Ignite Creation Date:
2024-05-06 @ 2:47 AM
Last Modification Date:
2024-10-26 @ 11:23 AM
Study NCT ID:
NCT02122913
Status:
COMPLETED
Last Update Posted:
2023-11-07
First Post:
2014-04-16
Brief Title:
A Study to Test the Safety of the Investigational Drug Larotrectinib in Adults That May Treat Cancer
Sponsor:
Bayer
Organization:
Bayer
Study Overview
Official Title:
A Phase 1 Study of the Oral TRK Inhibitor Larotrectinib in Adult Patients With Solid Tumors
Status:
COMPLETED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
True
If Expanded Access, NCT#:
NCT03025360
Has Expanded Access, NCT# Status:
APPROVED_FOR_MARKETING
Acronym:
None
Brief Summary:
This research study is done to test the safety of the drug larotrectinib in adult cancer patients The drug may be used to treat cancer with a change in a particular gene NTRK1 NTRK2 or NTRK3 because it blocks the action of these genes in cancer cells The study also investigates how the drug is absorbed and processed in the human body This is the first study to test larotrectinib in humans with cancer for whom no other effective therapy exists
Detailed Description:
The trial will be conducted in 2 parts an initial dose escalation phase of larotrectinib in subjects with advanced solid tumors will be followed by an expansion phase in subjects with solid tumors having a NTRK fusion
The objectives of the study are to determine the safety pharmacokinetic profile recommended dose and efficacy of orally administered larotrectinib in patients with NTRK fusions
The objectives of the study are to determine the safety pharmacokinetic profile recommended dose and efficacy of orally administered larotrectinib in patients with NTRK fusions
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| LOXO-TRK-14001 | OTHER | Loxo Inc | None |