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RECRUITING Phase 2

A Study of Cabozantinib as a Maintenance Agent to Prevent Progression or Recurrence in High-Risk Pediatric Solid Tumors

NCT05135975 · View on ClinicalTrials.gov ↗

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

FieldValue
Enrollment Target 86 participants
Start Date 2022-07-20
Est. Completion 2029-12
Phase Phase 2

Sponsor

Nationwide Children's Hospital

239 total trials

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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. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 86 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Nationwide Children's Hospital, which has 239 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05135975 reports 6 study locations spanning 6 distinct geographic areas — top geographies include Alabama, Colorado, District of Columbia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05135975?

The interventions under investigation include: Cabozantinib (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05135975?

This trial is sponsored by Nationwide Children's Hospital, which has 239 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial