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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

APPROVED_FOR_MARKETING

Study Classification

EXPANDED_ACCESS

Brief Summary

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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

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Conditions

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Tumors Harboring NTRK Fusion

Keywords

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Neurotrophic tyrosine receptor kinase (NTRK) NTRK1 NTRK2 NTRK3 Fusion Positive

Interventions

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Larotrectinib (Vitrakvi, BAY2757556)

Larotrectinib will be administered orally as capsule or liquid solution as specified by the treating physician.

Intervention Type DRUG

Other Intervention Names

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LOXO-101

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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20366

Identifier Type: -

Identifier Source: org_study_id