NCT02650401

Study Of Entrectinib (Rxdx-101) in Children and Adolescents With Locally Advanced Or Metastatic Solid Or Primary CNS Tumors And/Or Who Have No Satisfactory Treatment Options

A Phase 1/2, Open-Label, Dose-Escalation And Expansion Study Of Entrectinib (Rxdx-101) In Pediatrics With Locally Advanced Or Metastatic Solid Or Primary CNS Tumors And/Or Who Have No Satisfactory Treatment Options

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 69 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 0 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, Phase 1/2 multicenter dose escalation study in pediatric patients with relapsed or refractory extracranial solid tumors (Phase 1), with additional expansion cohorts (Phase 2) in patients with primary brain tumors harboring NTRK1/2/3 or ROS1 gene fusions, and extracranial solid tumors harboring NTRK1/2/3 or ROS1 gene fusions.

Conditions

• Solid Tumors
• CNS Tumors

Interventions

Type	Name	Description
DRUG	Entrectinib	TRKA/B/C, ROS1, and ALK inhibitor

Timeline

• Start date: 2016-05-03
• Primary completion: 2026-06-30
• Completion: 2026-06-30
• First posted: 2016-01-08
• Last updated: 2026-03-25

Locations

26 sites across 9 countries: United States, Canada, China, France, Germany, Hong Kong, Italy, Spain, United Kingdom