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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.
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Inclusion criteria
Patients must have a diagnosis of primary or therapy-related myelodysplastic syndrome or myelodysplastic/ myeloproliferative disorders as defined by the WHO
Patients may have low, intermediate-1, intermediate-2 or high risk MDS or CMML.
Patients are eligible without regard to prior treatment status except for allogenic bone marrow transplant.
Patients must be 18 years of age or older.
Patient has an estimated or measured creatinine clearance ≥30 ml/min at study enrollment.
AST, ALT, total bilirubin ≤ than 2.5 times the upper limit of normal.
ECOG performance status of 0-2.
Voluntary written informed consent before performance of any study-related procedure not part of normal medical care.
Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control.
Male subject agrees to use an acceptable method for contraception for the duration of the study therapy and for 2 weeks after study completion.
Exclusion criteria
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19 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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