What side effects are associated with this type of intervention?

Intravesical treatments for bladder cancer, such as those involving gemcitabine, mitomycin, adriamycin, and Bacillus Calmette-Guérin (BCG), commonly cause local side effects. These include chemical cystitis, which manifests as bladder irritation and discomfort, and hypersensitivity reactions like rashes on the palms, soles, and genitalia. Systemic absorption is minimal, so myelosuppression is rare. BCG therapy can also lead to more severe complications such as infections, including BCG infection, which may affect prosthetic devices. Overall, while these treatments are effective, they are associated with a range of local and occasionally systemic side effects.

What other types of research exist?

Promising novel alternatives to ONCOFID-P-B for bladder cancer patients include: 1) Intravesical gemcitabine, which has shown similar efficacy to mitomycin with a better toxicity profile. 2) Combination therapies such as sequential BCG and electromotive mitomycin (EMDA MMC), which have demonstrated decreased recurrence and progression rates. 3) Immunotherapeutic agents like atezolizumab and pembrolizumab, which are being explored for their efficacy in non-muscle-invasive bladder cancer (NMIBC). 4) Enfortumab vedotin, an antibody-drug conjugate, which has shown promise in advanced urothelial carcinoma. These alternatives offer various mechanisms of action and potential benefits for bladder cancer patients.

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Anti-metabolites

ONCOFID-P-B for Bladder Cancer

Q: What prior FDA approvals exist?

The FDA has approved several treatments for bladder cancer, including intravesical therapies similar to ONCOFID-P-B. Notably, Bacillus Calmette-Guérin (BCG) and mitomycin C are commonly used intravesical agents for non-muscle invasive bladder cancer (NMIBC). These treatments involve direct instillation into the bladder to target cancer cells locally. Additionally, systemic therapies such as pembrolizumab and atezolizumab have been approved for advanced urothelial carcinoma, providing broader treatment options for patients with more advanced stages of the disease.

Phase 3

Recruiting

Research Sponsored by Fidia Farmaceutici s.p.a.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

In patients with T1 papillary lesions undergoing resection of the base of the lesion, the biopsy should contain muscle fibers

In patients undergoing transurethal resection of their bladder tumors, absence of locally advanced disease should be confirmed by pelvic examination under anesthesia

Must not have

Presence of significant urologic disease interfering with intravesical therapy

Subjects who have a mean QTc >480 msec at baseline and who need concomitant medications which may cause QT prolongation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up dor rates will be evaluated at 6, 9, 12, 15, 18, 21, 30, 36, 42 and 48 after induction or re-induction start

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

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.

Who is the study for?

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.

What is being tested?

The trial is testing ONCOFID-P-B for bladder cancer patients unresponsive to BCG therapy. It involves an initial phase of weekly treatments for 12 weeks followed by monthly maintenance doses for responders up to a year.

What are the potential side effects?

Possible side effects include allergic reactions to paclitaxel or other ingredients in ONCOFID-P-B, as well as typical chemotherapy-related issues like fatigue, blood disorders, liver problems, and increased risk of infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My biopsy for the T1 papillary lesion included muscle fibers.

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My bladder cancer has not spread deeply, confirmed by an exam under anesthesia.

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I had surgery to remove early-stage bladder tumors, but may still have some cancer cells present.

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My blood counts and liver/kidney functions are within normal ranges.

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I can take care of myself and am up and about more than half of my waking hours.

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My bladder cancer has come back or hasn't gone away and hasn't spread.

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I have completed the recommended BCG treatment.

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I am a woman who cannot have children due to surgery or menopause.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a bladder condition that affects bladder treatments.

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My heart's electrical cycle is longer than normal, and I take medications that can extend it further.

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I have had cancer in my upper urinary tract or prostatic urethra.

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I am a man and will use birth control during and for 6 months after the study.

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My bladder cancer has invaded the muscle layer or has spread.

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I have received treatment for bladder cancer.

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I am allergic to paclitaxel or its ingredients.

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I have not had major surgery in the last 4 weeks.

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I am experiencing symptoms of a urinary tract infection or bladder infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ crr will be evaluated at 6, 9, 12, 15, 18, 21, 24, 30, 36, 42 and 48 months after induction or re-induction

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~crr will be evaluated at 6, 9, 12, 15, 18, 21, 24, 30, 36, 42 and 48 months after induction or re-induction

This trial's timeline: 3 weeks for screening, Varies for treatment, and crr will be evaluated at 6, 9, 12, 15, 18, 21, 24, 30, 36, 42 and 48 months after induction or re-induction for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Centrally assessed Complete Response Rate (CRR) at any time

Secondary study objectives

Centrally assessed CRR

Duration of Response (DoR)

Duration of Response (DoR) rate

+8 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups

Experimental Treatment

Group I: ONCOFID P-B (PACLITAXEL-HYALURONIC ACID)Experimental Treatment1 Intervention

0 / 17Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for bladder cancer include intravesical therapies, such as Bacillus Calmette-Guérin (BCG) and chemotherapeutic agents like mitomycin C and gemcitabine. These treatments involve direct instillation into the bladder, allowing high local concentrations of the drug with minimal systemic absorption. BCG works by stimulating the immune system to attack cancer cells, while chemotherapeutic agents like mitomycin C and gemcitabine inhibit DNA synthesis, leading to cancer cell death. The significance of these treatments lies in their ability to target the tumor directly, reducing the risk of systemic side effects and preserving bladder function, which is crucial for maintaining the patient's quality of life.

Oncofid-P-B: a novel treatment for BCG unresponsive carcinoma in situ (CIS) of the bladder: Results of a prospective European Multicentre study at 15 months from treatment start.Does it matter whether a T1 high-grade tumor is molecularly classified?[Mechanism of action of intravesical BCG. Biological bases and clinical applicability.]