In short
There is currently 1 ongoing clinical trial for recurrent osteosarcoma, investigating the use of Regorafenib in patients whose bone tumors have not responded to previous treatments. This trial is being conducted in Poland and focuses on evaluating the effectiveness and safety of this medication for young patients with resistant primary bone tumors.
Clinical trial locations
- Poland
Study on the Effectiveness and Safety of Regorafenib for Patients with Resistant Primary Bone Tumors
This clinical trial is examining whether Regorafenib can help young patients with bone tumors that have not responded to previous treatments or have returned after initial therapy.
Who can participate:
- Young people aged 9 to 21 years
- Patients with Ewing's sarcoma or osteosarcoma confirmed through tissue examination
- Those whose cancer did not respond to previous treatments or came back
- Patients with a life expectancy of at least 12 weeks
- Those able to swallow tablets
- Patients in puberty must agree to use effective birth control during treatment and for 2 years afterward
Who cannot participate:
- Patients without confirmed bone tumors that have not responded to treatment
- Those outside the specified age range
- Patients unable to follow study procedures or take the medication as required
- Those with other medical conditions that could interfere with the study or make participation unsafe
- Pregnant or breastfeeding patients
- Those already participating in another clinical trial
- Patients with allergies to Regorafenib or similar medications
What the trial involves:
The main goal of this study is to determine whether Regorafenib can help control bone tumors that have resisted other treatments and improve quality of life for young patients. The medication works by blocking certain proteins that help cancer cells grow and spread, which may slow down or stop tumor growth.
Participants will take Regorafenib as film-coated tablets by mouth. The dosage is carefully calculated to provide drug exposure similar to what is recommended for adults, particularly for patients aged 9 to 18 years. Throughout the study, patients will undergo regular health checks including laboratory tests, heart monitoring with echocardiography and ECG, and vital signs monitoring to ensure their safety.
The study will carefully track how the medication affects the tumors and monitor any side effects that occur. Researchers will also study how the body processes the medication, including how long it takes to reach steady levels in the bloodstream. This information will help determine the best way to use Regorafenib for treating resistant bone tumors in young patients.
The trial is expected to conclude by December 31, 2025, at which point final assessments will be made about the medication's effectiveness and safety.
Summary
Currently, there is one active clinical trial available for patients with recurrent osteosarcoma, located in Poland. This trial specifically targets young patients between 9 and 21 years of age whose bone tumors have not responded to standard treatments. The study is investigating Regorafenib, a medication that blocks proteins involved in cancer cell growth, as a potential treatment option for these difficult-to-treat cases. The trial includes comprehensive safety monitoring and is designed to provide important information about both the effectiveness and safety of this approach for young patients with resistant bone tumors.
