Last updated on September 2017

Phase 3 Randomized Open-Label Study of Guadecitabine vs Treatment Choice in Previously Treated Acute Myeloid Leukemia

Brief description of study

Multicenter, randomized, open-label, parallel-group study of guadecitabine vs treatment choice (TC). Subjects will be randomly assigned in a 1:1 ratio to either guadecitabine or TC. TC options include the 8 high or low intensity, locally available regimens below; or Best supportive Care (BSC) alone: - High intensity (intermediate or high dose cytarabine [HiDAC]; mitoxantrone, etoposide, and cytarabine [MEC]; or fludarabine, cytarabine, granulocyte colony stimulating factor [G-CSF], +/- idarubicin [FLAG/FLAG-Ida]). - Low intensity (low dose cytarabine [LDAC], decitabine, or azacitidine). - BSC.

Detailed Study Description

This Phase 3, randomized, open-label, parallel-group multicenter study of the efficacy and safety of guadecitabine in adults with previously treated AML will be conducted in approximately 20 countries. There will be a 14-day screening period, a treatment period, a safety follow-up visit, and a long-term follow-up period. The study is expected to last approximately 2 years. Duration of individual subject participation will vary, and subjects may continue to receive treatment for as long as they continue to benefit. Approximately 404 subjects from approximately 100 study centers will be randomly assigned to either guadecitabine or treatment choice (TC) in a 1:1 ratio (approximately 202 subjects per group). TC is as follows: - High intensity: intermediate or high dose cytarabine (HiDAC); mitoxantrone, etoposide, and cytarabine (MEC); or fludarabine, cytarabine, G-CSF, +/- idarubicin (FLAG/FLAG-Ida). - Low intensity: low dose cytarabine (LDAC), decitabine, or azacitidine. - Best Supportive Care (BSC). Guadecitabine will be given SC at a dose of 60 mg/m2 in 28-day cycles. In Cycle 1, guadecitabine will be given for 10 days on Days 1-5 and Days 8-12. Cycle 2 will be either the 5-day regimen (Days 1-5) or 10-day regimen (Days 1-5 and 8-12) based on assessment of disease response and hematologic recovery at the end of Cycle 1. In subsequent cycles, guadecitabine treatment will be for 5 days only (Days 1-5).

Clinical Study Identifier: NCT02920008


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Sondra Ortiz

University of Southern California
Los Angeles, CA United States
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Howard Weiner

The University of Chicago Medical Center
Chicago, IL United States
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Isabella van der Merwe

Franciscan Research Center
Indianapolis, IN United States
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Gillian Velardi

John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, NJ United States
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Daniel Weishampel

University of New Mexico School of Medicine
Albuquerque, NM United States
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Heather Bashaw

Roswell Park Cancer Institute
Buffalo, NY United States
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Latia Skerving

Weill Cornell Medical College
New York, NY United States
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Sebastian Munoz

Stony Brook University Hospital
Stony Brook, NY United States
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Rachel Stowe

Duke Cancer Institute
Durham, NC United States
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Lilanee Chanyothi

Temple University Hospital
Philadelphia, PA United States
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Channing Dudley

Vanderbilt University Medical Center
Nashville, TN United States
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Dana Wright

MD Anderson Cancer Center
Houston, TX United States
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Erik Bailey

Swedish Cancer Institute
Seattle, WA United States
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Patricia Beal

West Virginia University Hospitals, Inc.
Morgantown, WV United States
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Laura Salenbien

AZ Sint-Jan Brugge-Oostende AV
Brugge, Belgium
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Jonas Segaert

Universitair Ziekenhuis Gent
Gent, Belgium
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Jeff Greenway

Tom Baker Cancer Centre
Calgary, AB Canada
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Lori Rackel

University of Alberta Hospital
Edmonton, AB Canada
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Jennifer Kim

Princess Margaret Cancer Centre
Toronto, ON Canada
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Vera Sabadash

CHRU Montpellier - Saint Eloi
Montpellier, France
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Céline Haby

Groupe Hospitalier de la R gion de Mulhouse et Sud Alsace
Mulhouse, France
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Blandine Beve

H pital Saint-Louis
Paris, France
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Isabelle De Ponnat

Institut Universitaire du Cancer de Toulouse - Oncopole
Toulouse, France
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Gabriella Mezei

Debreceni Egyetem Klinikai K zpont
Debrecen, Hungary
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Éva Meskuláné Szilágyi

Somogy Megyei Kaposi M r Oktat K rh z
Kaposvar, Hungary
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Gábor Kollár

Pecsi Tudomanyegyetem Klinikai K zpont
Pécs, Hungary
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Agnes Nagyne

Szegedi Tudom nyegyetem
Szeged, Hungary
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Eun Jin Kim

Seoul National University Bundang Hospital
Seongnam-si, Korea, Republic of
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Jinyi Baek

Pusan National University Hospital
Busan, Korea, Republic of
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Ju-Hyun Lee

Seoul National University Hospital
Seoul, Korea, Republic of
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So-Young Choi

Severance Hospital
Seoul, Korea, Republic of
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Jayeon Kim

Samsung Medical Center
Seoul, Korea, Republic of
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Hae Jin Kang

Ulsan University Hospital (UUH)
Ulsan, Korea, Republic of
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Carmen Alcaine

Hospital San Pedro de Alc ntara
Cáceres, Spain
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Marta Hernández Martín

Hospital General Universitario Gregorio Mara n
Madrid, Spain
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Lavina Davey

East Kent Hospitals University NHS Foundation Trust - Kent and Canterbury Hospital
Canterbury, United Kingdom
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