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Regorafenib in Patients With Refractory Primary Bone Tumors
Sponsor: Institute of Mother and Child, Warsaw, Poland
Summary
The aim of the project is to improve treatment outcomes in patients with primary malignant bone tumors, refractory to standard therapy, by increasing the availability of advanced therapy, as well as to develop treatment options using advanced molecular diagnostics for patients who have not responded to the standard therapeutic regimen, and to introduce modern diagnostics for risk stratification and for the use in molecularly targeted therapies.
Official title: Evaluation of the Efficacy and Safety of Regorafenib in Patients With Refractory Primary Bone Tumors
Key Details
Gender
All
Age Range
9 Years - 21 Years
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2022-04-28
Completion Date
2026-06-30
Last Updated
2026-03-25
Healthy Volunteers
No
Conditions
Interventions
Regorafenib
Patients will receive regorafenib orally at doses adjusted for age, body surface area and pharmacokinetics. Treatment with regorafenib will be continued for up to 1 year or until disease progression, patient death, unacceptable toxicity, or study closure. Pharmacokinetics and safety profile of the investigational product (IP) will be determined throughout the course therapy. In the event of progression or relapse, patients in the control group will have the option to receive the IP along with the standard treatment of the next line.
Locations (2)
the Institute of Mother and Child
Warsaw, Poland
Maria Sklodowska-Curie National Research Institute of Oncology
Warsaw, Poland