Status:
ACTIVE_NOT_RECRUITING
Regorafenib in Patients With Refractory Primary Bone Tumors
Lead Sponsor:
Institute of Mother and Child, Warsaw, Poland
Collaborating Sponsors:
Maria Sklodowska-Curie National Research Institute of Oncology
Conditions:
Osteosarcoma
Ewing Sarcoma of Bone
Eligibility:
All Genders
9-21 years
Phase:
PHASE1
PHASE2
Brief 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 t...
Detailed Description
The scope of the project is to cover the entire population of children, adolescents and young adults from the age of 9 to the age of 21, who progressed to first-line treatment or who presented with a ...
Eligibility Criteria
Inclusion
- Age \>9 years ≤ 21 years.
- Histologically proven Ewing sarcoma or osteosarcoma.
- Failure of the treatment identified no earlier than 30 days prior to study treatment initiation (at least one of below needs to apply in order for this requirement to be satisfied):
- progression on the I line or next, or
- relapse.
- Signing of informed consent for trial participation (including for Regorafenib treatment) according with current legal regulations.
- Life expectancy of at least 12 weeks from the time informed consent was signed.
- Possibility of swallowing the tablet.
- Consent to the use of effective contraception throughout the period of the study and a minimum of 2 year after discontinuation of study treatment in patients at puberty and sexual maturity.
Exclusion
- Lack of inclusion criteria
- Previous treatment with Regorafenib.
- Pregnancy and breastfeeding.
- Hypersensitivity to the study drug or any of its ingredients.
- Simultaneous treatment with other drugs which might interact with Regorafenib.
- Persistent toxicity related to prior therapy, making it impossible to treat with Regorafenib.
- Diagnosis of other malignancies before study inclusion.
- Patients with uncontrolled hypertension.
- Patients with diseases of the coagulation system.
- Patients with heart defects and / or cardiac arrhythmias requiring permanent treatment with antiarrhythmic drugs.
- Other acute or persistent disorders, behaviors or abnormal laboratory test results, which might increase the risk related to the participation in this clinical trial or to taking the study drug, or which might influence the interpretation of the study results, or which, in the investigator's opinion, disqualify a patient from participating in the trial.
Key Trial Info
Start Date :
April 28 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05395741
Start Date
April 28 2022
End Date
December 31 2025
Last Update
April 10 2025
Active Locations (2)
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1
the Institute of Mother and Child
Warsaw, Poland, 01-211
2
Maria Sklodowska-Curie National Research Institute of Oncology
Warsaw, Poland, 02-781