Clinical Trial: Efficacy and Safety of INCB054828 in Subjects With Advanced/Metastatic or Surgically Unresectable Cholangiocarcinoma Who Failed Previous Therapy

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

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

Brief Summary: The purpose of this study is evaluate the efficacy of INCB054828 in subjects with advanced/metastatic or surgically unresectable cholangiocarcinoma with FGFR2 translocation who have failed at least 1 previous treatment.

Detailed Summary:
Sponsor: Incyte Corporation

Current Primary Outcome: Objective response rate (ORR) in subjects with FGFR2 translocations based on RECIST v1.1 [ Time Frame: Every 6 weeks for the first 2 cycles and every 9 weeks thereafter through end of treatment, up to 6 months. ]

ORR defined as the proportion of subjects who achieved a complete response (disappearance of all target lesions) or a partial response (≥ 30% decrease in the sum of the longest diameters of target lesions) based on RECIST v1.1.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • ORR in subjects with FGF/FGFR alterations other than FGFR2 translocations, all subjects with FGF/FGFR alterations, and subjects negative for FGF/FGFR alterations, based on RECIST v1.1 [ Time Frame: Every 6 weeks for the first 2 cycles and every 9 weeks thereafter through end of treatment, up to 6 months ]
    ORR defined as the proportion of subjects who achieved a complete response (disappearance of all target lesions) or a partial response (≥ 30% decrease in the sum of the longest diameters of target lesions) based on RECIST v1.1.
  • Progression-free survival based on RECIST v1.1 [ Time Frame: Every 6 weeks for the first 2 cycles and every 9 weeks thereafter through end of treatment, up to 6 months. ]
    Progression-free survival defined as the time from the first day of taking study drug to death or disease progression by RECIST v1.1.
  • 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 6 months. ]


Original Secondary Outcome: Same as current

Information By: Incyte Corporation

Dates:
Date Received: October 4, 2016
Date Started: October 2016
Date Completion: December 2018
Last Updated: May 5, 2017
Last Verified: May 2017