Last updated on December 2018

Open-label Study of FT-2102 With or Without Azacitidine or Cytarabine in Patients With AML or MDS With an IDH1 Mutation


Brief description of study

This Phase 1/2 study will evaluate the safety, efficacy, PK, and PD of FT-2102 as a single agent or in combination with azacitidine or cytarabine. The Phase 1 stage of the study is split into 2 distinct parts: a dose escalation part, which will utilize an open-label design of FT-2102 (single agent) and FT-2102 + azacitidine (combination agent) administered via one or more intermittent dosing schedules followed by a dose expansion part. The dose expansion part will enroll patients in up to 5 expansion cohorts, exploring single-agent FT-2102 activity as well as combination activity with azacitidine or cytarabine. Following the completion of the relevant Phase 1 cohorts, Phase 2 will begin enrollment. Patients will be enrolled across 6 different cohorts, examining the effect of FT-2102 (as a single agent) and FT-2102 + azacitidine (combination) on various AML/MDS disease states.

Clinical Study Identifier: NCT02719574

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Tanya Malak

Yale Cancer Center
New Haven, CT United States
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Kristen Englund

University of Miami, Sylvester Comprehensive Cancer Center
Miami, FL United States
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Shirra Dinner, MD

Northwestern University
Chicago, IL United States
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Melanie Coleman

Indiana Blood and Marrow Transplantation
Indianapolis, IN United States
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Tony Garn

Karmanos Cancer Institute
Detroit, MI United States
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Paul Baskind

New York Medical College
Hawthorne, NY United States
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Sarah Leach

Columbia University Medical Center
New York, NY United States
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Elena Lascu

Weill Cornell Medicine/New York-Presbyterian
New York, NY United States
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Jorge Cortes, MD

MD Anderson Cancer Center
Houston, TX United States
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Bruck Habtemariam

UCLA
Los Angeles, CA United States
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Hongxia Li

University of Maryland School of Medicine Greenebaum Comprehensive
Baltimore, MD United States
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Cancer Clinical Trials Office

Stony Brook Cancer Center
Stony Brook, NY United States
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Chase Brockett

Oregon Health & Science University
Portland, OR United States
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Rebekah Taylor

Vanderbilt Ingram Cancer Center
Nashville, TN United States
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Neil Bailey

Swedish Cancer Institute
Seattle, WA United States
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Linh Dang-Chu

UC Davis Comprehensive Cancer Center
Sacramento, CA United States
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Clinical Trials Office

Florida Cancer Specialists
Sarasota, FL United States
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Clinical Trials Office

Roswell Park Cancer Institute
Buffalo, NY United States
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Don Marx

North Shore Hematology Oncology Associates
East Setauket, NY United States
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Lisa Brenner

The Ohio State University
Columbus, OH United States
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Sarah Walls

Sarah Cannon Research Institute - Tennessee Oncology
Nashville, TN United States
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Andrew Wei, MD

The Alfred Hospital
Melbourne, Australia
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Jesika Reiner, MPH

University of California San Diego
La Jolla, CA United States
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Shannon Gleason

Emory Winship Cancer Institute
Atlanta, GA United States
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Duke University Medical Center
Durham, NC United States
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Prapti Patel, MD

UT Southwestern
Dallas, TX United States
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Houston Methodist Research Institute
Houston, TX United States
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Nada Hamad, MD

St Vincent's Hospital Sydney
Darlinghurst, Australia
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Devendra Hiwase, MD

Royal Adelaide Hospital
Adelaide, Australia
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Ashish Bajel, MD

Victoria Cancer Care Center
Parkville, Australia
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Carolyn Grove, MD

Sir Charles Gairdner Hospital
Nedlands, Australia
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Anthony Schwarer, MD

Box Hill Hospital
Box Hill, Australia
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Deborah Sanfelice

Princess Margaret Hospital
Toronto, ON Canada
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Douay Angelique

H pital Avicenne-APHP-Universit Paris
Bobigny, France
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Assistance Publique Hopitaux de Marseille (AP-HM) - Hopital Nord
Marseille, France
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Centre Hospitalier Universitaire Nantes
Nantes, France
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Pierre Fenaux, MD

H pital Saint-Louis
Paris, France
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Ollivier Legrand, MD

Hopitaux Universitaires Est Parisien Hopital Saint-Antoine
Paris, France
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Mathieu Sauvezie

Centre Hospitalier Universitaire (CHU) Bordeaux - Hospitaux du Haut Leveque
Pessac, France
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Xavier Thomas, MD

Centre Hospitalier Lyon Sud
Pierre-Bénite, France
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Stanislas Nimubona, MD

University Hospital of Rennes
Rennes, France
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Christian Recher, MD

Institut Universitaire du Cancer Toulouse - Oncopole
Toulouse, France
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Centre Hospitalier Universitaire de Nancy - Hopital Brabois
Vandœuvre-lès-Nancy, France
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Houssaini Soufyan

Institut de Canc rologie Gustave Roussy
Villejuif, France
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Sang Kyun Sohn, MD

Kyungpook National University Hospital
Daegu, Korea, Republic of
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Soo-Me Bang, MD

Seoul National University Bundang Hospital
Seongnam-si, Korea, Republic of
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Sung-Soo Yoon, MD

Seoul National University Hospital
Seoul, Korea, Republic of
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June Won Cheong, MD

Severance Hospital
Seoul, Korea, Republic of
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Chul Won Jung, MD

Samsung Medical Center
Seoul, Korea, Republic of
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Olga Salamero, MD

Hospital Vall d'Hebron
Barcelona, Spain
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Jordi Esteve, MD

Hospital Clinic de Barcelona
Barcelona, Spain
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Montserrat Arnan-Sangerman, MD

Institut Catal d'Oncologia-Hospital Duran i Reynals
Barcelona, Spain
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Hospital de la Princesa
Madrid, Spain
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Joaquin Martinez Lopez, MD

Hospital Universitario 12 De Octubre
Madrid, Spain
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Hospital Cl nico Universitario de Salamanca
Salamanca, Spain
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Mercedes Colorado, MD

Hospital Marques de Valdecilla
Santander, Spain
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Pau Montesinos, MD

Hospital La Fe
Valencia, Spain
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Clatterbridge Cancer Centre NHS Trust
Liverpool, United Kingdom
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Alexandra Browndson

University College London Hospitals NHS Foundation Trust
London, United Kingdom
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David Taussig, MD

Royal Marsden Hospital
Sutton, United Kingdom
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Recruitment Status: Open


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