Clinical Trial: Study to Evaluate Imatinib in Desmoid Tumors
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Phase II Study to Evaluate Glivec (Imatinib Mesylate) to Induce Progression Arrest in Aggressive Fibromatosis / Desmoid Tumors Not Amenable to
Brief Summary: The objective of the present study is to evaluate the activity and safety of imatinib in patients with aggressive fibromatosis who, after receiving the standard therapy, show an inoperable recurrent tumor or disease not readily controllable by surgery or radiotherapy.
Detailed Summary:
Sponsor: Heidelberg University
Current Primary Outcome: Non-progression rate after 6 months of treatment [ Time Frame: 6 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Non-progression rate after 12 and 24 months of treatment [ Time Frame: 12 and 24 months ]
- Response rate [ Time Frame: 12 and 24 months ]
- Progression-free survival (PFS) and overall survival (OS) [ Time Frame: 12 and 24 months ]
- Recording of patient quality of life [ Time Frame: 12 and 24 months ]
Original Secondary Outcome: Same as current
Information By: Heidelberg University
Dates:
Date Received: June 2, 2010
Date Started: June 2010
Date Completion:
Last Updated: May 2, 2017
Last Verified: May 2017
