INCB 54828-201: A Phase 2, Open-label, Single Agent, Multi-Center Study to Evaluate the Efficacy and Safety of a Pan-FGFR Tyrosine Kinase Inhibitor INCB054828 in Patients with Metastatic or Surgically Unresectable Urothelial Carcinoma Harboring FGF/FGFR Alterations
Laufzeit: 01.01.2018 - 31.12.2020
Kurzfassung
Primary Objective:
To evaluate the objective response rate (ORR) of INCB054828 as a monotherapy in the treatment of metastatic or surgically unresectable urothelial carcinoma harboring fibroblast growth factor receptor (FGFR) 3 mutations or fusions
Primary endpoint:
Objective response rate in subjects with FGFR3 mutations or fusions based on central genomics laboratory results (cohort A). Response will be based on review of scans by a centralized radiological review committee.Primary Objective:
To evaluate the objective response rate (ORR) of INCB054828 as a monotherapy in the treatment of metastatic or surgically unresectable urothelial carcinoma harboring fibroblast growth factor receptor (FGFR) 3 mutations or fusions
Primary endpoint:
Objective response rate in subjects with FGFR3 mutations or fusions based on central genomics laboratory results (cohort A). Response will be based on review of scans by a centralized radiological review committee.» weiterlesen» einklappen
Beteiligte Einrichtungen
