RecruitingPHASE1, PHASE2INTERVENTIONAL

A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Alectinib in Pediatric Participants With ALK Fusion-Positive Solid or CNS Tumors

This study is for children and teenagers (up to 17 years old) who have certain types of cancer affecting their organs or brain. These cancers have a specific genetic change called an 'ALK fusion.' The study focuses on those whose previous treatments haven't worked well, or if there isn't a standard treatment available for them. Researchers are giving a medicine called alectinib to these young people to understand if it's safe to use, how their bodies handle the medicine, and if it can make their cancer better. It's an important step to find new ways to treat these challenging cancers in young patients.

At a glance

Status

Recruiting

Phase

PHASE1, PHASE2

Sponsor

Hoffmann-La Roche

Enrolment target

Start

14 Sep 2021

Estimated completion

28 Feb 2032

ALK Fusion-positive Solid or CNS Tumors

What is this study about?

This research study is looking into a new treatment called alectinib for young people up to 17 years old. It's specifically for those with certain types of cancer that have a special genetic change called an 'ALK fusion.' These cancers can affect different parts of the body (solid tumors) or the brain and spinal cord (CNS tumors).

The main goals of this study are to understand three key things about alectinib: first, to check if it's safe and what side effects it might have; second, to see how the body uses and processes the medicine; and third, to find out if it can effectively treat these cancers. This study is especially for young patients whose cancer hasn't responded well to other treatments, or for whom there isn't a widely accepted standard treatment currently available. By gathering this information, doctors hope to learn if alectinib could be a new and helpful option for these challenging cases.

Finding new and better ways to treat cancer in children and teenagers is incredibly important. This study helps doctors understand more about how specific medicines like alectinib work in young bodies and against particular types of cancer. The information learned from this study could help improve treatment choices for young people with ALK fusion-positive cancers in the future.

Key takeaways

This study is for children and teenagers with specific ALK fusion-positive cancers.
It's for those whose current treatments haven't worked well or where no standard treatment exists.
The study tests a new medicine called alectinib.
Researchers want to understand if alectinib is safe and effective in young patients.
Participation involves regular check-ups and monitoring.
You can stop participating at any time.

Who may be eligible?

This study is looking for children and teenagers up to 17 years old who have been diagnosed with certain types of cancer that have a specific genetic change, known as an 'ALK fusion.' Your doctors would need to confirm this genetic change. Importantly, this study is for those whose cancer has either come back or hasn't improved with previous treatments, or if there isn't a standard treatment available for their specific situation. We would need to be able to measure your cancer to see if the treatment is working, and you'd also need to provide a sample of your cancer tissue for us to study.

To be considered, participants must also be well enough to take part. This means meeting certain health standards related to how well your body is functioning, especially your blood. There are also specific requirements about avoiding pregnancy for both male and female participants during the study. If you've previously taken medicines that are very similar to alectinib, you would not be able to join this particular study.

It's important to remember that these are just some of the main requirements. A doctor involved in the study would discuss all the details with you and your parents or guardians to see if this study might be a suitable option.

Quick self-check

Is my child under 18 years old?
Does my child have a cancer with an 'ALK fusion' genetic change?
Has my child's cancer not responded well to previous treatments, or are there no standard treatments available?
Are we willing to provide a sample of the cancer tissue for study?
Is my child generally well enough to participate in a study, as assessed by a doctor?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join this study, you would be taking a medicine called alectinib. Your healthcare team would regularly check your health to make sure the medicine is safe for you and to see how your body is responding. This would involve regular visits to the clinic, where you might have blood tests, scans, and other checks to monitor your cancer’s size and your overall well-being. You (or your parent/guardian) will also be asked to complete surveys to share how you're feeling throughout the study.

The total length of time you'd be involved in the study can vary, depending on how your cancer responds and how you are feeling. The doctors will explain the schedule of visits and tests during your time in the study. You will have regular follow-up appointments even after you stop taking the study medicine.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. While alectinib might help treat your cancer if other treatments haven't worked, there's no guarantee it will be effective for everyone. There's also a chance of experiencing side effects from the medicine, which your study team will discuss and monitor carefully. You will receive close medical attention and monitoring throughout the study. Remember, joining is entirely your choice, and you have the right to leave the study at any time without giving a reason, which will not affect your future medical care.

Locations (33)

Lucile Packard Children's Hospital
Palo Alto, United States· Recruiting
Johns Hopkins All Children's Hospital
St. Petersburg, United States· Recruiting
University of Michigan, C.S. Mott Children's Hospital
Ann Arbor, United States· Recruiting
Children's Minnesota
Minneapolis, United States· Recruiting
Memorial Sloan Kettering Cancer Center
New York, United States· Active not recruiting
Cincinnati Children's Hospital Medical Center
Cincinnati, United States· Recruiting
St. Jude Children'S Research Hospital
Memphis, United States· Recruiting
Sydney Children's Hospital
Randwick, Australia· Recruiting
Royal Children's Hospital
Parkville, Australia· Recruiting
Hospital de Cancer de Barretos
Barretos, Brazil· Recruiting
Graacc-Grupo de Apoio ao adolescente e a crianca com cancer
São Paulo, Brazil· Recruiting
The Hospital for Sick Children
Toronto, Canada· Recruiting

+21 more sites — see the official record for the full list.

Common questions

What is an 'ALK fusion-positive cancer'?

It's a type of cancer that has a specific genetic change where two genes join together, called an 'ALK fusion.' This change can make the cancer grow.

Is this study for all ages of children and teenagers?

Yes, it's for children and teenagers from birth up to 17 years old.

What is alectinib?

Alectinib is the study medicine being tested. It's designed to target the ALK fusion, which may help stop the cancer from growing.

What if my child's cancer has already been treated?

This study is specifically for those whose previous treatments haven't fully worked or if there isn't a standard treatment available for their type of cancer.

Will I have to pay to be part of this study?

No, you will not have to pay for the study medicine or study-related tests and procedures.

How to find out more

Reference Study ID Number: GO42286 https://forpatients.roche.com/

global-roche-genentech-trials@gene.com 888-662-6728 Official trial record

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