Overview

This trial is active, not recruiting.

Conditions leukemia, acute myeloid leukemia, acute nonlymphocytic leukemia
Treatments vosaroxin and cytarabine, placebo and cytarabine
Phase phase 3
Sponsor Sunesis Pharmaceuticals
Start date October 2010
End date June 2014
Trial size 675 participants
Trial identifier NCT01191801, 2010-021961-61, VOS-AML-301

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Vosaroxin will be administered in a blinded manner as a short IV infusion within 10 minutes on days 1 and 4 of each cycle (up to 4 cycles) and cytarabine will be administered in an unblinded manner as a 2-hour infusion on days 1-5 of each cycle.
vosaroxin and cytarabine
Vosaroxin days 1 and 4: 90 mg/m2 for induction 1; 70 mg/m2 for all other cycles Cytarabine 1 g/m2 daily on days 1-5 (IDAC)
(Experimental)
Placebo will be administered in a blinded manner as a short IV infusion within 10 minutes on days 1 and 4 of each cycle (up to 4 cycles) and cytarabine will be administered in an unblinded manner as a 2-hour infusion on days 1-5 of each cycle.
placebo and cytarabine
Placebo days 1 and 4: volume matched to vosaroxin Cytarabine 1 g/m2 daily on days 1-5 (IDAC)

Primary Outcomes

Measure
Overall survival
time frame: Up to 5 years or duration of study

Secondary Outcomes

Measure
CR rate
time frame: Up to 5 years or duration of study

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Provide signed, written informed consent - Are at least 18 years of age - Have a diagnosis of AML according to World Health Organization (WHO) classification - First relapsed or refractory AML (refractory to initial induction therapy) - Have an ECOG score of 0-2 - Have adequate liver and renal function as indicated by certain laboratory values - Are nonfertile or agree to use an adequate method of contraception until 30 days after the last treatment Exclusion Criteria: - Have received more than 2 cycles of induction therapy for AML - Refractory to or relapsed within the previous 3 months after therapy with an IDAC- or HIDAC-containing regimen - Have received a hematopoietic stem cell transplant (HSCT) within the previous 3 months - Have received active immunosuppressive therapy for graft-versus-host disease (GVHD) within 2 weeks before study start - Have any other severe concurrent disease, or have a history of serious disease involving the heart, kidney, liver, or other organ system - Have evidence of central nervous system involvement of active AML - Have other active malignancies (including other hematologic malignancies) or been diagnosed with other malignancies within the last 12 months, except nonmelanoma skin cancer or cervical intraepithelial neoplasia - Have an active, uncontrolled infection - Are receiving any other investigational therapy - Have received previous treatment with vosaroxin - Are pregnant or lactating - Have any other medical, psychological, or social condition that may interfere with consent, study participation, or follow-up

Additional Information

Official title 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)
Description 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
Trial information was received from ClinicalTrials.gov and was last updated in October 2013.
Information provided to ClinicalTrials.gov by Sunesis Pharmaceuticals.