drugset / Trial / NCT01980056
Vosaroxin for Intermediate 2 or High-risk MDS After Failure With Hypomethylating Agent-based Therapy
Phase 1/2
Completed
10 enrolled
Weill Medical College of Cornell University
Sunesis Pharmaceuticals · collab
SequentialOpen-labelTreatment
Summary
Study WCMC IST/VOS/MDS evaluates the safety and tolerability of escalating doses of vosaroxin in adult patients with pathologically confirmed Myelodysplastic Syndrome, or MDS, (\< 20% blasts in bone marrow, peripheral blood, or both) by World Health Organization (WHO) classification with an intermediate 2 (INT-2) or high-risk score (ie, ≥ 1.5) as assessed by the International Scoring System (IPSS) after failure of hypomethylating agent-based therapy. Based on 3 completed studies and xenograft models, Vosaroxin is hypothesized to be safe and will effective in this patient population.
Timeline
- Start
- 2013-10-25
- Primary completion
- 2015-01-19
- Completion
- 2015-01-19
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Vosaroxin | Small molecule | 50 mg/m2 | Intravenous |
| Subject | Vosaroxin | Small molecule | 72 mg/m2 | Intravenous |