Last updated on November 2018

A Safety and Efficacy Study of Oral AG-120 Plus Subcutaneous Azacitidine and Oral AG-221 Plus Subcutaneous Azacitidine in Subjects With Newly Diagnosed Acute Myeloid Leukemia (AML)


Brief description of study

This Phase 1b/2 study is an open-label, randomized, multicenter trial to evaluate the safety and efficacy of oral AG-120 + Subcutaneous (SC) azacitidine and oral AG-221 + SC azacitidine in subjects with newly diagnosed AML with an IDH1 or an IDH2 mutation, respectively. The study population consists of subjects who are not candidates to receive intensive Inductive chemotherapy (IC). The study comprises a Phase 1b dose-finding and AG-120 expansion stage and a Phase 2 randomized stage.

Detailed Study Description

The study was redesigned to expand the number of patients analyzed during the Phase 1b stage of the study to determine a safe and effective dose of AG-120 administered with azacitidine for future studies.

The Phase 1b (AG-120 expansion) stage will evaluate the safety, tolerability, and clinical activity of oral AG-120 when administered with Subcutaneous azacitidine.

The Phase 2 stage of the study will no longer include AG-120 administered with azacitidine (IDH1 subjects) and IDH1 patients will not longer be included in the azacitidine alone arm.

Clinical Study Identifier: NCT02677922

Contact Investigators or Research Sites near you

Start Over

Associate Director Clinical Trial Disclosure

City of Hope
Duarte, CA United States

Associate Director Clinical Trial Disclosure

Yale Cancer Center
New Haven, CT United States

Associate Director Clinical Trial Disclosure

Northwestern University
Chicago, IL United States

Associate Director Clinical Trial Disclosure

University of Chicago
Chicago, IL United States

Associate Director Clinical Trial Disclosure

Massachusetts General Hospital
Boston, MA United States

Associate Director Clinical Trial Disclosure

Beth Israel Deaconess Medical Center
Boston, MA United States

Associate Director Clinical Trial Disclosure

Dana Farber Cancer Institute
Boston, MA United States

Associate Director Clinical Trial Disclosure

Memorial Sloan Kettering Cancer Center
New York, NY United States

Associate Director Clinical Trial Disclosure

Sarah Cannon Research Inst
Nashville, TN United States

Associate Director Clinical Trial Disclosure

UT Southwestern Medical Center at Dallas
Dallas, TX United States

Associate Director Clinical Trial Disclosure

MD Anderson Cancer Center
Houston, TX United States

Associate Director Clinical Trial Disclosure

Royal Adelaide Hospital
Adelaide, Australia

Associate Director Clinical Trial Disclosure

Parkville Cancer Clinical Trials Unit
Melbourne, Australia

Associate Director Clinical Trial Disclosure

The Alfred Hospital
Melbourne, Australia

Associate Director Clinical Trial Disclosure

Royal Perth Hospital
Perth, Australia

Associate Director Clinical Trial Disclosure

Princess Margaret Hospital, Medical Oncology
Toronto, ON Canada

Associate Director Clinical Trial Disclosure

CHRU de Lille-Hopital Claude Huriez Service des Maladies du Sang
Lille, France

Associate Director Clinical Trial Disclosure

Institut Paoli Calmettes
Marseille Cedex 9, France

Associate Director Clinical Trial Disclosure

Centre Hospitalier Universitaire de Nantes
Nantes, France

Associate Director Clinical Trial Disclosure

Hopital Saint Louis
Paris Cedex 10, France

Associate Director Clinical Trial Disclosure

Hospital haut leveque
Pessac, France

Associate Director Clinical Trial Disclosure

Centre Hospitalier Lyon Sud
Pierre Benite, France

Associate Director Clinical Trial Disclosure

Institut Universitaire du Cancer Oncopole
Toulouse, France

Associate Director Clinical Trial Disclosure

Institut Gustave Roussy
Villejuif Cedex, France

Associate Director Clinical Trial Disclosure

Medizinische Klinik III Klinikum der Universit t M nchen-Gro hadern
Berlin, Germany

