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RECRUITING
NCT06528691
PHASE2

Entrectinib as a Single Agent in Upfront Therapy for Children <3 Years of Age With NTRK1/2/3 or ROS1-FUSED CNS Tumors

Sponsor: St. Jude Children's Research Hospital

View on ClinicalTrials.gov

Summary

This clinical trial tests how well entrectinib works to treat patients less than 3 years of age with NTRK 1/2/3 or ROS1 fused, high grade glioma or other central nervous system (CNS) tumors.

Official title: PHASE 2 Study of Entrectinib as a Single Agent in Upfront Therapy for Children <3 Years of Age With NTRK1/2/3 or ROS1-FUSED CNS Tumors (GLOBOTRK)

Key Details

Gender

All

Age Range

Any - 3 Years

Study Type

INTERVENTIONAL

Enrollment

52

Start Date

2026-05-01

Completion Date

2032-11

Last Updated

2026-05-13

Healthy Volunteers

No

Interventions

DRUG

Entrectinib

Given orally (PO) or enterally

DRUG

Cyclophosphamide

Given intravenous (IV)

DRUG

Etoposide

Given IV

DRUG

Carboplatin

Given IV

BIOLOGICAL

G-CSF

Given subcutaneous (SQ) or IV

BIOLOGICAL

Pegfilgrastim

Given SQ as part of recommended Bridging Therapy instead of G-CSF.

PROCEDURE

Surgery

A gross total resection or significant debulking may become possible if a response to entrectinib is seen.

Locations (6)

St. Jude Children's Research Hospital

Memphis, Tennessee, United States

Hospital de Câncer de Barretos

Barretos, São Paulo, Brazil

GRAACC Hospital (Grupo de Apoio ao Adolescente e à Criança com Câncer)

São Paulo, Brazil

Hospital Santa Marcelina

São Paulo, Brazil

King Hussein Cancer Center

Amman, Jordan

Instituto Nacional de Enfermedades Neoplásicas

Lima, Peru