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Open, not recruiting

STARTRK: Phase I/II Study of Entrectinib in Children and Young Adults with Aggressive Solid or Brain Tumors

About this study

This clinical trial will study the investigational drug entrectinib in children and adolescents with solid tumors and brain tumors. Investigational means that the drug has not been approved by health authorities. Entrectinib has been tested in adults. However, this study is the first time this drug is being tested in children.

Entrectinib is designed to target certain changes in cancer cells which may result in killing those cells.

This study is divided into two parts:

  • The first part will test different doses of entrectinib to find out the highest dose that can be given without serious side effects.
  • The second part will test entrectinib in patients who have specific changes in their cancer cells that may respond to the drug.

Because there is not much information about how entrectinib will affect cancers in humans, we do not know if you will benefit from taking part in this study. However, the information learned from this study may help doctors learn more about entrectinib as a treatment for these kinds of tumors. This information could help future participants with cancer.

Purpose of this clinical trial

The main goals of this study are:

  • To test the safety, tolerability and anti-tumor activity of entrectinib
  • To find out the highest dose of entrectinib that can be given without serious side effects
  • To find out how your body handles and breaks down entrectinib
  • To find out how entrectinib may benefit you or alter your cancer

Eligibility overview

  • Diagnosed with one of the following:
    • Relapsed or refractory extracranial solid tumor
    • Primary brain tumor with NTRK1/2/3, ROS1 or ALK gene fusion
    • Extracranial solid tumor with NTRK1/2/3, ROS1 or ALK gene fusion
  • Younger than 18 years old
  • Not pregnant

The above information is intended to provide only a basic description about a research protocol that may be currently active at St. Jude. The details made available here may not be the most up-to-date information on protocols used by St. Jude. To receive full details about a protocol and its status and or use at St. Jude, a physician must contact St. Jude directly.


Full title:

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

Study goal:

To determine the maximum tolerated dose (MTD), recommended Phase II dose (RP2D) and objective response rate of entrectinib.


Solid tumors, brain tumors, CNS tumors


0 years to 18 years

Clinical trials categories:

Childhood Cancer Solid Tumors Brain Tumors

For physicians and researchers

Patients accepted to St. Jude must be referred by a physician or other qualified medical professional. Learn how St. Jude can partner with you to care for your patient.


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