Clinical Trial: A Phase II Study of GSK1363089 (Formerly XL880) for Papillary Renal-Cell Carcinoma (PRC)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase 2 Study of the c-Met RTK Inhibitor GSK1363089 (Formerly XL880) in Subjects With Papillary Renal-Cell Carcinoma

Brief Summary: This clinical study is being conducted at multiple sites to determine the best confirmed response rate, safety, and tolerability of GSK1363089 treatment in papillary renal cell carcinoma. Papillary renal cell carcinoma may be classified into hereditary and sporadic forms; subjects with either classification will be accepted into this study.

Detailed Summary:
Sponsor: GlaxoSmithKline

Current Primary Outcome: Best confirmed tumor response rate [ Time Frame: 4 years ]

Primary efficacy


Original Primary Outcome: To determine the objective response rate (RECIST) of GSK1363089 on 2 different dosing regimens , to the evaluate safety and tolerability of GSK1363089 on 2 different dosing regimens

Current Secondary Outcome:

  • Progression free survival [ Time Frame: 4 years ]
    Efficacy secondary endpoint
  • time to response [ Time Frame: 4 years ]
    efficacy
  • duration of response [ Time Frame: 4 years ]
    efficacy
  • Duration of stable disease [ Time Frame: 4 years ]
    efficacy
  • Overall survival [ Time Frame: 4 years ]
    efficacy
  • Laboratory tests [ Time Frame: 4 years ]
    Safety
  • Adverse events [ Time Frame: 4 years ]
    Safety


Original Secondary Outcome: To evaluate progression free survival (PFS), duration of response, and overall survival, to characterize pharmacokinetic (PK) and pharmacodynamic parameters of GSK1363089

Information By: GlaxoSmithKline

Dates:
Date Received: July 29, 2008
Date Started: June 2006
Date Completion:
Last Updated: November 30, 2016
Last Verified: November 2016