🏛️ Verified NIH Record • Updated 2026-05-12

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

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)

🟢 Recruiting Phase2 💊 Investigational Drug / Biologic Sponsor: St. Jude Children's Research Hospital

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (7 items) and avoid the listed exclusions (50 items).

Location: St. Jude Children's Research Hospital — Memphis, Tennessee

Age range: Not specified to 3 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • Exclusion Criteria: Screening Phase
  • Previous exposure to cytotoxic chemotherapy or radiotherapy Inclusion Criteria: COHORT 1
  • Patients must be \<3 years of age at the time of diagnosis (date of surgical resection/biopsy)
  • High-grade glioma (World Health Organization \[WHO\] grade III or IV) harboring NTRK1/2/3 or ROS1 gene fusions as determined by central pathology review
  • Patients must have measurable disease as defined by RAPNO criteria
  • Patients are eligible at the time of diagnosis, prior to any exposure to chemotherapy, targeted therapy, immunotherapy, cellular therapy or radiation
  • ≤28 days since study screening
  • Lansky score ≥50% and a minimum life expectancy of ≥ 12 weeks
  • Neurologic deficits must have been stable for at least 7 days prior to study enrollment
  • Hemoglobin ≥ 8 g/dL (without transfusion or erythropoietin use within 7 days prior to enrollment)
  • Platelet count ≥ 75,000/µL (without transfusion within 7-day period prior to enrollment)
  • Absolute neutrophil count \>1,000/µL

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (6 Sites)

  • St. Jude Children's Research Hospital — Memphis, Tennessee
  • Hospital de Câncer de Barretos — Barretos, São Paulo
  • GRAACC Hospital (Grupo de Apoio ao Adolescente e à Criança com Câncer) — São Paulo,
  • Hospital Santa Marcelina — São Paulo,
  • King Hussein Cancer Center — Amman,
  • Instituto Nacional de Enfermedades Neoplásicas — Lima,

📞 Contact the Study Coordinator

Phone: (901) 595-2544

Email: tabatha.doyle@stjude.org

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

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💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