A Study of RO5503781 as Single Agent or in Combination With Cytarabine in Patients With Acute Myelogenous Leukemia
Myelogenous Leukemia, Acute
Conditions: official terms
Leukemia - Leukemia, Myeloid - Leukemia, Myeloid, Acute
Study Type
Study Phase
Phase 1
Study Design
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Name: RO5503781 MDP Type: Drug
Name: RO5503781 SDP Type: Drug
Name: anthracycline Type: Drug
Name: cytarabine Type: Drug
Overall Status
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: 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.
Los Angeles, California, United States
Status: Recruiting
Valhalla, New York, United States
Status: Active, not recruiting
Philadelphia, Pennsylvania, United States
Status: Recruiting
Houston, Texas, United States
Status: Completed
San Antonio, Texas, United States
Status: Terminated
East Melbourne, Victoria, Australia
Status: Recruiting
Toronto, Ontario, Canada
Status: Recruiting
Montreal, Quebec, Canada
Status: Recruiting
Marseille, France
Status: Active, not recruiting
Bologna, Emilia-Romagna, Italy
Status: Active, not recruiting
Seoul, Korea, Republic of
Status: Recruiting
Seoul, Korea, Republic of
Status: Recruiting
Glasgow, United Kingdom
Status: Active, not recruiting
Start Date
February 2013
Completion Date
May 2016
Hoffmann-La Roche
Hoffmann-La Roche
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page