Observational, Noninterventional Surveillance Study of Patients With Newly Diagnosed Osteosarcoma
Overview
- Phase
- Not Applicable
- Intervention
- Mifamurtide
- Conditions
- Osteosarcoma
- Sponsor
- Millennium Pharmaceuticals, Inc.
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- Short-term safety profile of mifamurtide during treatment (mifamurtide in combination with chemotherapy)
- Status
- Terminated
- Last Updated
- 9 years ago
Overview
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
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
High-grade osteosarcoma patients
Intervention: Mifamurtide
Outcomes
Primary Outcomes
Short-term safety profile of mifamurtide during treatment (mifamurtide in combination with chemotherapy)
Time Frame: 36 weeks
* Adverse events of special interest (AESIs), including important identified and potential risks * The frequency and pattern of mifamurtide-related infusion adverse events
The long-term safety profile of mifamurtide during and following treatment (mifamurtide in combination with chemotherapy)
Time Frame: Up to 5 years from the last dose of mifamurtide or until death
Assessment of AESIs, consisting of important identified and potential risks
Secondary Outcomes
- 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)