Clinical trialNCT05691478RecruitingPhase 2/PHASE3Interventional

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

SponsorNational Cancer Institute (NCI)Enrollment1,122High Grade OsteosarcomaLocalized OsteosarcomaMetastatic OsteosarcomaSecondary Osteosarcoma

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Michael W Bishop
Children's Oncology Group
Principal Investigator
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

202 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Australia

Sydney Children'S Hospital
Randwick, New South Wales, Australia
the Children'S Hospital at Westmead
Westmead, New South Wales, Australia
Queensland Children'S Hospital
South Brisbane, Queensland, Australia
Women'S and Children'S Hospital-Adelaide
North Adelaide, South Australia, Australia
Monash Medical Center-Clayton Campus
Clayton, Victoria, Australia
Royal Children'S Hospital
Parkville, Victoria, Australia
Perth Children'S Hospital
Perth, Western Australia, Australia

Canada

Alberta Children'S Hospital
Calgary, Alberta, Canada
University of Alberta Hospital
Edmonton, Alberta, Canada
Cancercare Manitoba
Winnipeg, Manitoba, Canada
Iwk Health Centre
Halifax, Nova Scotia, Canada
Children'S Hospital
London, Ontario, Canada
Children'S Hospital of Eastern Ontario
Ottawa, Ontario, Canada
Hospital for Sick Children
Toronto, Ontario, Canada
Centre Hospitalier Universitaire Sainte-Justine
Montreal, Quebec, Canada
the Montreal Children'S Hospital of the Muhc
Montreal, Quebec, Canada
Centre Hospitalier Universitaire de Sherbrooke-Fleurimont
Sherbrooke, Quebec, Canada
Jim Pattison Children'S Hospital
Saskatoon, Saskatchewan, Canada
Chu de Quebec-Centre Hospitalier de L'Universite Laval (chul)
Québec, Canada

New Zealand

Starship Children'S Hospital
Grafton, Auckland, New Zealand
Christchurch Hospital
Christchurch, New Zealand

United States

Children'S Hospital of Alabama
Birmingham, Alabama, United States
Banner Children'S at Desert
Mesa, Arizona, United States
Mayo Clinic Hospital in Arizona
Phoenix, Arizona, United States
Phoenix Childrens Hospital
Phoenix, Arizona, United States
Banner University Medical Center - Tucson
Tucson, Arizona, United States
Arkansas Children'S Hospital
Little Rock, Arkansas, United States
Kaiser Permanente Downey Medical Center
Downey, California, United States
City of Hope Comprehensive Cancer Center
Duarte, California, United States
Loma Linda University Medical Center
Loma Linda, California, United States
Miller Children'S and Women'S Hospital Long Beach
Long Beach, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
Children'S Hospital Los Angeles
Los Angeles, California, United States
Mattel Children'S Hospital Ucla
Los Angeles, California, United States
Valley Children'S Hospital
Madera, California, United States
Kaiser Permanente-Oakland
Oakland, California, United States
Ucsf Benioff Children'S Hospital Oakland
Oakland, California, United States
Children'S Hospital of Orange County
Orange, California, United States
Lucile Packard Children'S Hospital Stanford University
Palo Alto, California, United States
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States

162 more sites on the registry record.ClinicalTrials.gov ↗

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

CabozantinibCisplatinDoxorubicinMethotrexate

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 3 Mar 2023
Primary completion: 20 Mar 2030
Completion: 20 Mar 2030
Last update posted: 19 Aug 2026
Registered enrollment: 1,122
Registry id: NCT05691478

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.