MedTrace Logo

Study of Vosaroxin or Placebo in Combination With Cytarabine in Patients With First Relapsed or Refractory AML

NCT01191801 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 711

Last updated 2018-08-22

Study results available
· View outcomes & findings →

Summary

This study compared treatment groups of patients treated with vosaroxin and cytarabine versus patients treated with placebo and cytarabine.

Conditions

Interventions

DRUG

vosaroxin + 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)

DRUG

placebo + cytarabine

Placebo days 1 and 4: volume matched to vosaroxin Cytarabine 1 g/m2 daily on days 1-5 (IDAC)

Sponsors & Collaborators

  • Sunesis Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Linda Neuman, MD · Sunesis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-12-17
Primary Completion
2014-09-26
Completion
2017-03-01

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Canada
  • Czechia
  • France
  • Germany
  • Hungary
  • Italy
  • New Zealand
  • Poland
  • South Korea
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01191801 on ClinicalTrials.gov