A Phase 3, Randomized, Controlled, Double-Blind, Multinational Clinical Study of the Efficacy and Safety of Vosaroxin and Cytarabine Versus Placebo and Cytarabine in Patients With First Relapsed or Refractory Acute Myeloid Leukemia (VALOR)
Other objectives of this study include comparing the following between treatment groups:
Complete remission (CR) rate
Safety and tolerability
Combined CR rate, defined as CR+CRp+CRi
Overall remission (OR) rate
Event-free survival (EFS)
Durability of remission (CR and combined CR) assessed by leukemia-free survival (LFS)
Percentage of patients who have post-treatment transplantation
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Overall survival
Up to 5 years or duration of study
No
Sunesis Medical Monitor, MD
Study Director
Sunesis Pharmaceuticals
United States: Food and Drug Administration
VOS-AML-301
NCT01191801
October 2010
Name | Location |
---|---|
University of Michigan | Ann Arbor, Michigan 48109-0624 |
Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
University of Iowa Hospitals and Clinics | Iowa City, Iowa 52242 |
Medical University of South Carolina | Charleston, South Carolina 29425-0721 |
Ochsner Clinic Foundation | New Orleans, Louisiana 70121 |
Dartmouth-Hitchcock Medical Center | Lebanon, New Hampshire 03756 |
Indiana University Melvin and Bren Simon Cancer Center | Indianapolis, Indiana 46202-5289 |
Moores UCSD Cancer Center | La Jolla, California 92093-0658 |
Duke University Medical Center | Durham, North Carolina 27710 |
University of California San Francisco | San Francisco, California 941104206 |
Family Cancer Center | Collierville, Tennessee 38017 |
Henry Ford Health System | Detroit, Michigan 48202 |
Holy Cross Hospital | Fort Lauderdale, Florida 33308 |
H. Lee Moffitt Cancer Center & Research Institute | Tampa, Florida 33612 |
University of Chicago | Chicago, Illinois 60637 |
John Theurer Cancer Center at Hackensack University Medical Center | Hackensack, New Jersey 07601 |
Sharp Clinical Oncology Research | San Diego, California 92123 |
Wake Forest University Health Sciences | Winston-Salem, North Carolina 27157 |
Baptist Cancer Institute | Jacksonville, Florida 32207 |
Tennessee Oncology, PLLC | Clarksville, Tennessee 37043 |
Cancer Care Centers of South Texas | San Antonio, Texas 78229 |
Stony Brook University Medical Center | Stony Brook, New York 11794 |
UT Southwestern Medical Center at Dallas | Dallas, Texas 75390 |
Weill Cornell Medical College | New York, New York 10021 |
Mecklenburg Medical Group | Charlotte, North Carolina |
North Shore Long Island Jewish Health System | Lake Success, New York 11042 |
St. Francis Medical Group Oncology and Hematology Specialists | Indianapolis, Indiana 46237 |
Georgia Health Sciences University | Augusta, Georgia 30912 |
Henry-Joyce Cancer Clinic | Nashville, Tennessee 37232-5536 |
UCLA Division of Hematology/Oncology | Los Angeles, California 90095 |
HCA HealthONE - Rocky Mountain Blood and Marrow Transplant Program | Denver, Colorado 80218 |
George Washington University-Medical Faculty Associates | Washington, District of Columbia 20037 |
Rush University Medical Center, Division of Hematology/Oncology | Chicago, Illinois 60612 |
Ellis Fischel Cancer Center, University of Missouri Health Care | Columbia, Missouri 65203 |
New York Medical College, Division of Oncology/Hematology | Valhalla, New York 10595 |
University Hospitals fo Cleveland | Cleveland, Ohio 44106 |
The University of Texas, M.D. Anderson Cancer Center, Department of Leukemia | Houston, Texas 77030 |
Department of Medicine Section of Hematology/Oncology, West Virginia University Hospitals, Mary Babb Randolph Cancer Center, West Virginia University | Morgantown, West Virginia 26506 |