Status and phase
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About
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.
Enrollment
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Inclusion criteria
Additional inclusion criteria for Parts 1-4 may apply.
Exclusion criteria
Additional exclusion criteria for Parts 1-4 may apply.
Primary purpose
Allocation
Interventional model
Masking
122 participants in 4 patient groups
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Data sourced from clinicaltrials.gov
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