NCT04154189 : 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)

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Treatment<br/>TrialTypeTreatment
Trial

TwoPhase Two

2-25Age 2-25

Sarcoma<br/>CancersCancer LocationSarcoma
Cancers

Treatment | SarcomaOsteosarcoma

Trial Overview Read MoreRead more

This study aims to compare the safety and efficacy of multiple anti cancer medication in in Children, Adolescents, and Young Adults with Relapsed or Refractory Osteosarcoma .
 

This trial is treating patients with Osteosarcoma.

This is a systemic therapy treatment .

You may be able to join this trial if:

  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You have had treatment, but your cancer has come back.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have had certain treatments, surgical procedures or drugs.
  • You have previously been treated (or are currently being treated) on a clinical trial.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Scientific Title

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)

Commercial Sponsor

Eisai Co., Ltd.

Summary

Eligible Participants with relapsed or refractory osteosarcoma will receive lenvatinib in combination with ifosfamide and etoposide. Drug: Lenvatinib : Lenvatinib 14 milligrams per square meter (mg/m^2) capsules will be administered once daily on Days 1 to 21 of each 21-day cycle until disease progression (PD), development of unacceptable toxicity, participant request, withdrawal of consent, or discontinuation of study by the sponsor. An extemporaneous suspension of lenvatinib capsules may be used for participants unable to swallow capsules.

Recruiting Hospitals Read MoreRead more

Royal Childrens Hospital
Parkville
Trial Coordinator
CCC.ClinicalTrials@rch.org.au

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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