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Urothelial
General Information
Study Name:
A Phase 3 Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Subjects with Advanced Urothelial Cancer and Selected FGFR Gene Aberrations (THOR)
Age Group:
Adult
Protocol Number:
NCT03390504
Background Information:
The purpose of this study is to compare the effects (both good and bad) of an investigational drug called erdafitinib to those of docetaxel or vinflunine (chemotherapy) and of pembrolizumab (immunotherapy). Docetaxel, vinflunine and pembrolizumab are treatments already used to treat bladder cancer.
Offered at:
Inova Schar Cancer Institute
8081 Innovation Park Drive
Fairfax, VA 22031
A department of Inova Fairfax Hospital
Eligibility Information
Male or female at or over 18 years of age
Histologic demonstration of transitional cell carcinoma of the urothelium. Minor components (<50% overall) of variant histology such as glandular or squamous differentiation, or evolution to more aggressive types such as sarcomatoid or micropapillary change are acceptable
Documented progression of disease
Tumors must have at least 1 of the following translocations: FGFR2-BICC1, FGFR2-CASP7, FGFR3-TACC3, FGFR3-BAIAP2L1; or 1 of the following FGFR3 gene mutations: R248C, S249C, G370C, Y373C
A woman of childbearing potential who is sexually active must have a negative pregnancy test at screening (urine or serum).
Additional eligibility in protocol
Ineligibility Information
Symptomatic central nervous system metastases
Received prior FGFR inhibitor treatment
Known allergies, hypersensitivity, or intolerance to erdafitinib or its excipients
Current central serous retinopathy (CSR) or retinal pigment epithelial detachment of any grade
History of uncontrolled cardiovascular disease
Additional ineligibility in protocol
Contact Information
Contact Name:
Ebtehal Al-Shami
Contact Phone:
571-472-0628
Contact Email:
ebtehal.alshami@inova.org
For more information go to
https://clinicaltrials.gov/ct2/show/NCT03390504