We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu

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
Information provided by (Responsible Party):

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)

Layout table for study information
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

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

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.

Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

No Contacts or Locations Provided
Layout table for additonal information
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)
Fusion Positive