NCT01641250

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

Open Label, Multicenter, Dose Escalation Phase 1a/b Study of RO5429083, Administered as Intravenous Infusion Alone or in Combination With Cytarabine in Patients With Acute Myelogenous Leukemia (AML).

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Myelogenous Leukemia, Acute

Interventions

Type	Name	Description
DRUG	RO5429083	Multiple escalating doses
DRUG	cytarabine	1000 mg/m2 iv daily for 5 consecutive days, up to 4 cycles

Timeline

• Start date: 2012-08-01
• Primary completion: 2015-02-01
• Completion: 2015-02-01
• First posted: 2012-07-16
• Last updated: 2016-11-02

Locations

8 sites across 3 countries: France, Germany, Italy