RecruitingPHASE3INTERVENTIONAL

Study of ONCOFID-P-B (PACLITAXEL-HYALURONIC ACID)

This study investigates a new treatment called ONCOFID-P-B for a type of bladder cancer called Carcinoma in Situ (CIS). It's for adults whose cancer hasn't responded to standard BCG therapy or who aren't able or willing to have surgery to remove their bladder. The main goal is to see how well this new treatment works and if it's safe. Participants will receive the medication directly into their bladder over several months, with regular check-ups to monitor their cancer and overall health. The study hopes to offer a new option for patients with this specific type of bladder cancer.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Fidia Farmaceutici s.p.a.

Enrolment target

112

Start

29 Dec 2022

Estimated completion

01 Dec 2030

Bladder Carcinoma in Situ (CIS)

What is this study about?

This study is looking into a new treatment called ONCOFID-P-B for a specific type of bladder cancer. This cancer is called Carcinoma in Situ (CIS), and it's found on the inner lining of the bladder. The treatment is being tested for people whose cancer hasn't responded to the usual treatment (BCG therapy), or for those who can't or don't want to have major surgery to remove their bladder.

The medication, ONCOFID-P-B, is a combination of two substances. It's given directly into the bladder using a small tube, a procedure known as 'intravesical instillation'. This method targets the treatment directly where it's needed while trying to minimise effects on the rest of the body. The study aims to understand how effective this treatment is at clearing the cancer and whether it's safe for patients.

This is a 'Phase 3' study, which means it’s one of the final stages of testing before a new treatment might become widely available. This phase usually involves a larger number of patients and compares the new treatment against existing ones or a placebo (though this particular study doesn't include a placebo or a direct comparison group). Understanding the results of studies like this is crucial for developing new and better ways to manage bladder cancer for patients in the future.

Key takeaways

This study is for a specific type of bladder cancer (CIS) that hasn't responded to standard treatment.
The new treatment, ONCOFID-P-B, is given directly into the bladder.
It's an option for those who cannot or will not have surgery to remove their bladder.
Participation involves weekly and then monthly treatments, with long-term monitoring.
The study aims to find out if this treatment is safe and effective.
You can withdraw from the study at any time without affecting your medical care.

Who may be eligible?

To be considered for this study, you need to be an adult, 18 years or older, with a confirmed diagnosis of CIS bladder cancer. Your cancer must have either not responded to standard BCG therapy or you must be unable or unwilling to have surgery to remove your bladder.

For those who've had previous papillary lesions (other types of bladder tumours), these must have been completely removed before joining the study. You'll also need to be generally well enough to take part and have standard blood tests showing that your organs are working properly.

Quick self-check

Are you 18 years old or older?
Do you have confirmed bladder cancer (CIS) that hasn't spread?
Has your bladder cancer not responded to BCG therapy, or are you unable/unwilling to have a bladder removal surgery?
Are you generally well and able to physically take part in the study?
Are your routine blood tests (like blood count and liver/kidney function) within acceptable limits?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to join, you'll first give your written permission (consent). You'll then have a series of treatments where the study medication, ONCOFID-P-B, is put directly into your bladder. Initially, you'll receive these treatments once a week for 12 weeks. During this time, the medical team will closely monitor your progress using bladder examinations (cystoscopy), urine tests for cancer cells (cytology), and sometimes tissue samples (biopsies).

If the cancer hasn't responded enough after the first 12 weeks, you might be offered another course of treatment. If your cancer clears, you'll then move into a maintenance phase, receiving the treatment once a month for an additional 12 months. Throughout the study, you'll have regular check-ups, including bladder examinations and urine tests, for up to four years to see how well the treatment is working in the long term.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. While this new treatment aims to help people whose bladder cancer hasn't responded to standard care, there's no guarantee it will work for everyone, and it might not be better than other options. There could be side effects from the medication or the procedures involved, which the study team will discuss thoroughly with you. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (47)

Banner Health- MD Anderson Cancer Center
Gilbert, United States· Recruiting
Ochsner Clinic Foundation
New Orleans, United States· Recruiting
Johns Hopkins Kimmel Cancer Center
Baltimore, United States· Recruiting
University of Minnesota
Minneapolis, United States· Recruiting
TriState Urologic Services PSC Inc. dba The Urology Group
Cincinnati, United States· Recruiting
Medical University of South Carolina (MUSC)
Charleston, United States· Recruiting
CHU Bordeaux -Hopital Pellegrin
Bordeaux, France· Recruiting
CHU de Clermont-Ferrand - Hopital Gabriel Montpied
Clermont-Ferrand, France· Recruiting
CHU de Lille - Hopital Claude Huriez
Lille, France· Recruiting
Institute Paoli-Calmettes
Marseille, France· Recruiting
AP-HP Hopital Bichat-Claude Bernard
Paris, France· Recruiting
AP-HP Hopital Tenon
Paris, France· Terminated

+35 more sites — see the official record for the full list.

Common questions

What is Carcinoma in Situ (CIS) of the bladder?

CIS is a type of bladder cancer where abnormal cells are found only on the inner lining of the bladder and haven't spread deeper.

What does 'BCG unresponsive' mean?

It means the standard treatment, BCG therapy, hasn't worked to control the bladder cancer, or the cancer has come back soon after.

How is the study medication given?

The medication is given directly into your bladder through a small tube; this is called intravesical instillation.

How long will I be in the study?

The treatment phase can last several months, and you'll be followed up for a total of up to four years to monitor your health and the cancer.

Can I leave the study at any point?

Yes, you are free to withdraw from the study at any time, and this will not affect your future medical care.

How to find out more

Nicola Giordan

ngiordan@fidiapharma.it +390498232512 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.