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Biomarker Research Study for Patients With FGFR-Mutant Bladder Cancer Receiving Erdafitinib

NCT05052372 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 2

Last updated 2022-12-22

No results posted yet for this study

Summary

Bladder cancers are associated with genetic mutations that are present in the patient's bladder or urothelium, the lining of the lower urinary tract. Fibroblast growth factor (FGFR) alterations are present in approximately one in five patients with recurrent and refractory bladder cancer.

This study will collect biomarker data from subjects receiving erdafitinib to further investigate the relationship between treatment with erdafitinib and clinical response, progression, and/or genetic alterations.

Conditions

  • Bladder Cancer
  • Urothelial Carcinoma
  • Transitional Cell Carcinoma
  • Platinum-Resistant Urothelial Carcinoma
  • Bladder Urothelial Carcinoma
  • FGFR Mutation
  • FGFR2 Gene Mutation
  • FGFR3 Gene Mutation
  • FGFR2 Amplification
  • Locally Advanced Urothelial Carcinoma
  • Metastatic Urothelial Carcinoma
  • Refractory Bladder Carcinoma
  • Refractory Bladder Urothelial Carcinoma

Interventions

DRUG

Balversa

BALVERSA® is a prescription medicine used to treat adults with bladder cancer (urothelial cancer) that has spread or cannot be removed by surgery

Sponsors & Collaborators

  • xCures

    lead INDUSTRY

Principal Investigators

  • Daniel J. George, MD · Duke Health

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-21
Primary Completion
2022-12-20
Completion
2022-12-20
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05052372 on ClinicalTrials.gov