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Expanded Access to Provide Larotrectinib for the Treatment of Cancers With a NTRK Gene Fusion

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: NCT03025360
Expanded Access Status : Approved for marketing
First Posted : January 19, 2017
Last Update Posted : December 19, 2019
Sponsor:
Information provided by (Responsible Party):
Bayer

Study Description
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Brief Summary:

Larotrectinib expanded access is for patients with cancer with a NTRK1, NTRK2, or NTRK3 gene fusion, who are ineligible for an ongoing larotrectinib clinical trial or have other considerations that prevent access to larotrectinib through an existing clinical trial. Gene fusion occurs when a gene is made by joining parts of two different genes. NTRK gene fusion can lead to the development of solid tumors in a variety of tissue types. The study drug larotrectinib blocks the action of the NTRK gene fusion.

Expanded access is intended to treat individual patients with different types of cancers with a NTRK gene fusion who are unresponsive to current standard treatment for their condition and also are unable to participate in ongoing clinical trials.


Condition or disease Intervention/treatment
Tumors Harboring NTRK Fusion Drug: Larotrectinib (Vitrakvi, BAY2757556)

Study Design
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Study Type : Expanded Access
Expanded Access Type : Individual Patients
  See clinical trials of the intervention/treatment in this expanded access record.
Official Title: Expanded Access to Provide Larotrectinib (LOXO-101) for the Treatment of Cancers With a NTRK Gene Fusion

Resource links provided by the National Library of Medicine


Interventions
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Intervention Details:
  • Drug: Larotrectinib (Vitrakvi, BAY2757556)
    Larotrectinib will be administered orally as capsule or liquid solution as specified by the treating physician.
    Other Name: LOXO-101
Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of cancer with a NTRK1, NTRK2, or NTRK3 gene fusion
  • Subjects are unable to participate in an ongoing larotrectinib clinical trial
  • Medically suitable for treatment with larotrectinib

Exclusion Criteria:

  • Currently enrolled in an ongoing clinical study of larotrectinib or another TRK inhibitor
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT03025360    
Other Study ID Numbers: 20366
First Posted: January 19, 2017    Key Record Dates
Last Update Posted: December 19, 2019
Last Verified: December 2019
Keywords provided by Bayer:
Neurotrophic tyrosine receptor kinase (NTRK)
NTRK1
NTRK2
NTRK3
Fusion Positive