OLIE (Osteosarcoma-Lenvatinib-Ifosfamide-Etoposide)
Research type
Research Study
Full 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)
IRAS ID
275056
Contact name
Quentin Campbell-Hewson
Contact email
Sponsor organisation
Eisai Ltd
Eudract number
2019-003696-19
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 0 months, 12 days
Research summary
Lenvatinib is an anticancer agent authorised to treat progressive or advanced thyroid cancer in adults. Lenvatinib belongs to a type of anti-cancer treatments known as receptor tyrosine kinase (RTK) inhibitors, which are involved in the growth of cells and the development of new blood vessels that supply them.
Previous studies have shown Lenvatinib has activity in solid tumours, including relapsed or refractory osteosarcoma, and radioiodine-refractory differentiated thyroid carcinoma and is tolerable in children, adolescents and young adults. Combining Lenvatinib with Ifosfamide and etoposide may have more activity against relapsed or refractory osteosarcoma than when used alone.
This study will evaluate the efficacy and safety of Lenvatinib in combination with Ifosfamide and etoposide in comparison with compared to Ifosfamide and Etoposide in children, adolescents, and young adults with relapsed or refractory osteosarcoma.
Approximately 72 eligible participants will be randomised to 1 of the following 2 treatment arms in a 1:1 ratio:
Arm A: Lenvatinib + Ifosfamide and Etoposide
Arm B: Ifosfamide and Etoposide
The study will be conducted in 3 Phases: a Pre-randomization Phase (screening and baseline), a Randomization Phase (treatment and follow up), and an Extension Phase (treatment and follow up).This is an open label study which means that participants and their study doctors will know the treatment they will receive. It is expected to take about 12-18 months to complete plus a follow up period of up to two years. Study procedures include physical and neurologic examinations, vital signs, ECGs, blood and urine tests, CT/MRI scans.
The end of the study will be the date of data cut off for the final analysis or the time of last
subject last visit, whichever occurs later.Sponsor is Eisai Ltd.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
20/NE/0058
Date of REC Opinion
30 Apr 2020
REC opinion
Further Information Favourable Opinion