Tumors Harboring NTRK Fusion Clinical Trial
Official title:
Expanded Access to Provide Larotrectinib (LOXO-101) for the Treatment of Cancers With a NTRK Gene Fusion
| NCT number | NCT03025360 |
| Other study ID # | 20366 |
| Secondary ID | |
| Status | Approved for marketing |
| Phase | |
| First received | |
| Last updated |
| Verified date | December 2019 |
| Source | Bayer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Expanded Access |
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.
| Status | Approved for marketing |
| Enrollment | 0 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Bayer |