Trial Condition(s):

Tumors harboring NTRK fusion

Expanded access to provide larotrectinib for the treatment of cancers with a NTRK gene fusion

Bayer Identifier:

20366

ClinicalTrials.gov Identifier:

NCT03025360

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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.

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

Trial Summary

Enrollment Goal
11
Trial Dates
N/A
black-arrow
N/A
Phase
N/A
Could I receive a placebo?
No
Products
Vitrakvi (Larotrectinib, BAY2757556)
Accepts Healthy Volunteers
No

Where to Participate

Locations
Status
LocationsStatus

For details, please refer to trial results

Additional Information

Not Available