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Tests treatment safety and results for Ewing Sarcoma
Official title To Evaluate the Efficacy and Safety of Naxitamab in Patients With Refractory Ewing's Sarcoma (Butterfly)
ClinicalTrials.gov ID: NCT05968768
What this study is testing
What is Naxitamab?
Naxitamab is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for ewing sarcoma.
Also referred to as danyelza.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Prospective, interventional, open, randomized, national, multicenter, non-commercial trial
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 to 21
You may be able to join if
- Histologically proven Ewing sarcoma of the bone or soft tissues.
- Subject's archival tumour sample (formalin-fixed, paraffin-embedded; FFPE) available for evaluation of GD2 expression.
- Documented disease progression (during or after completion of at least one line treatment) or any subsequent recurrence.
- GD2 positive tumor assessed by IHC.
- Age ≥ 2 years and ≤ 21 years.
You likely can't join if
- Failure to meet any of the inclusion criteria.
- Not eligible to IT.
- Previous treatment with an anti-GD2 antibody.
- Hypersensitivity to the study drugs or any of their ingredients (covers IT and naxitamab).
- Simultaneous treatment with other drugs which might interact with naxitamab or IT regimen.
- Persistent toxicity related to prior therapy, making it impossible to treat with naxitamab.
See the full eligibility criteria
- Histologically proven Ewing sarcoma of the bone or soft tissues.
- Subject's archival tumour sample (formalin-fixed, paraffin-embedded; FFPE) available for evaluation of GD2 expression.
- Documented disease progression (during or after completion of at least one line treatment) or any subsequent recurrence.
- GD2 positive tumor assessed by IHC.
- Age ≥ 2 years and ≤ 21 years.
- Life expectancy of at least 12 weeks from the time informed consent was signed.
- Previous systemic anticancer treatment completed ≥ 3 weeks, major surgery ≥ 2 weeks, and radiation therapy ≥ 4 weeks prior to study enrollment.
- Recovered from adverse effects of prior surgery, radiotherapy, or Clinical trial protocol BUTTERFLY version 1.0 of 30.09.2022 r.anti-neoplastic therapy at the discretion of the investigator.
- Signing of informed consent for trial participation (including for naxitamab treatment) according with current legal regulations.
- Consent to the use of effective contraception throughout the period of the study and a minimum of 1 year after discontinuation of study treatment in patients at puberty and sexual maturity
- Failure to meet any of the inclusion criteria.
- Not eligible to IT.
- Previous treatment with an anti-GD2 antibody.
- Hypersensitivity to the study drugs or any of their ingredients (covers IT and naxitamab).
- Simultaneous treatment with other drugs which might interact with naxitamab or IT regimen.
- Persistent toxicity related to prior therapy, making it impossible to treat with naxitamab.
- Significant cardiac conduction abnormalities, including known familial prolonged QT syndrome, or screening corrected QT interval (QTc) \>480 msec.
- Symptoms of congestive heart failure or left ventricular ejection fraction \<50%.
- Inadequate pulmonary function defined as evidence of dyspnea at rest, exercise intolerance, and/or chronic oxygen requirement. In addition, room air pulse oximetry \< 94% and/or abnormal pulmonary function tests if...
- Requirement, or likely requirement, for corticosteroids at doses \>10 mg prednisolone (or equivalent) per day or other immunosuppressive agents.
- Diagnosis of other malignancies before study inclusion.
- Planning to become pregnant (while being treated with IT or naxitamab), pregnancy or breastfeeding.
- 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 study team makes the final eligibility decision.
Where it's taking place
- Warsaw, Mazowian, Poland
- Wroclaw, Poland
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, 2 years to 21 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Warsaw, Mazowian, Poland; Wroclaw, Poland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.