NCT05395741CompletedPhase 1/2
Regorafenib in Patients With Refractory Primary Bone Tumors
Evaluation of the Efficacy and Safety of Regorafenib in Patients With Refractory Primary Bone Tumors
Source: ClinicalTrials.gov · Last updated 7 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 30 (actual)
- First submitted
- 5 May 2022
- Start date
- 28 Apr 2022
- Primary completion date
- 12 Sept 2025
- Lead sponsor
- Institute of Mother and Child, Warsaw, Poland
- Diseases
- Childhood cancers, Sarcoma
- NCT number
- NCT05395741
What you commit to
- Study type: Interventional · Phase 1/2
- Participants enrolled: 30
- From 28 Apr 2022 to the primary completion date, 12 Sept 2025
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous treatment with Regorafenib.
- Simultaneous treatment with other drugs which might interact with Regorafenib.
- Persistent toxicity related to prior therapy, making it impossible to treat with Regorafenib.
- Patients with heart defects and / or cardiac arrhythmias requiring permanent treatment with antiarrhythmic drugs.
Other illness
- Hypersensitivity to the study drug or any of its ingredients.
- Diagnosis of other malignancies before study inclusion.
- Patients with uncontrolled hypertension.
- Patients with diseases of the coagulation system.
Lab values
- 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.
Other
- Lack of inclusion criteria
- Pregnancy and breastfeeding.
Who the study is looking for
- 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.
Age in the registry: 9 years to 21 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| the Institute of Mother and Child Coordinator of this site? Confirm its status | Warsaw | Poland | Unknown status |
| Maria Sklodowska-Curie - National Research Institute of Oncology Coordinator of this site? Confirm its status | Warsaw | Poland | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.