Sorafenib in Myelodysplastic Syndrome
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|ClinicalTrials.gov Identifier: NCT00510289|
Recruitment Status : Terminated (Early closure of study due to poor response)
First Posted : August 1, 2007
Results First Posted : February 11, 2014
Last Update Posted : April 19, 2016
|Condition or disease||Intervention/treatment||Phase|
|Myelodysplastic Syndromes Leukemia, Myelomonocytic, Chronic||Drug: Sorafenib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||19 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of Sorafenib in Patients With Myelodysplastic Syndrome|
|Study Start Date :||July 2006|
|Primary Completion Date :||July 2011|
|Study Completion Date :||July 2011|
Experimental: all patients
400 mg twice a day until progression or unacceptable toxicity develops.
Other Name: Nexavar
- Number of Subjects Achieving Hematological Response [ Time Frame: During treatment - up to a maximum of 5 years ]Hematological response is defined as the number of subjects who achieve either a complete response (CR), Partial response (PR) or Hematologic improvement.(HI). HI is defined as peripheral blood counts with hemoglobin ≥11 g/dL, absolute neutrophil count ≥1x10(9)/L and platelet count ≥100x10(9)/L, and normal bone marrow morphology with no evidence of dysplasia or blasts. CR is defined as the disappearance of all signs and symptoms related to disease, along with HI. PR is defined as fulfilling the criteria for CR in the peripheral blood but blasts decreasing by 50% or more in the bone marrow or to a less advanced WHO classification pretreatment.
- Number of Subjects Requiring Dose Reductions [ Time Frame: While on study drug, a maximum of 5 years ]The number of subjects who took study drug for more than 1 cycle and required a dose reduction down to the next dose level.
- Time to Progression [ Time Frame: 5 years ]Time to progression will be defined as the number of months between on-study and the date of progression or death, whichever comes first, in subjects who took study drug for at least cycle 1.
- Overall Survival [ Time Frame: 1 year from the last dose of study drug ]Overall Survival is defined as the number of months from enrollment onto the study until death from any cause in subjects who took study drug for at least cycle 1.
- Change in Microvessel Density [ Time Frame: Measured before and after treatment ]Microvessel density will be measured before and after treatment, and the distribution of change across time will be summarized with descriptive statistics.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00510289
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||David A Rizzieri, MD||Duke University|