Ongoing, recruitingPhase I and Phase II (Integrated)- OtherInterventional

I3Y-MC-JPCS: A Phase 1b/2 Study of Abemaciclib in Combination with Irinotecan and Temozolomide (Part A) and Abemaciclib in Combination with Temozolomide (Part B) in Pediatric and Young Adult Patients with Relapsed/Refractory Solid Tumors and Abemaciclib in Combination with Dinutuximab, GM-CSF, Irinotecan, and Temozolomide in Pediatric and Young Adult Patients with Relapsed/Refractory Neuroblastoma (Part C).

This research study is looking at new ways to treat solid cancers in children and young adults when their cancer has returned or hasn't responded well to earlier treatments. The study is particularly interested in a medicine called abemaciclib. It's being tested in combination with other established cancer drugs like irinotecan and temozolomide. For a specific type of cancer called neuroblastoma, abemaciclib is being studied with even more treatments, including dinutuximab and GM-CSF. The main goals are to find out the safest dose of these new combinations, understand how the body handles the medicines, and see if they can help treat the cancer. This is a Phase 1b/2 study, meaning it checks safety first and then looks at how well the treatments work.

At a glance

Status

Ongoing, recruiting

Phase

Phase I and Phase II (Integrated)- Other

Sponsor

Eli Lilly & Co.

Enrolment target

Start

08 Apr 2024

Relapsed/Refractory Solid Tumors

What is this study about?

This study is exploring potential new treatment options for young people suffering from solid tumours that have either returned after previous treatment or haven't responded well to the treatments they've had. Solid tumours are a type of cancer that forms a mass, like a lump, in the body. Dealing with cancer when it becomes resistant to treatment can be very challenging, so finding new approaches is really important.

The main focus of this study is a medicine called abemaciclib. Researchers want to see if combining abemaciclib with other existing cancer drugs, like irinotecan and temozolomide, can be an effective way to fight these resistant cancers. For a specific type of cancer called neuroblastoma, which often affects young children, abemaciclib will also be tested with other medicines like dinutuximab and GM-CSF.

This study is a 'Phase 1b/2' trial. This means it has two main aims. First, in Phase 1b, doctors will carefully increase the doses of the new drug combinations to find the safest dose that causes the fewest serious side effects. This safe level is called the 'maximum tolerated dose.' Once they find this dose, they'll move to Phase 2 to see how well these new combinations work at treating the cancer. They will also study how the body absorbs and uses these medicines.

Key takeaways

This study is for children and young adults with solid cancers that have returned or are hard to treat.
It's testing a new medicine called abemaciclib in combination with other cancer drugs.
The study aims to find the safest dose and see if the new combinations can help treat the cancer.
Participants will have regular check-ups, blood tests, and scans.
You can stop participating in the study at any time.
It's a Phase 1b/2 study, meaning it focuses on safety first, then effectiveness.

Who may be eligible?

This study is open to both children and young adults aged up to 18 years and above, with a specific type of cancer. It includes both boys and girls. The main condition for joining is having a solid tumour that has either come back after past treatment or hasn't responded effectively to previous treatments.

To ensure the study is safe and the results are clear, doctors will check that participants are generally well enough to receive potent cancer treatments. This will involve looking at their overall health, how their organs like the liver and kidneys are working, and their blood test results.

There will also be other specific medical checks and requirements. For example, participants might need to have stopped their previous cancer treatments for a certain amount of time before joining. It's crucial to discuss all your medical history with the study doctor to find out if this study is the right fit for you.

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 child or young adult (up to 18 years old or older, depending on final criteria)?
Do you have a solid tumour?
Has your cancer come back after treatment, or is it not responding to past treatments?
Are you generally well enough to receive cancer treatment (as determined by a doctor)?
Are you able to attend regular hospital visits and appointments?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be given the study drugs, including abemaciclib, either by mouth (as tablets) or through an IV drip, depending on the specific medicine. You'll have regular hospital visits, which may include physical exams, blood tests, and scans (like CT or MRI) to see how the treatment is working and check for any side effects. These visits will be more frequent at the beginning of the study.

The total length of time you'll be in the study will vary. Some parts of the study focus on finding the right dose, which might be shorter, while other parts will continue for as long as the treatment is helping you and side effects are manageable. After you stop taking the study drugs, there will typically be a follow-up period to monitor your health. You can expect to have a schedule provided by the study team detailing all your appointments and what will happen at each one.

Potential risks and benefits

Like all medical treatments, there are potential benefits and risks to consider. A potential benefit of joining this study is getting access to a new treatment combination that might help control your cancer, especially if other treatments haven't worked well. However, there's no guarantee the treatment will work for everyone, and it's also possible you might not benefit personally. The main risks involve potential side effects from the study medicines, which can be similar to those of standard cancer treatments, such as tiredness, sickness, and effects on blood counts. The study team will carefully monitor you for these and manage them as best they can. You are free to withdraw from the study at any time, for any reason, without affecting your future medical care.

Locations (1)

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

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Unverified
Spain

Common questions

What is a 'solid tumour'?

A solid tumour is a type of cancer that forms a solid mass or lump in the body, as opposed to blood cancers like leukaemia.

What does 'relapsed/refractory' mean?

'Relapsed' means the cancer has come back after treatment. 'Refractory' means the cancer didn't respond to previous treatments.

What is abemaciclib?

Abemaciclib is a specific medicine being tested in this study. It's a targeted therapy designed to block certain signals that allow cancer cells to grow.

Will I receive the new medicine alone or with other drugs?

In this study, abemaciclib is always given in combination with other established cancer medicines like irinotecan and temozolomide, or additional drugs for neuroblastoma.

Is this a new medicine or one already used for cancer?

Abemaciclib is an approved cancer drug for adults with certain breast cancers, but this study is testing its use in combination for children and young adults with other solid tumours.