A Study of RO5045337 in Combination With Cytarabine in Patients With Acute Myelogenous Leukemia
Status:
Completed
Trial end date:
2013-10-01
Target enrollment:
Participant gender:
Summary
This multi-center, open-label, Phase 1b study will evaluate the safety, pharmacokinetics and
efficacy of RO5045337 in combination with cytarabine in patients with acute myelogenous
leukemia. In Arm A, cohorts of previously untreated patients deemed unsuitable for standard
induction therapy will receive escalating oral doses of RO5045377 and cytarabine 20 mg/m2
subcutaneously daily for Days 1 to 10 of each 28-day cycle. In Arm B, cohorts of patients who
have relapsed or are refractory after at least one cytarabine/anthracycline containing
regimen will receive escalating oral doses of RO5045377 on Days 1 to 5 and cytarabine 1 gm/m2
intravenously on Days 1 to 6 of each 28-day cycle. Patients will receive up to 4 cycles of
therapy, patients in Arm A who achieve hematologic response may continue additional cycles
until disease progression.