Clinical Trial: Evaluation of Votrient in Angiosarcoma

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Single-arm, Multicenter, Open Label Phase II Trial to Evaluate the Efficacy of Pazopanib in Combination With Paclitaxel in Advanced and Relapsed Angiosarcoma

Brief Summary: Open-label phase II trial investigating the efficacy and safety of the investigational combination of pazopanib and paclitaxel.

Detailed Summary: Open-label phase II trial investigating the efficacy and safety of the investigational combination of pazopanib and paclitaxel.This multi-center, open-label, prospective, single arm phase II study was designed to evaluate the clinical efficacy and safety of the experimental combination of pazopanib with paclitaxel in the treatment of patients with advanced or metastatic angiosarcoma.The safety evaluations (physical examination, laboratory checks as defined in protocol, toxicity/adverse event assessment according Eastern Cooperative Oncology Group version 4.0) are scheduled every cycle at day 1, 8, 15 and 29 (= day 1 of the next cycle).
Sponsor: Heidelberg University

Current Primary Outcome: Rate of progression-free survival [ Time Frame: 6 Month ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Overall survival [ Time Frame: 24 weeks after EOS of last patient ]
  • Response rate [ Time Frame: 8 weeks during first 6 month then 12 weeks follow-up period until progression or death ]
    Measurable skin lesions will be evaluated clinically and documented photographically, all other target lesions will be evaluated radiologically by CT or MRI according to RECIST Version 1.1.
  • Toxicity [ Time Frame: 30 days after EOS of last patient ]
    Number of patients in which adverse events occur during treatment according to Common Toxicity Criteria for Adverse Effects , Version 4.0


Original Secondary Outcome: Same as current

Information By: Heidelberg University

Dates:
Date Received: July 29, 2014
Date Started: July 2014
Date Completion: March 2020
Last Updated: October 26, 2016
Last Verified: October 2016