Last updated on August 2018

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

Brief description of study

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.

Detailed Study Description

Subjects will receive FF-10501-01 orally on a twice daily schedule for 14, 21 or 28 days repeated every 28 days (=1 cycle). Disease assessments, including analysis of blood and bone marrow aspirates, will be performed at the end of Cycle 1 and every 2 cycles thereafter. Subjects who demonstrate objective response or stable disease will be allowed to continue therapy with FF-10501-01 until progression of disease, observation of unacceptable adverse events, intercurrent illness or changes in condition that prevent further study participation.

Clinical Study Identifier: NCT02193958

Contact Investigators or Research Sites near you

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Mikkael Sekeres, MD

Cleveland Clinic at Taussig Cancer Center
Cleveland, OH United States
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Guillermo Garcia-Manero, MD

M D Anderson Cancer Center
Houston, TX United States
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