Sorafenib in Myelodysplastic Syndrome

Myelodysplastic Syndromes Clinical Trial

Official title: Phase II Trial of Sorafenib in Patients With Myelodysplastic Syndrome

Status Terminated

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leukemia, Myelomonocytic, Chronic
• Myelodysplastic Syndromes
• Preleukemia
• Syndrome

• NCT number: NCT00510289
• Study type: Interventional
• Source: Duke University
• Status: Terminated
• Phase: Phase 2
• Start date: July 2006
• Completion date: July 2011