Regorafenib in Patients With Refractory Primary Bone Tumors

PHASE1/PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

April 28, 2022

Primary Completion Date

September 12, 2025

Study Completion Date

December 31, 2025

Conditions
OsteosarcomaEwing Sarcoma of Bone
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.

Trial Locations (2)

01-211

the Institute of Mother and Child, Warsaw

02-781

Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw

All Listed Sponsors
collaborator

Maria Sklodowska-Curie National Research Institute of Oncology

OTHER

lead

Institute of Mother and Child, Warsaw, Poland

OTHER