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Clinical Trials Search at Vanderbilt-Ingram Cancer Center



Investigating Abnormal Signaling in Acute Myeloid Leukemia (AML)

Leukemia

Leukemia
N/A
Ferrell, Paul
VICCHEM1305

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

Multiple Cancer Types

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.
Leukemia, Myelodysplastic Syndrome
I/II
Ferrell, Paul
NCT02719574
VICCHEM1709

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