Status:
COMPLETED
Study of Voreloxin (Vosaroxin) in Older Patients With Untreated Acute Myeloid Leukemia
Lead Sponsor:
Sunesis Pharmaceuticals
Conditions:
Leukemia
Acute Disease
Eligibility:
All Genders
60+ years
Phase:
PHASE2
Brief 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 (...
Eligibility Criteria
Inclusion
- Key
- 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)
- At least 20% blasts by BM biopsy or aspirate
- ECOG performance status of 0,1,or 2
- Adequate cardiac, renal and liver function
- Key
Exclusion
- Uncontrolled DIC
- Active central nervous system involvement by AML
- Requiring hemodialysis or peritoneal dialysis
- Some prior history of heart attack or stroke (depending on how long ago the event occurred)
Key Trial Info
Start Date :
May 15 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 23 2009
Estimated Enrollment :
113 Patients enrolled
Trial Details
Trial ID
NCT00607997
Start Date
May 15 2008
End Date
November 23 2009
Last Update
June 28 2017
Active Locations (20)
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1
Mayo Clinic Hospital
Phoenix, Arizona, United States, 85054
2
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States, 85259
3
Scripps Cancer Center
La Jolla, California, United States, 92037
4
Rocky Mountain Blood and Marrow Transplant Program
Denver, Colorado, United States, 80218