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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03066661
Expanded Access Status : No longer available
First Posted : February 28, 2017
Last Update Posted : April 26, 2019
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment
Cancers With NTRK, ROS1, or ALK Gene Fusions Drug: Entrectinib

Study Design
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Study Type : Expanded Access
  See clinical trials of the intervention/treatment in this expanded access record.
Official Title: Expanded Access to Entrectinib (RXDX-101) for the Treatment of Cancers With NTRK, ROS1, or ALK Gene Fusions

Resource links provided by the National Library of Medicine

Drug Information available for: Entrectinib

Interventions
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Intervention Details:
  • Drug: Entrectinib
    Open-label expanded access, capsules
    Other Name: RXDX-101
Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03066661


Locations
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United States, California
1-844-Startrk (782-7875)
San Diego, California, United States, 92121
Sponsors and Collaborators
Hoffmann-La Roche
More Information
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT03066661    
Other Study ID Numbers: Entrectinib (RXDX-101) - EAP
First Posted: February 28, 2017    Key Record Dates
Last Update Posted: April 26, 2019
Last Verified: April 2019
Additional relevant MeSH terms:
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Entrectinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action