NCT01635296

A Study of RO5045337 in Combination With Cytarabine in Patients With Acute Myelogenous Leukemia

A Multicenter, Open Label, Phase 1B Study of Escalating Doses of RO5045337 Administered Orally, With Cytarabine Administered A) Subcutaneously, or B) Intravenously, in Patients With Acute Myelogenous Leukemia (AML)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This multi-center, open-label, Phase 1b study will evaluate the safety, pharmacokinetics and efficacy of RO5045337 in combination with cytarabine in patients with acute myelogenous leukemia. In Arm A, cohorts of previously untreated patients deemed unsuitable for standard induction therapy will receive escalating oral doses of RO5045377 and cytarabine 20 mg/m2 subcutaneously daily for Days 1 to 10 of each 28-day cycle. In Arm B, cohorts of patients who have relapsed or are refractory after at least one cytarabine/anthracycline containing regimen will receive escalating oral doses of RO5045377 on Days 1 to 5 and cytarabine 1 gm/m2 intravenously on Days 1 to 6 of each 28-day cycle. Patients will receive up to 4 cycles of therapy, patients in Arm A who achieve hematologic response may continue additional cycles until disease progression.

Conditions

• Myelogenous Leukemia, Acute

Interventions

Type	Name	Description
DRUG	RO5045377	Multiple escalating oral doses, Days 1 to 10 of each 28-day cycle
DRUG	RO5045377	Multiple escalating oral doses, Days 1 to 5 of each 28-day cycle
DRUG	cytarabine	20 mg/m2 sc, Days 1 to 10 of each 28-day cycle
DRUG	cytarabine	1 gm/m2 iv, Days 1 to 6 of each 28-day cycle

Timeline

• Start date: 2012-07-01
• Primary completion: 2013-10-01
• Completion: 2013-10-01
• First posted: 2012-07-09
• Last updated: 2016-11-02

Locations

9 sites across 5 countries: United States, Canada, France, Italy, United Kingdom