Ignite Creation Date:
2024-05-06 @ 6:53 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05828303
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-11
First Post:
2023-03-28
Brief Title:
A Phase 1 Study to Evaluate the Potential Drug Interactions Between Repotrectinib and Metformin Digoxin and Rosuvastatin in Patients With Advanced Solid Tumors
Sponsor:
Turning Point Therapeutics Inc
Organization:
Turning Point Therapeutics Inc
Study Overview
Official Title:
A Phase 1 Open-Label Fixed-Sequence Study to Evaluate the Potential Drug Interactions Between Repotrectinib and Metformin Digoxin and Rosuvastatin in Patients With Advanced Solid Tumors Harboring ROS1 or NTRK1-3 Rearrangements
Status:
NOT_YET_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#:
NCT05926232
Has Expanded Access, NCT# Status:
AVAILABLE
Acronym:
None
Brief Summary:
This is a Phase 1 study to evaluate the potential drug-drug interaction DDI effect of repotrectinib on certain drug transporters in patients with advanced cancer
Detailed Description:
This is a Phase 1 open-label fixed-sequence study to evaluate the potential drug-drug interaction DDI effect of repotrectinib on drug transporters metformin digoxin and rosuvastatin following multiple dose administration of repotrectinib in patients with advanced cancer harboring ROS1 and NTRK1 Rearrangements
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