Spots Global Cancer Trial Database for Study of Voreloxin (Vosaroxin) in Older Patients With Untreated Acute Myeloid Leukemia
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Trial Identification
Brief Title: Study of Voreloxin (Vosaroxin) in Older Patients With Untreated Acute Myeloid Leukemia
Official Title: 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
Study ID: NCT00607997
Interventions
Study Description
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 (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
Eligibility
Minimum Age: 60 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Mayo Clinic Hospital, Phoenix, Arizona, United States
Mayo Clinic Scottsdale, Scottsdale, Arizona, United States
Scripps Cancer Center, La Jolla, California, United States
Rocky Mountain Blood and Marrow Transplant Program, Denver, Colorado, United States
Rush University Medical Center, Chicago, Illinois, United States
The University of Chicago, Chicago, Illinois, United States
Indiana University Cancer Center, Indianapolis, Indiana, United States
St. Francis Hospital & Health Systems at Beech Grove Campus, Indianapolis, Indiana, United States
Cancer Center of Kansas, Wichita, Kansas, United States
Cancer Center of Kansas, Wichita, Kansas, United States
LSU Health Sciences Center at Shreveport, Shreveport, Louisiana, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
University of Mississippi Medical Center, Jackson, Mississippi, United States
University of MO Ellis Fischel Cancer Center, Columbia, Missouri, United States
University of Pittsburgh Cancer Institute, Pittsburgh, Pennsylvania, United States
Hollings Cancer Center at Medical University of South Carolina, Charleston, South Carolina, United States
Vanderbilt-Ingram Cancer Center, Nashville, Tennessee, United States
MD Anderson Cancer Center, Houston, Texas, United States
Huntsman Cancer Institute at the University of Utah, Salt Lake City, Utah, United States
Contact Details
Name: Adam Craig, MD
Affiliation: Sunesis Pharmaceuticals
Role: STUDY_DIRECTOR
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