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Study of Vosaroxin or Placebo in Combination With Cytarabine in Patients With First Relapsed or Refractory Acute Myeloid Leukemia (AML) (VALOR)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2013 by Sunesis Pharmaceuticals.
Recruitment status was:  Active, not recruiting
Information provided by (Responsible Party):
Sunesis Pharmaceuticals Identifier:
First received: August 27, 2010
Last updated: October 10, 2013
Last verified: October 2013
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.

Condition Intervention Phase
Acute Myeloid Leukemia
Acute Nonlymphocytic Leukemia
Drug: vosaroxin and cytarabine
Drug: placebo and cytarabine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)

Resource links provided by NLM:

Further study details as provided by Sunesis Pharmaceuticals:

Primary Outcome Measures:
  • Overall survival [ Time Frame: Up to 5 years or duration of study ]

Secondary Outcome Measures:
  • CR rate [ Time Frame: Up to 5 years or duration of study ]

Estimated Enrollment: 675
Study Start Date: October 2010
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A: vosaroxin + cytarabine
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.
Drug: 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: Group B: placebo + cytarabine
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.
Drug: placebo and cytarabine

Placebo days 1 and 4: volume matched to vosaroxin

Cytarabine 1 g/m2 daily on days 1-5 (IDAC)

Detailed 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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01191801

  Show 124 Study Locations
Sponsors and Collaborators
Sunesis Pharmaceuticals
Study Director: Sunesis Medical Monitor, MD Sunesis Pharmaceuticals
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Sunesis Pharmaceuticals Identifier: NCT01191801     History of Changes
Other Study ID Numbers: VOS-AML-301
2010-021961-61 ( EudraCT Number )
Study First Received: August 27, 2010
Last Updated: October 10, 2013

Keywords provided by Sunesis Pharmaceuticals:
Acute Myeloid Leukemia
Hematologic diseases
First Relapsed AML
Refractory AML

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs processed this record on April 28, 2017