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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: Active Phase 1 study of Urothelial Carcinoma, sponsored by Janssen Research & Development.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Number of participants with DLTs were reported. The DLTs as per National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE version 5.0) are specific adverse events defined as grade 3 (severe), grade 4 (life-threatening), and grade 5 (death) non-hematological toxicity or hematological toxicity.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 125 participants |
| Start Date | 2018-04-05 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 1 |
What the registry record for NCT03473743 still lists
NCT03473743 is an interventional study that assigns participants to a tested intervention. The registered 125 participants enrollment target is mid-sized for trials with a published cap, below the 238-participant average among 85 other Urothelial Carcinoma trials with a reported enrollment target (47% lower).
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 names 20 study sites across 11 states, led by 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.
Learn More About Clinical Trials
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Where NCT03473743's enrollment target sits among peer trials
125 33rd of 85 higher than 53 of 85 other Urothelial Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Urothelial Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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