drugset / Trial / NCT01641250
A Study of RO5429083 Alone or in Combination With Cytarabine in Patients With Acute Myelogenous Leukemia
Non-randomizedParallel-groupOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2012-08
- Primary completion
- 2015-02
- Completion
- 2015-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cytarabine | Small molecule | 1000 mg/m2 | Intravenous |
| Subject | RO5429083 | Unknown | — | — |