A Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Participants With Advanced Urothelial Cancer and Selected Fibroblast Growth Factor Receptor (FGFR) Gene Aberrations

Official Title

A Phase 3 Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Subjects With Advanced Urothelial Cancer and Selected FGFR Gene Aberrations

Summary:

The purpose of this study is to evaluate efficacy of erdafitinib versus chemotherapy or pembrolizumab in participants with advanced urothelial cancer harboring selected fibroblast growth factor receptor (FGFR) aberrations who have progressed after one prior treatment.

Trial Description

Primary Outcome:

  • Overall Survival (OS)
Secondary Outcome:
  • Progression-free Survival (PFS)
  • Overall Response Rate (ORR)
  • Time to Worsening in Symptom Items and Functioning Subscales in Patient-Reported Health Status of the Functional Assessment of Cancer Therapy-Bladder Cancer (FACT-Bl)
  • Change from Baseline in Patient-Global Impression of Severity (PGIS) Score
  • Change from Baseline in the Visual Analog Scale (VAS) of the EQ-5D-5L
  • Change from Baseline in the Utility Scale of the EQ-5D-5L
  • Duration of Response (DOR)
  • Number of Participants with Adverse Events (AEs) as a Measure of Safety
  • Oral Clearance (CL/F) of Erdafitinib
  • Area Under the Plasma Concentration-Time Curve from Time Zero to Time 't' (AUC[0-t]) of Erdafitinib
A study of erdafitinib versus standard of care, consisting of chemotherapy (docetaxel or vinflunine) or PD1 agent pembrolizumab, in participants with advanced urothelial cancer and selected FGFR aberrations who have progressed on or after one prior line of systemic therapy. It will consist of screening, treatment phase (from randomization until disease progression, intolerable toxicity, withdrawal of consent or decision by investigator to discontinue treatment, post-treatment follow-up (from end-of-treatment to participants death, withdraws consent, lost to follow-up, or end of study, whichever comes first). Efficacy, pharmacokinetics, biomarkers, patient reported outcomes, medical resource utilization and safety will be assessed.

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society