Open Clinical Trials

A Phase II Trial of Dasatinib in Advanced Sarcomas


Phase:
Phase II ( Phase 2 )
Trial for Patients with:
Advanced sarcomas (see conditions below)
Treatment involved:
Drug taken twice daily by mouth
Age Requirement:
13 and older
Location:
Arkansas, California, District of Columbia, Georgia, Idaho, Illinois, Indiana, Maryland, Massachusetts, Michigan, Nebraska, Pennsylvania and Texas
Description This study will examine the response rate and the 6-month progression-free survival rates of subjects with advanced sarcoma treated with dasatinib. Subjects take Dasatinib twice daily by mouth for 28 days per 28 day cycle. Subjects will be seen for interim medical history, physical exam and laboratory studies prior to each cycle. Subjects will undergo tumor imaging every 2 months (8 weeks) for the first 6 months and approximately every 3 months thereafter while on treatment. A blood sample for collection of specimens with which to later study serum level of Dasatinib and effects on biomarkers of drug activity will be obtained approximately 2 to 4 weeks after the start of treatment. Central collection of archival tumor with which to later study the frequency of expression and/or mutation of kinases inhibited by dasatinib will occur. Subjects will be followed for approximately every 3 months until 2 years from registration and then approximately yearly until 5 years from registration. The total expected enrollment is 452 patients.
Conditions
Excluded conditions: Liposarcoma and Leiomyosarcoma - no longer eligible
Trial Start Date: May 2007
Trial End Date: December 2013 (estimated)
ClinicalTrials.gov: NCT00464620 : detailed information at ClinicalTrials.gov
This page was last updated on: March 23, 2009