Ignite Creation Date:
2024-05-06 @ 9:35 AM
Last Modification Date:
2024-10-26 @ 12:17 PM
Study NCT ID:
NCT03025360
Status:
APPROVED_FOR_MARKETING
Last Update Posted:
2019-12-19
First Post:
2017-01-16
Brief Title:
Expanded Access to Provide Larotrectinib for the Treatment of Cancers With a NTRK Gene Fusion
Sponsor:
Bayer
Organization:
Bayer
Study Overview
Official Title:
Expanded Access to Provide Larotrectinib LOXO-101 for the Treatment of Cancers With a NTRK Gene Fusion
Status:
APPROVED_FOR_MARKETING
Status Verified Date:
2019-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None