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New pill targets rare gene in Hard-to-Treat cancers

NCT ID NCT02122913

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested a new pill called larotrectinib in 75 adults with advanced cancers that have a specific gene change (NTRK fusion). The main goals were to check the drug's safety, find the best dose, and see how the body processes it. Participants had no other good treatment options left.

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

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

75 people

The number who actually took part.

Started

May 2014

Finished

Apr 2021

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

18 years and older

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: * Adult patients with a locally advanced or metastatic solid tumor that has progressed or was nonresponsive to available therapies, are unfit for standard chemotherapy or for which no standard or available curative therapy exists * Proof of a malignancy harboring a NTRK fusion * Eastern Cooperative Oncology Group (ECOG) score of 0, 1 or 2 and a life expectancy of at least 3 months * Adequate hematologic, hepatic, and renal function Exclusion Criteria: * Patients with unstable primary central-nervous-system tumors or metastasis, exceptions possible * Clinically significant active cardiovascular disease or history of myocardial infarction * Active uncontrolled systemic bacterial, viral, or fungal infection * Current treatment with a strong CYP3A4 inhibitor or inducer * Pregnancy or lactation

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Hospital of the University of Pennsylvania - Radiology

    Philadelphia, Pennsylvania, 19104, United States

  • Mass General Cancer Center

    Boston, Massachusetts, 02114, United States

  • OHSU Hospital - Neurology

    Portland, Oregon, 97239, United States

  • SCRI Oncology Partners

    Nashville, Tennessee, 37203, United States

  • The University of Texas MD Anderson Cancer Center - Texas Medical Center

    Houston, Texas, 77030, United States

  • UCHealth Cancer Center - Anschutz Medical Campus - University of Colorado Cancer Center

    Aurora, Colorado, 80045, United States

  • UH Seidman Cancer Center

    Cleveland, Ohio, 44106, United States

  • UPMC Mercy - Oncology

    Pittsburgh, Pennsylvania, 15219, United States

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