Expanded Access to Provide Selitrectinib for the Treatment of Cancers With a NTRK Gene Fusion

• Conditions: Solid Tumors Harboring NTRK Fusion

• Registration Number: NCT03206931
• Lead Sponsor: Bayer

Brief Summary

Selitrectinib expanded access is for minor and adult patients with cancer having a change in a particular gene (NTRK1, NTRK2, or NTRK3 gene fusion). The patients are ineligible for an ongoing selitrectinib clinical trial or have other considerations that prevent access to selitrectinib through an existing clinical trial. Expanded access is intended to treat individual patients with different types of cancers with a NTRK gene fusion, including blood cancers, who have previously received tropomyosin receptor kinase (TRK) inhibitor therapy.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-06-29
• Study First Submitted QC: 2017-06-29
• Study First Posted: 2017-07-02
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-08
• Last Update Posted: 2021-09-16

Recruitment & Eligibility

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

Inclusion Criteria

• Diagnosis of cancer with a NTRK1, NTRK2, and NTRK3 gene fusion
• Previous treatment with a kinase inhibitor with known activity on TRK inhibition
• Unable to participate in an ongoing selitrectinib clinical trial
• Medically suitable for treatment with selitrectinib

Exclusion Criteria

• Currently enrolled in an ongoing clinical study with a TRK inhibitor

Study & Design

• Study Type: EXPANDED_ACCESS
• Study Design: Not specified