What is cabozantinib studying for osteosarcoma?

Cabozantinib is being studied in combination with standard chemotherapy to see if it improves treatment outcomes for patients with newly diagnosed osteosarcoma. Researchers want to understand if adding cabozantinib affects survival and symptom burden. The trial is supported by the National Cancer Institute.

Who may be eligible for this osteosarcoma clinical trial?

Patients under 40 years old with newly diagnosed high-grade osteosarcoma may be eligible. Both localized and metastatic cases are included, and patients must meet health and lab requirements. Please review eligibility criteria for more details.

Is there any cost to participate in this osteosarcoma clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered.

Actively Recruiting

Phase 2

Phase 3

Age: 0 - 40Years

All Genders

ID05691478

Evaluating Cabozantinib with Standard Chemotherapy in Patients Under 40 with Newly Diagnosed Osteosarcoma

Led by National Cancer Institute (NCI) · Updated on 2026-07-31

1122

Participants Needed

202

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the safety, side effects, and optimal dose of cabozantinib combined with standard chemotherapy in patients newly diagnosed with osteosarcoma. This phase IIIII trial aims to compare the effects of adding cabozantinib, a kinase inhibitor that may slow tumor growth, to the usual chemotherapy drugs methotrexate, doxorubicin, and cisplatin. The study focuses on patients under 40 years old with high-grade osteosarcoma, including both localized and metastatic cases. Participants receive treatment in two main phases. The feasibility phase now closed tested cabozantinib with chemotherapy in metastatic patients with resectable tumors, using cycles of oral cabozantinib and intravenous chemotherapy drugs over several months. The ongoing efficacy phase randomly assigns patients to either standard chemotherapy alone or chemotherapy combined with cabozantinib, with treatment divided into induction, consolidation, and maintenance cycles lasting 35 or 28 days each. Imaging scans, blood samples, and surgery are part of the treatment and evaluation process. During the study, participants undergo regular assessments including X-rays, CT scans, MRI, PET or bone scans, and blood sample collection at diagnosis and throughout treatment. Researchers monitor event-free survival, overall survival, symptom burden, and side effects reported by patients. The trial lasts up to 5 years after treatment to assess long-term outcomes, gather tumor and blood samples for further biological studies, and evaluate the impact of cabozantinib addition on patient health and response.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 0 - 40Years

All Genders

Eligibility Criteria

You may qualify if you...

Patients must be under 40 years of age at enrollment.
Body surface area must be at least 0.8 square meters.
Histologic diagnosis of newly diagnosed high-grade osteosarcoma confirmed by a pathologist.
Primary tumors at any extremity or axial site are eligible.
Osteosarcoma as a second malignancy is eligible if no prior systemic chemotherapy.
For the feasibility phase: metastatic disease with resectable primary tumor as determined by a multidisciplinary team.
For efficacy phase: both localized and metastatic disease are eligible, with patients grouped by standard or high risk.
Kidney function must meet specified creatinine, urine clearance, or GFR thresholds.
Total bilirubin must be less than or equal to 1.5 times the upper limit of normal for age.
Alanine aminotransferase (ALT) must be less than or equal to 135 U/L.
No history of serious cardiac conditions; heart function must meet specific measures.
Corrected QT interval less than 480 msec on ECG.
Blood counts and coagulation values must meet minimum levels.
HIV-infected patients may participate if on effective therapy and not on certain interacting drugs.
Written informed consent must be signed.
All institutional and regulatory requirements for human studies must be met.

You will not qualify if you...

Previous systemic therapy for osteosarcoma or prior oncologic diagnosis.
Central nervous system metastases.
Central cavitating pulmonary lesions invading or encasing major lung blood vessels.
Inability to swallow tablets; tablets cannot be crushed or chewed.
Active gastrointestinal disorders with high risk of perforation or fistula.
Recent significant GI bleeding, perforation, obstruction, abscess, fistula, or pulmonary hemorrhage.
Active bleeding or bleeding disorders within 3 months prior to enrollment.
Uncompensated or symptomatic hypothyroidism.
Moderate to severe liver impairment (Child-Pugh B or C).
Prior tumor resection or attempted curative metastasis resection before enrollment.
Major surgery within 14 days prior to enrollment (except certain procedures).
History of serious or non-healing wound or bone fracture (except pathologic fracture of primary tumor).
Conditions interfering with absorption of cabozantinib.
Allergy or hypersensitivity to study drug components.
Receiving other investigational agents not specified in the protocol.
Inability to comply with safety monitoring.
Recent use of enzyme-inducing anticonvulsants.
History of hypertension requiring medication.
Use of drugs that prolong QTc interval.
Use of certain anticoagulants and platelet inhibitors (with some exceptions).
Use of strong CYP3A4 inducers or inhibitors.
Pregnant or lactating females.
Sexually active patients of reproductive potential not using effective contraception.

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Evaluating Cabozantinib with Standard Chemotherapy in Patients Under 40 with Newly Diagnosed Osteosarcoma

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria