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Cancer drug cabozantinib tested in kids and young adults with bone cancer

NCT ID NCT06341712

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested the drug cabozantinib in children, teens, and young adults with osteosarcoma (a bone cancer) that could not be fully removed by surgery. Participants who had stable or partially improved disease after chemotherapy received either cabozantinib plus best supportive care or best supportive care alone. The goal was to see if cabozantinib could delay cancer progression. The trial was terminated early and enrolled only 10 people, so its findings are very limited.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
cabozantinib (a cancer drug taken as a tablet)
What this could lead to
If it works, this could offer a way to delay cancer growth in young people with osteosarcoma that cannot be surgically removed.
What could go wrong
This trial was terminated early with only 10 participants, so results are very limited. Cabozantinib may cause side effects like fatigue, diarrhea, or high blood pressure, and it is not a cure.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

10 people

The number who actually took part.

Started

Nov 2024

Finished

Feb 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

5 to 30 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria : * Participants must be ≥5 and ≤30 years of age at the time of study entry. * Histologically or cytologically confirmed diagnosis of high-grade osteosarcoma as defined by a local pathologist * Participants with unresectable residual disease after standard chemotherapy treatment at diagnosis or first relapse (treated with systemic chemotherapy). A minimum of 4 cycles of systemic chemotherapy (or minimum of 2 cycles if chemotherapy was stopped early due to toxicity) must have been received. * Measurable residual or evaluable disease by RECIST version 1.1. Participants will be considered with evaluable disease if they have only non-measurable disease as per RECIST version 1.1 criteria. * Absence of Progressive Disease (PD) (defined by the investigator according to RECIST version 1.1) at study entry. Note, the two most recent radiological evaluations (e.g. computerised tomography (CT) or magnetic resonance resonance imaging (MRI) scan) including the one following completion of chemotherapy should be available later to facilitate BIRC review. * Chemotherapy must be the last anticancer treatment received by participants before study entry and must have been completed at least 4 weeks but no longer than 2 months before randomization. * Participants must have recovered to Grade ≤1, except for alopecia, ototoxicity, and Grade ≤2 peripheral neuropathy, per Common Terminology Criteria for Adverse Events (CTCAE) version 5.0) from the acute toxic effects of all prior anticancer therapy at study entry, unless AEs are clinically non significant and/or stable on supportive therapy, per investigator clinical judgment. * Life expectancy \>6 months. * Performance level: participants must have a Lansky or Karnofsky performance status score of ≥70 corresponding to Eastern Cooperative Oncology Group (ECOG) categories 0-1. * Adequate organ and marrow function. * Adequately controlled blood pressure (BP) with or without antihypertensive medications. * Male and/or female (according to their reproductive organs and functions assigned by chromosomal complement) (FDA 2016) * Contraception and barriers as well as pregnancy testing is required as appropriate for the age and sexual activity of pediatric participants and as required by local regulations. * All participants (typically ≥18 years) and/or their parents or legal guardians must sign a written informed consent and assent must be obtained from minor participants according to local guidelines. Exclusion Criteria : * Low grade osteosarcoma and periosteal osteosarcoma * Previous treatment with cabozantinib or another Mesenchymal-epithelial transition (MET)/hepatocyte growth factor (HGF) inhibitor (e.g., tivantinib, crizotinib). * Receipt of any type of small molecule kinase inhibitor (including investigational kinase inhibitor) within 2 weeks or 5 half-lives of the agent, whichever is longer, before first dose of study intervention. * Receipt of any type of cytotoxic, biologic or other systemic anticancer therapy (including investigational) within 4 weeks before first dose of study intervention (or washout of at least 5 half-lives, whichever is shorter). * Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery or major surgery e.g., removal or biopsy of brain metastasis) and stable for at least 4 weeks prior to randomization. Eligible participants must be neurologically asymptomatic and without systemic corticosteroid treatment at the time of randomization. Note: Participants with a known seizure disorder who are receiving non-enzyme inducing anticonvulsants and have well-controlled seizures on a stable dose of anti-convulsant may be enrolled. * Participants who have an uncontrolled/active infection requiring systemic therapy. * Participants who are unable to swallow intact tablets. * Participants with uncontrolled, significant intercurrent or recent illness. * Previously identified allergy or hypersensitivity to components of the study treatment formulations. * Any other active malignancy at time of first dose of study intervention or diagnosis of another malignancy within 3 years prior to first dose of study intervention that requires active treatment. * Pregnancy or breast-feeding. * Participants who in the opinion of the investigator may not be able to comply with the requirements of the study are not eligible * Major surgery (eg, orthopaedic surgery, removal or biopsy of brain metastasis) within 8 weeks before randomization. Complete wound healing from major surgery must have occurred 4 weeks before randomization and from minor surgery (eg, simple excision, tooth extraction) at least 10 days before randomization. Participants with clinically relevant ongoing complications from prior surgery are not eligible.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • AOU Città della Salute e della Scienza di Torino

    Piemonte, Italy

  • Amsterdam UMC - Locatie AMC

    Amsterdam, Netherlands

  • Birmingham Children's Hospital

    Birmingham, United Kingdom

  • Centre Oscar Lambret

    Lille, France

  • Children's Hospital of the King's Daughters

    Norfolk, Virginia, 23507, United States

  • Dr. von Haunerschen Kinderspital

    München, Germany

  • Hospital Infantil Universitario Nino Jesus

    Madrid, Spain

  • Hospital Universitari i Politecnic La Fe

    Valencia, Spain

  • Hospital Universitario Vall d'Hebron

    Barcelona, Spain

  • Hospital de La Santa Creu i Sant Pau

    Barcelona, Spain

  • Instytut Matki i Dziecka

    Warsaw, Poland

  • McGill University Health Centre - Centre for Innovative Medicine

    Québec, Canada

  • Ospedale Ortopedico Rizzoli di Bologna

    Bologna, Italy

  • Princess Margaret cancer center

    Toronto, Canada

  • University Hospital Gent

    Ghent, Belgium

  • Universitätsmedizin Mainz

    Mainz, Germany

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