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NCT06341712 · ClinicalTrials.gov registry record · Phase 2
Effects of Maintenance Cabozantinib+BSC Versus BSC in Children and AYA With Osteosarcoma
A Phase 2 study of Osteosarcoma and Osteosarcoma in Children, sponsored by Ipsen.
- Active
- Registry status
- Phase 2
- Development phase
- 10
- Enrollment target
- 16
- Study locations
NCT06341712 is a Phase 2 study of Osteosarcoma and Osteosarcoma in Children that is active but no longer recruiting, run by Ipsen. The registered enrollment target is 10 participants, below the 302-participant average among 46 other Osteosarcoma trials with a reported enrollment target (97% lower). The trial reports 16 study locations across 2 states.
The verdict
NCT06341712, a Phase 2 study of Osteosarcoma and Osteosarcoma in Children, is active but no longer recruiting, sponsored by Ipsen.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 10 participants
- Enrollment target
- 16
- Study locations
Study Summary
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.
Conditions Studied
Interventions
- DRUG Cabozantinib
- OTHER Best Supportive Care (BSC)
Study Locations (16)
Other
- University Hospital Gent - Ghent
- McGill University Health Centre - Centre for Innovative Medicine - Québec
- Princess Margaret cancer center - Toronto
- Centre Oscar Lambret - Lille
- Universitätsmedizin Mainz - Mainz
- Dr. von Haunerschen Kinderspital - München
- Ospedale Ortopedico Rizzoli di Bologna - Bologna
- AOU Città della Salute e della Scienza di Torino - Piemonte
- Amsterdam UMC - Locatie AMC - Amsterdam
- Instytut Matki i Dziecka - Warsaw
- Hospital de La Santa Creu i Sant Pau - Barcelona
- Hospital Universitario Vall d'Hebron - Barcelona
- Hospital Infantil Universitario Nino Jesus - Madrid
- Hospital Universitari i Politecnic La Fe - Valencia
- Birmingham Children's Hospital - Birmingham
Virginia
- Children's Hospital of the King's Daughters - Norfolk
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2024-11-22 |
| Est. Completion | 2028-06-15 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06341712
The ClinicalTrials.gov registry entry for NCT06341712 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 302-participant average among 46 other Osteosarcoma trials with a reported enrollment target (97% lower). The listed sponsor is Ipsen, which has 85 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Osteosarcoma appearing as the primary indexed condition, and to 2 interventions - of which Cabozantinib is the first listed.
NCT06341712 reports 16 study locations spanning 2 distinct geographic areas - top geographies include Other, Virginia.
Frequently Asked Questions
What is clinical trial NCT06341712 about?
NCT06341712 is a clinical study titled "Effects of Maintenance Cabozantinib+BSC Versus BSC in Children and AYA With Osteosarcoma". 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 ...
What is the current status of trial NCT06341712?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 10 participants. The study started on 2024-11-22. Estimated completion is 2028-06-15.
What conditions does trial NCT06341712 study?
This clinical trial studies the following conditions: Osteosarcoma, Osteosarcoma in Children, Osteosarcoma in Adolescents and Young Adults.
What interventions are being tested in trial NCT06341712?
The interventions under investigation include: Cabozantinib (DRUG), Best Supportive Care (BSC) (OTHER).
Who is sponsoring clinical trial NCT06341712?
This trial is sponsored by Ipsen, which has 85 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06341712 being conducted?
This trial has 16 study locations across Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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