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Diagnosis | Osteosarcoma | Study Status | Completed |
Phase | II |
Age | Child, Adult - (2 Years to 25 Years) | Randomisation | YES |
Line of treatment | Disease relapse or progression |
Routes of Treatment Administration | Levatinib taken by mouth (oral capsules or liquid)
Ifosfamide and Etoposide administered through intravenous infusion
|
Last Posted Update | 2022-02-22 |
ClinicalTrials.gov # | NCT04154189 |
International Sponsor
Eisai Inc.Principal Investigators for Canadian Sites
The Hospital for Sick Children - Dr. Daniel MorgensternCentres
Study Description
This clinical trial studies whether adding an oral medication called lenvatinib to chemotherapy with ifosfamide/etoposide improves outcomes for patients with osteosarcoma that has come back (relapse).
Lenvatinib blocks cell proteins and signals directed at blood vessels that help the cancer to survive.
Patients can be treated in two different arms: Arm A: chemotherapy + lenvatinib or Arm B : chemotherapy. The participants will be divided by chance into those two separate groups through a computerised process. The treating team will NOT decide into which arm a given patient will be assigned. At this time, it is not known which treatment option is best.
Inclusion Criteria
- Age between 2 and 25 years
- Osteosarcoma that has come back (relapse) or is not improving despite treatments (refractory)
- Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team