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Title
Status

 

OLIE - A Multicenter, Open-label, Randomized Phase 2 Study to Compare the Efficacy and Safety of Lenvatinib in Combination With Ifosfamide and Etoposide Versus Ifosfamide and Etoposide in Children, Adolescents and Young Adults With Relapsed or Refractory Osteosarcoma (OLIE)

Completed

OLIE - A Multicenter, Open-label, Randomized Phase 2 Study to Compare the Efficacy and Safety of Lenvatinib in Combination With Ifosfamide and Etoposide Versus Ifosfamide and Etoposide in Children, Adolescents and Young Adults With Relapsed or Refractory Osteosarcoma (OLIE)

Go to Health Care Provider version

DiagnosisOsteosarcoma Study StatusCompleted
PhaseII
AgeChild, Adult - (2 Years to 25 Years) RandomisationYES
Line of treatmentDisease relapse or progression
Routes of Treatment AdministrationLevatinib taken by mouth (oral capsules or liquid) Ifosfamide and Etoposide administered through intravenous infusion
Last Posted Update2022-02-22
ClinicalTrials.gov #NCT04154189
International Sponsor
Eisai Inc.
Principal Investigators for Canadian Sites
The Hospital for Sick Children - Dr. Daniel Morgenstern
Centres
Medical contact

Dr. Daniel Morgenstern

daniel.morgenstern@sickkids.ca

Social worker/patient navigator contact

Karen Fung 

karen.fung@sickkids.ca

Clinical research contact

New Agent and Innovative Therapies (NAIT) 

nait.info@sickkids.ca

 

 

 

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