MedTrace Logo

Vosaroxin for Intermediate 2 or High-risk MDS After Failure With Hypomethylating Agent-based Therapy

NCT01980056 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2019-02-19

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

DRUG

Vosaroxin

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

Sponsors & Collaborators

  • Sunesis Pharmaceuticals

    collaborator INDUSTRY

  • Weill Medical College of Cornell University

    lead OTHER

Principal Investigators

  • Gail Roboz, MD · Weill Medical College of Cornell University

Study Design

Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-25
Primary Completion
2015-01-19
Completion
2015-01-19
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01980056 on ClinicalTrials.gov