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Tyrosine Kinase Inhibitor

Cabozantinib + Supportive Care for Bone Cancer (CabOSTar Trial)

Phase 2

Recruiting

Research Sponsored by Ipsen

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Must not have

Participants with uncontrolled, significant intercurrent or recent illness

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 4 months and 1 year after randomization.

Awards & highlights

No Placebo-Only Group

Summary

This trial involves children, teenagers, and young adults with a type of bone cancer called osteosarcoma that cannot be fully removed by surgery. Participants must have shown a partial response or stable disease after

Who is the study for?

This trial is for children and young adults aged 5 to 30 with high-grade osteosarcoma that's not fully removable by surgery. They should have stable disease after chemotherapy, a life expectancy over 6 months, good performance status, and proper organ/marrow function. Those with progressive disease or severe side effects from previous treatments are excluded.

What is being tested?

The study compares the effectiveness of Cabozantinib taken orally plus Best Supportive Care (BSC) versus BSC alone in managing osteosarcoma. BSC includes symptom control and pain management but no tumor-specific therapy. Participants can switch to Cabozantinib if their condition worsens.

What are the potential side effects?

Cabozantinib may cause side effects such as fatigue, mouth sores, hand-foot skin reactions, high blood pressure, diarrhea, weight loss, decreased appetite, nausea and potential liver issues. The severity of these side effects varies among individuals.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 5 and 30 years old.

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My diagnosis of high-grade osteosarcoma has been confirmed by a pathologist.

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I've had at least 4 rounds of chemo for cancer that couldn't be surgically removed.

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My cancer has not worsened according to my last two scans.

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I can take care of myself and perform normal activities without help.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any severe, uncontrolled illnesses.

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I have not had major surgery in the last 8 weeks or minor surgery in the last 10 days without complications.

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My condition is a type of bone cancer called low grade or periosteal osteosarcoma.

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I have been treated with drugs targeting MET/HGF before.

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I haven't had cancer treatment or experimental drugs in the last 4 weeks.

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I am currently fighting an infection that needs treatment.

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I cannot swallow pills whole.

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I do not have any other cancer that needs treatment right now.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 4 months and 1 year after randomization.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 4 months and 1 year after randomization.

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 4 months and 1 year after randomization. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression-free Survival (PFS) assessed by Blinded Independent Radiology Committee (BIRC)

Secondary study objectives

1-year overall survival rate

Acceptability and palatability in children and adolescents assessed using a horizontal visual assessment scale.

Change from baseline in European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) (EORTC QLQ-C30) for adult participants

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