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Clinical Trials List

Protocol Number42756493BLC3001
NCT Number(ClinicalTrials.gov Identfier)NCT03390504
Completed

2018-10-30 - 2022-12-31

Phase III

Recruiting2

Terminated10

ICD-10C68.9

Malignant neoplasm of urinary organ, unspecified

A Phase 3 Study of Erdafitinib Compared with Vinflunine or Docetaxel or Pembrolizumab in Subjects with Advanced Urothelial Cancer and Selected FGFR Gene Aberrations

  • Trial Applicant

    Johnson & Johnson

  • Sponsor

    Janssen Research & Development, LLC

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator Wen-Pin Su Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Audit

None

Principal Investigator 吳鴻昌 Division of Hematology & Oncology
Chi Mei Medical Center

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 鄭元佐 Division of Urology
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

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

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 黃國埕 Division of Hematology & Oncology
Koo Foundation Sun Yat-Sen Cancer Center

Co-Principal Investigator

  • 陳鵬宇 Division of Hematology & Oncology

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 裘坤元 Division of Urology
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 林炯森 Division of Hematology & Oncology
MacKay Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

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 Terminated

Principal Investigator Yu-Chieh Tsai Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Audit

None

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

2 Terminated

Principal Investigator Su-Peng Yeh Division of Hematology & Oncology
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 林炯森 Division of Hematology & Oncology
MacKay Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Condition/Disease

Urothelial Cancer

Objectives

The primary objective of this study is to evaluate efficacy of erdafitinib versus chemotherapy or pembrolizumab in subjects with advanced urothelial cancer harboring selected FGFR aberrations who have progressed after one prior treatment. The primary endpoint of overall survival (OS) will be evaluated in 2 cohorts: Cohort 1: erdafitinib versus chemotherapy (docetaxel or vinflunine) [subjects who have received prior anti-PD(L)1 agent] Cohort 2: erdafitinib versus pembrolizumab [subjects who have not received prior anti-PD-(L)1 agent]

Test Drug

Erdafitinib

Active Ingredient

Erdafitinib

Dosage Form

film-coated tablet

Dosage

3 mg, 4 mg and 5mg

Endpoints

1. Efficacy: Assessment of responses for solid tumors will be performed according to RECIST (version 1.1) by investigators.
2. Safety: Safety assessments will be based on medical review of adverse event reports and the results of vital sign measurements, electrocardiograms, physical examinations, clinical laboratory tests, ECOG performance status, ophthalmologic examinations, and other safety evaluations at specified time points as described in the Time and Events Schedule.
3. Pharmacokinetics: Venous blood samples will be collected for determination of plasma concentrations of erdafitinib and alpha-1-acid glycoproteins, total protein, and fraction unbound, if required, at the time points specified in the Time and Events Schedule, for all subjects randomized to erdafitinib arms (Arm 1A and Arm 2A). Tissue collected on study will be used to assess the immune marker status and identify the molecular subtype of patient tumors.
4. Quality of life: Patients health-related quality of life symptoms, functioning, and general well-being will be captured using 3 PRO measures: the FACT-Bl, PGIS, and the EQ-5D-5L.

Inclution Criteria

1. ≥20 years of age.
2. Histologic demonstration of transitional cell carcinoma of the urothelium.
3. Stage IV disease (metastatic or surgically unresectable cancer).
4. Documented progression of disease, defined as any progression that requires a change in treatment, prior to randomization.
5. Only one line of prior systemic treatment for metastatic urothelial cancer.
6. Subjects must meet appropriate molecular eligibility criteria (as determined by central laboratory screening)
7. Eastern Cooperative Oncology Group (ECOG) performance status Grade 0, 1, or 2.
8. Adequate bone marrow, liver, and renal function.
9. 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.
10. A woman of childbearing potential who is sexually active must have a negative pregnancy test at Screening (urine or serum).
11. Contraceptive use by men or women should be consistent with local regulations regarding the use of contraceptive methods for subject participating in clinical studies.

Exclusion Criteria

1. Treatment with any other investigational agent or participation in another clinical study within 30 days prior to enrolment in the study.
2. Active malignancies (ie, requiring treatment change in the last 24 months) other than urothelial cancer (except skin cancers within the last 24 months that is considered completely cured).
3. Symptomatic central nervous system metastases.
4. Received prior FGFR inhibitor treatment.
5. Known allergies, sensitivity, or intolerance to erdafitinib or its components.
6. Corneal or retinal abnormality likely to increase the risk of eye toxicity.
7. History of uncontrolled cardiovascular disease.
8. Known active AIDS (human immunodeficiency virus (HIV) infection).
9. Known active hepatitis B or C infection.
10. Not recovered from reversible toxicity of prior anticancer therapy (except toxicities which are not clinically significant such as alopecia, skin discoloration, mild neuropathy, mild hearing loss).
11. Impaired wound healing capacity defined as skin/decubitus ulcers, chronic leg ulcers, known gastric ulcers, or unhealed incisions.
12. Major surgery within 4 weeks before randomization.
13. Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the patient (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments. Examples include poorly controlled diabetes, or ongoing active infection requiring intravenous antibiotics.

The Estimated Number of Participants

  • Taiwan

    18 participants

  • Global

    630 participants

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