RecruitingPHASE3INTERVENTIONAL

An Extension Study for Patients Previously Enrolled in Studies With Pelabresib

This study is a continuation for patients who have already taken part in trials involving a medicine called pelabresib. The main goal is to check how safe pelabresib is over a longer period and whether it continues to help patients with blood cancers or solid tumours. Some patients who previously had a placebo (dummy drug) or stopped pelabresib for other reasons might also join. Researchers will monitor patients' health, how their disease is progressing, and their survival. This helps doctors understand the long-term effects and benefits of pelabresib for different cancer types.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Novartis Pharmaceuticals

Enrolment target

Start

13 Aug 2024

Estimated completion

30 Jun 2027

Hematologic Malignancy Solid Tumor Advanced Malignancies

What is this study about?

This study is a follow-up for people who have previously taken part in a clinical trial testing a medication called pelabresib. The main purpose is to see how safe this medicine is over a longer time and whether it continues to provide benefits for people with different types of cancer, including blood cancers (like leukaemia) or solid tumours.

Researchers will closely watch your health and keep track of how your cancer is doing. They will also look at how long people live after taking pelabresib. This is important to understand the full picture of the medicine's effects beyond the initial trial period.

Some patients who were in previous pelabresib studies might have received a placebo (a dummy drug with no active medicine) or might have stopped taking pelabresib for reasons other than joining this follow-up study. They might also be able to join this extension, allowing researchers to gather even more information about the medicine's impact on survival and disease progression.

Key takeaways

This is an extension study for people previously in pelabresib trials.
It aims to understand long-term safety and benefits of pelabresib for various cancers.
Patients continuing treatment will be closely monitored for health and side effects.
Some patients might join just for 'survival follow-up' without taking the drug.
You can stop participating at any time.
Effective birth control is usually required for those who can father or become pregnant.

Who may be eligible?

To join the study and continue taking pelabresib, you must be at least 18 years old and have already been taking pelabresib in a previous study. Your doctor must believe that the medicine is currently helping you, and you need to be willing to follow all the study rules and attend appointments.

If you're a woman who could become pregnant, you'll need to have a negative pregnancy test and use very effective birth control during and for several months after the study. Men will also need to use effective birth control for a period of time. If you have severe stomach problems, allergies to pelabresib, or are already in another clinical trial, you generally won't be able to join.

Even if you stopped taking pelabresib or received a placebo in a previous study, you might still be able to join for 'survival follow-up.' This means researchers will just keep track of your health and survival without you taking the medicine again, as long as you agree and are 18 or older.

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 at least 18 years old?
Have you previously taken part in a pelabresib study?
Does your doctor believe pelabresib is currently helping you (if planning to continue treatment)?
Are you willing and able to attend regular appointments and follow study rules?
Are you able to use effective birth control if you can become pregnant or father children?

Answer every question to see your result.

What does participation involve?

If you join the study, there will be an initial check period of up to 28 days to make sure you're suitable. Once you've agreed to take part, your doctor will confirm your eligibility. If you meet all the criteria, you’ll start taking pelabresib again, usually at the same dose you were on before, unless a change is needed because of side effects.

You'll continue to take pelabresib as long as it's helping you and you're not experiencing worrying side effects. During this time, the study team will collect information about your disease, survival, and any side effects you might experience. You'll have regular visits to the clinic to monitor your health and gather this information.

After you stop taking pelabresib, there will be a 'safety follow-up' visit about 30 days later to check for any lasting side effects. All patients will also have a 'survival follow-up' for a longer period, where the study team will regularly check in on your health. The total duration of your participation will depend on how long you continue taking the medicine and how long the survival follow-up lasts.

Potential risks and benefits

Taking part in this study may offer the benefit of continuing treatment with pelabresib if it's currently helping your cancer. It also contributes valuable information that can help future patients. However, like all medicines, pelabresib can cause side effects, and some could be serious. You will be closely monitored for these. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (15)

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

Hematologic Malignancy/Stem (Department of Medicine, Division of Hematology/Oncology)
Verified postcode
Los Angeles, United States· Recruiting
Mayo Clinic (Cancer Clinical Research Office)
Verified postcode
Jacksonville, United States· Recruiting
Northwestern Memorial Hospital (Oncology)
Verified postcode
Chicago, United States· Recruiting
UMHS - University of Michigan Medical Center (Radiation Oncology)
Verified postcode
Ann Arbor, United States· Recruiting
Mount Sinai Hospital - Oncology
Verified postcode
New York, United States· Recruiting
Weill Cornell Medicine - New York Presbyterian Hospital (Oncology)
Verified postcode
New York, United States· Recruiting
ZNA Cadix-Hematology
Verified postcode
Antwerp, Belgium· Recruiting
Az St-Jan Brugge-Oostende A.V.
Verified postcode
Bruges, Belgium· Recruiting
AOU Careggi (Department of Experimental and Clinical Medicine)
Verified postcode
Florence, Italy· Recruiting
Azienda Ospedaliero - Universitaria Maggiore della Carità (SCDU Ematologia)
Verified postcode
Novara, Italy· Enrolling by invitation
AO Ospedale di Circolo, PO Varese (Ematologia)
Verified postcode
Varese, Italy· Recruiting
Amsterdam UMC location Vumc (Hematology)
Verified postcode
Amsterdam, Netherlands· Recruiting

Common questions

What is pelabresib?

Pelabresib is a medicine being studied for its effects on different types of cancer, including blood cancers and solid tumours.

Why is this study happening?

This study wants to learn more about the long-term safety and benefits of pelabresib for people who have already used it in previous trials.

Do I have to take pelabresib again if I join?

If you join the 'ongoing treatment' part, yes, you will continue taking pelabresib. If you join for 'survival follow-up' only, you will not take the medicine.

What happens after I stop taking pelabresib?

You'll have a safety check-up about a month after your last dose, and researchers will continue to keep track of your health for a longer period.

Can I leave the study at any time?

Yes, you can choose to leave the study at any point without it affecting your medical care.

How to find out more

Novartis Pharmaceuticals

novartis.email@novartis.com 1-888-669-6682 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.