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

• Status: Completed
• Trial end date: 2009-11-23
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sunesis Pharmaceuticals

Criteria

Key Inclusion Criteria:

1. At least 60 years of age and diagnosis of previously untreated AML (either de novo or from an antecedent hematologic disorder or therapy related AML)

2. At least 20% blasts by BM biopsy or aspirate

3. ECOG performance status of 0,1,or 2

4. Adequate cardiac, renal and liver function

Key Exclusion Criteria:

1. Uncontrolled DIC

2. Active central nervous system involvement by AML

3. Requiring hemodialysis or peritoneal dialysis

4. Some prior history of heart attack or stroke (depending on how long ago the event occurred)