Spots Global Cancer Trial Database for Sorafenib in Myelodysplastic Syndrome
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Trial Identification
Brief Title: Sorafenib in Myelodysplastic Syndrome
Official Title: Phase II Trial of Sorafenib in Patients With Myelodysplastic Syndrome
Study ID: NCT00510289
Interventions
Study Description
Brief 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.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Duke University Medical Center, Durham, North Carolina, United States
Contact Details
Name: David A Rizzieri, MD
Affiliation: Duke University
Role: PRINCIPAL_INVESTIGATOR
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