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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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21 January 2013 |
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Main ID: |
NCT01191801 |
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Date of registration:
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27/08/2010 |
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Primary sponsor: |
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Public title:
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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 |
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Scientific title:
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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) |
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Date of first enrolment:
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October 2010 |
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Target sample size:
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500 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01191801 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Countries of recruitment
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Australia
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Austria
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Belgium
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Canada
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Czech Republic
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France
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Germany
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Hungary
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Italy
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New Zealand
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Poland
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Spain
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United Kingdom
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United States
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Contacts
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Name:
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Sunesis Medical Monitor |
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Address:
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Telephone:
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650-266-3555 |
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Email:
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VALOR@sunesis.com |
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Affiliation:
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Name:
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Sunesis Medical Monitor, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Sunesis Pharmaceuticals |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Acute Myeloid Leukemia
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Acute Nonlymphocytic Leukemia
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Leukemia
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Intervention(s)
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Drug: placebo and cytarabine
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Drug: vosaroxin and cytarabine
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Primary Outcome(s)
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Overall survival
[Time Frame: Up to 5 years or duration of study]
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Secondary Outcome(s)
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CR rate
[Time Frame: Up to 5 years or duration of study]
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Secondary ID(s)
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2010-021961-61
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VOS-AML-301
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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