Regorafenib in Patients With Refractory Primary Bone Tumors

Last Update Posted : 2023-03-22

This trial will assess the effectiveness and safety of regorafenib in treating bone cancer. This includes osteosarcoma. People in this trial will be randomly split into two groups. One group will be given regorafenib alongside standard cancer treatment. Group two will be given only the standard treatment. This trial also aims to better understand how genetic mutations affect how cancer behaves and responds to treatment. This will help to inform future research and treatments.

There are two groups in this trial. People in group two will have the option to have regorafenib if their cancer progresses while on only standard treatment.

Regorafenib is a tyrosine kinase receptor (TKI). TKIs work by blocking the activation of enzymes known as tyrosine kinases. Tyrosine kinases are involved in multiple processes in the body and are also involved in cancer growth. By blocking their activity TKIs can prevent cancer cells from growing and dividing. There are many different types of TKIs. TKIs are usually given as tablets although they can also be given as an injection or a drip through a vein. Side effects include tiredness, loss of appetite, and diarrhoea. Each TKI will also have its own specific side effects that a doctor will explain before you start on one. TKIs are currently licenced for use in some cancers and are being tested in clinical trials to treat osteosarcoma.
Visit our drugs and interventions page to find out more about this treatment, including how it works and what it’s used for.

The below points are a summary of who can enter the trial.
People who have had a sample of tumour analysed to confirm the diagnosis.
People with osteosarcoma that has returned on progressed on standard treatment.
People who can swallow tablets.
People who agree to use effective contraception throughout the trial and for 2 years after (if applicable).
People who have sufficiently recovered from previous treatment.

The below points are a summary of who can’t enter the trial.
People who have had previous treatment with regorafenib.
People who are pregnant or breastfeeding.
People with a known sensitivity to any of the drug components.
People who are taking another drug that might interact with regorafenib. Your doctor will know this.
People with another type of cancer.
People with high blood pressure that is not controlled by medication.
People with diseases that affect the blood clotting.
People with heart defects or irregular heartbeats that need treatment.
People with medical conditions that may put them at risk or affect the trial. The trial team will discuss this.

ONTEX is intended to supplement, not replace, your healthcare team. Patients should always discuss a clinical trial with their healthcare team. If a patient is eligible for a trial the trial team will be able to provide more in-depth information about the trial so the patient can make an informed decision before taking part. Trial information has been sourced from www.clinicaltrials.gov. The content is then reviewed weekly by the Osteosarcoma Now team. All the trials also have a patient-friendly summary and key information section written by the team at Osteosarcoma Now. We have also included a description of the medications being used in the trial and summarised the inclusion and exclusion criteria in the ‘who is this trial (not) for’ sections. To the best of our knowledge the clinical trial database is up-to-date and accurate.However, we cannot assume any liability for the accuracy or completeness of the information.