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

Sponsor

Bayer (Industry)

Overall Status

No longer available

CT.gov ID

NCT03206931

Collaborator

(none)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Solid Tumors Harboring NTRK Fusion	Drug: Selitrectinib (BAY2731954)

Study Design

Study Type:

Expanded Access

Official Title:

Expanded Access to Provide Selitrectinib (BAY2731954) for the Treatment of Cancers With a NTRK Gene Fusion.

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Month and Older

Sexes Eligible for Study:

All

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