Clinical Trial: A Study of PRO95780 in Patients With Advanced Chondrosarcoma (APM4171g)
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: A Phase II, Open-Label, Multicenter Study of the Efficacy and Safety of Single-Agent PRO95780 in Patients With Advanced Chondrosarcoma
Brief Summary: This is a multicenter, open-label, Phase II trial designed to evaluate the efficacy and safety of PRO95780 when given as a single agent in patients with advanced chondrosarcoma. Up to 90 patients with confirmed chondrosarcoma will be enrolled.
Detailed Summary:
Sponsor: Genentech, Inc.
Current Primary Outcome:
- Adverse events
- Change in vital signs before and after PRO95780 infusions; clinical laboratory evaluations
- Objective response
Original Primary Outcome: Objective response
Current Secondary Outcome:
- Duration of objective response
- Progression-free survival
- Overall survival
- Pharmacokinetic parameters
Original Secondary Outcome:
- Duration of objective response
- Progression-free survival
- Overall survival
- Apomab minimum and maximum serum concentrations (Cmin and Cmax)
Information By: Genentech, Inc.
Dates:
Date Received: October 12, 2007
Date Started: June 2007
Date Completion:
Last Updated: June 19, 2013
Last Verified: June 2013