🏛️ Verified NIH Record • Updated 2026-06-22

Study Of Entrectinib (Rxdx-101) in Children and Adolescents With Locally Advanced Or Metastatic Solid Or Primary CNS Tumors And/Or Who Have No Satisfactory Treatment Options (NCT02650401)

A Phase 1/2, Open-Label, Dose-Escalation And Expansion Study Of Entrectinib (Rxdx-101) In Pediatrics With Locally Advanced Or Metastatic Solid Or Primary CNS Tumors And/Or Who Have No Satisfactory Treatment Options

🔵 Active, Not Recruiting Phase1 / Phase2 💊 Investigational Drug / Biologic Sponsor: Hoffmann-La Roche

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

This is an open-label, Phase 1/2 multicenter dose escalation study in pediatric patients with relapsed or refractory extracranial solid tumors (Phase 1), with additional expansion cohorts (Phase 2) in patients with primary brain tumors harboring NTRK1/2/3 or ROS1 gene fusions, and extracranial solid tumors harboring NTRK1/2/3 or ROS1 gene fusions.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (20 items) and avoid the listed exclusions (13 items).

Location: University of California San Diego — La Jolla, California

Age range: 0 Years to 18 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:
  • Receiving other experimental therapy
  • Known congenital long QT syndrome
  • History of recent (3 months) symptomatic congestive heart failure or ejection fraction ≤50% at screening
  • Known active infections
  • Familial or personal history of congenital bone disorders, bone metabolism alterations or osteopenia
  • Receiving Enzyme Inducing Antiepileptic Drugs (EIAEDs) within 14 days of first dose.
  • Prior treatment with approved or investigational TRK or ROS1 inhibitors
  • Known hypersensitivity to entrectinib or any of the other excipients of the investigational medicinal product
  • Patients with NB with bone marrow space-only disease
  • Incomplete recovery from acute effects of any surgery prior to treatment.
  • Active gastrointestinal disease or other malabsorption syndromes that would impact drug absorption.

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

📍 All Participating Trial Locations (26 Sites)

Showing the first 25 of 26 sites.

  • University of California San Diego — La Jolla, California
  • UCSF Benioff Children's Hospital — San Francisco, California
  • Children's Hospital Colorado — Aurora, Colorado
  • Egleston Children's Hospital at Emory University Atlanta — Atlanta, Georgia
  • University of Chicago — Chicago, Illinois
  • Johns Hopkins University — Baltimore, Maryland
  • Dana Farber Cancer Institute — Boston, Massachusetts
  • Washington University,St. Louis Children's Hospital — St Louis, Missouri
  • Memorial Sloan Kettering Cancer Center — New York, New York
  • Nationwide Children's Hospital — Columbus, Ohio
  • Oregon Health & Science Uni — Portland, Oregon
  • Children's Hospital of Philadelphia — Philadelphia, Pennsylvania
  • St. Jude Children'S Research Hospital — Memphis, Tennessee
  • Texas Children's Cancer and Hematology Center — Houston, Texas
  • Primary Children's Hospital — Salt Lake City, Utah
  • The Hospital for Sick Children — Toronto, Ontario
  • Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine — Shanghai, Shanghai Municipality
  • Beijing Children's Hospital, Capital Medical University — Beijing,
  • Centre Leon Berard — Lyon,
  • Hôpital de la Timone, Oncologie Pédiatrique — Marseille,
  • Universitaetsklinikum Heidelberg — Heidelberg, Baden-Wurttemberg
  • Hong Kong Children's Hospital — Hong Kong,
  • Fondazione IRCCS Istituto Nazionale dei Tumori — Milan, Lombardy
  • Hospital Infantil Universitario Nino Jesus — Madrid,
  • Royal Marsden Hospital (Sutton) — London,

💰 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.

Explore by condition: All Solid Tumors clinical trials

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  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 ↗