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ACTIVE NOT RECRUITING
NCT05395741
PHASE1/PHASE2

Regorafenib in Patients With Refractory Primary Bone Tumors

Sponsor: Institute of Mother and Child, Warsaw, Poland

View on ClinicalTrials.gov

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

Interventions

DRUG

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