Expanded Access to Provide Larotrectinib for the Treatment of Cancers With a NTRK Gene Fusion
NCT03025360 · Status: APPROVED_FOR_MARKETING · Type: EXPANDED_ACCESS
Last updated 2019-12-19
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
Interventions
- DRUG
-
Larotrectinib (Vitrakvi, BAY2757556)
Larotrectinib will be administered orally as capsule or liquid solution as specified by the treating physician.
Sponsors & Collaborators
- lead INDUSTRY
Eligibility
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
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