NCT00607997

Study of Voreloxin (Vosaroxin) in Older Patients With Untreated Acute Myeloid Leukemia

A Phase 2, Open-Label, Multicenter Clinical Study of the Safety and Efficacy of Voreloxin (Vosaroxin) Injection in Patients Equal to or Greater Than 60 Years of Age With Previously Untreated Acute Myeloid Leukemia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 113 (actual)
• Sponsor: Sunesis Pharmaceuticals · Industry
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the overall remission rate of treatment with vosaroxin (formerly voreloxin) Injection in patients at least 60 years of age with previously untreated AML

Detailed description

Other objectives of this study include: 1. Assess the safety of treatment with vosaroxin, including the 30 and 60 day all-cause mortality 2. Assess leukemia free survival (LFS), event-free survival (EFS), overall survival (OS), and duration of remission (DR). 3. Characterize the pharmacokinetic (PK) profile of vosaroxin in this patient population. 4. Evaluate potential stratification biomarkers by evaluating DNA-damage and apoptotic pathways in bone marrow samples before and after treatment with vosaroxin

Conditions

• Leukemia
• Acute Disease
• Acute Myeloid Leukemia
• Nonlymphocytic Leukemia
• Myelodysplastic Syndromes

Interventions

Type	Name	Description
DRUG	vosaroxin	Vosaroxin was administered by slow intravenous (IV) infusion or via syringe pump within 10 minutes.Patients could have completed up to 4 treatment cycles consisting of 1 or 2 induction treatment cycles and up to 2 consolidation treatment cycles. For Schedule A, an induction cycle was a minimum of 21 days during which patients received vosaroxin on Days 1, 8, and 15, followed by weekly observations until hematologic recovery for patients with aplastic marrow after the postinduction bone marrow assessment. For Schedules B and C, an induction cycle was a minimum of 15 days, during which patients received vosaroxin on Days 1 and 8 (Schedule B), or Days 1 and 4 (Schedule C), followed by the same weekly observations until hematologic recovery as for Schedule A.

Timeline

• Start date: 2008-05-15
• Primary completion: 2009-11-01
• Completion: 2009-11-23
• First posted: 2008-02-06
• Last updated: 2017-06-28
• Results posted: 2017-06-28

Locations

20 sites across 1 country: United States