Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A Phase 1b Study of AMG 757 in Subjects with Neuroendocrine Prostate Cancer

This research study is for men with a specific type of advanced prostate cancer known as neuroendocrine prostate cancer. This kind of prostate cancer can be diagnosed for the first time, or it can develop after other treatments. The study is in an early stage, which means researchers are mainly focusing on understanding how a new medicine, called AMG 757, works in the body and if it's safe. They will also look at how the body handles the medicine and any side effects it might cause. The aim is to see if this new treatment could be a future option for men with this type of prostate cancer.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Amgen Inc.

Enrolment target

Start

02 Aug 2024

What is this study about?

Prostate cancer is a condition where cells in the prostate gland grow in an uncontrolled way. However, there are different types of prostate cancer. This study is specifically looking at a type called neuroendocrine prostate cancer. This type can be diagnosed when someone first gets prostate cancer, or it can develop later on, sometimes after other treatments have been tried.

Researchers are investigating a new medicine, AMG 757. This is an early-stage study, often called a Phase 1b study. This means it's one of the first times this medicine is being tested in people. The main goals at this stage are not to cure the cancer, but to understand if the new medicine is safe, what dose works best, and how the body absorbs, uses, and gets rid of it. They also want to see if it has any early signs of benefit.

Finding new ways to treat neuroendocrine prostate cancer is very important. This study helps gather crucial information about AMG 757, which could potentially lead to new treatment options in the future. It's a step towards better understanding and managing this specific type of prostate cancer.

Key takeaways

This study is for men with a specific type of prostate cancer called neuroendocrine prostate cancer.
It's an early-stage study to test a new medicine, AMG 757, for safety and how it works.
Participants will receive the new medicine and have regular check-ups.
No guarantee of direct benefit, but participation helps medical knowledge.
You can withdraw from the study at any time.

Who may be eligible?

This study is looking for adult men who have been diagnosed with a specific type of prostate cancer called neuroendocrine prostate cancer. This diagnosis could be recent, meaning it's the first time you've had it, or it could be that your prostate cancer has changed into this type after you've had other treatments.

To be considered for this study, you must be at least 18 years old. The study is specifically for men, as it focuses on prostate cancer. Other specific medical requirements would need to be checked by the study doctors to make sure it's safe for you to take part.

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 an adult male?
Have you been diagnosed with neuroendocrine prostate cancer?
Has your doctor discussed this specific type of cancer with you?
Are you at least 18 years old?

Answer every question to see your result.

What does participation involve?

If you join this study, you will be given the new medicine, AMG 757. You will have regular appointments with the study team. These appointments will involve various medical checks, such as blood tests, physical examinations, and scans to see how your body is responding to the medicine and how your cancer is doing. The exact number of visits and the types of tests will be clearly explained by the study team.

You will be closely monitored for any side effects from the medicine. The full duration of your involvement in the study, including treatment and follow-up, will be discussed in detail before you decide to participate. This type of study often involves several months of treatment and observation, followed by further monitoring.

Potential risks and benefits

Taking part in a clinical study means you could be among the first to try a new medicine, which might help your condition. However, because this is a new medicine, there might be side effects or risks that are not yet fully known. The study team will explain all known risks and benefits. There's no guarantee the medicine will help you, but your participation helps researchers learn more, which could benefit others in the future. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (3)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

—
Unverified
Netherlands
—
Unverified
Belgium
—
Unverified
France

Common questions

What is neuroendocrine prostate cancer?

It's a less common but often aggressive type of prostate cancer that can be diagnosed initially or develop after other treatments.

What does 'Phase 1b study' mean?

It's an early stage of testing a new medicine in people. The main goals are to check its safety, find the right dose, and see how the body handles it.

Will I get a new medicine if I join?

Yes, if you meet the study criteria, you will receive the new medicine called AMG 757.

What kind of tests will I have?

You'll have regular medical checks, including blood tests, physical exams, and scans, to monitor your health and the medicine's effects.

Can I leave the study if I change my mind?

Yes, you can choose to leave the study at any time, for any reason, and your regular medical care will not be affected.