A Study of ONO-7475 in Patients With Acute Leukemias

Active:	No
Cancer Type:	Leukemia Myelodysplastic Syndromes (MDS)	NCT ID:	NCT03176277
Trial Phases:	Phase I Phase II	Protocol IDs:	ONO-7475-01 (primary) NCI-2017-01115
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Ono Pharmaceutical Company Limited
NCI Full Details:	http://clinicaltrials.gov/show/NCT03176277

Summary

[Updated]: To assess the safety and tolerability of ONO-7475 monotherapy in patients with
relapsed or refractory acute myeloid leukemia or relapsed or refractory myelodysplastic
syndromes and to assess: i) safety and tolerability and ii) preliminary efficacy of the
combination of ONO-7475 and venetoclax in patients with relapsed or refractory acute
myeloid leukemia.

Objectives

Part A is a dose escalation study of ONO-7475 in patients with acute myeloid leukemia or
relapsed or refractory myelodysplastic syndromes.

Part D is a dose escalation study of ONO-7475 in combination with venetoclax. ONO-7475
starting dose is selected following safety and tolerability outcome of Part A.

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