Last updated on May 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 Phase 1, 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

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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