Who can enter
• Children/adolescents/young adults with osteosarcoma.
• Age: from 5 till 18 years old
Goal
The goal of this study is to look at how safe the combination of cabozantinib and best supportive care (BSC) is for the treatment of osteosarcoma. And how well it works.
Background
This medical-scientific study is being conducted to learn more about young people (children, adolescents and young adults) who have osteosarcoma, and if a drug called cabozantinib in combination with the best supportive care is effective as a maintenance therapy, when compared to the best supportive care (no active anticancer drug), in treating this type of cancer. In this medical-scientific study we will also examine how safe the study drug, cabozantinib, is for these young people, and how well they tolerate the drug.
Cabozantinib is an oral (taken by mouth) cancer drug. It is a type of drug called a small molecule inhibitor and works by reducing tumor growth and tumor blood vessel growth. We are using cabozantinib because it seems to work against cancer in test tubes, animals and in humans (adults and children).
Study details
Official title
A phase II, randomized, open-label study to assess the efficacy, safety, and pharmacokinetics (PK) of maintenance cabozantinib (XL184) plus best supportive care (BSC) versus BSC in children, adolescents and young adults (AYA) with unresectable residual osteosarcoma either at diagnosis or at first relapse after standard treatment.
Cancer type
Osteosarcoma
Phase
2
Maximum number of patients
90, of whom 9-10 are expected to participate in the Netherlands.
Start date
July 30, 2024
Status
Open
Local principal investigator
Dr. Natasha van Eijkelenburg
Sponsor
Ipsen Innovation
Approval
The study of this new treatment has been reviewed by an accredited medical research ethics committee. This committee has decided that it is justified to ask patients to participate in this study. More information can be found at: CCMO and Government of the Netherlands.
Trial registry number
EU clinical trial register: EudraCT 2023-506229-12-00
In order to participate in a study please refer to your/your child’s doctor. For international patients: please feel welcome to contact our International Patients Office.
Last reviewed
July 30, 2024
