RecruitingOBSERVATIONAL

Study to Learn More About the Safety and Effectiveness of the Drug VITRAKVI During Routine Use in Patients With TRK Fusion Cancer Which is Locally Advanced or Spread From the Place Where it Started to Other Places in the Body

This study aims to understand more about VITRAKVI (also known as larotrectinib), a medicine used to treat a specific type of cancer called TRK fusion cancer. TRK fusion cancer occurs when a change in the NTRK gene causes cancer cells to grow. VITRAKVI works by blocking these changed genes. Researchers are observing how safe and effective this drug is when used routinely by patients in the UK, whether their cancer is locally advanced or has spread. This isn't a traditional 'trial' where new treatments are tested; instead, it's observing care that doctors have already decided is best for their patients, both adults and children.

At a glance

Status

Recruiting

Sponsor

Bayer

Enrolment target

150

Start

03 Apr 2020

Estimated completion

31 Mar 2030

Locally Advanced or Metastatic Solid Tumor Harboring an NTRK Gene Fusion

What is this study about?

This study is designed to learn more about a medicine called VITRAKVI (its active ingredient is larotrectinib) when it's used in day-to-day medical care for people with a specific type of cancer. This cancer is known as TRK fusion cancer. This isn't a cancer of a particular body part, but rather it refers to various cancers that are caused by a specific genetic change. This change happens when a gene called NTRK (Neurotrophic Tyrosine Kinase) joins, or 'fuses,' with another gene. This fusion then creates proteins that can make cancer cells grow and multiply.

VITRAKVI is a treatment that has already been approved. It works by blocking the action of these 'TRK fusion proteins,' which helps to stop the cancer from growing. The aim of this study is to see how well VITRAKVI works and how easily patients tolerate it when doctors prescribe it as part of their usual treatment, for cancer that is locally advanced or has spread to other parts of the body.

Doctors will simply collect information from patients' existing medical records, such as how VITRAKVI treatment is going, any other medicines they are taking, changes in their health, and any new symptoms. This means patients won't receive any extra tests or different treatments beyond what their doctor already plans. Both adults and children with TRK fusion cancer, whose doctors have decided VITRAKVI is the right treatment for them, can take part.

Key takeaways

This study observes how VITRAKVI works in people with TRK fusion cancer.
It's for adults and children whose doctors have prescribed VITRAKVI as routine treatment.
No new treatments or extra tests are involved.
Information is collected from your existing medical records over 2-5 years.
Helps doctors understand VITRAKVI's real-world safety and effectiveness.

Who may be eligible?

You might be able to take part in this study if you are an adult or a child (from birth up to 18 years old) and have a solid cancer that is either locally advanced or has spread. A key requirement is that your cancer must have a specific genetic change called an NTRK gene fusion. This fusion has to be confirmed by a medical test.

Also, your doctor must have already decided that VITRAKVI is the appropriate treatment for your cancer, and you must be expected to live for at least three more months. You can still join the study even if you started VITRAKVI treatment up to two months before the study consent is signed.

However, you cannot take part if you are pregnant, have any reasons listed in the VITRAKVI product information that would make it unsuitable for you, or have already taken VITRAKVI or similar drugs. You also can't join if your cancer has a different type of genetic change (NTRK gene amplification or point mutation), or if you are already in another research study that involves new treatments outside of routine care.

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 or a child (under 18) with a solid cancer?
Has your doctor confirmed your cancer has an NTRK gene fusion?
Has your doctor decided VITRAKVI is the right treatment for you?
Are you not pregnant?
Have you not previously taken VITRAKVI or similar drugs?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you won't need to do anything differently from your normal medical care. Your doctor will simply collect information from your regular check-ups and medical records. This includes details about your VITRAKVI treatment, any other medications you're taking, how your cancer is responding, and any health changes or symptoms you experience. There will be no extra visits, tests, or procedures specifically for this study. The information will be collected over a period ranging from two to five years (24 to 60 months) from when you start VITRAKVI.

Potential risks and benefits

The main benefit of taking part is that your health information will help doctors and researchers learn more about how VITRAKVI works in real patients. This could help others with TRK fusion cancer in the future. As this study only involves collecting routine medical information, there are no additional physical risks or side effects from participating. The risks are those associated with the VITRAKVI treatment itself, which your doctor would have already discussed with you. You are free to withdraw from the study at any time without affecting your medical care.

Locations (76)

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

Banner Desert Medical Center
Verified postcode
Mesa, United States· Withdrawn
California Research Inst.
Verified postcode
Los Angeles, United States· Recruiting
USC / Norris Comprehensive Cancer Center
Verified postcode
Los Angeles, United States· Withdrawn
UCLA - Mattel Children's Hospital
Verified postcode
Los Angeles, United States· Recruiting
Hoag Memorial Hospital Presbyterian
Verified postcode
Newport Beach, United States· Recruiting
UCSF Benioff Children's Hospital Oakland
Verified postcode
Oakland, United States· Withdrawn
Stanford Univ Med Ctr. / Lucile Packard Children's Hosp
Verified postcode
Palo Alto, United States· Recruiting
Providence Health System - Southern California
Verified postcode
Santa Monica, United States· Terminated
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Verified postcode
Torrance, United States· Withdrawn
SCL Health
Verified postcode
Grand Junction, United States· Withdrawn
Yale University
Verified postcode
New Haven, United States· Recruiting
Mayo Clinic
Verified postcode
Jacksonville, United States· Withdrawn

Common questions

What is TRK fusion cancer?

TRK fusion cancer isn't a specific type of cancer by location. Instead, it's a type of cancer that happens when two genes join together (fuse), creating proteins that can make cancer cells grow.

What is VITRAKVI and how does it work?

VITRAKVI is a medicine that blocks the proteins created by the TRK gene fusion, which helps to stop the cancer cells from growing. It's an approved treatment for TRK fusion cancer.

Will I receive new treatment or tests if I join this study?

No, you will not receive any new treatments or extra tests. This study simply collects information from your existing medical records and routine care, as decided by your doctor.

How long will I be in the study?

Your medical information will be collected for a period of two to five years (24 to 60 months) from when you start your VITRAKVI treatment.

Can children take part in this study?

Yes, both adults and children (from birth up to 18 years old) can take part, provided they meet the other study requirements and their doctor has decided VITRAKVI is the right treatment for them.

How to find out more

Bayer Clinical Trials Contact

clinical-trials-contact@bayer.com (+)1-888-84 22937 Official trial record

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