Ignite Creation Date:
2024-05-05 @ 5:29 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00464620
Status:
COMPLETED
Last Update Posted:
2018-11-23
First Post:
2007-04-20
Brief Title:
Trial of Dasatinib in Advanced Sarcomas
Sponsor:
Sarcoma Alliance for Research through Collaboration
Organization:
Sarcoma Alliance for Research through Collaboration
Study Overview
Official Title:
A Phase II Trial of Dasatinib in Advanced Sarcomas
Status:
COMPLETED
Status Verified Date:
2018-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will examine the response rate and the 6-month progression-free survival rates of subjects with advanced sarcoma treated with dasatinib
Detailed Description:
Further details provided by SARC Sarcoma Alliance for Research through Collaboration
Treatment 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 andor 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
Treatment 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 andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None