18 and older, any sex, with Myelodysplastic Syndrome. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Dosage Determination for IV-infusion of Vosaroxin in Int-2 or High-risk MdsPrimary· 1 year
Maximum tolerated dose of vosaroxin for short IV infusion in INT-2 or high-risk MDS
Group
Value
95% CI
All Study Participants
200
Number of Subjects Who Experience a ResponseSecondary· 15 months
Evaluate the clinical activity of vosaroxin in MDS subjects by observing number of patients who achieve complete remission.
Group
Value
95% CI
Vosaroxin: Dose Level 1: Vosaroxin 50 mg/m^2 IV on Days 1 & 4
0
Dose Level 2: Vosaroxin 72 mg/m^2 IV on Days 1 and 4 of 28 Day
0
Dose Level 3: Vosaroxin 50 mg/m^2 IV on Days 1, 4, 8 and 11 of
0
Number of Transfusions Required During Treatment With VosaroxinSecondary· 15 months
Characterize the blood product transfusion requirements in this patient population when treated with vosaroxin
Group
Value
95% CI
Vosaroxin: Dose Level 1: Vosaroxin 50 mg^m2 IV on Days 1 and 4
19.8
2 – 44
Dose Level 2: Vosaroxin 72 mg^m2 IV on Days 1 and 4 of 28 Day
22.5
12 – 33
Dose Level 3: Vosaroxin 50 mg^m2 IV on Days 1, 4, 8 and 11 of
22
17 – 27
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events were collected over a period of 15 months..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Dose Level 1: Vosaroxin 50 mg/m2 IV on Days 1 and 4 of 28 Day
Serious: 3/4 (75%)
Deaths: 1/4
Dose Level 2: Vosaroxin 72 mg/m2 IV on Days 1 and 4 of 28 Day
Serious: 1/4 (25%)
Deaths: 1/4
Dose Level 3: Vosaroxin 50 mg/m2 IV on Days 1, 4, 8 and 11 of
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.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
NCT03338348 — Study of Vosaroxin With Azacitidine in Patients With Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndrome
· Phase 2
· completed
NCT01893320 — Study of Vosaroxin and Decitabine in Older Patients With Acute Myeloid Leukemia and High-risk Myelodysplastic Syndrome
· Phase 1, PHASE2
· completed
Other recruiting trials for Myelodysplastic Syndrome
Currently open trials in the same condition.
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NCT07422480 — A Study to Compare Elritercept With Epoetin Alfa to Treat Anemia in Adults With Very Low, Low, or Intermediate Risk Myel
· Phase 3
· recruiting
NCT07107126 — Safety and Proof-of-Concept Study of RPT1G in Adults With Acute Myeloid Leukemia and High-Risk Myelodysplastic Syndromes
· Phase 1
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NCT06781099 — Feasibility Trial of Extracorporeal Iron Purification in Patients With Myelodysplastic Syndrome or Myelofibrosis
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NCT07285044 — The Cancer Connected Access and Remote Expertise Beyond Walls Program to Provide In-Home Cancer Treatment and Improve Tr
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· recruiting
Other Weill Medical College of Cornell University trials
Trials by the same sponsor.
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· not yet recruiting
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· not yet recruiting
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· not yet recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Weill Medical College of Cornell University
Last refreshed: 19 February 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01980056.