion 2026-06-30
Phase Phase 3

Interested in This Trial?

Always speak with your doctor before enrolling in a clinical trial.

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03173248

The ClinicalTrials.gov registry entry for NCT03173248 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 146 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Institut de Recherches Internationales Servier, which has 16 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 4 conditions, with Leukemia, Myeloid, Acute appearing as the primary indexed condition, and to 3 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03173248 reports 20 study locations spanning 10 distinct geographic areas — top geographies include Other, South Australia, São Paulo. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT03173248 about?

NCT03173248 is a clinical study titled "Study of AG-120 (Ivosidenib) vs. Placebo in Combination With Azacitidine in Participants With Previously Untreated Acute Myeloid Leukemia With an IDH1 Mutation". Study AG120-C-009 is a global, Phase 3, multicenter, double-blind, randomized, placebo-controlled clinical trial to evaluate the efficacy and safety of AG-120 (ivosidenib) + azacitidine vs placebo + azacitidine in adult participants with previously untreated IDH1m AML who are considered appropriate ...

What is the current status of trial NCT03173248?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 146 participants. The study started on 2017-06-26. Estimated completion is 2026-06-30.

What conditions does trial NCT03173248 study?

This clinical trial studies the following conditions: Leukemia, Myeloid, Acute, Untreated AML, Newly Diagnosed Acute Myeloid Leukemia (AML), AML Arising From Myelodysplastic Syndrome (MDS). These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03173248?

The interventions under investigation include: Placebo (DRUG), Azacitidine (DRUG), AG-120 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03173248?

This trial is sponsored by Institut de Recherches Internationales Servier, which has 16 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT03173248 being conducted?

This trial has 20 study locations across Kentucky, Massachusetts, New South Wales, South Australia, São Paulo. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial