Last updated on July 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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University of Chicago

Chicago, IL United States
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Ochsner Clinic Foundation

Jefferson, LA United States
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John Theurer Cancer Center

Hackensack, NJ United States
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New York Medical College

Valhalla, NY United States
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Brody School of Medicine at ECU

Greenville, NC 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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MD Anderson Cancer Center

Houston, TX United States
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Flinders Medical Centre

Bedford Park, Australia
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Hotel Dieu

Nantes, France
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CHU Estaing

Clermont-Ferrand, France
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National Cancer Center

Goyang, Korea, Republic of
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Ajou University Hospital

Suwon-si, Korea, Republic of
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SINACOR

Culiacan, Mexico
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VU Medisch Centrum

Amsterdam, Netherlands
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Regional Clinical Hospital

Krasnoyarsk, Russian Federation
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City Clinical Hospital # 40

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

Petrozavodsk, Russian Federation
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CHUS H. Clinico U. de Santiago

Santiago de Compostela, Spain
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Hospital Son Llatzer

Palma de Mallorca, Spain
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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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Pilgrim Hospital

Boston, United Kingdom
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Flinders Medical Centre

Bedford park, Australia
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Hospital de Gran Canaria Doctor Negrin

Las Palmas De Gran Canaria, Spain
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Recruitment Status: Open


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