| Study Name |
|
Expanded Access of Adagrasib (MRTX849) in Patients With Advanced Solid Tumors Who Have a KRAS G12C Mutation |
| ClinicalTrials.gov Identifier (if applicable) |
|
NCT05162443 |
| Clinical Trial Category (check all that apply) |
|
|
| Study Center |
| Institution Name |
|
Multiple Sites |
| State |
|
– Please Select – |
| Country |
|
United States |
| Website |
|
https://clinicaltrials.gov/ct2/show/NCT05162443 |
| List additional Institutions (include address, phone number, and website) |
|
Please see https://clinicaltrials.gov/ct2/show/NCT05162443 or contact Early Access Care (Mirati.ExpandedAccess@earlyaccesscare.com) if interested in participating or opening the EAP. |
| Study Contacts |
| Principal Investigator |
|
Multiple |
| P.I. Phone |
|
(475) 522-2200 |
| P.I. Email |
|
Mirati.ExpandedAccess@earlyaccesscare.com |
| Study Coordinator |
|
Johanna Hancock |
| Study Coordinator Phone |
|
(475) 522-2200 |
| Study Coordinator Email |
|
Mirati.ExpandedAccess@earlyaccesscare.com |
| OVERVIEW – in layman’s terms (150 words max) |
|
This EAP is to provide expanded access of adagrasib (MRTX849) to patients with previously treated advanced solid tumors harboring a KRAS G12C mutation. |
| Enrollment |
|
up to 100 patients |
| Study Start Date |
|
12/17/2021 |
| Estimated Completion Date |
|
N/A: approved for marketing, last updated 5/19/23 |
| Inclusion Criteria – Patients Must: |
|
- Have histologically or cytologically confirmed diagnosis of an advanced/metastatic solid tumor
- Have confirmed presence of a KRASG12C mutation
- Be ineligible for an ongoing clinical trial of MRTX849 No available or not eligible for standard of care treatment
- Have adequate organ function
- Have an ECOG performance status of ≤ 2
|
| Exclusion Criteria – Patients Must NOT: |
|
- Have a history of intestinal disease, inflammatory bowel disease, major gastric surgery, or other gastrointestinal conditions likely to alter absorption of MRTX849 treatment or result in inability to swallow
- Have received prior therapy targeting a KRAS G12C mutation
- Have an other active cancer
|
