Erdafitinib vs Chemotherapy for Bladder Cancer
Trial Summary
What is the purpose of this trial?
This trial tests erdafitinib, a pill that targets proteins to stop cancer growth, in patients with a type of bladder cancer that has returned after standard treatment. The drug blocks signals that help cancer cells grow. Erdafitinib is approved for treating a specific type of advanced bladder cancer.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the drug erdafitinib for bladder cancer?
Erdafitinib has been shown to be effective in treating advanced bladder cancer, particularly in patients with specific genetic changes (FGFR2 and FGFR3 alterations), by stopping or reducing tumor growth. It is approved for use in patients whose cancer has progressed after other treatments, like chemotherapy.12345
Is erdafitinib safe for humans?
How is the drug erdafitinib different from other treatments for bladder cancer?
Erdafitinib is unique because it is an oral drug that specifically targets and inhibits fibroblast growth factor receptors (FGFRs), which are often altered in certain bladder cancers. This makes it particularly effective for patients with FGFR3 or FGFR2 alterations, offering a targeted approach compared to traditional chemotherapy.12389
Research Team
Janssen Research & Development, LLC Clinical Trial
Principal Investigator
Janssen Research & Development, LLC
Eligibility Criteria
This trial is for adults with high-risk non-muscle-invasive bladder cancer that has returned after BCG therapy. Participants must have specific FGFR mutations or fusions, be unable to undergo cystectomy, and have good performance status (ECOG 0-1). They need proper organ function and a negative pregnancy test for women of childbearing potential.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either erdafitinib or investigator's choice of intravesical chemotherapy
Follow-up
Participants are monitored for recurrence-free survival and adverse events
Long-term extension
Participants may continue treatment with erdafitinib if they demonstrate recurrence
Treatment Details
Interventions
- Erdafitinib
- Gemcitabine
- Mitomycin C
Erdafitinib is already approved in United States, European Union for the following indications:
- Locally advanced or metastatic urothelial carcinoma with susceptible FGFR3 genetic alterations
- Locally advanced or metastatic urothelial carcinoma with susceptible FGFR3 genetic alterations
Find a Clinic Near You
Who Is Running the Clinical Trial?
Janssen Research & Development, LLC
Lead Sponsor
Giacomo Salvadore
Janssen Research & Development, LLC
Chief Medical Officer since 2023
MD from the University of Rome, Tor Vergata
Ricardo Attar
Janssen Research & Development, LLC
Chief Executive Officer since 2008
PhD in Molecular Biology from the University of Buenos Aires