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.

Approved for marketing
Individual Patients
Tumors Harboring 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

Eligibility Gender
Eligibility Age
Minimum: N/A ~ Maximum: N/A
NCT Number
Neurotrophic tyrosine receptor kinase (NTRK)
Fusion Positive