Effects of Maintenance Cabozantinib+BSC Versus BSC in Children and AYA With Osteosarcoma

Part of paid clinical trials in Norfolk, Virginia.

Sponsor
Ipsen
Study ID
NCT06341712
Phase
PHASE2
Status
Terminated

Conditions

  • Osteosarcoma
  • Osteosarcoma in Adolescents and Young Adults
  • Osteosarcoma in Children

Eligibility Criteria

Sex
ALL
Age
5 Years - 30 Years
Healthy Volunteers
Not accepted

Interventions

  • Cabozantinib — DRUG
    Participants will receive cabozantinib orally Once daily (QD) on a continuous dosing schedule for cycles of 28 days.
  • Best Supportive Care (BSC) — OTHER
    Participants will receive BSC. BSC includes antibiotics, nutritional support, correction of metabolic disorders, optimal symptom control and pain management (including palliative radiotherapy), etc. but does not include tumor specific therapy.
  • Best Supportive Care (BSC) — OTHER
    Participants will receive BSC alone. BSC includes antibiotics, nutritional support, correction of metabolic disorders, optimal symptom control and pain management (including palliative radiotherapy), etc. but does not include tumor specific therapy.

Study Details

The participants of this study will be children, adolescents, and young adults with residual osteosarcoma, which cannot be removed completely through surgery. Participants will have achieved a partial response or stable disease at the end of conventional chemotherapy. Osteosarcoma is cancer of the bone. The cancer cells make immature bone cells, known as osteoid. Osteosarcoma is very rare, but it is the most common type of bone cancer in children and teens. It is most common in teens and young adults. In this study, participants will receive either cabozantinib and best supportive care or the best supportive care alone. Best supportive care will be provided at the investigator's discretion and according to institutional guidelines. It includes antibiotics, nutritional support, correction of metabolic disorders, optimal symptom control and pain management (including radiotherapy), etc. but does not include tumor specific therapy. Cabozantinib will be taken by mouth (orally), as a tablet, once a day. Cabozantinib will be provided to participants who tolerate it for as long as their disease does not progress. Participants in the study receiving best supportive care alone may switch to treatment with cabozantinib and best supportive care if their disease progresses and if other eligibility criteria are met. Participants may withdraw consent to participate at any time. The estimated duration of the study for participants is 24 months, however a participant could remain in the study longer if demonstrating treatment benefit.

Key Dates

Start date
Nov 22, 2024
Status verified
Mar 2026
Primary completion
Feb 27, 2026
Completion
Feb 27, 2026

Study Design

Enrollment
10 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A: Cabozantinib+ Best supportive care (BSC)
    Participants will receive cabozantinib and BSC.
  • Other: Arm B: Best supportive care (BSC)
    Participants will receive BSC alone administered per investigator's discretion and institutional guidelines.

Primary Outcome Measure

Progression-free Survival (PFS) assessed by Blinded Independent Radiology Committee (BIRC) [ Time Frame: From randomization until disease progression or death from any cause, whichever occurs first (approximately 34 months). ]

Locations (1)

FacilityCityStateZIPSite coordinators
Children's Hospital of the King's DaughtersNorfolkVirginia23507-

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By research site
Children's Hospital of the King's Daughters· Norfolk, VA

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