NCT00510289

Sorafenib in Myelodysplastic Syndrome

Phase II Trial of Sorafenib in Patients With Myelodysplastic Syndrome

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Myelodysplastic Syndromes
• Leukemia, Myelomonocytic, Chronic

Interventions

Type	Name	Description
DRUG	Sorafenib	400 mg twice a day until progression or unacceptable toxicity develops.

Timeline

• Start date: 2006-07-01
• Primary completion: 2011-07-01
• Completion: 2011-07-01
• First posted: 2007-08-01
• Last updated: 2016-04-19
• Results posted: 2014-02-11

Locations

1 site across 1 country: United States