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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-017204-89 | EudraCT Number |
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Regulatory agency commitment fulfilled.
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This study is an observational safety surveillance study designed to prospectively assess patients with high-grade osteosarcoma who are candidates for treatment with mifamurtide within the context of prevailing standard oncology practice
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High-grade osteosarcoma patients |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mifamurtide | Drug | Mifamurtide will be prescribed to patients with high-grade osteosarcoma as part of their treatment regimen within the context of prevailing standard oncology practice. The recommended dose of mifamurtide is 2 mg/m2. Mifamurtide will be administered for 36 weeks as adjuvant therapy following surgical resection. |
| Measure | Description | Time Frame |
|---|---|---|
| Short-term safety profile of mifamurtide during treatment (mifamurtide in combination with chemotherapy) |
| 36 weeks |
| The long-term safety profile of mifamurtide during and following treatment (mifamurtide in combination with chemotherapy) | Assessment of AESIs, consisting of important identified and potential risks | Up to 5 years from the last dose of mifamurtide or until death |
| Measure | Description | Time Frame |
|---|---|---|
| Disease-free survival | Up to 5 years from the last dose of mifamurtide or until death | |
| Overall Survival | Up to 5 years from the last dose of mifamurtide or until death |
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Inclusion Criteria
Each patient must meet all of the following inclusion criteria to be enrolled in the study:
Exclusion Criteria
Patients meeting any of the following exclusion criteria are not to be enrolled in the study:
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The study population consists of patients with high-grade osteosarcoma who are candidates for treatment with mifamurtide within the context of prevailing standard oncology practice.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Millennium Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AKH Wien Universitätsklinik für Innere Medizin I Klinische Abteilung für Onkologie | Vienna | Austria |
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| ID | Term |
|---|---|
| D012516 | Osteosarcoma |
| ID | Term |
|---|---|
| D018213 | Neoplasms, Bone Tissue |
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C037144 | mifamurtide |
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| D009369 | Neoplasms |
| D012509 | Sarcoma |