Last updated on August 2019

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 8 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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New York Medical College

Hawthorne, NY United States
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The Alfred Hospital

Melbourne, Australia
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Northwestern University

Chicago, IL United States
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Karmanos Cancer Institute

Detroit, MI United States
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Swedish Cancer Institute

Seattle, WA United States
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MD Anderson Cancer Center

Houston, TX United States
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The Ohio State University

Columbus, OH United States
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Yale Cancer Center

New Haven, CT United States
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UCLA Medical Center

Los Angeles, CA United States
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Yale University

New Haven, CT United States
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Churchill Hospital

Oxford, United Kingdom
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Southampton General Hospital

Southampton, United Kingdom
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Royal Marsden Hospital

Sutton, United Kingdom
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