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Evaluation of the Safety and Efficacy of Mifamurtide Versus Standard Treatment With Sorafenib in Patients With High-risk Osteosarcoma

ConditionOsteosarcoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age5-30
SponsorAnna Raciborska

About this trial

Prospective, open, interventional, randomized, non-commercial trial

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 5 to ≤ 30 years at the time of qualification.

Histopathologically confirmed osteosarcoma based on previous diagnostic tests.

Provision of written, informed consent to participate in the study, including treatment with mifamurtide and sorafenib, in accordance with current legal regulations, prior to the initiation of any study procedures.

Participants of the Part I classified as high-risk.

Disqualifiers

Failure to meet any of the inclusion criteria.

Previous treatment with mifamurtide.

Hypersensitivity to the investigational drug or any of its components (including mifamurtide and sorafenib).

Concurrent treatment with drugs that may interact with mifamurtide, sorafenib, or other cytostatics.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Mifamurtide

    Drug

    Mifamurtide is a synthetic analog of muramyl dipeptide, which works by stimulating the immune system to destroy cancer cells. The exact mechanism of this activation in humans is unknown. The MEPACT product is a liposomal form of mifamurtide specifically formulated to reach macrophages in vivo after administration by intravenous infusion.

  • Sorafenib

    Drug

    Sorafenib is a small-molecule, broad-spectrum tyrosine kinase inhibitor that slows cancer cell growth and reduces angiogenesis. Sorafenib is unique among new kinase inhibitors as it simultaneously inhibits the Raf, Mek, and Erk kinase pathways.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: ExperimentalExperimental treatment 1 intervention
Group B: StandardOther 1 intervention

Trial outcomes

Primary outcomes

1

Event-Free Survival (EFS)

EFS (Event-Free Survival) - the time from randomization to the first event, i.e., death, disease progression, or disease relapse, whichever occurs first. Assessment will be conducted from the date of randomization until the date of the event or the date of the last available assessment

Time frame
10,3 months

Secondary outcomes

1

Overall Survival (OS)

Defined as the time from randomization to death from any cause.

Time frame
5,5 years
2

Progression-Free Survival (PFS)

Defined as the time from randomization to documented disease progression or death as assessed by RECIST v1.1.

Time frame
5,5 years
3

Overall Response Rate (ORR)

Defined as the percentage of patients achieving the best overall response of Complete Response (CR) or Partial Response (PR) as assessed by RECIST v1.1.

Time frame
5,5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Anna Raciborska

Lead sponsor

Institute of Mother and Child, Warsaw, Poland

Sponsor institution

Maria Sklodowska-Curie National Research Institute of Oncology

Collaborator

Source ClinicalTrials.gov
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