New hope for young bone cancer patients: drug combo targets tough tumors
NCT ID NCT05395741
First seen Jun 27, 2026 · Last updated Aug 21, 2026 · Updated 1 time
Summary
This study tests the drug regorafenib in 30 patients aged 9 to 21 with bone cancers (osteosarcoma or Ewing sarcoma) that have not responded to standard therapy. The goal is to see if the drug can help control the disease and improve survival, while also checking its safety. The approach combines advanced diagnostics to tailor treatment for each patient.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
-
30 people
The number who actually took part.
- Started
-
Apr 2022
- Finished
-
Jun 2026
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
9 to 21 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age \>9 years ≤ 21 years. 2. Histologically proven Ewing sarcoma or osteosarcoma. 3. 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): 1. progression on the I line or next, or 2. relapse. 4. Signing of informed consent for trial participation (including for Regorafenib treatment) according with current legal regulations. 5. Life expectancy of at least 12 weeks from the time informed consent was signed. 6. Possibility of swallowing the tablet. 7. 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 Criteria: 1. Lack of inclusion criteria 2. Previous treatment with Regorafenib. 3. Pregnancy and breastfeeding. 4. Hypersensitivity to the study drug or any of its ingredients. 5. Simultaneous treatment with other drugs which might interact with Regorafenib. 6. Persistent toxicity related to prior therapy, making it impossible to treat with Regorafenib. 7. Diagnosis of other malignancies before study inclusion. 8. Patients with uncontrolled hypertension. 9. Patients with diseases of the coagulation system. 10. Patients with heart defects and / or cardiac arrhythmias requiring permanent treatment with antiarrhythmic drugs. 11. 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Ewing sarcoma of bone are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Maria Sklodowska-Curie National Research Institute of Oncology
Warsaw, 02-781, Poland
-
the Institute of Mother and Child
Warsaw, 01-211, Poland
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- A vast data bank could unlock secrets of bone and muscle diseases
- Can an immune booster outsmart High-Risk bone cancer?
- Can a new tracer light up bone cancer tumors?
- Can a Two-Drug combo beat tough childhood cancers?
- A simple blood test may reveal hidden infertility risk in young cancer survivors
- Can a targeted pill stall advanced sarcomas?