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| Diagnosis | Osteosarcoma | Study Status | Open |
| Phase | II |
| Age | 5 Years to 30 Years | Randomisation | YES |
| Line of treatment | Disease relapse or progression |
| Routes of Treatment Administration | Drug: Cabozantinib (oral)
Once daily (QD) on a continuous dosing schedule for cycles of 28 days. |
| Last Posted Update | 2025-03-31 |
| ClinicalTrials.gov # | NCT06341712 |
International Sponsor
IpsenPrincipal Investigators for Canadian Sites
The Hospital for Sick Children - Dr. Daniel Morgenstern
Princess Margaret Cancer Centre (AYA) - Dr. Abha GuptaCentres
Study Description
This study is for children, teens, and young adults who have a type of bone cancer called osteosarcoma. Osteosarcoma is rare but is the most common bone cancer in young people. It happens when cancer cells make immature bone. The study includes participants whose cancer couldn’t be completely removed with surgery and who have shown some improvement or stable disease after regular chemotherapy.
In the study, participants will either:
- Take a medication called cabozantinib (a daily tablet) along with supportive care, or
- Receive supportive care only, which can include treatments like antibiotics, nutritional support, pain management, and other care but not cancer-specific therapy.
If the cancer worsens for those receiving only supportive care, they might switch to also taking cabozantinib if they meet certain conditions. Cabozantinib will continue as long as it is helping and well-tolerated. The study is expected to last about 24 months for each participant, but they may stay in the study longer if they are benefiting from the treatment. Participants can choose to leave the study at any time.
Inclusion Criteria
- Participants must be ≥5 and ≤30 years old
- Have a confirmed diagnosis of high-grade osteosarcoma
- Have cancer that couldn’t be fully removed after standard chemotherapy, participants must have had at least 4 cycles of chemotherapy, unless it was stopped early due to side effects.
- Recovered from most side effects of previous treatments (except for hair loss, hearing issues, or mild nerve problems).
- Be able to do most daily activities, and be up and about at least 70% of their waking hours
- Meet organs and bone marrow functioning requirements
- Have blood pressure under control, with or without medication.
- Follow guidelines for preventing pregnancy if appropriate for their age and situation.
- Sign consent forms: participants 18 or older must sign, and younger participants need a parent or guardian’s consent, plus their agreement if required.
Other inclusion and exclusion criteria may apply and will be discussed with you by the study team.
