Overview

Sorafenib in Myelodysplastic Syndrome

Status:
Terminated
Trial end date:
2011-07-01
Target enrollment:
Participant gender:
Summary
The purpose of this study is to evaluate the efficacy of sorafenib in patients with Myelodysplastic Syndrome (MDS). Eligible subjects will receive Sorafenib administered at 400mg orally twice a day, given on days 1-28 of a 28-day cycle. Patients will be evaluated for hematological response after 2 cycles and then every 3 cycles thereafter for a maximum of 5 years from study entry. If a patient achieves a complete response they may receive an additional 6 cycles of therapy beyond documentation of complete response unless unacceptable toxicity occurs. For patients with partial response, hematological improvement or stable disease they will continue treatment until relapse, progression of disease, or unacceptable toxicity occurs.
Phase:
Phase 2
Details
Lead Sponsor:
Duke University
Collaborator:
Bayer
Treatments:
Niacinamide
Sorafenib