Study of FF-10101-01 in Patients With Relapsed or Refractory Acute Myeloid Leukemia


Study Number
66718
Phase
I/IIa
Purpose

A Phase 1/2a dose escalation and dose ranging study of FF-10101-01 in subjects with relapsed or refractory acute myeloid leukemia to determine the safety, tolerability, PK and preliminary efficacy. A total of 9 cohorts will be enrolled in Phase 1 to establish the Maximum Tolerated Dose (MTD). Phase 2a will consist of up to 3 dose levels (high, medium, and low) of which subjects with FLT3 mutations will randomly be assigned.

Full Title

A First-in-Human Phase 1/2a Study to Assess the Safety, Tolerability, Efficacy, and Pharmacokinetics of FF-10101-01 in Subjects with Relapsed or Refractory Acute Myeloid Leukemia

ClinicalTrials.Gov ID
NCT03194685

To inquire about participating in these studies, call 1-800-ROSWELL (1-800-767-9355) or e-mail askroswell@roswellpark.org.