Expanded Access to Provide Larotrectinib for the Treatment of Cancers With a NTRK Gene Fusion
Sponsor: Bayer
ClinicalTrials ID:NCT03025360
This expanded access program provides larotrectinib to patients with cancer harboring NTRK1, NTRK2, or NTRK3 gene fusions who cannot join existing trials. Eligible patients must be medically suitable for larotrectinib, which is administered orally as capsules or liquid. This program targets those unresponsive to standard treatments and unable to access ongoing clinical trials.
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Program Overview
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.
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
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