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

Expanded Access to Provide Larotrectinib (LOXO-101) for the Treatment of Cancers With a NTRK Gene Fusion

Status
APPROVED_FOR_MARKETING
Phases
Unknown
Study type
Expanded Access
Source
ClinicalTrials.gov
Registry ID
NCT03025360
Enrollment
Unknown
Registered
2017-01-19
Start date
Unknown
Completion date
Unknown
Last updated
2019-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tumors Harboring NTRK Fusion

Keywords

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

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.

Interventions

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

Sponsors

Bayer
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026