Associate Director Clinical Trial Disclosure

Universitaetsklinikum Carl Gustav Carus TU Dresden
Dresden, Germany

Associate Director Clinical Trial Disclosure

Universitatsklinikum Frankfurt
Frankfurt, Germany

Associate Director Clinical Trial Disclosure

Zentrum Innere Medizin Klinik fur Hamatologie
Hannover, Germany

Associate Director Clinical Trial Disclosure

Universitatsklinikum Ulm
Ulm, Germany

Associate Director Clinical Trial Disclosure

Azienda Ospedaliero-Universitaria Careggi
Firenze, Italy

Associate Director Clinical Trial Disclosure

Azienda Ospedaliera Universitaria S. Martino di Genova
Genova, Italy

Associate Director Clinical Trial Disclosure

Azienda Ospedaliera San Luigi Gonzaga
Orbassano, Italy

Associate Director Clinical Trial Disclosure

Azienda Ospedaliera Ospedali Riuniti Marche Nord AORMN
Pesaro, Italy

Associate Director Clinical Trial Disclosure

Azienda Ospedaliera S. Andrea - Universit La Sapienza
Roma, Italy

Associate Director Clinical Trial Disclosure

Samsung Medical Center
Seoul, Korea, Republic of

Associate Director Clinical Trial Disclosure

The Catholic University of Korea Seoul - Saint Mary's Hospital
Seoul, Korea, Republic of

Associate Director Clinical Trial Disclosure

Asan Medical Center
Seoul, Korea, Republic of

Associate Director Clinical Trial Disclosure

VU University Medical Center
Amsterdam, Netherlands

Associate Director Clinical Trial Disclosure

Universitair Medisch Centrum Groningen
Groningen, Netherlands

Associate Director Clinical Trial Disclosure

University Medical Center Utrecht
Utrecht, Netherlands

Associate Director Clinical Trial Disclosure

Instituto Portugues de Oncologia de Lisboa
Lisboa, Portugal

Associate Director Clinical Trial Disclosure

Centro Hospitalar de Lisboa Central - Hospital de Santo Ant nio dos Capuchos
Lisboa, Portugal

Associate Director Clinical Trial Disclosure

Instituto Portugues de Oncologia do Porto
Porto, Portugal

Associate Director Clinical Trial Disclosure

H Clinic I Provincial
Barcelona, Spain

Associate Director Clinical Trial Disclosure

Hospital de Bellvitge
Barcelona, Spain

Associate Director Clinical Trial Disclosure

Hospital Universitario Vall D Hebron
Barcelona, Spain

Associate Director Clinical Trial Disclosure

Hospital San Pedro de Alcantara
Caceres, Spain

Associate Director Clinical Trial Disclosure

Hospital General Universitario Gregorio Maranon
Madrid, Spain

Associate Director Clinical Trial Disclosure

M. D. Anderson
Madrid, Spain

Associate Director Clinical Trial Disclosure

Hospital General Carlos Haya
Malaga, Spain

Associate Director Clinical Trial Disclosure

Hospital Universitario La Fe
Valencia, Spain

Associate Director Clinical Trial Disclosure

UniversitatsSpital Basel
Basel, Switzerland

Associate Director Clinical Trial Disclosure

Centre Hospitalier Universitaire Vaudois CHUV BH-04
Lausanne, Switzerland

Associate Director Clinical Trial Disclosure

Universitatsspital Zurich
Zurich, Switzerland

Associate Director Clinical Trial Disclosure

Queen Elizabeth Hospital UHB NHS Foundation Trust
Birmingham, United Kingdom

Associate Director Clinical Trial Disclosure

John Radcliffe Hospital
Headington, United Kingdom

Associate Director Clinical Trial Disclosure

Leeds Teaching Hospitals Trust
Leeds, United Kingdom

Associate Director Clinical Trial Disclosure

Barts Cancer Institute, Queen Mary University of London, Charterhouse Square
London, United Kingdom

Associate Director Clinical Trial Disclosure

King's College Hospital
London, United Kingdom

Associate Director Clinical Trial Disclosure

Queen Marys NHS Trust
Sidcup, United Kingdom

Associate Director Clinical Trial Disclosure

CHRU Hopital Bretonneau
Tours cedex, France

Associate Director Clinical Trial Disclosure

Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi
Bologna, Emilia-Romagna, Italy

Associate Director Clinical Trial Disclosure

Heinrich Heine Universitat Dusseldorf
Düsseldorf, Germany

Associate Director Clinical Trial Disclosure

Hospital of Di Padova
Padova, Italy

Associate Director Clinical Trial Disclosure

Erasmus University Medical Center
Rotterdam, Netherlands

Associate Director Clinical Trial Disclosure

Hospital General de la Palma
Breña Alta, Spain

Recruitment Status: Closed


Brief Description Eligibility Contact Research Team


Receive Emails About New Clinical Trials!

Sign up for our FREE service to receive email notifications when clinical trials are posted in the medical category of interest to you.