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NCT04083976 · ClinicalTrials.gov registry record · Phase 2
A Study of Erdafitinib in Participants With Advanced Solid Tumors and Fibroblast Growth Factor Receptor (FGFR) Gene Alterations
A Phase 2 study of Advanced Solid Tumor, sponsored by Janssen Research & Development.
- Active
- Registry status
- Phase 2
- Development phase
- 316
- Enrollment target
- 20
- Study locations
NCT04083976: Active Phase 2 study of Advanced Solid Tumor, sponsored by Janssen Research & Development.
NCT04083976 is a Phase 2 study of Advanced Solid Tumor that is active but no longer recruiting, run by Janssen Research & Development. The registered enrollment target is 316 participants, above the 191-participant average among 189 other Advanced Solid Tumor trials with a reported enrollment target (65% higher). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04083976, a Phase 2 study of Advanced Solid Tumor, is active but no longer recruiting, sponsored by Janssen Research & Development.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 316 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to evaluate the efficacy of erdafitinib in terms of overall response rate (ORR) in adult and pediatric participants with advanced solid tumors with fibroblast growth factor receptor (FGFR) alterations (mutations or gene fusions). It will also evaluate ORR in pediatric participants with advanced solid tumors and FGFR alterations.
Primary Outcome
ORR is defined as the percentage of participants who achieved a complete response (CR), or partial response (PR) based on Response Assessment in Neuro-Oncology (RANO) criteria. According to RANO criteria whereby overall RANO response is based on both radiographic response (CR: disappearance of all target lesions; PR: sum of products of diameters \[SPD\] decreased by \>=50 percent \[%\] from baseline value) and clinical performance status with steroid dose information.
Conditions Studied
Interventions
- DRUG Erdafitinib
Study Locations (20)
Florida
- Memorial Cancer Institute - Hollywood
- Cancer Specialists of North Florida - Jacksonville
New York
- Mount Sinai - New York
- Memorial Sloan Kettering Cancer Center - New York
Ohio
- Oncology Hematology Care - Cincinnati
- Nationwide Children's Hospital - Columbus
Pennsylvania
- Thomas Jefferson University - Philadelphia
- University of Pittsburgh Medical Center - Pittsburgh
Tennessee
- Tennessee Oncology, PLLC - Chattanooga
- Tennessee Oncology - Nashville
Arizona
- Arizona Oncology Associates, PC - HOPE - Tucson
Colorado
- Rocky Mountain Cancer Centers - Colorado Springs
Georgia
- Emory University - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 316 participants |
| Start Date | 2019-11-20 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 2 |
What the registry record for NCT04083976 still lists
NCT04083976 is an interventional study that assigns participants to a tested intervention. The registered 316 participants enrollment target is mid-sized for trials with a published cap, above the 191-participant average among 189 other Advanced Solid Tumor trials with a reported enrollment target (65% higher).
The record links to 1 condition, with Advanced Solid Tumor appearing as the primary indexed condition, and to 1 intervention - of which Erdafitinib is the first listed.
NCT04083976 names 20 study sites across 15 states, led by Florida, New York, Ohio.
Frequently Asked Questions
What is clinical trial NCT04083976 about?
NCT04083976 is a clinical study titled "A Study of Erdafitinib in Participants With Advanced Solid Tumors and Fibroblast Growth Factor Receptor (FGFR) Gene Alterations". The purpose of this study is to evaluate the efficacy of erdafitinib in terms of overall response rate (ORR) in adult and pediatric participants with advanced solid tumors with fibroblast growth factor receptor (FGFR) alterations (mutations or gene fusions). It will also evaluate ORR in pediatric pa...
What is the current status of trial NCT04083976?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 316 participants. The study started on 2019-11-20. Estimated completion is 2026-12-31.
What conditions does trial NCT04083976 study?
This clinical trial studies the following conditions: Advanced Solid Tumor.
What interventions are being tested in trial NCT04083976?
The interventions under investigation include: Erdafitinib (DRUG).
Who is sponsoring clinical trial NCT04083976?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04083976 being conducted?
This trial has 20 study locations across Arizona, Colorado, Florida, Georgia, Hawaii. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04083976's enrollment target sits among peer trials
316 33rd of 189 higher than 157 of 189 other Advanced Solid Tumor trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Advanced Solid Tumor 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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