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8110 Gatehouse Road, Falls Church, VA 22042

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)

General Information

Age Group

Adult

Status

Recruiting

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

For more information go to: https://clinicaltrials.gov/ct2/show/NCT03390504