NCT03194685

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 97 (actual)
• Sponsor: Fujifilm Pharmaceuticals U.S.A., Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A Phase 1 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).

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.

Conditions

• AML, Adult

Interventions

Type	Name	Description
DRUG	FF-10101-01	FF-10101-01 will be administered orally once a day on Days 1-28 of a 28-day cycle. In Phase 1, the dose escalation will proceed until MTD is reached.

Timeline

• Start date: 2017-05-05
• Primary completion: 2021-07-31
• Completion: 2021-07-31
• First posted: 2017-06-21
• Last updated: 2024-12-24

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study