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

Titre officiel

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

Sommaire:

Le but de cette étude est d’évaluer l’efficacité de l’erdafitinib par rapport à une chimiothérapie ou au pembrolizumab chez des participants atteints d’un cancer urothélial au stade avancé abritant certaines aberrations du récepteur du facteur de croissance des fibroblastes (FGFR pour Fibroblast Growth Factor Receptor) et ayant progressé après un traitement antérieur.

Description de l'essai

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 anti-PD-(L) 1 agent pembrolizumab, in participants with advanced urothelial cancer and selected FGFR aberrations who have progressed on or after 1 or 2 prior treatments, at least 1 of which includes an anti-PD-(L) 1 agent (cohort 1) or 1 prior treatment not containing an anti-PD-(L) 1 agent (cohort 2). 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 followup (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.

Voir cet essai sur ClinicalTrials.gov

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