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NCT03173248 · ClinicalTrials.gov registry record · 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
A Phase 3 study of Leukemia, Myeloid, Acute and Untreated AML, sponsored by Institut de Recherches Internationales Servier.
- Active
- Registry status
- Phase 3
- Development phase
- 146
- Enrollment target
- 20
- Study locations
NCT03173248 is a Phase 3 study of Leukemia, Myeloid, Acute and Untreated AML that is active but no longer recruiting, run by Institut de Recherches Internationales Servier. The registered enrollment target is 146 participants, above the 111-participant average among 30 other Leukemia, Myeloid, Acute trials with a reported enrollment target (32% higher). The trial reports 20 study locations across 10 states.
The verdict
NCT03173248, a Phase 3 study of Leukemia, Myeloid, Acute and Untreated AML, is active but no longer recruiting, sponsored by Institut de Recherches Internationales Servier.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 146 participants
- Enrollment target
- 20
- Study locations
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.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 146 participants |
| Start Date | 2017-06-26 |
| Est. Completion | 2026-06-30 |
| Phase | Phase 3 |
Interested in This 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, categorized as Phase 3. The registered enrollment target is 146 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 111-participant average among 30 other Leukemia, Myeloid, Acute trials with a reported enrollment target (32% higher). The listed sponsor is Institut de Recherches Internationales Servier, which has 27 total studies on file at ClinicalTrials.gov.
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.
NCT03173248 reports 20 study locations spanning 10 distinct geographic areas - top geographies include Other, South Australia, São Paulo.
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).
What interventions are being tested in trial NCT03173248?
The interventions under investigation include: Placebo (DRUG), Azacitidine (DRUG), AG-120 (DRUG).
Who is sponsoring clinical trial NCT03173248?
This trial is sponsored by Institut de Recherches Internationales Servier, which has 27 total clinical trials registered on ClinicalTrials.gov.
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.
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