Ignite Creation Date:
2024-05-06 @ 12:31 PM
Last Modification Date:
2024-10-26 @ 1:00 PM
Study NCT ID:
NCT03785249
Status:
RECRUITING
Last Update Posted:
2024-06-21
First Post:
2018-12-18
Brief Title:
Phase 12 Study of MRTX849 in Patients With Cancer Having a KRAS G12C Mutation KRYSTAL-1
Sponsor:
Mirati Therapeutics Inc
Organization:
Mirati Therapeutics Inc
Study Overview
Official Title:
A Phase 12 Multiple Expansion Cohort Trial of MRTX849 in Patients With Advanced Solid Tumors With KRAS G12C Mutation KRYSTAL-1
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
True
If Expanded Access, NCT#:
NCT05162443
Has Expanded Access, NCT# Status:
APPROVED_FOR_MARKETING
Acronym:
None
Brief Summary:
This study will evaluate the safety tolerability drug levels molecular effects and clinical activity of MRTX849 adagrasib in patients with advanced solid tumors that have a KRAS G12C mutation
Detailed Description:
This study will evaluate the safety tolerability pharmacokinetics metabolites pharmacodynamics and clinical activity of MRTX849 adagrasib in patients with advanced solid tumors with a KRAS G12C mutation MRTX849 adagrasib is an orally-available small molecule inhibitor of KRAS G12C
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 |
|---|---|---|---|
| CA239-0008 | OTHER | None | None |
| 849-001 | OTHER | None | None |