check_circleStudy Completed

Tumors harboring NTRK fusion

Bayer Identifier:

20366

ClinicalTrials.gov Identifier:

NCT03025360

EudraCT Number:

Not Available

EU CT Number:

Not Available
Expanded access to provide larotrectinib for the treatment of cancers with a NTRK gene fusion

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.

Key Participants Requirements

Sex

All

Age

NaN - N/A
  • - 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

Trial summary

Enrollment Goal
11
Trial Dates
null - Today
Phase
N/A
Could I Receive a placebo
No
Products
Vitrakvi (Larotrectinib, BAY2757556)
Accepts Healthy Volunteer
No

Trial design

Expanded access to provide larotrectinib (LOXO-101) for the treatment of cancers with a NTRK gene fusion
Trial Type
Expanded Access
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
N/A
Blinding
N/A
Assignment
Single Group Assignment
Trial Arms
1