To evaluate the efficacy and safety of regorafenib in patients with refractory primary bone tumors.

Phase 1

Recruiting

Conditions: Refractory primary bone tumors
MedDRA version: 27.0Level: PTClassification code: 10015562Term: Ewing´s sarcoma metastatic Class: 100000004864
MedDRA version: 27.0Level: PTClassification code: 10031294Term: Osteosarcoma metastatic Class: 100000004864
MedDRA version: 20.0Level: PTClassification code: 10015564Term: Ewing's sarcoma recurrent Class: 100000004864
MedDRA version: 21.1Level: PTClassification code: 10031296Term: Osteosarcoma recurrent Class: 100000004864
Therapeutic area: Diseases [C] - Neoplasms [C04]

Registration Number: CTIS2024-514720-17-00

Lead Sponsor: Instytut Matki I Dziecka

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 30

Inclusion Criteria

Age> 9 years and = 21 years at the time of inclusion for the study., Ewing's sarcoma or osteosarcoma confirmed by histopathological examination and the tests performed so far., Treatment failure identified no earlier than 30 days prior to study treatment initiation (at least one subsection must be met for the patient to meet this criterion): a. progression on treatment of I or another line or b. relapse., Giving written, informed consent to participate in the study prior to the commencement of the procedures included in the study protocol, including treatment with regorafenib in accordance with the current legal regulations., Life expectancy of at least 12 weeks from signing the informed consent., Possibility of swallowing the tablet., Consent to use effective contraception throughout the period of regorafenib treatment and at least 2 years after its discontinuation in patients in puberty.

Exclusion Criteria

Failure to meet any of the inclusion criteria., Patients with heart defects and / or cardiac arrhythmias requiring permanent treatment with antiarrhythmic drugs., Other acute or chronic medical conditions, behaviors, or abnormal laboratory values that may increase the risk of participating in this clinical trial or taking the study medication, or may affect the interpretation of the study results, or, in the investigator's opinion, may cause that the patient should not be enrolled in the study., Prior treatment with regorafenib., Pregnancy and breastfeeding., Known hypersensitivity to the drug or any of its ingredients., Taking medications that cannot be used while under regorafenib treatment., Persistent toxicity related to previous therapy, preventing drug incorporation., Diagnosis of other neoplastic disease prior to inclusion in the study., Patients with uncontrolled hypertension., Patients with diseases related to the coagulation disorders.