Study on Erdafitinib for Patients with Advanced Urothelial Cancer

Sponsor: Janssen Research & Development, LLC

Sponsor score: 60

ClinicalTrials ID:NCT03473743

This clinical trial is testing the safety and effectiveness of the drug erdafitinib, alone and in combination with other treatments, for patients with advanced urothelial cancer. The study aims to find the best dose and treatment schedule for future research.

Patient Parameters

Program Overview

The purpose of this study is to evaluate the safety and effectiveness of erdafitinib, a drug used to treat advanced urothelial cancer, both on its own and in combination with other treatments. The study will test erdafitinib with cetrelimab, an immunotherapy drug, and with chemotherapy drugs cisplatin and carboplatin. Researchers want to find the best dose and schedule for these treatments and see how well they work in patients who cannot take cisplatin and have not had previous treatment for their metastatic cancer.

Description

This study is open-label, meaning both the researchers and participants know which treatments are being given. It takes place at multiple medical centers. The study has two main parts: Phase 1b and Phase 2. In Phase 1b, researchers will determine the safest and most effective doses of erdafitinib when combined with cetrelimab and chemotherapy. Participants in this phase may have had previous treatments. In Phase 2, the study will compare erdafitinib alone to the combination of erdafitinib and cetrelimab in patients who have not had prior treatment for their metastatic cancer and cannot take cisplatin. The study includes a screening phase, a treatment phase, and a follow-up phase. Researchers will evaluate the effectiveness, safety, and how the body processes the drugs.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of urothelial cancer, including certain subtypes.
  • Have advanced or metastatic urothelial cancer.
  • Have measurable cancer as shown by scans.
  • For Phase 1b: May have had previous treatments; for Phase 2: No previous treatments for metastatic cancer and cannot take cisplatin due to specific health reasons.
  • Have a performance status score indicating good overall health (ECOG 0-2).
  • Meet specific kidney function requirements for chemotherapy.

Exclusion Criteria

  • Have participated in another clinical trial or received an investigational treatment within 30 days before starting this study.
  • For Phase 1b: Have had certain chemotherapy treatments recently.
  • Have had previous treatments with specific immunotherapy drugs unless it was more than 12 months ago and did not cause severe side effects.
  • Have other active cancers requiring treatment.
  • Have cancer that has spread to the brain causing symptoms.

Locations

FACILITYZIPCITYSTATE
Rocky Mountain Cancer Centers80012AuroraColorado
Norton Cancer Institute40202LouisvilleKentucky
Maryland Oncology Hematology, PA20850RockvilleMaryland
Hackensack University Medical Center07601HackensackNew Jersey
Weill Cornell Medical College - NY Presbyterian Hospital10021New YorkNew York
White Plains Hospital Center for Cancer Care10601White PlainsNew York
Levine Cancer Institute, Carolinas HealthCare System28204CharlotteNorth Carolina
Toledo Clinic Cancer Centers43623-3536ToledoOhio
Penn State Hershey Cancer Institute17033HersheyPennsylvania
Texas Oncology, P.A.76104Fort WorthTexas

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