A Multicenter, Open Label, Phase 1B Study of Escalating Doses of RO5045337 Administered Orally, With Cytarabine Administered A) Subcutaneously, or B) Intravenously, in Patients With Acute Myelogenous Leukemia (AML)
Inclusion Criteria:
- Adult patients, >/= 18 years of age
- Patients with histologically or cytologically documented acute myelogenous leukemia
appropriate for cytarabine therapy including:
- Arm A: Patients who have not received prior standard induction chemotherapy,
considered unsuitable for standard induction therapy
- Arm B: Patients who have failed their 1st or greater line of standard induction
chemotherapy (primary refractory) or patients who originally achieved a complete
response but are currently in first or greater relapse
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
- All non-hematological adverse events of any prior chemotherapy, surgery, or
radiotherapy must have resolved to NCI-CTC AE Grade =2
- Adequate hepatic and renal function
- Patient must be willing to submit the blood sampling and bone marrow sampling for PK
and PD analyses and exploratory biomarkers
Exclusion Criteria:
- History of allergic or toxic reactions attributed to cytarabine or a history of
allergic reactions to components of the formulated product
- Current evidence of CNS leukemia
- Any severe and/or uncontrolled medical condition or other conditions that could
affect the participation in the study
- Pregnant or breastfeeding women
- HIV-positive patients receiving combination anti-retroviral therapy