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

NCT03025360 | Unknown

• 1 other identifier: 20366
• Study Type: expanded_access
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Tumors Harboring NTRK Fusion

Keywords

Neurotrophic tyrosine receptor kinase (NTRK); NTRK1; NTRK2; NTRK3; Fusion Positive

Interventions

Larotrectinib (Vitrakvi, BAY2757556) DRUG

Larotrectinib will be administered orally as capsule or liquid solution as specified by the treating physician.

Also known as: LOXO-101

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Currently enrolled in an ongoing clinical study of larotrectinib or another TRK inhibitor

Sponsors & Collaborators

• Bayer: lead

MeSH Terms

Interventions

larotrectinib

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2017
• First Posted: January 19, 2017
• Last Updated: December 19, 2019

Record last verified: 2019-12