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

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated August 12, 2025 (before its estimated July 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Notable Primary completion date: Jul 2025 to Jul 2026
    • Eligibility criteria expanded, about 46 words
    • Site contacts updated at 1 of 6 sites
    v10
  2. Minor Site contacts updated at 2 of 6 sitesv9
  3. Minor Study sites: 5 to 6v8
  4. Minor Study sites: 4 to 5v7
  5. Notable Start date: Oct 18, 2021 to Jul 20, 2022
    • Primary completion date: Dec 2025 to Jul 2025
    v6
Show 4 earlier versionsHide 4 earlier versions
  1. Minor Study sites: 1 to 4v5
  2. Minor Enrollment target: 100 to 86
    • Eligibility criteria shortened, about 268 words
    • Study description expanded, about 61 words
    v4
  3. Minor Eligibility criteria shortened, about 216 wordsv3
  4. Notable Trial status: Active, Not Recruiting to Recruiting
    • Site details revised
    v2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05135975
Lead Sponsor Nationwide Children's Hospital
Collaborators: Exelixis
Conditions
(from sponsor)
Neuroblastoma, Sarcoma
Related terms Neuroblastoma, Osteosarcoma, Rhabdoid Tumor, Rhabdomyosarcoma, Sarcoma, Sarcoma, Ewing, Wilms Tumor
Enrollment 86 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov