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

AML, Adult Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• AML, Adult
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

• NCT number: NCT03194685
• Study type: Interventional
• Source: Fujifilm Pharmaceuticals U.S.A., Inc.
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: May 5, 2017
• Completion date: July 31, 2021