Phase 2
Completed N=110
Safety and Tolerability Study of Voreloxin and Cytarabine Combination in Acute Myeloid Leukemia in Humans
Source: ClinicalTrials.gov NCT00541866 ↗Enrolled (actual)
110
Serious AEs
46.3%
Results posted
Jan 2018
Primary outcomePrimary: Incidence of Dose-Limiting Toxicity (DLT) to Determine Maximum Tolerated Dose in Schedule A and Schedule B of Dose Escalation Phase (Group 1 and Group 2) — 0; 0; 0; 0 Participants
Summary
This study will evaluate the safety and tolerability of voreloxin (vosaroxin) injection in combination with cytarabine in patients with relapsed or refractory acute myeloid leukemia.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Dose-Limiting Toxicity (DLT) to Determine Maximum Tolerated Dose in Schedule A and Schedule B of Dose Escalation Phase (Group 1 and Group 2) |
0; 0; 0; 0; 1; 1 | — |
| SECONDARY Remission Rates (CR+CRp) |
9; 4; 7; 3; 4; 27 | — |
| SECONDARY Leukemia-free Survival (LFS) |
12.0; 4.7; 7.4; 25.2; NA | — |
| SECONDARY Overall Survival |
4.1; 8.0; 4.1; 7.1; 5.9 | — |
| SECONDARY All Cause Mortality |
8; 0; 1; 0; 1; 10 | — |
Eligibility Criteria
KEY INCLUSION CRITERIA
- Relapsed or refractory AML subtypes defined by WHO, except acute promyelocytic leukemia. Relapsed/refractory disease may be de novo AML or secondary AML
- Treated with one to threee induction/reinduction AML regimens, prior induction or consolidation therapy with cytarabine allowed
- At least 10% blasts by BM biopsy or aspirate
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
- 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:
- Allogenic bone marrow transplant/stem cell transplant
- 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
- Acute promyelocytic leukemia
- Disseminated intravascular coagulation
- Active infections, unless adequately treated with antibiotic, antiviral, or antifungal agents within in 7 days before Induction Day 1
- Active central nervous system involvement by AML
- Other active malignancies or other malignancies within the last 12 months except nonmelanoma skin cancer or cervical intraepithelial neoplasia
- A requirement for hemodialysis or peritoneal dialysis
- A history of myocardial infarction within the 3 months before treatment with vosaroxin
- A history of cerebrovascular accident/transient ischemic attack within the 3 months before treatment with vosaroxin
- A thromboembolic event (deep vein thrombosis or pulmonary embolus) within 28 days before treatment with vosaroxin
- 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.
- A known intolerance to cytarabine or known allergy to D-sorbitol or methanesulfonic acid (excipients used in vosaroxin)
- Prior exposure to vosaroxin
- 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:
- Women who are pregnant or breastfeeding
- 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
Data sourced from ClinicalTrials.gov (NCT00541866). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.