A Study of Erdafitinib Compared with Vinflunine or Docetaxel or Pembrolizumab inParticipants with Advanced Urothelial Cancer and Selected Fibroblast Growth Factor Receptor (FGFR) Gene Aberrations.
- Conditions
- Health Condition 1: null- Advanced Urothelial Cancer
- Registration Number
- CTRI/2018/07/014718
- Lead Sponsor
- Janssen Research Development LLC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Applicable
- Sex
- Not specified
- Target Recruitment
- 0
1.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.
2.Stage IV disease (metastatic or surgically unresectable, cT4b, N+, or M+ cancer)
3.Documented progression of disease, defined as any progression that requires a change in treatment, prior to randomization
4.Only one line of prior systemic treatment for metastatic urothelial cancer. Participants 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 chemotherapy in the metastatic setting Cohort 1: prior chemotherapy and anti-PD(L)1 [in combination or in maintenance setting] (anti-PD(L)1 alone is allowed only for participants with documented cisplatin ineligibility) and Cohort 2: prior chemotherapy (no prior anti-PD(L)1 treatment)
5.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)
6.Participants must meet appropriate molecular eligibility criteria
7.Eastern Cooperative Oncology Group (ECOG) performance status Grade 0, 1, or 2
8.Adequate bone marrow, liver, and renal function
1.Treatment with any other investigational agent or participation in another clinical study with therapeutic intent within 30 days prior to randomization
2.Active malignancies (that is, 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 fibroblast growth factor receptor (FGFR) inhibitor treatment
5.Known allergies, hypersensitivity, or intolerance to erdafitinib or its excipients
6.Corneal or retinal abnormality likely to increase the risk of eye toxicity
7.History of uncontrolled cardiovascular disease including
8.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 SurvivalTimepoint: Date of first randomization to the date of participantâ??s death (After treatment, participants will be followed up every 12 weeks to assess survival status until death, withdrawal of consent, lost for follow-up or end of study whichever occurs first. The study is considered completed with the last follow-up survival assessment for the last participant in the study or 12 months after the last participant is enrolled)
- Secondary Outcome Measures
Name Time Method