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Anti-metabolites

ONCOFID-P-B for Bladder Cancer

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
Age 18 years or older, male or female
In patients with T1 papillary lesions undergoing resection of the base of the lesion, the biopsy should contain muscle fibers
Timeline
Screening 3 weeks
Treatment Varies
Follow Up rate of patients undergoing cystectomy will be evaluated at 3 months (end of induction phase), 15 and 24 months after treatment start.
Awards & highlights

Study Summary

This trialstudies if a drug improves bladder cancer treatment when BCG is not working.

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.Check my eligibility
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.See study design
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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I am 18 years old or older.
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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 have bladder cancer that didn't respond to BCG and I can't or won't have surgery to remove my bladder.
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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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I agree to use effective birth control methods if my partner can become pregnant.
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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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~progression rate will be evaluated at 3, 15 and 24 months after treatment start
This trial's timeline: 3 weeks for screening, Varies for treatment, and progression rate will be evaluated at 3, 15 and 24 months after treatment start for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Centrally assessed Complete Response Rate (CRR) - end of induction phase
Secondary outcome measures
Centrally assessed CRR
Duration of Response (DoR)
Duration of Response (DoR) rate
+7 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: ONCOFID P-B (PACLITAXEL-HYALURONIC ACID)Experimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

Fidia Farmaceutici s.p.a.Lead Sponsor
32 Previous Clinical Trials
4,380 Total Patients Enrolled

Media Library

ONCOFID P-B (PACLITAXEL-HYALURONIC ACID) (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT05024773 — Phase 3
Bladder Cancer Research Study Groups: ONCOFID P-B (PACLITAXEL-HYALURONIC ACID)
Bladder Cancer Clinical Trial 2023: ONCOFID P-B (PACLITAXEL-HYALURONIC ACID) Highlights & Side Effects. Trial Name: NCT05024773 — Phase 3
ONCOFID P-B (PACLITAXEL-HYALURONIC ACID) (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05024773 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available slots for participation in this research trial?

"It appears that this clinical trial is currently in its recruitment phase, as indicated by information posted on the website clinicaltrials.gov. The process began on December 29th 2022 and has been updated as recent as January 18th 2023."

Answered by AI

What clinical indication is ONCOFID P-B (PACLITAXEL-HYALURONIC ACID) utilized to address?

"Patients with locally advanced non-small cell lung cancer are well served by the administration of ONCOFID P-B (PACLITAXEL-HYALURONIC ACID). This medication is also useful for treating metastatic bladder cancers, dermabrasion and skin conditions."

Answered by AI

How many volunteers are taking part in this experiment?

"Affirmative. According to clinicaltrials.gov, the trial that was initiated on December 29th 2022 is currently recruiting participants. A total of 112 volunteers will be sought from 1 medical centre for this study."

Answered by AI

Has the FDA sanctioned ONCOFID P-B (PACLITAXEL-HYALURONIC ACID) for use in medical treatments?

"Clinical evidence points towards ONCOFID P-B (PACLITAXEL-HYALURONIC ACID) as a safe treatment, thus it is given a rating of 3 on our scale. Phase 3 trials have further confirmed its efficacy with multiple rounds of data affirming safety."

Answered by AI

Can you provide any details on prior research utilizing ONCOFID P-B (PACLITAXEL-HYALURONIC ACID)?

"Presently, the number of active clinical trials researching ONCOFID P-B (PACLITAXEL-HYALURONIC ACID) is 799 with 217 in Phase 3. The main hub for these investigations is Woolloongabba, Queensland but other sites are also conducting research across 43471 different locations."

Answered by AI
~63 spots leftby Nov 2025