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NCT03473743 · ClinicalTrials.gov registry record · Phase 1

A Study of Erdafitinib in Participants With Metastatic or Locally Advanced Urothelial Cancer

A Phase 1 study of Urothelial Carcinoma, sponsored by Janssen Research & Development.

Active
Registry status
Phase 1
Development phase
125
Enrollment target
20
Study locations

NCT03473743 is a Phase 1 study of Urothelial Carcinoma that is active but no longer recruiting, run by Janssen Research & Development. The registered enrollment target is 125 participants, below the 238-participant average among 85 other Urothelial Carcinoma trials with a reported enrollment target (47% lower). The trial reports 20 study locations across 11 states.

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The verdict

NCT03473743, a Phase 1 study of Urothelial Carcinoma, is active but no longer recruiting, sponsored by Janssen Research & Development.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
125 participants
Enrollment target
20
Study locations

Study Summary

The purpose of this study is to: (a) characterize the safety and tolerability of and to identify the recommended Phase 2 dose (RP2D) and schedule for erdafitinib in combination with cetrelimab, and for erdafitinib in combination with cetrelimab and platinum (cisplatin and carboplatin) chemotherapy and; (b) to evaluate the safety and clinical activity of erdafitinib alone and in combination with cetrelimab in cisplatin-ineligible participants with metastatic or locally advanced urothelial cancer (UC) with select fibroblast growth factor receptor (FGFR) gene alterations and no prior systemic therapy for metastatic disease.

Conditions Studied

Urothelial Carcinoma

Interventions

  • DRUG Carboplatin
  • DRUG Cisplatin
  • DRUG Cetrelimab
  • DRUG Erdafitinib

Study Locations (20)

Other

  • Brest Regional Oncology Dispensary - Brest
  • Grodno University Hospital - Grodno
  • Gomel Regional Clinical Oncology Dispensary - Homyel
  • State Institution N.N. Alexandrov Republican Scientific and - Lesnoy
  • Minsk city Clinical Oncological Dispensary - Minsk
  • Mogilev Regional Hospital - Mogilev
  • Vitebsk Regional Clinical Hospital - Vitebsk
  • ULB Hôpital Erasme - Brussels

New York

  • Weill Cornell Medical College - NY Presbyterian Hospital - New York
  • White Plains Hospital Center for Cancer Care - White Plains

Texas

  • Texas Oncology, P.A. - Fort Worth
  • The University of Texas MD Anderson Cancer Center - Houston

Colorado

  • Rocky Mountain Cancer Centers - Aurora

Kentucky

  • Norton Cancer Institute - Louisville

Maryland

  • Maryland Oncology Hematology, PA - Rockville

New Jersey

  • Hackensack University Medical Center - Hackensack

North Carolina

  • Levine Cancer Institute, Carolinas HealthCare System - Charlotte

Trial Details

FieldValue
Enrollment Target 125 participants
Start Date 2018-04-05
Est. Completion 2026-12-31
Phase Phase 1

Sponsor

Janssen Research & Development

593 total trials

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What the Registry Record Tells You About NCT03473743

The ClinicalTrials.gov registry entry for NCT03473743 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 125 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 238-participant average among 85 other Urothelial Carcinoma trials with a reported enrollment target (47% lower). The listed sponsor is Janssen Research & Development, which has 593 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Urothelial Carcinoma appearing as the primary indexed condition, and to 4 interventions - of which Carboplatin is the first listed.

NCT03473743 reports 20 study locations spanning 11 distinct geographic areas - top geographies include Other, New York, Texas.

Frequently Asked Questions

What is clinical trial NCT03473743 about?

NCT03473743 is a clinical study titled "A Study of Erdafitinib in Participants With Metastatic or Locally Advanced Urothelial Cancer". The purpose of this study is to: (a) characterize the safety and tolerability of and to identify the recommended Phase 2 dose (RP2D) and schedule for erdafitinib in combination with cetrelimab, and for erdafitinib in combination with cetrelimab and platinum (cisplatin and carboplatin) chemotherapy a...

What is the current status of trial NCT03473743?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 125 participants. The study started on 2018-04-05. Estimated completion is 2026-12-31.

What conditions does trial NCT03473743 study?

This clinical trial studies the following conditions: Urothelial Carcinoma.

What interventions are being tested in trial NCT03473743?

The interventions under investigation include: Carboplatin (DRUG), Cisplatin (DRUG), Cetrelimab (DRUG), Erdafitinib (DRUG).

Who is sponsoring clinical trial NCT03473743?

This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03473743 being conducted?

This trial has 20 study locations across Colorado, Kentucky, Maryland, New Jersey, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.