Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

C3651003 A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO INVESTIGATE THE EFFICACY, SAFETY AND TOLERABILITY OF PONSEGROMAB IN PATIENTS WITH CANCER, CACHEXIA, AND ELEVATED CONCENTRATIONS OF GDF-15, FOLLOWED BY AN OPTIONAL OPEN-LABEL TREATMENT PERIOD (PROACC -1)

This research study is about a new medicine called ponsegromab for individuals living with cancer who are experiencing a condition called cachexia. Cachexia causes significant weight and muscle loss, making people feel very weak and tired. This study aims to find out if ponsegromab can help people regain weight and muscle, and generally feel better. Researchers will compare ponsegromab to a dummy treatment (placebo) over 12 weeks to see if it's effective and safe. They'll also check how it affects daily activities and how participants feel, with an optional longer treatment period available afterwards to continue tracking progress.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Pfizer Inc.

Enrolment target

Start

29 Mar 2024

Cancer cachexia

What is this study about?

This study is called PROACC-1 and it's looking into a new treatment for a serious condition called cancer cachexia. If you have cancer, you might experience cachexia, which means you lose a lot of weight and muscle, even if you try to eat. This can make you feel very weak, tired, and unwell. This new medicine, ponsegromab, is designed to target a specific substance in the body that is thought to contribute to this weight loss.

The main goal of this study is to see if ponsegromab can help people with cancer cachexia gain weight. Researchers will also be checking to see if it helps with other important things, like how much energy people have for daily activities, how much they can walk, and how they feel overall, including their appetite, nausea, and tiredness. They want to understand if this medicine not only helps with weight but also improves quality of life.

Because this is a 'Phase 2' study, it means the medicine has already been through initial safety checks, and now researchers are testing it on a larger group of people to get a better idea of how well it works and if it has any side effects. Participants will be given either the new medicine or a dummy treatment (a placebo) to fairly compare the effects. This helps researchers work out if any changes are truly due to the medicine or something else.

Key takeaways

This study is testing a new medicine for cancer cachexia, which causes weight and muscle loss.
It aims to see if the medicine helps people gain weight and feel better over 12 weeks.
Participants will receive either the new medicine or a dummy treatment (placebo).
It involves regular clinic visits, injections, and tracking of health and activity.
This is a Phase 2 study focused on efficacy and safety in a specific patient group.

Who may be eligible?

To join this study, participants must be at least 18 years old. There's no upper age limit, so older adults can also take part. The study is open to both men and women.

Participants must have cancer and be experiencing cancer cachexia, which means they are losing weight and muscle. They will also need to have higher-than-normal levels of a specific marker in their blood called GDF-15, which the study medicine targets.

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 18 years old or older?
Do you have a diagnosis of cancer?
Are you currently experiencing significant weight and muscle loss (cancer cachexia)?
Have you been told your blood tests show high levels of GDF-15?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would be involved in the study for a main period of 12 weeks. During this time, you would receive either the study medicine, ponsegromab, or a placebo (a dummy treatment that looks just like the real medicine but contains no active drug) via injection. You won't know which one you're receiving, and neither will your study doctor.

Throughout the 12 weeks, you'll have regular visits to the clinic for assessments. These will include check-ups, blood tests to monitor your health and how the medicine is affecting you, and measurements of your weight. You might also wear special digital sensors that track your physical activity, like how much you move and walk. You'll complete questionnaires about your appetite, how you're feeling, and any tiredness or nausea. After the initial 12 weeks, there's an optional period where you might continue to receive the active medicine in an 'open-label' part of the study, meaning everyone gets the active drug and knows it.

Potential risks and benefits

Participating in a clinical trial may offer potential benefits, such as gaining access to a new treatment before it's widely available and receiving close medical monitoring. However, there are also potential risks, including side effects from the study medicine, which might be mild or more serious, and the possibility that the treatment may not help your condition. You also might be on the placebo, which means you won't be getting the active drug. Your participation is always voluntary, and you have the right to withdraw from the study at any time, for any reason, without affecting your usual medical care.

Locations (4)

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

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Unverified
Bulgaria
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Unverified
Poland
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Unverified
Spain
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Unverified
Slovakia

Common questions

What is cancer cachexia?

Cancer cachexia is a condition where people with cancer lose a lot of weight and muscle, making them feel weaker and more tired. It's not just about not eating enough; it's a complex process related to the cancer itself.

What does 'placebo-controlled' mean?

It means some participants will receive the active medicine, and others will get a 'dummy' treatment that looks identical but contains no medicine. This helps researchers compare the real effects of the drug.

What will I have to do if I join?

You'll have regular clinic visits over 12 weeks for injections, blood tests, weight checks, and may wear sensors to track your activity. You'll also fill out questionnaires about how you're feeling.

Can I leave the study at any time?

Yes, your participation is completely voluntary. You can decide to leave the study at any point, and it won't affect your ongoing medical care.

What is a 'Phase 2' study?

A Phase 2 study means the medicine has already shown some safety in earlier tests, and now researchers are looking more closely at how well it works and its side effects in a larger group of people with the condition.