Clinical Trial: A Study to Evaluate the Efficacy and Safety of INCB054828 in Subjects With Urothelial Carcinoma

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

Official Title: A Phase 2, Open-Label, Single-Agent, Multicenter Study to Evaluate the Efficacy and Safety of INCB054828 in Subjects With Metastatic or Surgically Unresectable Urothelial Carcino

Brief Summary: The purpose of this study is to evaluate the overall response rate (ORR) of INCB054828 as a monotherapy in the treatment of metastatic or surgically unresectable urothelial carcinoma harboring FGF/FGFR alterations.

Detailed Summary:
Sponsor: Incyte Corporation

Current Primary Outcome: Overall response rate (ORR) based on RECIST v1.1 [ Time Frame: Every 9 weeks throughout the study, up to approximately 6 months ]

Defined as the proportion of subjects with best response (complete response or partial response) by RECIST v1.1.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Safety and tolerability of INCB054828 as assessed by the frequency, duration, and severity of adverse events [ Time Frame: From screening through 30-35 days after end of treatment, up to approximately 6 months ]
  • Progression-free survival (PFS) based on RECIST v1.1 [ Time Frame: Every 9 weeks throughout the study, up to approximately 6 months ]
    Defined as number of days from the first day of taking study drug dose to the earlier of death or disease progression by RECIST v1.1 as assessed by the central radiographic review committee
  • Duration of response [ Time Frame: Every 9 weeks throughout the study, up to approximately 6 months ]
    Defined as the number of days from the date of the first confirmed response to the date of the first documented evidence of disease progression or death.


Original Secondary Outcome: Same as current

Information By: Incyte Corporation

Dates:
Date Received: August 16, 2016
Date Started: August 2016
Date Completion: September 2018
Last Updated: May 5, 2017
Last Verified: May 2017