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