A Phase 1b Open-Label, Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of ARV-110 in Combination with Abiraterone in Patients with Metastatic Prostate Cancer
This research study is for men with advanced prostate cancer where the cancer has spread to other parts of the body. It's an early-stage trial (Phase 1b) to see how safe a new experimental drug, called ARV-110, is when given alongside an existing prostate cancer medicine, abiraterone. Researchers also want to understand how the body processes these medicines. Participants will be closely monitored to check for any side effects and to see if the treatment is well-tolerated. The main goal is to gather information about safety and how the drugs work in the body, rather than to see if it cures the cancer at this stage.
At a glance
What is this study about?
This study is an important step in developing new treatments for men living with prostate cancer that has spread, also known as metastatic prostate cancer. When prostate cancer spreads, it can be more challenging to treat effectively. Researchers are always looking for better ways to help manage the condition and improve patients' lives.
This particular study is exploring a new approach by combining an experimental drug called ARV-110 with a medicine already used for prostate cancer, called abiraterone. You might be familiar with abiraterone or similar treatments. The idea is that combining these two drugs might be more effective than using one alone. Because ARV-110 is a newer drug, this is an early-stage study, meaning it's one of the first times this combination is being tested in people.
The main aim of this early study is not to cure cancer, but to carefully check a few key things. Firstly, how safe is this combination of medicines? Secondly, how well do people tolerate the treatment, meaning are there side effects and how manageable are they? And finally, the study will look at how the body absorbs, uses, and gets rid of these drugs. This information is vital for deciding if the treatment should be studied further in larger trials.
Key takeaways
- This study evaluates a new drug (ARV-110) combined with an existing prostate cancer drug (abiraterone).
- It's for men with prostate cancer that has spread (metastatic).
- The main goals are to check safety and how the body handles the treatment.
- It's an early-stage study, so the focus is on understanding the drug, not necessarily curing the cancer.
- Participants will receive the active study medication, no placebo.
Who may be eligible?
To join this study, you must be a man aged 18 or older. The study is specifically for men who have prostate cancer that has spread to other parts of the body.
There will be other detailed medical criteria that the study doctors will review. These criteria are in place to ensure your safety throughout the trial and to make sure the study results are clear and accurate. Examples of what they might look at include your overall health, any other medical conditions you have, and the treatments you've had in the past.
It's important to remember that even if you meet the main age and diagnosis criteria, the study team will need to perform a full health check and review your medical history to confirm if you are suitable to participate.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you a man?
- Are you 18 years old or older?
- Do you have prostate cancer that has spread to other parts of your body?
- Are you willing and able to attend regular hospital or clinic visits?
- Are you willing to discuss your full medical history with the study team?
What does participation involve?
If you decide to take part in this study, you would receive the investigational drug ARV-110 along with abiraterone. You would have regular visits to the hospital or clinic, which would typically involve physical examinations, blood tests, and possibly other scans or tests to monitor your health and how your body is responding to the treatment. The research team will explain exactly how often these visits would be and what each visit would involve.
You would be closely monitored for any side effects or changes in your health. All medications and study-related procedures would be provided to you. There would also be follow-up appointments after you stop taking the study medication to ensure your well-being. The total length of your participation would be fully explained by the study team.
Potential risks and benefits
Locations (1)
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Common questions
What does 'metastatic prostate cancer' mean?
It means prostate cancer that has spread from the prostate to other parts of your body, like bones or other organs.
What is a 'Phase 1b' study?
It's an early-stage study primarily focused on checking how safe a new treatment is and understanding how your body handles it.
Will I get fake medicine (a placebo) in this study?
No, this study is 'open-label,' meaning everyone who participates will receive the active study medications (ARV-110 and abiraterone).
What is ARV-110?
ARV-110 is a new, experimental drug that is being tested in this study alongside an existing prostate cancer medicine.
How long will I be in the study?
The study team will explain the specific duration of treatment and follow-up during your initial discussions.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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