Clinical Trial: Brostallicin Clinical Trial for Myxoid Liposarcoma
Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional
Official Title: A Phase II, Multicenter Study to Explore the Efficacy and Safety of Brostallicin in Patients With Myxoid Liposarcoma With (12:16) Translocation
Brief Summary: This is a Phase II, multicenter, open-label clinical trial designed to determine the efficacy and safety of Brostallicin when administered once every 3 weeks in patients with myxoid liposarcoma with (12;16) translocation. The primary objective of this study is to determine the response rate following Brostallicin administration.
Detailed Summary:
Sponsor: Systems Medicine LLC
Current Primary Outcome: To determine the overall response rate and response rate, as measured by RECIST criteria of myxoid liposarcoma with (12;16) translocation, to Brostallicin. [ Time Frame: Tumor measurements after every 2 cycles and there is no limit to the number of cycles. ]
Original Primary Outcome: To determine the overall response rate and response rate, as measured by RECIST criteria of myxoid liposarcoma with (12;16) translocation, to Brostallicin. [ Time Frame: After the average treatment of four 3 week cycles ]
Current Secondary Outcome:
- To describe the safety profile of Brostallicin when administered every 3 weeks in this patient population. [ Time Frame: Tumor measurements after every 2 cycles and there is no limit to the number of cycles. ]
- Duration of response [ Time Frame: Tumor measurements after every 2 cycles and there is no limit to the number of cycles. ]
- To determine progression free survival. [ Time Frame: Tumor measurements after every 2 cycles and there is no limit to the number of cycles. ]
Original Secondary Outcome:
- To describe the safety profile of Brostallicin when administered every 3 weeks in this patient population. [ Time Frame: After the average treatment of four 3 week cycles ]
- Duration of response [ Time Frame: After the average treatment of four 3 week cycles ]
- To determine progression free survival. [ Time Frame: After the average treatment of four 3 week cycles ]
Information By: Systems Medicine LLC
Dates:
Date Received: March 3, 2008
Date Started: August 2007
Date Completion: June 2010
Last Updated: February 24, 2010
Last Verified: February 2010