A Study of RO5429083 Alone or in Combination With Cytarabine in Patients With Acute Myelogenous Leukemia

Roche

Status and phase

Completed

Phase 1

Conditions

Myelogenous Leukemia, Acute

Treatments

Drug: cytarabine

Drug: RO5429083

Study type

Interventional

Funder types

Industry

Identifiers

NCT01641250

2012-001027-12 (EudraCT Number)

BP28085

Details and patient eligibility

About

This multi-center, open-label study will evaluate the safety, pharmacokinetics, pharmacodynamics and efficacy of RO5429083 alone and in combination with cytarabine in patients with acute myelogenous leukemia. In Part A, patients will receive multiple escalating doses of RO5429083 intravenously. In Part B, patients will receive RO5429083 plus up to 4 cycles of cytarabine (1000 mg/m2 iv daily for 5 consecutive days). Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.

Enrollment

44 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Adult patients, >/= 18 years of age
Histologically or cytologically confirmed, acute myelogenous leukemia (all subtypes except acute promyelotic leukemia) according to WHO criteria
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, except alopecia
Adequate hepatic and renal function
Patient must be willing to submit blood and bone marrow samples for PK and PD analyses and exploratory biomarkers

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
History of allergic reactions attributed to components of cytarabine and/or the formulated product
Current evidence of CNS leukemia
Increased QTc interval (QTc > 470 ms), baseline resting bradycardia < 45 beats per minute, or baseline resting tachycardia < 100 beats per minute
Family history of long QT syndrome or other risk factors for torsades de pointes, and/or the use of concomitant medications that prolong QT/QTc interval
Uncontrollable intercurrent illness
Pregnant or breast-feeding women
HIV-positive patients receiving anti-retroviral therapy
- Patients who refuse to potentially receive blood products and/or have a hypersensitivity to blood products