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

NCT06528691 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2026-05-13

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

Principal Investigators

  • Daniel Moreira, MD, MEd · St. Jude Children's Research Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
3 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-01
Primary Completion
2027-11-30
Completion
2032-11-30
FDA Drug
Yes

Countries

  • United States
  • Brazil
  • Jordan
  • Peru

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06528691 on ClinicalTrials.gov