Expanded Access to Entrectinib for Cancers With NTRK1/2/3, ROS1, or ALK Gene Fusions

April 24, 2019 updated by: Hoffmann-La Roche

Expanded Access to Entrectinib (RXDX-101) for the Treatment of Cancers With NTRK, ROS1, or ALK Gene Fusions

Expanded access to entrectinib will be given to patients with cancers harboring NTRK1/2/3, ROS1, or ALK gene fusions who do not qualify for participation in, or who are otherwise unable to access, an ongoing clinical trial for entrectinib.

Study Overview

Status

No longer available

Conditions

Intervention / Treatment

Study Type

Expanded Access

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92121
        • 1-844-Startrk (782-7875)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Description

Inclusion Criteria:

  • Diagnosis of advanced cancer with an NTRK1, NTRK2, NTRK3, ROS1, or ALK gene fusion
  • Unable to participate in an ongoing entrectinib (RXDX-101) clinical trial
  • Willing and able to provide written, signed informed consent
  • Medically suitable for treatment with entrectinib (RXDX-101)

Exclusion Criteria:

  • Currently enrolled in an ongoing clinical study with any other investigational agent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

February 23, 2017

First Submitted That Met QC Criteria

February 23, 2017

First Posted (Actual)

February 28, 2017

Study Record Updates

Last Update Posted (Actual)

April 26, 2019

Last Update Submitted That Met QC Criteria

April 24, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Entrectinib (RXDX-101) - EAP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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