Bladder Cancer Clinical Trial
A Study of Erdafitinib Versus Investigator Choice of Intravesical Chemotherapy in Participants Who Received Bacillus Calmette-Guérin (BCG) and Recurred With High Risk Non-Muscle-Invasive Bladder Cancer (NMIBC)
Summary
The purpose of this study is to evaluate recurrence-free survival (RFS) in participants treated with erdafitinib vs Investigator's Choice, for participants with high-risk non-muscle-invasive bladder cancer (NMIBC) who harbor fibroblast growth factor receptor (FGFR) mutations or fusions, and who recurred after bacillus calmette-guerin (BCG) therapy.
Full Description
This study enrolls participants with high risk NMIBC and FGFR mutations or fusions. Erdafitinib is an oral pan-fibroblast growth factor receptor (FGFR) 1-4 inhibitor with demonstrated clinical activity in participants with solid tumors, including urothelial carcinoma, with alterations in the FGFR pathway. In Cohort 1, participants will be randomized to erdafitinib or to Investigators Choice (intravesical gemcitabine or intravesical MMC/hyperthermic MMC). The study consists of Screening period, Treatment Phase and Follow-up Phase.
Eligibility Criteria
Inclusion Criteria:
Histologically confirmed, recurrent, non-muscle-invasive urothelial carcinoma of the bladder. Variant pathology are allowed
Tumor with specified fibroblast growth factor receptor (FGFR) mutations or fusions
Bacillus Calmette- Guerin (BCG)-unresponsive after adequate BCG therapy or BCG experienced participants
Refuses or is not eligible for cystectomy (Cohort 1 and Cohort 2 only)
Eastern Cooperative Oncology Group (ECOG) performance status Grade 0-1
Must sign an informed consent form (ICF) (or their legally acceptable representative must sign) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study
A woman of childbearing potential must have a negative pregnancy test (beta-hCG [beta-human chorionic gonadotropin]) (urine or serum) within 7 days before randomization (Cohort 1) or the first dose of study drug (Cohort 2 and Cohort 3)
Adequate bone marrow, liver, and renal function as specified in the protocol
Exclusion Criteria:
Histologically confirmed, muscle-invasive (T2 or higher stage) urothelial carcinoma of the bladder
Histopathology demonstrating any small cell component, pure adenocarcinoma, pure squamous cell carcinoma, or pure squamous CIS of the bladder
Prior treatment with an FGFR inhibitor
Active malignancies other than the disease being treated under study. The only allowed exceptions are: (a) skin cancer treated within the last 24 months that is considered completely cured (b) adequately treated lobular carcinoma in situ (LCIS) and ductal CIS (c) history of localized breast cancer and receiving antihormonal agents, or history of localized prostate cancer (N0M0) and receiving androgen deprivation therapy
Current central serous retinopathy or retinal pigment epithelial detachment of any grade
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There are 147 Locations for this study
Tucson Arizona, 85741, United States
Los Angeles California, 90033, United States
Denver Colorado, 80211, United States
Hialeah Florida, 33016, United States
Atlanta Georgia, 30322, United States
Chicago Illinois, 60611, United States
Springfield Illinois, 62702, United States
Westwood Kansas, 66205, United States
Albany New York, 12208, United States
Bronx New York, 10461, United States
New York New York, 10016, United States
Sanborn New York, 14132, United States
Charlotte North Carolina, 28204, United States
Cincinnati Ohio, 45212, United States
Columbus Ohio, 43210, United States
Portland Oregon, 97239, United States
Bala-Cynwyd Pennsylvania, 19004, United States
