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

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

239

Participants

Timeline

Start Date

April 22, 2015

Primary Completion Date

September 15, 2022

Study Completion Date

December 31, 2026

Conditions
Urothelial Cancer
Interventions
DRUG

Erdafitinib

8 mg orally once daily for 28 days on a 28 day cycle.

DRUG

Midazolam

Participants who enrolled in DDI substudy will receive pretreatment with single dose of midazolam on Day -2 and single dose of midazolam on Day 13.

DRUG

Metformin

Participants who enrolled in DDI substudy will receive pretreatment with single dose of metformin on Day -1 and single dose of metformin on Day 14.

Trial Locations (105)

Unknown

Sedona

Los Angeles

Orange

Sacramento

Stanford

Aurora

Washington D.C.

Chicago

Iowa City

Louisville

Minneapolis

Omaha

Las Vegas

New York

Charlotte

Medford

Tualatin

Hershey

Pittsburgh

Myrtle Beach

Nashville

Dallas

Denton

Houston

Hampton

Graz

Linz

Vienna

Aalst

Brussels

Charleroi

Ghent

Wilrijk

Angers

Bordeaux

Caen Cédex 05

Dijon

Lyon

Nice

Nîmes

Paris

Saint-Herblain

Suresnes

Villejuif

Berlin

Erlangen

Essen

Freiburg im Breisgau

Göttingen

Greifswald

Hamburg

Hanover

Heidelberg

München

Münster

Regensburg

Straubing

Weiden/Opf

Bangalore

Kolkata

Mira Road (East)

Nadiād

Beer Yaakov

Beersheba

Haifa

Kfar Saba

Petah Tikva

Tel Aviv

Chisinau

Bucharest

Cluj-Napoca

Craiova

Iași

Barnaul

Moscow

Omsk

Pyatigorsk

Saint Petersburg

Ufa

Daejeon

Goyang-si

Incheon

Seoul

Badalona

Barcelona

Madrid

Málaga

Pamplona

Sabadell

Santander

Santiago de Compostela

Seville

Valencia

Taichung

Tainan City

Taipei

Taoyuan District

Istanbul

Blackburn

Dundee

Essex

London

Metropolitan Borough of Wirral

Plymouth

Sutton

All Listed Sponsors
lead

Janssen Research & Development, LLC

INDUSTRY