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NCT05135975 · ClinicalTrials.gov registry record · Phase 2
A Study of Cabozantinib as a Maintenance Agent to Prevent Progression or Recurrence in High-Risk Pediatric Solid Tumors
A Phase 2 study of Sarcoma and Neuroblastoma, sponsored by Nationwide Children's Hospital.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 86
- Enrollment target
- 6
- Study locations
NCT05135975 is a Phase 2 study of Sarcoma and Neuroblastoma that is actively recruiting participants, run by Nationwide Children's Hospital. The registered enrollment target is 86 participants, below the 921-participant average among 122 other Sarcoma trials with a reported enrollment target (91% lower). The trial reports 6 study locations across 6 states.
The verdict
NCT05135975, a Phase 2 study of Sarcoma and Neuroblastoma, is actively recruiting participants, sponsored by Nationwide Children's Hospital.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 86 participants
- Enrollment target
- 6
- Study locations
Study Summary
This study will expand the types of pediatric cancers being evaluated for response to cabozantinib. The current COG study is restricted to Ewing sarcoma, osteosarcoma, rhabdomyosarcoma, Wilms tumor, and a handful of uncommon tumors. The proposed study will extend this evaluation to tumors that have been shown to either express known targets of cabozantinib or with preclinical evidence of efficacy, including specifically neuroblastomas. These tumors have high morbidity and mortality, particularly in the relapse setting, and few or no proven therapeutic options. As such, evaluation of cabozantinib in these studies is warranted. The study hypothesizes that use of cabozantinib in patients with ultra-high-risk pediatric solid tumors with minimal disease burden, as defined in the inclusion criteria below, can prevent and/or slow recurrent tumor formation in pediatric solid tumors and thereby significantly extend the period of disease control and/or induce a durable cure.
Conditions Studied
Interventions
- DRUG Cabozantinib
Study Locations (6)
Alabama
- Children's Hospital of Alabama/UAB - Birmingham
Colorado
- Children's Hospital of Colorado - Aurora
District of Columbia
- Children's National Medical Center - Washington D.C.
New York
- Children's Hospital at Montefiore - The Bronx
Ohio
- Nationwide Children's Hospital - Columbus
Utah
- Primary Children's Hospital - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 86 participants |
| Start Date | 2022-07-20 |
| Est. Completion | 2029-12 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05135975
The ClinicalTrials.gov registry entry for NCT05135975 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 86 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 921-participant average among 122 other Sarcoma trials with a reported enrollment target (91% lower). The listed sponsor is Nationwide Children's Hospital, which has 188 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Sarcoma appearing as the primary indexed condition, and to 1 intervention - of which Cabozantinib is the first listed.
NCT05135975 reports 6 study locations spanning 6 distinct geographic areas - top geographies include Alabama, Colorado, District of Columbia.
Frequently Asked Questions
What is clinical trial NCT05135975 about?
NCT05135975 is a clinical study titled "A Study of Cabozantinib as a Maintenance Agent to Prevent Progression or Recurrence in High-Risk Pediatric Solid Tumors". This study will expand the types of pediatric cancers being evaluated for response to cabozantinib. The current COG study is restricted to Ewing sarcoma, osteosarcoma, rhabdomyosarcoma, Wilms tumor, and a handful of uncommon tumors. The proposed study will extend this evaluation to tumors that have ...
What is the current status of trial NCT05135975?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 86 participants. The study started on 2022-07-20. Estimated completion is 2029-12.
What conditions does trial NCT05135975 study?
This clinical trial studies the following conditions: Sarcoma, Neuroblastoma.
What interventions are being tested in trial NCT05135975?
The interventions under investigation include: Cabozantinib (DRUG).
Who is sponsoring clinical trial NCT05135975?
This trial is sponsored by Nationwide Children's Hospital, which has 188 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05135975 being conducted?
This trial has 6 study locations across Alabama, Colorado, District of Columbia, New York, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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