Ignite Creation Date:
2024-05-06 @ 7:57 AM
Last Modification Date:
2024-10-26 @ 11:54 AM
Study NCT ID:
NCT02637687
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-08
First Post:
2015-12-10
Brief Title:
A Study to Test the Safety and Efficacy of the Drug Larotrectinib for the Treatment of Tumors With NTRK-fusion in Children
Sponsor:
Bayer
Organization:
Bayer
Study Overview
Official Title:
A Phase 12 Study of the Oral TRK Inhibitor Larotrectinib in Pediatric Patients With Advanced Solid or Primary Central Nervous System Tumors
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
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:
SCOUT
Brief Summary:
The study is being done to test the safety of a cancer drug called larotrectinib in children The cancer must have a change in a particular gene NTRK1 NTRK2 or NTRK3 Larotrectinib blocks the actions of these NTRK genes in cancer cells and can therefore be used to treat cancer
The first study part Phase 1 is done to determine what dose level of larotrectinib is safe for children how the drug is absorbed and changed by their bodies and how well the cancer responds to the drug The main purpose of the second study part Phase 2 is to investigate how well and how long different cancer types respond to the treatment with larotrectininb
The first study part Phase 1 is done to determine what dose level of larotrectinib is safe for children how the drug is absorbed and changed by their bodies and how well the cancer responds to the drug The main purpose of the second study part Phase 2 is to investigate how well and how long different cancer types respond to the treatment with larotrectininb
Detailed Description:
None
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 |
|---|---|---|---|
| 2016-003498-16 | EUDRACT_NUMBER | CTIS EU | None |
| LOXO-TRK-15003 | OTHER | None | None |
| 2022-502668-20-00 | OTHER | None | None |