drugset / Trial / NCT02441309
A Eurosarc Study of Mifamurtide in Advanced Osteosarcoma (MEMOS)
Phase 2
Terminated
8 enrolled
University of Oxford
European Commission · collabMillennium: The Takeda Oncology Company · collabNational Institute for Health Research, United Kingdom · collabOxford University Hospitals NHS Trust · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a Bayesian designed multi-arm, multi-centre, open label phase II study. The target sample size of 40 patients will be recruited from up to 8 EU countries, but this may be revised in light of the interim analysis. Patients with relapsed or metastatic osteosarcoma will be divided into three treatment groups. They will all either have surgery or a biopsy before and after six weeks exposure to either Mifamurtide alone, Ifosfamide alone, or Mifamurtide combined with Ifosfamide. They will then receive further treatment to a maximum of 42 or 36 weeks in total (depending on Arm), with all patients being able to receive 36 weeks of Mifamurtide treatment.
Timeline
- Start
- 2014-10
- Primary completion
- 2016-11-04
- Completion
- 2016-11-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ifosfamide | Small molecule | 12 g | Intravenous |
| Subject | Ifosfamide | Small molecule | 15 g | Intravenous |
| Subject | Mifamurtide | Other / unclassified | 2 mg/m2 | Intravenous |