last updated at 25.08.2019

INCB 54828-202-Incyte

A Phase 2, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of INCB054828 in Subjects with Advanced/Metastatic or Surgically Unresectable Cholangiocarcinoma With FGFR2 Translocations, Other FGF/FGFR Alterations or Negative FGF/FGFR Altera

Status: Aktiv

ISRCTN EudraCT Clinicaltrials.gov DRKS
2016-002422-36

Diagnose

  • Gallenblasenkarzinom

Studienziel / Fragestellung

Primäres Prüfziel
  • To 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.

Sekundäre Prüfziele
  • 1) To evaluate the efficacy of INCB054828 in subjects with advanced/metastatic or surgically unresectable cholangiocarcinoma with different molecular subgroups.

    2) To evaluate the safety of INCB054828 in subjects with advanced/metastatic or surgically unresectable cholangiocarcinoma who have failed at least 1 previous treatment.

    3) To identify and evaluate covariates that may influence the pharmacokinetics of INCB054828 in this subject population through population pharmacokinetic analysis. Additionally

  • exposure-response analyses for key efficacy and safety parameters will also be considered if there is sufficient data available.

Patientenmerkmale

Alter

-

Studiendesign

  • Phase II

Intervention

Dokumente (passwortgeschützt)

Zuständigkeiten Gesamtstudie

Sponsor

  • Incyte Coporation

Prüfzentrum 1

 

  • Medizinische Klinik I (UKBonn)

Studienbüro

  • Studienzentrum Onkologische Gastroenterologie

Studienkontakt im Prüfzentrum

  • PD Dr. med. Maria Gonzalez-Carmona

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