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

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2017-01-16
• Study First Submitted QC: 2017-01-16
• Study First Posted: 2017-01-19
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-18
• Last Update Posted: 2019-12-19

Recruitment & Eligibility

• Status: APPROVED_FOR_MARKETING
• Sex: All
• Target Recruitment: Not specified

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

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Exclusion Criteria

• Currently enrolled in an ongoing clinical study of larotrectinib or another TRK inhibitor

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Study & Design

• Study Type: EXPANDED_ACCESS
• Study Design: Not specified