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Cabozantinib S-malate in Treating Patients With Relapsed Osteosarcoma or Ewing Sarcoma | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE2

Cabozantinib S-malate in Treating Patients With Relapsed Osteosarcoma or Ewing Sarcoma

A Phase 2 Study of XL184 (Cabozantinib) in Treating Patients With Relapsed Osteosarcomas and Ewing Sarcomas

NCT02243605•National Cancer Institute (NCI)

View on ClinicalTrials.gov

Summary

This phase II trial studies how well cabozantinib s-malate works in treating patients with osteosarcoma or Ewing sarcoma that has grown or returned (come back) after a period of improvement. Cabozantinib s-malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and may also prevent the growth of new blood vessels that tumors need to grow.

Detailed Description

PRIMARY OBJECTIVES: I. To evaluate the antitumor activity of cabozantinib s-malate (cabozantinib) for Ewing sarcomas, in terms of 6-month objectives response as per the Response Evaluation Criteria in Solid Tumors, Revised (RECIST version \[v\]1.1). II. To evaluate the antitumor activity of cabozantinib for osteosarcoma, in terms of 6-month objective response (complete response, partial response) and 6-month non-progression (complete response, partial response and stable disease), as per RECIST v1.1. SECONDARY OBJECTIVES: I. 6-month objective response. (Ewing sarcoma only) II. Best overall response (as per the revised RECIST v1.1). (Ewing sarcoma and osteosarcoma) III. 1- and 2-year progression-free survival. (Ewing sarcoma and osteosarcoma) IV. 1- and 2-year overall survival. (Ewing sarcoma and osteosarcoma) V. Cabozantinib safety. (Ewing sarcoma and osteosarcoma) VI. To assess the ability of metabolic tumor response as measured by fludeoxyglucose (FDG)-positron emission tomography (PET) at the end of one cycle of treatment to predict progression-free survival (PFS). (Ewing sarcoma and osteosarcoma) VII. Translational research: to determine and compare tumor expression of MET, phosphorylated (phosphor)-MET and circulating levels of HGF, soluble MET (sMET), VEGF-A, and soluble VEGF receptor 2 (VEGFR2) (sVEGFR2) prior to and following administration of cabozantinib. (Ewing sarcoma and osteosarcoma) OUTLINE: Patients receive cabozantinib s-malate orally (PO) once daily (QD) on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 6 months.

Eligibility

Age

12 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Young patient age between 12 - 15 could be included in only 6 centers (Bordeaux, Lyon, Villejuif, Lille, Marseille and Paris)
•Patients must have histologically confirmed diagnosis of osteosarcoma or Ewing sarcoma by central review, except if the diagnosis was already confirmed by the RRePS (Reseau de Reference en Pathologie des Sarcomes et des Tissus Mous et des Visceres) network
•Relapsed disease after standard chemotherapy
•Patients must have measurable disease (lesion in previously irradiated field could be considered as measurable if progressive at inclusion) defined as per RECIST v1.1 with at least one lesion that can be measured in at least one dimension (longest diameter to be recorded) as \>= 10 mm with spiral computed tomography (CT) scan
•Eastern Cooperative Oncology Group (ECOG) performance status =\< 1
•Life expectancy of greater than 3 months
•Absolute neutrophil count \>= 1,500/mcL
•Lymphocyte count \> 1,000/mcL
•Platelets \>= 100,000/mcL
•Total bilirubin =\< 1.5 x upper limit of normal (ULN)
+17 more criteria

Exclusion Criteria

•The subject has received cytotoxic chemotherapy (including investigational cytotoxic chemotherapy) or biologic agents (e.g., cytokines or antibodies) within 3 weeks, or nitrosoureas/mitomycin C within 6 weeks before the first dose of study treatment
•Prior treatment with cabozantinib
•Receipt of any type of small molecule kinase inhibitor (including investigational kinase inhibitor) within 14 days before the first dose of study treatment; note: subjects with prostate cancer currently receiving luteinizing hormone-releasing hormone (LHRH) or gonadotropin-releasing hormone (GnRH) agonists may be maintained on these agents
•The subject has received any other type of investigational agent within 28 days before the first dose of study treatment
•The subject has not recovered to baseline or Common Terminology Criteria for Adverse Events (CTCAE) =\< grade 1 from toxicity due to all prior therapies except alopecia and other non-clinically significant adverse events (AEs)
•The subject has a primary brain tumor
•Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 2 weeks before the first dose of study treatment; eligible subjects must be neurologically asymptomatic and without corticosteroid treatment at the time of the start of study treatment
•The subject has prothrombin time (PT)/international normalized ratio (INR) or partial thromboplastin time (PTT) test \>= 1.3 x the laboratory ULN within 7 days before the first dose of study treatment
•The subject requires concomitant treatment, in therapeutic doses, with anticoagulants such as warfarin or warfarin-related agents, heparin, thrombin or factor Xa inhibitors, or antiplatelet agents (e.g., clopidogrel); low dose aspirin (=\< 81 mg/day), low-dose warfarin (=\< 1 mg/day), and prophylactic low molecular weight heparin (LMWH) are permitted
•The subject requires chronic concomitant treatment of strong cytochrome P450 family 3, subfamily A, polypeptide 4 (CYP3A4) inducers (e.g., dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, phenobarbital, and St. John's wort)
+46 more criteria

Locations (11)

Institut Bergonie Cancer Center

Bordeaux, France

Centre Georges-Francois Leclerc

Dijon, France

Centre Oscar Lambert

Lille, France

Centre Leon Berard

Lyon, France

Hopital De La Timone

Marseille, France

Centre Antoine Lacassagne

Nice, France

Institut Curie Paris

Paris, France

Institut de Cancerologie de l'Ouest-Rene Gauducheau

Saint-Herblain, France

CHRU Strasbourg - Hospital Civil

Strasbourg, France

Center Claudius Regaud

Toulouse, France

Key Dates

Start Date

December 19, 2014

Primary Completion Date

June 30, 2019

Completion Date

July 11, 2026

Last Updated

March 20, 2026

Enrollment

ACTUAL participants

Conditions

Metastatic Ewing SarcomaMetastatic OsteosarcomaRecurrent Ewing SarcomaRecurrent OsteosarcomaStage III Osteosarcoma AJCC v7Stage IV Osteosarcoma AJCC v7Stage IVA Osteosarcoma AJCC v7Stage IVB Osteosarcoma AJCC v7Unresectable Ewing SarcomaUnresectable Osteosarcoma

Interventions

Cabozantinib S-malate

DRUG

Laboratory Biomarker Analysis

OTHER

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 20, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Cabozantinib S-malate in Treating Patients With Relapsed Osteosarcoma or Ewing Sarcoma

Inclusion Criteria

Exclusion Criteria

Thoracotomy Versus Thoracoscopic Management of Pulmonary Metastases in Patients With Osteosarcoma

Tegavivint for the Treatment of Recurrent or Refractory Solid Tumors, Including Lymphomas and Desmoid Tumors

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