INCYTE, Efficacy and Safety of INCB054828 in Urothelial Cancer
Research type
Research Study
Full 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 Carcinoma Harboring FGF/FGFR Alterations
IRAS ID
214926
Contact name
Robert Jones
Contact email
Sponsor organisation
Incyte Corporation
Eudract number
2016-001321-14
Duration of Study in the UK
0 years, 6 months, 1 days
Research summary
The purpose of this study is to evaluate the efficacy, safety, and tolerability of INCB054828 in subjects with advanced/nonresectable or metastatic urothelial carcinoma with Fibroblast growth factor / Fibroblast growth factor Receptor(FGF/FGFR) alterations. Cancers have several common characteristics that can be observed across numerous tumour types. One common characteristic is the uncontrolled growth and survival of cells and their ability to become invasive throughout the body. Fibroblast growth factor (FGF) signaling produces cell division (mitogenic), survival (anti-apoptotic), and formation of new blood cells (angiogenic) responses in cells, which leads to a deregulated state. The study drug INCB054828 is an inhibitor of the FGF/FGFR family of receptor tyrosine kinases that is proposed for the treatment of Cancers. This is an open-label monotherapy study of INCB054828 in subjects with metastatic or surgically unresectable urothelial cancer harbouring FGF/FGFR alterations.
Potential subjects may be identified based on local genomic sequencing but must be screened for the FGF/FGFR alteration through the sponsor's central laboratory; if positive, the subject will then undergo screening to meet the rest of the inclusion/exclusion criteria. Once a subject has completed screening and has enrolled into the study, treatment will start on Day 1.
Subjects will receive INCB054828 at a once-daily, starting dose of 13.5 mg on a 2-weeks-on-therapy and 1-week-off-therapy schedule. Subjects will be eligible if they have a known FGF/FGFR alteration and have either 1) failed at least 1 previous treatment for their metastatic or surgically unresectable urothelial carcinoma (ie, chemotherapy, immunotherapy) or 2) are platinum ineligible. Subjects may have undergone cystectomy(surgical removal of all or part of the bladder).
Subjects will undergo regular safety assessments during treatment as well as regular efficacy assessments. Subjects will be allowed to continue receiving study drug in 21-day cycles until documented disease progression or unacceptable toxicity is reported.
This study is sponsored by Incyte Corporation and 100 subjects will be enrolled.REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
16/EM/0465
Date of REC Opinion
12 Jan 2017
REC opinion
Further Information Favourable Opinion