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) - VALOR

Phase 1

• Conditions: First Relapsed or Refractory Acute Myeloid Leukemia; MedDRA version: 9.1Level: LLTClassification code 10060558; MedDRA version: 9.1Level: LLTClassification code 10054296

• Registration Number: EUCTR2010-021961-61-IT
• Lead Sponsor: SUNESIS PHARMACEUTICALS, INC.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02-21
• Last Update Posted: 19 February 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 750

Inclusion Criteria

1. Able to understand and provide written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization, as appropriate 2. At least 18 years of age 3. Diagnosis of acute myeloid leukemia (AML) by World Health Organization (WHO) classification 4. Relapsed or refractory AML with at least 5% blasts by bone marrow biopsy or aspirate, or at least 1% blasts in peripheral blood, and meeting the criteria for relapsed or refractory AML detailed in section 4.1 of the protocol 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 6. Local clinical laboratory values as follows: - Serum creatinine = 2.0 mg/dL - Total bilirubin = 1.5 x the upper limit of normal (ULN), unless due to Gilbert’s syndrome - Aspartate aminotransferase (AST) = 2.5 x ULN - Alanine aminotransferase (ALT) = 2.5 x ULN 7. Left ventricular ejection fraction (LVEF) at least 40% by multiple gated acquisition (MUGA) scan or echocardiogram (ECHO) 8. Clinically significant nonhematologic toxicity after prior chemotherapy has recovered to grade 1 per Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 or newer 9. Females must be surgically or biologically sterile or postmenopausal (amenorrheic for at least 12 months) or if of childbearing potential, must have a negative urine or serum pregnancy test within 14 days before the first vosaroxin or placebo administration, and must agree to use an adequate method of contraception during the study until 30 days after the last treatment. Males must be surgically or biologically sterile or agree to use an adequate method of contraception during the study until 30 days after the last treatment
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Acute promyelocytic leukemia (APL) 2. More than 2 cycles of induction therapy for AML 3. Refractory to or relapsed = 90 days after any induction or consolidation therapy with an intermediate or high dose cytarabine (IDAC or HIDAC) regimen containing a cumulative dose of = 5 g/m2 cytarabine 4. Transplantation for AML (either allogeneic or autologous) = 90 days of randomization or on active immunosuppressive therapy for graft versus host disease (GVHD) within 2 weeks before the first dose of vosaroxin or placebo 5. Central nervous system (CNS) involvement of active AML 6. Other active malignancies (including other hematologic malignancies) or other malignancies within the last 12 months, except nonmelanoma skin cancer or cervical intraepithelial neoplasia 7. Uncontrolled active infection of any type - Infections under control with antibiotic treatment are acceptable - Chronic hepatitis is acceptable 8. Uncontrolled invasive fungal infection (positive blood or tissue culture) 9. History of myocardial infarction (MI), unstable angina, cerebrovascular accident, or transient ischemic attack (CVA/TIA) within 3 months before the first dose of vosaroxin or placebo 10. Prior or current therapy: - Hydroxyurea or other oral medications to reduce blast count within 24 hours before the first dose of vosaroxin or placebo - Treatment with an investigational product within 14 days before the first dose of vosaroxin or placebo, or not recovered from all acute effects of previously administered investigational products 11. Hemodialysis or peritoneal dialysis required 12. Prior exposure to vosaroxin 13. Pregnant or breastfeeding 14. Any other medical, psychological, or social condition that may interfere with study participation or compliance, or compromise patient safety in the opinion of the investigator or medical monitor

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified