NCT06528691View on ClinicalTrials.gov

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

PHASE2RecruitingINTERVENTIONAL
Enrollment

52

Participants

Timeline

Start Date

October 31, 2025

Primary Completion Date

November 30, 2027

Study Completion Date

November 30, 2032

Conditions
High Grade GliomaCNS Tumor
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.

Trial Locations (1)

38105

RECRUITING

St. Jude Children's Research Hospital, Memphis

All Listed Sponsors
collaborator

Hoffmann-La Roche

INDUSTRY

lead

St. Jude Children's Research Hospital

OTHER

NCT06528691 - Entrectinib as a Single Agent in Upfront Therapy for Children <3 Years of Age With NTRK1/2/3 or ROS1-FUSED CNS Tumors | Biotech Hunter | Biotech Hunter