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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Sunesis Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01191801
First received: August 27, 2010
Last updated: October 10, 2013
Last verified: October 2013

August 27, 2010
October 10, 2013
October 2010
June 2014   (final data collection date for primary outcome measure)
Overall survival [ Time Frame: Up to 5 years or duration of study ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01191801 on ClinicalTrials.gov Archive Site
CR rate [ Time Frame: Up to 5 years or duration of study ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Study of Vosaroxin or Placebo in Combination With Cytarabine in Patients With First Relapsed or Refractory Acute Myeloid Leukemia (AML)
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)

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.

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

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Leukemia
  • Acute Myeloid Leukemia
  • Acute Nonlymphocytic Leukemia
  • 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)

  • Drug: placebo and cytarabine

    Placebo days 1 and 4: volume matched to vosaroxin

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

  • 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.
    Intervention: Drug: vosaroxin and cytarabine
  • 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.
    Intervention: Drug: placebo and cytarabine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
675
Not Provided
June 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Austria,   Belgium,   Canada,   Czech Republic,   France,   Germany,   Hungary,   Italy,   Korea, Republic of,   New Zealand,   Poland,   Spain,   United Kingdom
 
NCT01191801
VOS-AML-301, 2010-021961-61
Yes
Sunesis Pharmaceuticals
Sunesis Pharmaceuticals
Not Provided
Study Director: Sunesis Medical Monitor, MD Sunesis Pharmaceuticals
Sunesis Pharmaceuticals
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP