drugset / Trial / NCT05135975

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

NCT05135975 ↗

Phase 2 Recruiting 86 enrolled Nationwide Children's Hospital Exelixis · collab
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2022-07-20
Primary completion
2026-07
Completion
2029-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Cabozantinib Small molecule 40 mg/m2 —

Indications