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New hope for young bone cancer patients: drug combo targets tough tumors

NCT ID NCT05395741

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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.

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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

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Other studies related to the condition(s) this trial covers.