Ignite Creation Date:
2024-05-06 @ 10:16 AM
Last Modification Date:
2024-10-26 @ 12:27 PM
Study NCT ID:
NCT03215511
Status:
COMPLETED
Last Update Posted:
2024-03-26
First Post:
2017-06-30
Brief Title:
A Study to Test the Safety of the Investigational Drug Selitrectinib in Children and Adults That May Treat Cancer
Sponsor:
Bayer
Organization:
Bayer
Study Overview
Official Title:
A Phase 1 Study of the TRK Inhibitor Selitrectinib BAY 2731954 in Adult and Pediatric Subjects With Previously Treated NTRK Fusion Cancers
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
True
If Expanded Access, NCT#:
NCT03206931
Has Expanded Access, NCT# Status:
NO_LONGER_AVAILABLE
Acronym:
None
Brief Summary:
This research study is done to test the safety of the new drug selitrectinib in children and adults with cancer having a change in a particular gene NTRK1 NTRK2 or NTRK3 The drug may treat cancer by interfering with the effect of the NTRK genes on cancer growth The study also investigates how the drug is absorbed and processed in the human body and how well and for how long the cancer responds to the drug This is the first study to test selitrectinib in humans with cancer for whom no other effective therapy exists
Detailed Description:
The primary objective is to determine the recommended dose for further study of oral selitrectinib with previously treated neurotrophic tyrosine kinase NTRK cancers in 2 patient groups a aged 12 years and older and b younger than 12 years Secondary objectives of Phase I are to characterize the pharmakokinetic properties of the test drug its safety and tolerability and to assess the objective response rate ORR of NTRK-tumors
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-EXT-17005 | OTHER | None | None |
| 2017-004246-20 | EUDRACT_NUMBER | Loxo Oncology Inc | None |