A Multi-Center, Open-Label, Phase 1/1B Study of Escalating Doses of RO5503781 Administered Orally as a Single Agent or in Combination With Cytarabine in Patients With Acute Myelogenous Leukemia (AML)
Inclusion Criteria:
- Adult patients, >/= 18 years of age
- Documented acute myelogenous leukemia (AML), except for acute promyelocytic leukemia
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2 in Part 1 and
Part 2, patients enrolled in the extension/tail portion must have an ECOG performance
status of 0 or 1
- All non-hematological adverse events of any prior chemotherapy, surgery or
radiotherapy must have resolved to NCI-CTCAE Grade =2 prior to starting therapy
- Adequate hepatic and renal function
- Willing to submit the blood sampling and bone marrow sampling required by protocol
Exclusion Criteria:
- Patients receiving any other investigational or commercial agents or therapies
administered with the intention to treat their malignancy within 14 days of first
receipt of study drug, with the exception of hydroxyurea as defined in protocol
- History of allergic or toxic reactions attributed to cytarabine (Part 2) or history
of allergic reactions to components of the formulated product
- Current evidence of central nervous system (CNS) leukemia
- Patients with severe and/or uncontrolled medical conditions or other conditions that
could affect their participation in the study
- Patients with evidence of electrolyte imbalance of Grade >/= 2 which cannot be
corrected prior to study initiation
- Pregnant or breastfeeding women
- HIV-positive patients receiving anti-retroviral therapy
- Patients who refuse to potentially receive blood products and/or have a
hypersensitivity to blood products