BridgeMD
To evaluate the efficacy and safety of regorafenib in patients with refractory primary bone tumors.
EU CTIS ID: 2024-514720-17-00
What this study is testing
To evaluate the efficacy and safety of regorafenib in patients with refractory primary bone tumors
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- 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.
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.