Clinical trial NCT00541866 (phase 1/phase 2, status: completed)
Conditions: acute myeloid leukemia
ICD codes: C92.A1, C92.A2, C92.61, C92.62, C92.A0, C92.60
Drugs: voreloxin injection and cytarabine
SMILES: NC1=NC(=O)N(C=C1)[C@@H]1O[C@H](CO)[C@@H](O)[C@@H]1O
Eligibility criteria:

        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