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NCT02365597 · ClinicalTrials.gov registry record · Phase 2

An Efficacy and Safety Study of Erdafitinib (JNJ-42756493) in Participants With Urothelial Cancer

A Phase 2 study of Urothelial Cancer, sponsored by Janssen Research & Development.

Active
Registry status
Phase 2
Development phase
239
Enrollment target
20
Study locations

NCT02365597 is a Phase 2 study of Urothelial Cancer that is active but no longer recruiting, run by Janssen Research & Development. The registered enrollment target is 239 participants, below the 565-participant average among 25 other Urothelial Cancer trials with a reported enrollment target (58% lower). The trial reports 20 study locations across 15 states.

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The verdict

NCT02365597, a Phase 2 study of Urothelial Cancer, is active but no longer recruiting, sponsored by Janssen Research & Development.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
239 participants
Enrollment target
20
Study locations

Study Summary

The purpose of this study is to evaluate the objective response rate (complete response \[CR\]+ partial response \[PR\]) of the selected dose regimen in participants with metastatic or surgically unresectable urothelial cancers that harbor specific FGFR genomic alterations.

Conditions Studied

Interventions

  • DRUG Midazolam
  • DRUG Metformin
  • DRUG Erdafitinib

Study Locations (20)

California

  • - Los Angeles
  • - Orange
  • - Sacramento
  • - Stanford

Oregon

  • - Medford
  • - Tualatin

Pennsylvania

  • - Hershey
  • - Pittsburgh

Arizona

  • - Sedona

Colorado

  • - Aurora

District of Columbia

  • - Washington D.C.

Illinois

  • - Chicago

Iowa

  • - Iowa City

Trial Details

FieldValue
Enrollment Target 239 participants
Start Date 2015-04-22
Est. Completion 2027-03-31
Phase Phase 2

Sponsor

Janssen Research & Development

593 total trials

What the Registry Record Tells You About NCT02365597

The ClinicalTrials.gov registry entry for NCT02365597 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 239 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 565-participant average among 25 other Urothelial Cancer trials with a reported enrollment target (58% 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 Cancer appearing as the primary indexed condition, and to 3 interventions - of which Midazolam is the first listed.

NCT02365597 reports 20 study locations spanning 15 distinct geographic areas - top geographies include California, Oregon, Pennsylvania.

Frequently Asked Questions

What is clinical trial NCT02365597 about?

NCT02365597 is a clinical study titled "An Efficacy and Safety Study of Erdafitinib (JNJ-42756493) in Participants With Urothelial Cancer". The purpose of this study is to evaluate the objective response rate (complete response \[CR\]+ partial response \[PR\]) of the selected dose regimen in participants with metastatic or surgically unresectable urothelial cancers that harbor specific FGFR genomic alterations.

What is the current status of trial NCT02365597?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 239 participants. The study started on 2015-04-22. Estimated completion is 2027-03-31.

What conditions does trial NCT02365597 study?

This clinical trial studies the following conditions: Urothelial Cancer.

What interventions are being tested in trial NCT02365597?

The interventions under investigation include: Midazolam (DRUG), Metformin (DRUG), Erdafitinib (DRUG).

Who is sponsoring clinical trial NCT02365597?

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

Where is trial NCT02365597 being conducted?

This trial has 20 study locations across Arizona, California, Colorado, District of Columbia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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.