Spots Global Cancer Trial Database for Study of FF-10101-01 in Patients With Relapsed or Refractory Acute Myeloid Leukemia
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Trial Identification
Brief Title: Study of FF-10101-01 in Patients With Relapsed or Refractory Acute Myeloid Leukemia
Official 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
Study ID: NCT03194685
Conditions
Interventions
Study Description
Brief Summary: 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.
Detailed Description: Subjects will receive FF-10101-01 orally once a day repeated every 28 days =1 cycle Frequent blood draws will be collected to measure pharmacodynamic parameters and pharmacodynamic activity. Disease assessments, including bone marrow aspirates, will be performed at the beginning of cycles 1-3, and every 3 months thereafter. Subjects who demonstrate objective response or stable disease will be allowed to continue therapy with FF-10101-01 until , observation of unacceptable adverse events, or until the subject is no longer deriving benefit based on the opinion of the investigator. For Phase 2a long term phone follow-up for assessment of overall survival will also occur.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of California Los Angeles, David Geffen School of Medicine, Los Angeles, California, United States
University Of California, San Francisco School of Medicine, San Francisco, California, United States
Northwestern University, Chicago, Illinois, United States
Johns Hopkins Hospital - Sidney Kimmel Cancer Center, Baltimore, Maryland, United States
Massachusetts General Hospital Cancer Center, Boston, Massachusetts, United States
Roswell Park Comprehensive Cancer Center, Buffalo, New York, United States
University of Pennsylvania, Philadelphia, Pennsylvania, United States
Contact Details
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