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New hope for kids with tough cancers: entrectinib trial underway

NCT ID NCT02650401

Disease control Sponsor: Hoffmann-La Roche Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a drug called entrectinib in children with advanced solid tumors or brain tumors that have come back or haven't responded to other treatments. The trial has two parts: first finding the best dose, then seeing how well it works in children whose tumors have specific gene changes. About 69 children are taking part across multiple centers.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
entrectinib
What this could lead to
If it works, this could provide a new treatment option for children with certain hard-to-treat cancers that have specific gene changes.
What could go wrong
This is an early-phase trial with only 69 participants, so results may not apply to all children. The drug may cause side effects or not shrink tumors as hoped.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

69 people

The number who actually took part.

Started

May 2016

Expected to finish

Jun 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

0 to 18 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Disease status: * Phase 1 portion (closed): Participants must have measurable or evaluable disease, as defined by RECIST v1.1 * Phase 2 portion: * Part B: Participants must have measurable or evaluable disease, as defined by RANO * Part C (closed): Participants must have measurable or evaluable disease, as defined by RECIST v1.1 ± Curie Scale * Part D: Participants must have measurable or evaluable disease, as defined by RECIST v1.1 * Part E (closed): Participants must have measurable or evaluable disease, as defined by RECIST v1.1 ± Curie Scale or RANO 2. Tumor type: * Phase 1 portion: \* Part A: Relapsed or refractory extracranial solid tumors * Phase 2 portion * Part B: Primary brain tumors with NTRK1/2/3 or ROS1 gene fusions; gene fusions are defined as those predicted to translate into a fusion protein with a functional TRKA/B/C or ROS1 kinase domain, without a concomitant second oncodriver as determined by a nucleic acid-based diagnostic testing method * Part D: Extracranial solid tumors (including NB) with NTRK1/2/3 or ROS1 gene fusions; gene fusions are defined as those predicted to translate into a fusion protein with a functional TRKA/B/C or ROS1 kinase domain, without a concomitant second oncodriver as determined by a nucleic acid-based diagnostic testing method 3. Histologic/molecular diagnosis of malignancy at diagnosis or the time of relapse 4. Archival tumor tissue from diagnosis or, preferably, at relapse 5. Performance status: Lansky or Karnofsky score ≥ 60% and minimum life expectancy of at least 4 weeks 6. Prior therapy: Participants must have a disease that is locally advanced, metastatic, or where surgical resection is likely to result in severe morbidity, and who have no satisfactory treatment options for solid tumors and primary CNS tumors that are neurotrophic tyrosine receptor kinase (NTRK) or ROS1 fusion-positive 7. Participants must have recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to enrollment 8. Adequate organ and neurologic function 9. Females of childbearing potential must have a negative serum pregnancy test during screening and be neither breastfeeding nor intending to become pregnant during study participation. Agreement to remain abstinent or use use combined contraceptive methods prior to study entry, for the duration of study participation and in the following 90 days after discontinuation of study treatment. 10. For male participants with a female partner of childbearing potential or a pregnant female partner: Agreement to remain abstinent or use a condom during the treatment period and for at least 3 months after the last dose of study drug Exclusion Criteria: 1. Receiving other experimental therapy 2. Known congenital long QT syndrome 3. History of recent (3 months) symptomatic congestive heart failure or ejection fraction ≤50% at screening 4. Known active infections 5. Familial or personal history of congenital bone disorders, bone metabolism alterations or osteopenia 6. Receiving Enzyme Inducing Antiepileptic Drugs (EIAEDs) within 14 days of first dose. 7. Prior treatment with approved or investigational TRK or ROS1 inhibitors 8. Known hypersensitivity to entrectinib or any of the other excipients of the investigational medicinal product 9. Patients with NB with bone marrow space-only disease 10. Incomplete recovery from acute effects of any surgery prior to treatment. 11. Active gastrointestinal disease or other malabsorption syndromes that would impact drug absorption. 12. Other severe acute or chronic medical or psychiatric condition or lab abnormality that may increase the risk associated with study participation, drug administration or may interfere with the interpretation of study results.

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Conditions

The condition(s) this trial relates to.

brain cancer central nervous system cancer central nervous system neoplasm Ewing sarcoma glioma medulloblastoma mesoblastic nephroma Neoplasm Metastasis neuroblastoma NTRK fusion positive cancer Recurrence salivary gland cancer sarcoma Thyroid Cancer, Papillary Wilms tumor

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

CNS tumors Solid tumors

Contacts and locations

Locations

  • Beijing Children's Hospital, Capital Medical University

    Beijing, China

  • Centre Leon Berard

    Lyon, 69373, France

  • Children's Hospital Colorado

    Aurora, Colorado, 80045, United States

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104, United States

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • Egleston Children's Hospital at Emory University Atlanta

    Atlanta, Georgia, 30322, United States

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, Lombardy, 20133, Italy

  • Hong Kong Children's Hospital

    Hong Kong, 00000, Hong Kong

  • Hospital Infantil Universitario Nino Jesus

    Madrid, 28009, Spain

  • Hôpital de la Timone, Oncologie Pédiatrique

    Marseille, 13385, France

  • Johns Hopkins University

    Baltimore, Maryland, 21205, United States

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • Nationwide Children's Hospital

    Columbus, Ohio, 43205, United States

  • Oregon Health & Science Uni

    Portland, Oregon, 97239, United States

  • Primary Children's Hospital

    Salt Lake City, Utah, 84113, United States

  • Royal Marsden Hospital (Sutton)

    London, SW3 6JJ, United Kingdom

  • Royal Victoria Infirmary

    Newcastle upon Tyne, NE1 4LP, United Kingdom

  • St. Jude Children'S Research Hospital

    Memphis, Tennessee, 38105, United States

  • Texas Children's Cancer and Hematology Center

    Houston, Texas, 77030, United States

  • The Hospital for Sick Children

    Toronto, Ontario, M5G 1X8, Canada

  • UCSF Benioff Children's Hospital

    San Francisco, California, 94158, United States

  • Universitaetsklinikum Heidelberg

    Heidelberg, Baden-Wurttemberg, 69120, Germany

  • University of California San Diego

    La Jolla, California, 92093-0706, United States

  • University of Chicago

    Chicago, Illinois, 60637, United States

  • Washington University,St. Louis Children's Hospital

    St Louis, Missouri, 63110, United States

  • Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality, 200082, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.