Last updated on April 2019

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

Brief description of study

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 subjects with previously untreated IDH1m AML who are considered appropriate candidates for non-intensive therapy. The primary endpoint is Overall Survival (OS). The key secondary efficacy endpoints are Event free Survival (EFS), rate of complete remission (CR), Rate of CR and complete remission with partial hematologic recovery (CRh), and overall response rate (ORR). Subjects 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 392 subjects will participate in the study.

Clinical Study Identifier: NCT03173248

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UCLA Medical Center

Los Angeles, CA United States
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Norton Cancer Institute

Louisville, KY United States
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Gabrail Cancer Center

Canton, OH United States
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Oncology Hematology Care, Inc.

Cincinnati, OH United States
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Baylor Research Institute

Dallas, TX United States
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City of Hope

Duarte, CA United States
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University of Chicago

Chicago, IL United States
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New York Medical College

Valhalla, NY United States
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Kaiser Permanente

Portland, OR United States
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MD Anderson Cancer Center

Houston, TX United States
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CHU Estaing

Clermont-Ferrand, France
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National Cancer Center

Goyang-si, Korea, Republic of
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Samsung Medical Center

Seoul, Korea, Republic of
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VU Medisch Centrum

Amsterdam, Netherlands
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Regional Clinical Hospital

Krasnoyarsk, Russian Federation
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Republican Hospital n.a. V.A. Baranov

Petrozavodsk, Russian Federation
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Hospital Son Llatzer

Palma de Mallorca, Spain
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Ochsner Cancer Institute

New Orleans, LA United States
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Flinders Medical Centre

Bedford Park, Australia
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La Tronche, France
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Ajou University Hospital

Suwon-si, Korea, Republic of
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City Clinical Hospital #40

Moscow, Russian Federation
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Emory/Winship Cancer Center

Atlanta, GA United States
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Hospital de Gran Canaria Doctor Negrin

Las Palmas De Gran Canaria, Spain
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Maidstone Hospital

Maidstone, United Kingdom
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Churchill Hospital

Oxford, United Kingdom
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Culiacán, Mexico
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Recruitment Status: Open

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