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

Bayer

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

Official Title: 
Expanded Access to Provide Larotrectinib (LOXO-101) for the Treatment of Cancers With a NTRK Gene Fusion
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.
Available
EA Type
Individual Patients
Tumors Habouring NTRK Fusion

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: 

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

Eligibility Gender: 
All
Contacts: 

Bayer Clinical Trials Contact
(+)1-888-84 22937
clinical-trials-contact@bayer.com

EA Number: 
Keywords: 
Neurotrophic tyrosine receptor kinase (NTRK), NTRK1, NTRK2, NTRK3, Fusion Positive
Disclaimer:
Expanded Access program information for companies listed in the Expanded Access Company Directory is pulled daily from ClinicalTrials.gov, a resource provided by the National Institutes of Health in cooperation with the U.S. Food and Drug Administration. Click here for more information about ClinicalTrials.gov.