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ONCOFID-P-B for Bladder Cancer
Study Summary
This trialstudies if a drug improves bladder cancer treatment when BCG is not working.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I am 18 years old or older.My biopsy for the T1 papillary lesion included muscle fibers.I haven't had bladder treatments except for one dose of specific drugs after a bladder tumor surgery recently.I have a bladder condition that affects bladder treatments.I have no other cancers in the last 5 years, except for certain skin cancers, cervical or low-risk prostate cancer.My bladder cancer has not spread deeply, confirmed by an exam under anesthesia.My heart's electrical cycle is longer than normal, and I take medications that can extend it further.I have had cancer in my upper urinary tract or prostatic urethra.I have bladder cancer that didn't respond to BCG and I can't or won't have surgery to remove my bladder.I had surgery to remove early-stage bladder tumors, but may still have some cancer cells present.I agree to use effective birth control methods if my partner can become pregnant.My blood counts and liver/kidney functions are within normal ranges.I can take care of myself and am up and about more than half of my waking hours.I am not pregnant, breastfeeding, and if capable of becoming pregnant, I agree to use birth control during the study and for 3 months after.My bladder cancer has come back or hasn't gone away and hasn't spread.I am a man and will use birth control during and for 6 months after the study.My bladder cancer has invaded the muscle layer or has spread.I have received treatment for bladder cancer.You have a history of substance or alcohol abuse.I am allergic to paclitaxel or its ingredients.I have not had major surgery in the last 4 weeks.I cannot undergo bladder procedures due to serious health conditions like heart or lung problems.I have completed the recommended BCG treatment.I am a woman who cannot have children due to surgery or menopause.I am experiencing symptoms of a urinary tract infection or bladder infection.
- Group 1: ONCOFID P-B (PACLITAXEL-HYALURONIC ACID)
- 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.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
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."
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