Study of FF-10501-01 in Patients With Relapsed or Refractory Hematological Malignancies

NCT02193958 ↗

Phase 1/2 Completed 55 enrolled Fujifilm Pharmaceuticals U.S.A., Inc.

Non-randomizedSingle-groupOpen-labelTreatment

Summary

A Phase 1/2a Dose Escalation Study of FF-10501-01 in Patients with Relapsed or Refractory Hematological Malignancies to determine the safety and tolerability. A total of 6 cohorts will be enrolled in Phase 1 to establish the MTD. A total of 20 subjects with MDS/CMML treated at the RP2D are planned, including MDS/CMML subjects treated at the RP2D in Phase 1.

Timeline

Start: 2014-07
Primary completion: 2019-08-09
Completion: 2019-10-15

Publications

Garcia-Manero G, Pemmaraju N, Alvarado Y, Naqvi K, Ravandi F, Jabbour E, De Lumpa R, Kantarjian H, Advani A, Mukherjee S, Gerds A, Carraway HE, Nazha A, Iwamura H, Murase M, Bavisotto L, Kurman M, Maier G, Johansen M, Sekeres MA. Results of a Phase 1/2a dose-escalation study of FF-10501-01, an IMPDH inhibitor, in patients with acute myeloid leukemia or myelodysplastic syndromes. Leuk Lymphoma. 2020 Aug;61(8):1943-1953. doi: 10.1080/10428194.2020.1747065. Epub 2020 Apr 7.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	FF-10501-01	Unknown	50 mg/m2	Oral
Subject	FF-10501-01	Unknown	100 mg/m2	Oral
Subject	FF-10501-01	Unknown	200 mg/m2	Oral
Subject	FF-10501-01	Unknown	300 mg/m2	Oral
Subject	FF-10501-01	Unknown	400 mg/m2	Oral
Subject	FF-10501-01	Unknown	500 mg/m2	Oral

Study of FF-10501-01 in Patients With Relapsed or Refractory Hematological Malignancies

Summary

Timeline

Publications

Drugs

Indications