Clinical trials
A ‘clinical trial’ is a research study in which a potential new treatment is investigated to prevent, cure or improve a disease or medical condition. A clinical trial also looks at how participants react to the potential new treatment and if any unwanted effects occur. This helps to determine if the new investigational treatment works, is safe, and is better than those that are already available. Many clinical trials also compare existing treatments or test new ways to use or combine with existing treatments.
All new drugs must be tested in clinical trials before they can be prescribed to patients. Without people taking part in these research studies, we would have no new drugs to help others with their condition.
Clinical trial of Debio 4228 in patients with advanced prostate cancer
Debio 4228-201 is a randomized, open-label Definition Open-label is a type of medical study where both the doctors and the participants know which treatment is being given clinical trial evaluating Debio 4228, a new formulation of a GnRH antagonist medication currently available to treat advanced prostate cancer that is either confined to the prostate, has spread to nearby areas, or has spread to other parts of the body. It works by decreasing the amount of testosterone in the body, which the tumor needs to grow. The currently available formulation is injected every 4 weeks.
Debio 4228 allows for less frequent injections (every 12 weeks) than the current formulation. This is because Debio 4228 is released in the body over a longer period of time. Therefore, patients with prostate cancer need fewer injections, while Debio 4228 is expected to work just as well and be just as safe as the 4-week formulation.
The clinical trial includes 3 groups: Group 1 receives Debio 4228 at the first dose level, Group 2 receives Debio 4228 at a higher dose level, and Group 3 receives Debio 4228 at a dose level based on what is observed in the first 2 groups. The objective of the trial is to determine the best dose that is both effective and safe for patients.
You may be able to take part in this clinical trial if:
- You have been diagnosed with prostate cancer that is either:
- Recently diagnosed, responds to hormone treatment, and has spread or is advanced, or
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- Still in the prostate but cannot be treated with surgery or other local treatments.
- You are willing and able to follow the study plan and procedures, and agree to use effective birth control methods during the trial.
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Phases
When a potential new medication is being developed, it is first tested in a laboratory setting. If the results are positive, the drug may enter a clinical trial program. This means that it will be tested in humans in several ‘phases’ of study.
Phase I = Safety evaluation. The very first administration in humans, typically carried out in a small group of healthy volunteers to assess if the drug is safe.
Phase II = Efficacy evaluation. The first trials in patients with the intended disease to check if the drug works efficiently and if there are any unwanted side effects.
Phase III = Confirming findings. Trials in large numbers of patients that generally compare the drug to the best treatments available.
_Phases
- P
- Ⅰ
- Ⅱ
- Ⅲ
- M
Talk with your medical doctor
If you are interested in participating in an upcoming clinical trial (can be also referred to as a clinical study), ask your doctor if a clinical trial might be right for you. Your doctor knows both you and your health history, which is invaluable in making this decision. Your doctor can help you gather the information needed to locate a trial and help you identify what questions might be important to ask the clinical trial doctor before deciding to participate.