Surveillance Study of Patients With Newly Diagnosed Osteosarcoma
- Registration Number
- NCT01194284
- Lead Sponsor
- Millennium Pharmaceuticals, Inc.
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 25
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description High-grade osteosarcoma patients Mifamurtide -
- Primary Outcome Measures
Name Time Method Short-term safety profile of mifamurtide during treatment (mifamurtide in combination with chemotherapy) 36 weeks * Adverse events of special interest (AESIs), including important identified and potential risks
* The frequency and pattern of mifamurtide-related infusion adverse eventsThe long-term safety profile of mifamurtide during and following treatment (mifamurtide in combination with chemotherapy) Up to 5 years from the last dose of mifamurtide or until death Assessment of AESIs, consisting of important identified and potential risks
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
AKH Wien Universitätsklinik für Innere Medizin I Klinische Abteilung für Onkologie
🇦🇹Wien, Austria