CabOSTar CLIN-60000-461
Active, not recruiting
Who can enter
Children/adolescents/young adults with osteosarcoma
Age: from 5 till 18 years old
Goal
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 effective it is.
Background
Background
This clinical trial is being conducted to learn more about young persons (children, adolescents and young adults) who have osteosarcoma. We will evaluate 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 clinical trial we will also examine how safe the study drug, cabozantinib, is for these young persons, 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).
Last reviewed
Last reviewed
March 20, 2026
Study details
- 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 treatmentCancer type
OsteosarcomaPhase
2Maximum number of patients
90, of whom 9-10 are expected to participate in the NetherlandsStart date
July 30, 2024Status
Gesloten voor deelnameLocal principal investigator
Dr. Natasha van EijkelenburgSponsor
Ipsen InnovationApproval
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.Trial registry number
EU Clinical Trials Register: 2023-506229-12-00
The above information is intended as a brief summary only and may not reflect the most up-to-date information. For full details and the current status of a protocol, physicians can contact the Princess Máxima Center directly.