ONCOFID-P-B for Bladder Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests ONCOFID-P-B, a bladder-inserted medication, in adults with certain types of bladder cancer who did not respond to standard treatment and cannot or do not want surgery. The treatment aims to directly target and kill cancer cells in the bladder. ONCOFID-P-B is a new compound developed by Fidia Farmaceutici S.p.A. with specific binding to the CD44 receptor, showing high safety and effectiveness in patients with bladder cancer that did not respond to previous treatments.
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications. However, it mentions that you should not have had intravesical therapy within 4 weeks before starting the study, except for certain cytotoxic agents. It's best to discuss your specific medications with the study team.
Is ONCOFID-P-B safe for human use?
What makes the drug ONCOFID-P-B unique for treating bladder cancer?
ONCOFID-P-B is unique because it combines paclitaxel, a common cancer drug, with hyaluronic acid, which helps target cancer cells that overexpress certain receptors, potentially increasing the drug's effectiveness and reducing side effects. This combination is designed to be water-soluble and is administered directly into the bladder, which may enhance its ability to treat superficial bladder cancer.12345
What data supports the effectiveness of the drug ONCOFID-P-B for bladder cancer?
Research shows that a similar paclitaxel-hyaluronic acid bioconjugate has been effective in treating bladder cancer cells in the lab, suggesting potential for ONCOFID-P-B. Additionally, this type of drug has shown strong anti-cancer activity in other cancers, like ovarian cancer, by targeting specific cancer cell receptors.12345
Are You a Good Fit for This Trial?
Adults with bladder cancer that hasn't spread, who haven't responded to BCG therapy and can't or won't have their bladder removed. They must be in good health overall, not pregnant, willing to use contraception, and able to follow the study plan.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Induction
Participants receive 12 weekly intravesical instillations of ONCOFID-P-B
Re-induction
Eligible participants with residual CIS receive additional intravesical instillations
Maintenance
Participants achieving complete response receive monthly intravesical instillations for up to 12 months
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- ONCOFID P-B (PACLITAXEL-HYALURONIC ACID)
ONCOFID P-B (PACLITAXEL-HYALURONIC ACID) is already approved in European Union for the following indications:
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Who Is Running the Clinical Trial?
Fidia Farmaceutici s.p.a.
Lead Sponsor