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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)

This study is currently recruiting participants.
Verified February 2013 by Sunesis Pharmaceuticals
Sponsor:
Information provided by (Responsible Party):
Sunesis Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01191801
First received: August 27, 2010
Last updated: February 21, 2013
Last verified: February 2013
History of Changes
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

Drug Information available for: Cytarabine
U.S. FDA Resources

Further study details as provided by Sunesis Pharmaceuticals:

Primary Outcome Measures:
  • Overall survival [ Time Frame: Up to 5 years or duration of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • CR rate [ Time Frame: Up to 5 years or duration of study ] [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: October 2010
Estimated Primary Completion Date: March 2013 (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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01191801

Contacts
Contact: Sunesis Medical Monitor 650-266-3555 VALOR@sunesis.com

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

No publications provided

Responsible Party: Sunesis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01191801     History of Changes
Other Study ID Numbers: VOS-AML-301, 2010-021961-61
Study First Received: August 27, 2010
Last Updated: February 21, 2013
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Australia: Department of Health and Ageing Therapeutic Goods Administration
New Zealand: Medsafe
Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Austria: Agency for Health and Food Safety
Czech Republic: State Institute for Drug Control
Hungary: National Institute of Pharmacy
Italy: The Italian Medicines Agency
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Spain: Spanish Agency of Medicines

Keywords provided by Sunesis Pharmaceuticals:
Leukemia
Acute Myeloid Leukemia
Hematologic
Hematologic diseases
Blood
Cancer
Malignancy
Vosaroxin
 Cytarabine
First Relapsed AML
Refractory AML
VALOR
Sunesis
Voreloxin
SNS-595

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Neoplasms by Histologic Type
Neoplasms
Cytarabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
 Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 13, 2013