OncoMatch/Clinical Trials/NCT05691478
A Study to Test the Addition of the Drug Cabozantinib to Chemotherapy in Patients With Newly Diagnosed Osteosarcoma
Is NCT05691478 recruiting? Yes, currently enrolling (May 2026). This Phase 2/3 trial studies multiple treatments including Cabozantinib S-malate and Cisplatin for high grade osteosarcoma.
Treatment: Cabozantinib S-malate · Cisplatin · Doxorubicin Hydrochloride · Methotrexate — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Osteosarcoma
Disease stage
Grade: high grade
newly diagnosed high grade osteosarcoma
Prior therapy
Cannot have received: systemic therapy
Exception: no prior exposure to systemic chemotherapies for osteosarcoma or a prior oncologic diagnosis
Patients who have received previous systemic therapy for osteosarcoma or a prior oncologic diagnosis
Lab requirements
Blood counts
ANC ≥ 1000/uL; Platelet count ≥ 100,000/uL (transfusion independent); Hemoglobin ≥ 8.0 g/dL; INR ≤ 1.5
Kidney function
Serum creatinine based on age/sex (see protocol table); OR 24 hour urine creatinine clearance ≥ 70 mL/min/1.73 m^2; OR GFR ≥ 70 mL/min/1.73 m^2 by direct measurement
Liver function
Total bilirubin ≤ 1.5 x ULN for age; SGPT (ALT) ≤ 135 U/L (ULN for SGPT (ALT) set to 45 U/L)
Cardiac function
No history of congenital prolonged QTc syndrome, NYHA Class III/IV CHF, unstable angina, serious arrhythmias; Shortening fraction ≥ 27% or ejection fraction ≥ 50%; QTcF < 480 msec
A serum creatinine based on age/sex as follows... OR - a 24 hour urine creatinine clearance ≥ 70 mL/min/1.73 m^2 OR - a glomerular filtration rate (GFR) ≥ 70 mL/min/1.73 m^2... Total bilirubin ≤ 1.5 x ULN for age... SGPT (ALT) ≤ 135 U/L... No history of congenital prolonged corrected QT (QTc) syndrome, NYHA Class III or IV congestive heart failure, unstable angina pectoris, serious cardiac arrhythmias... Shortening fraction of ≥ 27%, or Ejection fraction of ≥ 50%... Corrected QT interval by Fridericia (QTcF) < 480 msec... Peripheral absolute neutrophil count (ANC) ≥ 1000/uL... Platelet count ≥ 100,000/uL (transfusion independent)... Hemoglobin ≥ 8.0 g/dL... INR ≤ 1.5
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Children's Hospital of Alabama · Birmingham, Alabama
- Banner Children's at Desert · Mesa, Arizona
- Phoenix Childrens Hospital · Phoenix, Arizona
- Banner University Medical Center - Tucson · Tucson, Arizona
- Arkansas Children's Hospital · Little Rock, Arkansas
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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