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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

StatusRecruiting
PhasePhase 2
Started2026-05-01
View on ClinicalTrials.gov ↗

Amendment history

2026-05-12
minor
Study Status, Contacts/Locations v19
Start dateestimated 2026-05→confirmed 2026-05-01
Study sites4→6
2026-04-21
minor
Study Status, Contacts/Locations v18
Start date2026-04→2026-05
Study sites2→4
2026-03-20
minor
Study Status v17
Start date2026-03→2026-04
2026-02-16
minor
Study Status v16
Start date2026-02→2026-03
2026-02-05
minor
Study Status, Contacts/Locations v15
Study sites1→2
Show 14 earlier versions
2026-01-09
minor
Study Status v14
Start date2026-01→2026-02
2025-11-25
minor
Study Status v13
Start date2025-11→2026-01
2025-10-30
minor
Study Status v12
Start date2025-10→2025-11
2025-09-05
minor
Study Status v11
Start date2025-09→2025-10
2025-08-12
minor
Study Status v10
Start date2025-08→2025-09
2025-07-03
minor
Study Status, Oversight, Eligibility v9
Start date2025-07→2025-08
Eligibility criteriarevised
[...] tient must have measurable disease based on RAPNO criteria ≤4284 days since surgery (resection or biopsy) Available tumor ti [...]
2025-06-03
minor
Study Status v8
Start date2025-05→2025-07
2025-04-08
minor
Study Status v7
Start date2025-03→2025-05
2025-02-27
minor
Study Status v6
Start date2025-02→2025-03
2025-01-10
minor
Study Status v5
Start date2025-01→2025-02
2024-12-13
minor
Study Status v4
Start date2024-12→2025-01
2024-11-01
minor
Study Status v3
Start date2024-10→2024-12
2024-08-27
minor
Study Status v2
Start date2024-08→2024-10
2024-08-09
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Study sitesdetails revised at 1 of 1 site
2024-07-25
minor
Original filing
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.
Trial Details
NCT Number NCT06528691
Lead Sponsor St. Jude Children's Research Hospital
Collaborators: Hoffmann-La Roche
Conditions High Grade Glioma, CNS Tumor
Enrollment 52 participants
Start Date 2026-05-01
Primary Completion 2027-11 (estimated)
Study Completion 2032-11 (estimated)
Updated on ClinicalTrials.gov 2026-05-13