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)

Status
Active
Cancer Type
Leukemia
Trial Phase
Phase III
Eligibility
18 and over, Male and Female
Study Type
Treatment
NCD ID
NCT01191801
Protocol IDs
VOS-AML-301 (primary)
2010-021961-61
Study Sponsor
Sunesis Pharmaceuticals, Incorporated

Summary

This study will compare the overall survival (OS) between treatment groups of patients treated with vosaroxin and cytarabine versus patients treated with placebo and cytarabine.

Objectives

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

Treatment Sites in Georgia


Georgia Cancer Center at Augusta University
1411 Laney Walker Boulevard
Augusta, GA 30912
www.augusta.edu/cancer/

Study Coordinator:
Pam Bourbo
706-721-7230