Expanded Access to Provide Larotrectinib for the Treatment of Cancers With a NTRK Gene Fusion
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03025360|
Expanded Access Status : Approved for marketing
First Posted : January 19, 2017
Last Update Posted : December 19, 2019
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.
|Condition or disease||Intervention/treatment|
|Tumors Harboring NTRK Fusion||Drug: Larotrectinib (Vitrakvi, BAY2757556)|
|Study Type :||Expanded Access|
|Expanded Access Type :||Individual Patients|
|See clinical trials of the intervention/treatment in this expanded access record.|
|Official Title:||Expanded Access to Provide Larotrectinib (LOXO-101) for the Treatment of Cancers With a NTRK Gene 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