RecruitingPhase 2NCT06528691

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

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)


Sponsor

St. Jude Children's Research Hospital

Enrollment

52 participants

Start Date

May 1, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Max Age: 3 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Carboplatin, a drug called Cyclophosphamide, and others for people with cns tumor and high grade glioma. The study is currently recruiting participants at 6 locations. People eligible for this study include up to age 3 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEntrectinib

Given orally (PO) or enterally

DRUGCyclophosphamide

Given intravenous (IV)

DRUGEtoposide

Given IV

DRUGCarboplatin

Given IV

BIOLOGICALG-CSF

Given subcutaneous (SQ) or IV

BIOLOGICALPegfilgrastim

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

PROCEDURESurgery

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

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NCT06528691


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