At a glance
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A Phase 1/2, Open-label, Dose Escalation Clinical Study of the Safety and Clinical Activity of Vosaroxin in Patients With Intermediate 2 or High-risk Myelodysplastic Syndrome (MDS) After Failure of Hypomethylating Agent-based Therapy
In Brief
A Phase 2 clinical trial evaluating Vosaroxin for Myelodysplastic Syndrome. Completed, enrolled 10 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Dose level 1: Vosaroxin 50 mg\^m2 IV on Days 1 and 4 of 28 day cycle Dose level 2: Vosaroxin 72 mg\^m2 IV on Days 1 and 4 of 28 day cycle Dose level 3: Vosaroxin 50 mg\^m2 IV on Days 1, 4, 8 and 11 of 28 day cycle