Expanded Access to Provide Larotrectinib for the Treatment of Cancers With a NTRK Gene Fusion
- Conditions
- Tumors Harboring NTRK Fusion
- Registration Number
- NCT03025360
- Lead Sponsor
- Bayer
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- APPROVED_FOR_MARKETING
- Sex
- All
- Target Recruitment
- Not specified
- 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
- Currently enrolled in an ongoing clinical study of larotrectinib or another TRK inhibitor
Study & Design
- Study Type
- EXPANDED_ACCESS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method