A Study to Compare the Efficacy and Safety of Ifosfamide and Etoposide With or Without Lenvatinib in Children, Adolescents and Young Adults With Relapsed and Refractory Osteosarcoma

Official Title

A Multicentre, 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)

Summary:

This Is a Multicentre, Randomized, Open-Label, Parallel-Group, 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.

Trial Description

Primary Outcome:

  • Progression-free Survival (PFS)
Secondary Outcome:
  • Progression-free Survival Rate at Month 4 (PFS-4m Rate)
  • Progression-free Survival Rate at 1 Year or Month 12 (PFS-1y rate)
  • Overall Survival (OS)
  • Objective Response Rate at Month 4 (ORR-4m)
  • Objective Response Rate (ORR)
  • Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
  • Plasma Concentration of Lenvatinib - Arm A
  • Change From Baseline in Score for all Pediatric Quality of Life Inventory (PedsQL) Scales Including Generic Core Scales and Cancer Modules
  • Palatability and Acceptability of the Suspension Formulation of Lenvatinib in Participants Receiving the Suspension Formulation, as Assessed Using Palatability Questionnaire

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society