Pittsburgh Pennsylvania, 15232, United States
Nashville Tennessee, 37209, United States
Dallas Texas, 75390, United States
Seattle Washington, 98008, United States
Milwaukee Wisconsin, 53226, United States
Buenos Aires , C1419, Argentina
Buenos Aires , , Argentina
Ciudad Autonoma de Buenos Aires , C1431, Argentina
Ciudad Autonoma de , C1199, Argentina
Cordoba , 5000, Argentina
Cordoba , X5000, Argentina
Cordoba , XX501, Argentina
Bedford Park , 5042, Australia
Darlinghurst , 2010, Australia
Macquarie University , 2109, Australia
Melbourne , 3000, Australia
Gent , 9000, Belgium
Leuven , 3000, Belgium
Liege , 4000, Belgium
Roeselare , 8800, Belgium
Curitiba , 81520, Brazil
Fortaleza , 60135, Brazil
Goiania , 74605, Brazil
Natal , 59075, Brazil
Porto Alegre , 90050, Brazil
Porto Alegre , 91350, Brazil
Recife , 50070, Brazil
Ribeirão Preto , 14048, Brazil
Rio de Janeiro , 22250, Brazil
Rio de Janeiro , 22775, Brazil
Santo Andre , 09060, Brazil
Sao Paulo , 01246, Brazil
Sao Paulo , 04039, Brazil
São Paulo , 01308, Brazil
Nanjing , 21000, China
Shanghai , 20003, China
Shanghai , 20024, China
Wuhan , 43003, China
Brno , 656 9, Czechia
Liberec , 460 6, Czechia
Praha 2 , 128 0, Czechia
Praha 5 , 150 0, Czechia
Bordeaux , 33076, France
Clermont Ferrand , 63000, France
Lille , 59037, France
Lyon Cedex 03 , 69437, France
Marseille Cedex 9 , 13273, France
Paris , 75013, France
Paris , 75020, France
Paris , 75877, France
Poitiers , 86021, France
Rennes Cedex , 35033, France
Rouen , 76031, France
Saint Gregoire , 35760, France
Toulouse , 31000, France
Vandœuvre-lès-Nancy Cedex , 54519, France
Villejuif Cedex , 94800, France
Duisburg , 47169, Germany
Herne , 44625, Germany
Lubeck , 23538, Germany
Muenchen , 81675, Germany
Muenster , 48149, Germany
Mülheim an der Ruhr , 45468, Germany
Nuernberg , 90491, Germany
Nuertingen , 72622, Germany
Wesseling , 50389, Germany
Bangalore , 56002, India
Delhi , 11008, India
Lucknow , 22600, India
Madhurai , 62510, India
Nadiad , 38700, India
Pune , 41104, India
Acquaviva delle Fonti , 70021, Italy
Aosta , 11100, Italy
Cefalu , 90015, Italy
Guastalla , 42016, Italy
Lecce , 73100, Italy
Macerata , 62100, Italy
Milano , 20133, Italy
Milan , 20132, Italy
Napoli , 80138, Italy
Roma , 00189, Italy
Verona , 37126, Italy
Bunkyo-Ku , 113-8, Japan
Bunkyo-Ku , 113-8, Japan
Chiba , 289-2, Japan
Hakodate , 040-8, Japan
Hidaka , 350-1, Japan
Hitachi , 317-0, Japan
Kanagawa , 216-8, Japan
Nagoya , 466-8, Japan
Osaka , 591-8, Japan
Ota , 373-8, Japan
Takatsuki , 569-8, Japan
Tokyo , 105-8, Japan
Tokyo , 135-8, Japan
Toyoake , 470-1, Japan
Tsukuba-City , 305-8, Japan
Yokohama , 232-0, Japan
Busan , 49241, Korea, Republic of
Cheongju , 361-7, Korea, Republic of
Daegu , 41404, Korea, Republic of
Goyang-si , 10408, Korea, Republic of
Jeollanam-do , 58128, Korea, Republic of
Seoul , 02841, Korea, Republic of
Seoul , 03080, Korea, Republic of
Seoul , 03181, Korea, Republic of
Seoul , 03722, Korea, Republic of
Seoul , 06351, Korea, Republic of
Gdansk , 80-21, Poland
Krakow , 30-72, Poland
Rzeszow , 35-05, Poland
Szczecin , 70-11, Poland
Warszawa , 02-47, Poland
Warszawa , 02-79, Poland
Wroclaw , 50-55, Poland
Barcelona , 08025, Spain
Barcelona , 8036, Spain
Madrid , 28034, Spain
Madrid , 28041, Spain
Madrid , 28046, Spain
Sabadell , 08208, Spain
Santander , 39008, Spain
Valencia , 46009, Spain
Kaohsiung , 80756, Taiwan
Taichung , 40447, Taiwan
Taichung , 40705, Taiwan
Taipei , 10002, Taiwan
Taipei , 11217, Taiwan
Taoyuan County , 33305, Taiwan
Manchester , M20 4, United Kingdom
Sheffield , S10 2, United Kingdom
Stevenage , SG1 4, United Kingdom
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