A Study of RO5503781 as Single Agent or in Combination With Cytarabine in Patients With Acute Myelogenous Leukemia
| Status: | Completed |
|---|---|
| Conditions: | Other Indications, Blood Cancer, Hematology |
| Therapuetic Areas: | Hematology, Oncology, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 8/6/2016 |
| Start Date: | February 2013 |
| End Date: | June 2016 |
A MULTI-CENTER, OPEN-LABEL, PHASE 1/1B STUDY OF ESCALATING DOSES OF RO5503781 ADMINISTERED ORALLY AS 1) A SINGLE AGENT, 2) IN COMBINATION WITH CYTARABINE, OR 3) WITH CYTARABINE AND ANTHRACYCLINE AND 4) ASSESSING PK AND SAFETY OF NEW OPTIMIZED FORMULATION OF RO5503781 WITH CYTARABINE IN PATIENTS WITH ACUTE MYELOGENOUS LEUKEMIA (AML)
This phase I/IB, open-label study will evaluate the safety and pharmacokinetics of
escalating doses of RO5503781 as single agent or in combination with cytarabine in patients
with acute myelogenous leukemia. An optional Part 3 in which RO5503781 is 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.
escalating doses of RO5503781 as single agent or in combination with cytarabine in patients
with acute myelogenous leukemia. An optional Part 3 in which RO5503781 is 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.
Inclusion Criteria:
- Adult patients, >/= 18 years of age
- Documented/confirmed 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, Part 3 and Part 4 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
- Adequate hepatic and renal function
- Willing to submit the blood sampling and bone marrow sampling required by protocol
Additional inclusion criteria for Parts 1-4 may apply.
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 Additional exclusion criteria for Parts 1-4 may
apply.
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