A Study of Erdafitinib Compared with Vinflunine or Docetaxel or Pembrolizumab in Participants with Advanced Urothelial Cancer and Selected Fibroblast Growth Factor Receptor (FGFR) Gene Aberrations
- Conditions
- rothelial Cancer
- Registration Number
- JPRN-jRCT2080223892
- Lead Sponsor
- Janssen Pharmaceutical K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 631
Histologic demonstration of transitional cell carcinoma of the urothelium. Minor components ( less than [<] 50 percent [%] overall) of variant histology such as glandular or squamous differentiation, or evolution to more aggressive phenotypes such as sarcomatoid or micropapillary change are acceptable
- Metastatic or surgically unresectable urothelial cancer
- Documented progression of disease, defined as any progression that requires a change in treatment, prior to randomization
- Cohort 1: Prior treatment with an anti-PD-(L) 1 agent as monotherapy or as combination therapy; no more than 2 prior lines of systemic treatment.
Cohort 2: No prior treatment with an anti-PD-(L) 1 agent; only 1 line of prior systemic treatment for metastatic urothelial cancer. Subjects who received neoadjuvant or adjuvant chemotherapy and showed disease progression (as defined above), within 12 months of the last dose are considered to have received systemic therapy chemotherapy in the metastatic setting.
- A woman of childbearing potential who is sexually active must have a negative pregnancy test (beta human chorionic gonadotropin [beta hCG]) at Screening
(urine or serum)
- Participants must meet appropriate molecular eligibility criteria
- Eastern Cooperative Oncology Group (ECOG) performance status Grade 0, 1, or 2
- Adequate bone marrow, liver, and renal function
- Treatment with any other investigational agent or participation in another clinical study with therapeutic intent within 30 days prior to randomization
- Active malignancies (that is, requiring treatment change in the last 24 months). The only allowed exceptions are: urothelial cancer, skin cancer treated within the last 24 months that is considered completely cured, localized prostate cancer with a gleason score of 6 (treated within the last 24 months or untreated and under surveillance) and localized prostate cancer with a gleason score of 3+4 that has been treated more than 6 months prior to full study screening and considered have a very low risk of recurrence.
- Symptomatic central nervous system metastases
- Received prior fibroblast growth factor receptor (FGFR) inhibitor treatment
- Known allergies, hypersensitivity, or intolerance to erdafitinib or its excipients
- Current central serous retinopathy (CSR) or retinal pigment epithelial detachment of any grade.
- History of uncontrolled cardiovascular disease including
- Impaired wound healing capacity defined as skin/decubitus ulcers, chronic leg ulcers, known gastric ulcers, or unhealed incisions
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall Survival (OS)<br>-Date of first randomization to the date of participant's death (approximately up to 3 years)<br>-Overall survival is measured from the date of randomization to the date of the participant's death. If the participant is alive or the vital status is unknown, the participant will be censored at the date the participant was last known to be alive.
- Secondary Outcome Measures
Name Time Method