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NCT05691478 · ClinicalTrials.gov record · last posted 2026-08-24

A Study to Test the Addition of the Drug Cabozantinib to Chemotherapy in Patients With Newly Diagnosed Osteosarcoma

StatusSuspended
PhasePhase 2/3
Started2023-03-03
View on ClinicalTrials.gov ↗
Why the trial stopped
Other - Extend the observation period for current patients
from the ClinicalTrials.gov record
This phase II/III trial tests the safety, side effects, and best dose of the drug cabozantinib in combination with standard chemotherapy, and to compare the effect of adding cabozantinib to standard chemotherapy alone in treating patients with newly diagnosed osteosarcoma. Cabozantinib is in a class of medications called kinase inhibitors which block protein signals affecting new blood vessel formation and the ability to activate growth signaling pathways. This may help slow the growth of tumor cells. The drugs used in standard chemotherapy for this trial are methotrexate, doxorubicin, and cisplatin (MAP). Methotrexate stops cells from making DNA and may kill tumor cells. It is a type of antimetabolite. Doxorubicin is in a class of medications called anthracyclines. It works by slowing or stopping the growth of tumor cells in the body. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of tumor cells. Adding cabozantinib to standard chemotherapy may work better in treating newly diagnosed osteosarcoma.

Protocol amendment history 4 changes detected by DataLookout

2026-08-15
critical
Recruitment suspended
2026-08-15
critical
Recruitment suspended: Other - Extend the observation period for current patients
2026-07-24
minor
Trial sites expanded: 199 → 202 locations
2026-05-08
minor
Trial sites expanded: 191 → 194 locations
Trial Details
NCT Number NCT05691478
Lead Sponsor National Cancer Institute (NCI)
Conditions High Grade Osteosarcoma, Localized Osteosarcoma, Metastatic Osteosarcoma, Secondary Osteosarcoma
Enrollment 1,122 participants
Start Date 2023-03-03
Primary Completion 2030-03-20 (estimated)
Study Completion 2030-03-20 (estimated)
Updated on ClinicalTrials.gov 2026-08-24