A Study of RO5503781 as a Single Agent or in Combination With Cytarabine in Participants With Acute Myelogenous Leukemia
Status:
Completed
Trial end date:
2016-06-01
Target enrollment:
Participant gender:
Summary
This Phase 1/1b, open-label study will evaluate the safety and pharmacokinetics of escalating
doses of RO5503781 as a single agent or in combination with cytarabine in participants with
acute myelogenous leukemia. In Part 1, RO5503781 will be administered in escalating doses as
a single agent, and in Part 2, RO5503781 will be administered in combination with cytarabine.
An optional Part 3 in which RO5503781 will be administered with cytarabine and anthracycline
may be considered . In Part 4, the safety and pharmacokinetic profile of an optimized
formulation of RO5503781 in combination with cytarabine will be assessed.