Safety and Tolerability Study of Voreloxin and Cytarabine Combination in Acute Myeloid Leukemia in Humans

KEY INCLUSION CRITERIA

1. Relapsed or refractory AML subtypes defined by WHO, except acute promyelocytic leukemia. Relapsed/refractory disease may be de novo AML or secondary AML
2. Treated with one to threee induction/reinduction AML regimens, prior induction or consolidation therapy with cytarabine allowed
3. At least 10% blasts by BM biopsy or aspirate
4. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
5. Clinical laboratory values of a) Serum creatinine ≤1.5 mg/dL and calculated or measured creatinine clearance (CRcl) of ≥50 mL/min, b) Total bilirubin ≤1.5 X upper limit of normal and c) Aspartate aminotransferase (AST) or alkaline phosphatase ≤2.5 X ULN.

KEY EXCLUSION CRITERIA

Patients with:

1. Allogenic bone marrow transplant/stem cell transplant
2. Persistent, clinically significant, chronic toxicities from prior AML therapy that would contraindicate the patient's participation in the clinical study due to safety concerns or compliance with study procedures
3. Acute promyelocytic leukemia
4. Disseminated intravascular coagulation
5. Active infections, unless adequately treated with antibiotic, antiviral, or antifungal agents within in 7 days before Induction Day 1
6. Active central nervous system involvement by AML
7. Other active malignancies or other malignancies within the last 12 months except nonmelanoma skin cancer or cervical intraepithelial neoplasia
8. A requirement for hemodialysis or peritoneal dialysis
9. A history of myocardial infarction within the 3 months before treatment with vosaroxin
10. A history of cerebrovascular accident/transient ischemic attack within the 3 months before treatment with vosaroxin
11. A thromboembolic event (deep vein thrombosis or pulmonary embolus) within 28 days before treatment with vosaroxin
12. Investigational products taken within 28 days before treatment with vosaroxin, and non-investigational cancer therapies or radiation therapy within 14 days before treatment with vosaroxin, with the exception of hydroxyurea.
13. A known intolerance to cytarabine or known allergy to D-sorbitol or methanesulfonic acid (excipients used in vosaroxin)
14. Prior exposure to vosaroxin
15. Any other medical, psychological, or social condition that contraindicates their participation in the clinical study due to safety concerns or compliance with study procedures in the opinion of the Investigator,or Sunesis Medical Monitor

    In addition:
16. Women who are pregnant or breastfeeding
17. Women who are of childbearing potential or male patients who had partners of childbearing potential who were unwilling to use an approved, effective means of contraception according to the study site's standards