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Paclitaxel Obaluronate

This article discusses the ongoing clinical trials of Paclitaxel Obaluronate, also known as ONCOFID-P-B, for the treatment of bladder cancer. Specifically, the drug is being studied in patients with BCG-unresponsive Carcinoma in Situ (CIS) of the bladder, with or without Ta-T1 papillary disease. The trial aims to evaluate the efficacy and safety of this intravesical treatment option for patients who have not responded to standard therapy.

Table of Contents

What is ONCOFID-P-B?

ONCOFID-P-B is a new medication being studied for the treatment of certain types of bladder cancer. It is classified as a new chemical entity, which means it’s a novel drug that hasn’t been previously approved for medical use. The active substance in ONCOFID-P-B is called paclitaxel obaluronate.[1]

Medical Condition Treated

ONCOFID-P-B is being investigated for the treatment of BCG-unresponsive Carcinoma in Situ (CIS) of the bladder, with or without Ta-T1 papillary disease. This is a specific type of bladder cancer that hasn’t responded to the standard treatment called BCG (Bacillus Calmette-Guérin).[1]

To understand this better:

  • Carcinoma in Situ (CIS): This is an early form of cancer that is still confined to the surface layer of the bladder.
  • BCG-unresponsive: This means the cancer hasn’t responded to or has come back after treatment with BCG, which is typically the first-line treatment for this type of bladder cancer.
  • Ta-T1 papillary disease: These are types of bladder tumors that grow out from the bladder lining but haven’t invaded deeper layers.

How ONCOFID-P-B Works

ONCOFID-P-B is a combination of two substances:

  1. Paclitaxel: This is a chemotherapy drug that has been used to treat various types of cancer.
  2. Hyaluronic acid: This is a natural substance found in the body that helps with tissue repair and hydration.

The combination of these two substances creates a unique drug that is designed to target cancer cells in the bladder more effectively than traditional chemotherapy.[1]

How ONCOFID-P-B is Administered

ONCOFID-P-B is administered as an intravesical solution. This means the medication is delivered directly into the bladder through a catheter. This method of administration allows for a high concentration of the drug to reach the cancer cells while minimizing side effects in other parts of the body.[1]

Current Clinical Trial

ONCOFID-P-B is currently being studied in a Phase III clinical trial. This is an advanced stage of research that aims to confirm the effectiveness and safety of the drug. The trial is called “Orion-BC” and is designed to evaluate how well ONCOFID-P-B works in patients who have not responded to standard BCG treatment.[1]

Who is Eligible for the Treatment?

The clinical trial has specific criteria for who can participate. Some key eligibility factors include:

  • Adults (18 years or older) with confirmed BCG-unresponsive CIS of the bladder
  • Patients who have not responded to adequate BCG therapy
  • Patients who are not suitable for or refuse radical cystectomy (surgical removal of the bladder)
  • Adequate organ function and overall health status

It’s important to note that there are also several exclusion criteria, such as having muscle-invasive or metastatic bladder cancer, or having certain other medical conditions.[1]

Potential Benefits

The main goals of the ONCOFID-P-B treatment being studied are:

  • To achieve a complete response (disappearance of the cancer)
  • To maintain this response for as long as possible
  • To prevent progression to more advanced stages of bladder cancer
  • To avoid the need for radical cystectomy (removal of the bladder)
  • To improve overall survival

These potential benefits are being carefully evaluated in the clinical trial.[1]

Important Considerations

While ONCOFID-P-B shows promise, it’s crucial to remember:

  • This is an investigational drug still being studied, and its effectiveness and safety are not yet fully established.
  • Participation in the clinical trial involves regular follow-ups and medical assessments.
  • As with any medical treatment, there may be potential risks and side effects that are being carefully monitored in the trial.
  • The decision to participate in a clinical trial or try a new treatment should always be made in consultation with your healthcare provider.

If you have bladder cancer and are interested in learning more about ONCOFID-P-B or the clinical trial, it’s important to discuss this with your oncologist or urologist. They can provide more information and help determine if this might be an appropriate option for your specific situation.[1]

Aspect Details
Drug Name ONCOFID-P-B (Paclitaxel Obaluronate)
Trial Phase Phase III
Condition BCG-unresponsive Carcinoma in Situ of the bladder with or without Ta-T1 papillary disease
Administration Intravesical solution
Primary Endpoint Complete Response Rate (CRR) at any time
Key Secondary Endpoints Duration of Response, Progression Rate, Time to Cystectomy, Event-Free Survival, Overall Survival
Maximum Daily Dose 600 mg
Maximum Total Dose 21.6 g
Treatment Period Up to 19 months

FAQ

  • What is ONCOFID-P-B? ONCOFID-P-B is an intravesical solution containing Paclitaxel Obaluronate, a new chemical entity being studied for the treatment of bladder cancer. It is administered directly into the bladder to target cancer cells.
  • Who is eligible for this clinical trial? The trial is for adults (18 years or older) with BCG-unresponsive Carcinoma in Situ of the bladder, with or without Ta-T1 papillary disease. Patients must have not responded to standard BCG therapy and either refuse or be unfit for radical cystectomy.
  • What is the main goal of this clinical trial? The main objective is to evaluate the antitumor activity of ONCOFID-P-B by measuring the complete response rate (CRR) at any time during the treatment period.
  • How is the drug administered in this trial? ONCOFID-P-B is administered intravesically, which means it is delivered directly into the bladder through a catheter. The maximum daily dose is 600 mg, with a maximum total dose of 21.6 g over a treatment period of up to 19 months.
  • What are some of the key outcomes being measured in this trial? The trial is measuring several outcomes, including complete response rate, duration of response, progression rates, time to progression, rate of patients undergoing cystectomy, event-free survival, and overall survival.

Ongoing Clinical Trials on Paclitaxel Obaluronate

  • Study of ONCOFID-P-B for Patients with Bladder Carcinoma in Situ Unresponsive to BCG Treatment

    Not recruiting

    1 1 1
    Investigated drugs:
    France Italy Poland Spain

Glossary

  • Intravesical: A method of administering medication directly into the bladder through a catheter.
  • BCG-unresponsive: A condition where bladder cancer does not respond to or recurs after treatment with Bacillus Calmette-Guérin (BCG) therapy.
  • Carcinoma in Situ (CIS): A very early form of cancer that has not spread from where it started.
  • Ta-T1 papillary disease: Stages of bladder cancer where tumors are confined to the inner lining of the bladder (Ta) or have grown into the connective tissue beneath the bladder lining (T1).
  • Complete Response Rate (CRR): The percentage of patients whose cancer disappears completely after treatment.
  • Cystectomy: A surgical procedure to remove all or part of the urinary bladder.
  • Event-Free Survival (EFS): The length of time after treatment during which no specified events (such as disease recurrence or progression) are detected.
  • Overall Survival (OS): The length of time from the start of treatment that patients are still alive.

References

  1. http://clinicaltrials.eu/trial/study-of-oncofid-p-b-for-patients-with-bladder-carcinoma-in-situ-unresponsive-to-bcg-treatment/