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

NCT03194685 ↗

Phase 1 Completed 97 enrolled Fujifilm Pharmaceuticals U.S.A., Inc.

Non-randomizedSequentialOpen-labelTreatment

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).

Timeline

Start: 2017-05-05
Primary completion: 2021-07-31
Completion: 2021-07-31

Publications

Levis M, Perl A, Schiller G, Fathi AT, Roboz G, Wang ES, Altman J, Rajkhowa T, Ando M, Suzuki T, Subach RA, Maier G, Madden T, Johansen M, Cheung K, Kurman M, Smith C. A phase 1 study of the irreversible FLT3 inhibitor FF-10101 in relapsed or refractory acute myeloid leukemia. Blood Adv. 2024 May 28;8(10):2527-2535. doi: 10.1182/bloodadvances.2023010619.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	FF-10101-01	Small molecule	10 mg	Oral
Subject	FF-10101-01	Small molecule	20 mg	Oral
Subject	FF-10101-01	Small molecule	35 mg	Oral
Subject	FF-10101-01	Small molecule	50 mg	Oral
Subject	FF-10101-01	Small molecule	75 mg	Oral
Subject	FF-10101-01	Small molecule	100 mg	Oral
Subject	FF-10101-01	Small molecule	150 mg	Oral
Subject	FF-10101-01	Small molecule	225 mg	Oral

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

Summary

Timeline

Publications

Drugs

Indications