Phase II clinical trial - Pédiatrie Sarcomes

E7080-G000-230 OLIE
Pédiatrie Sarcomes
Ouvert depuis le: 10.17.2021
Site: Paris
Public cible
Enfant
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
Description de l'essai

The study 230, is a randomized, controlled Phase 2 study, which aims to assess the efficacy and safety of use of lenvatinib in combination with ifosfamide and etoposide in children, adolescents and young adults with relapsed or refractory osteosarcoma. Eligible patients between the ages of 2 and 25 will receive ifosfamide and etoposide, with or without lenvatinib (14 mg/m2; DRP2 from Study 207). Patients randomized into arm A may receive lenvatinib continuously until the disease progresses, toxicity exceeds the tolerable threshold, or the patient withdraws consent. Approximately 72 patients will be treated in this study. The main objective of the study is to demonstrate that lenvatinib, combined with ifosfamide and etoposide, is more effective compared to ifosfamide and etoposide based on the progression-free survival rate at 4 months in children, adolescents and young adults with relapsed or refractory osteosarcoma.