Phase 1/2, Open-label, Dose Escalation Study of Vosaroxin in Patients with Intermediate 2 or High-risk Myelodysplastic Syndrome (MDS) after Failure of Hypomethylating Agent-based Therapy

Study Status

Open to Enrollment

Study Description

This clinical trial is for men and women with myelodysplastic syndrome (MDS) that is relapsed or refractory after treatment with a hypomethylating agent-based therapy.

The study is evaluating an experimental drug called vosaroxin, which is given as an IV infusion. The purpose of the study is to determine the safety and effectiveness of vosaroxin in treating relapsed/refractory high risk MDS.

The study is being done in two parts.  

Part 1 (Dose Escalation Phase): this part of the study will look at the safety of increasing dose levels of vosaroxin in people with intermediate-2 or high-risk MDS. The dose determined to have the most effect without too many side effects will be used in Part 2.

Part 2 (Cohort Expansion Phase): participants in this part of the study will receive the dose that was determined to have the most effect in Part 1. Part 2 will evaluate how this dose of vosaroxin affects MDS.

The study is expected to last for about 5 years. A participant’s total length of time depends on how well he/she responds to therapy. Participants may continue on therapy as long as they are responding well to treatment and not experiencing unacceptable side effects.

Disease Status and/or Stage

myelodysplastic syndrome

Sponsor

Sunesis Pharmaceuticals

Key Eligibility

  • Men and women age 18 and older
  • Intermediate-2 or high risk MDS
  • Must have received at least 4 cycles of decitabine-based or 6 cycles of azacitidine-based therapy and are either refractory to, relapsed after, or are intolerant of prior therapy with either agent
  • Detailed eligibility reviewed when you contact the study team

Healthy Volunteers

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Contact Us

For general inquiries, or if you need assistance finding a study, please contact:

Erica Bersin
Tel: (646) 962-8232
[email protected]

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