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Clinical Trials List

Protocol Number42756493BLC2003
NCT Number(ClinicalTrials.gov Identfier)NCT04172675
Completed

2020-02-28 - 2023-08-04

Phase II

Not yet recruiting6

ICD-10C67.0

Malignant neoplasm of trigone of bladder

ICD-10Z51.12

Encounter for antineoplastic immunotherapy

ICD-9188.0

Malignant neoplasm of trigone of urinary bladder

A Randomized Phase 2 Study of Erdafitinib Versus Investigator Choice of Intravesical Chemotherapy in Subjects Who Received Bacillus Calmette-Guérin (BCG) and Recurred With High Risk Non-Muscle-Invasive Bladder Cancer (NMIBC) and FGFR Mutations or Fusions

  • Trial Applicant

    Johnson & Johnson

  • Sponsor

    Janssen Research & Development, LLC

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator Kai-Jie Yu Division of Hematology & Oncology
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Hsi-Chin Wu Division of Urology
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator 裘坤元 Division of Urology
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Yi-Hsiu Huang Division of Urology
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator CHUNG-HSIN CHEN Division of Urology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Wen-Jeng Wu Division of Urology
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Condition/Disease

Non-Muscle-Invasive Bladder Cancer (NMIBC)

Objectives

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. 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.

Test Drug

Erdafitinib
Gemcitabine
Mitomycin

Active Ingredient

Erdafitinib
Gemcitabine hydrochloride
Mitomycin

Dosage Form

Tablet
powder for solution for infusion
Powder for solution

Dosage

3, 4, 5 mg

Endpoints

Primary Outcome Measures :
Recurrence-Free Survival (RFS) [ Time Frame: Up to 4 years ]
RFS is defined as the time from the date of randomization until the date of the reappearance of high-risk disease, or death, whichever is reported first.

Inclution 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

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

The Estimated Number of Participants

  • Taiwan

    18 participants

  • Global

    280 participants

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