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

NCT03173248 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 146

Last updated 2025-11-10

Study results available
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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.

Conditions

  • Newly Diagnosed Acute Myeloid Leukemia (AML)
  • Untreated AML
  • AML Arising From Myelodysplastic Syndrome (MDS)
  • Leukemia, Myeloid, Acute

Interventions

DRUG

AG-120

Tablets administered orally

DRUG

Placebo

Tablets administered orally

DRUG

Azacitidine

Administered SC or IV

Sponsors & Collaborators

  • Institut de Recherches Internationales Servier

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-26
Primary Completion
2021-03-18
Completion
2026-06-30
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Austria
  • Brazil
  • Canada
  • China
  • Czechia
  • France
  • Germany
  • Israel
  • Italy
  • Japan
  • Mexico
  • Netherlands
  • Poland
  • Russia
  • South Korea
  • Spain
  • Taiwan
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03173248 on ClinicalTrials.gov