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
🩺 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 ChecklistCheck 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.
More studies in Solid Tumors
- Phase II Biomarker Study of BND-22 in Combination With Cemiplimab in Solid Tumors — Houston, Texas
- Study of AUBE00 in Patients With Solid Tumors — Grand Rapids, Michigan
- JAB-2485 Activity in Adult Patients With Advanced Solid Tumors — Detroit, Michigan
- Study of Pembrolizumab Following Surgery in Patients With Microsatellite Instability High (MSI-H) Solid Tumors — Basking Ridge, New Jersey
- Study of the Effect of Rifampicin on the Pharmacokinetics (PK) of Multiple Doses of Cediranib in Patients With Solid Tumours — Edmonton, Alberta
- DB-1311 in Combination With BNT327 or DB-1305 in Advanced/Metastatic Solid Tumors — Los Angeles, California
Explore by condition: All Solid Tumors clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.