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Basket Study of Entrectinib (RXDX-101) for the Treatment of Patients With Solid Tumors Harboring NTRK 1/2/3 (Trk A/B/C), ROS1, or ALK Gene Rearrangements (Fusions)

This research is testing a new drug called entrectinib for people with various types of advanced or widespread cancer. The study is particularly interested in cancers that have certain genetic changes, known as NTRK, ROS1, or ALK gene fusions. These fusions mean that parts of two different genes have joined together incorrectly, which can cause the cancer to grow. The study aims to find out how well entrectinib works in these cancers and what side effects it might have. This is a 'basket study,' meaning it includes different cancer types that all share these specific genetic changes, rather than focusing on just one type of cancer. Participants will be grouped based on their cancer type and the specific gene change they have.

At a glance

What is this study about?

This study is looking at a new medicine called entrectinib. It's designed for people who have advanced or widespread cancer that has specific genetic changes. These changes are called NTRK, ROS1, or ALK gene fusions. Think of gene fusions as a mix-up in the body's instruction manual (DNA) where two genes accidentally join together. This mix-up can sometimes make cancer grow.

Researchers want to see how effective entrectinib is at treating these cancers. The study is called a 'basket study' because, instead of focusing on just one type of cancer, it groups together different cancers (like breast cancer, lung cancer, or melanoma) that all share these particular genetic changes. This allows doctors to test the drug on a wider range of cancers that might respond to it.

By taking part, you would be helping doctors understand more about cancers with these specific gene changes and whether entrectinib could be a useful treatment option in the future. The information gathered from this study could lead to new ways to treat these types of cancer.

Key takeaways

  • This study is for advanced cancers with specific gene changes (NTRK, ROS1, or ALK fusions).
  • It tests a new drug called entrectinib.
  • Different cancer types are included if they have these gene changes.
  • Participation means regular clinic visits and health checks.
  • You can stop participating at any time.

Who may be eligible?

To join this study, people generally need to be 18 or older and have a type of cancer that has spread locally or throughout the body. Crucially, your cancer must have one of those specific genetic changes we mentioned: NTRK, ROS1, or ALK gene fusions. Doctors will need to confirm this with a tissue sample from your cancer.

You might still be able to join even if your cancer has spread to your brain, as long as it's not causing serious symptoms or has been treated and is under control. You can also have had previous cancer treatments like chemotherapy or radiotherapy, but there are some rules about how long ago you finished them. For example, if you've had certain cancer-targeting drugs before, you might not be able to join, depending on the specific drug and your cancer type.

There are also general health requirements, like being well enough to carry out daily activities and having your organs (like your liver and kidneys) working properly. You must be able to swallow the study drug whole. The study cannot accept people who are currently in another medical study testing a new treatment.

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.

  1. Are you 18 years old or older?
  2. Has your doctor confirmed your cancer has NTRK, ROS1, or ALK gene fusions?
  3. Is your general health good enough for you to be active most days?
  4. Are you able to swallow tablets whole?
  5. Are you not currently taking part in another new drug study for cancer?
Answer every question to see your result.

What does participation involve?

If you join this study, you would receive the study drug, entrectinib. The study is open-label, meaning both you and your doctors would know you are receiving entrectinib. You would have regular appointments at the study clinic for assessments, which might include blood tests, scans, and physical exams to see how your cancer is responding and to check for any side effects. The exact schedule of visits and tests would be explained in detail by the study team. You would continue treatment for as long as it is helping you and you are tolerating it well. After stopping treatment, there would be follow-up appointments to monitor your health.

Potential risks and benefits

Taking part in a clinical trial offers potential benefits, such as access to a new treatment that might help your specific cancer, which may not be available outside of a study. However, there are also risks. The drug entrectinib might cause side effects, some of which could be serious, and it may not work for everyone. The research team will carefully explain all known risks and potential benefits. Remember, your participation is voluntary, and you have the right to withdraw from the study at any time, for any reason, without affecting your standard medical care.

Locations (130)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Dignity Health St Joseph's Hospital and Medical Center
    Verified postcode
    Phoenix, United States
  • Mayo Clinic
    Verified postcode
    Phoenix, United States
  • City of Hope Cancer Center
    Verified postcode
    Duarte, United States
  • City of Hope Duarte - Comprehensive Cancer Center, Investigational Drug Services
    Verified postcode
    Duarte, United States
  • Scripps Clinic
    Verified postcode
    La Jolla, United States
  • University of California San Diego Moores Cancer Center
    Verified postcode
    La Jolla, United States
  • Southern California Kaiser Permanente
    Verified postcode
    Los Angeles, United States
  • University of Southern California Medical Center
    Verified postcode
    Los Angeles, United States
  • Univ Of California Irvine College Of Medicine
    Verified postcode
    Orange, United States
  • UCSF Mount Zion Medical Ctr
    Verified postcode
    San Francisco, United States
  • UCSF Mission Bay
    Verified postcode
    San Francisco, United States
  • Sarcoma Oncology Center
    Verified postcode
    Santa Monica, United States

Common questions

What are NTRK, ROS1, or ALK gene fusions?

These are specific genetic changes where parts of two different genes accidentally join together, which can sometimes cause cancer to grow.

What is a 'basket study'?

It's a type of study that includes different cancer types – like breast, lung, or melanoma – as long as they all share the same specific genetic change being investigated.

What does 'open-label' mean?

It means both you and your doctors will know that you are receiving the study drug, entrectinib.

Can I join if my cancer has spread to my brain?

Yes, potentially, as long as it's not causing serious symptoms or has been well-controlled by previous treatment.

What is entrectinib?

Entrectinib is the new medicine being tested in this study. It's designed to target cancers that have specific genetic changes.

How to find out more

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

Discussion

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