Expanded Access of Adagrasib (MRTX849) in Patients With Advanced Solid Tumors Who Have a KRAS G12C Mutation

ClinicalTrials.gov Identifier

NCT05162443

Institution Name

Multiple Sites

Institution Country

United States

Institution Website

https://clinicaltrials.gov/ct2/show/NCT05162443

Additional Institutions

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.

Principal Investigator

Multiple

Principal Investigator Phone

(475) 522-2200

Principal Investigator Email

Mirati.ExpandedAccess@earlyaccesscare.com

Study Coordinator

Johanna Hancock

Study Coordinator Phone

(475) 522-2200

Study Coordinator Email

Mirati.ExpandedAccess@earlyaccesscare.com

Study Overview

This EAP is to provide expanded access of adagrasib (MRTX849) to patients with previously treated advanced solid tumors harboring a KRAS G12C mutation.

Enrollment Information

up to 100 patients

Study Start Date

20211217

Inclusion Criteria

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

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

Financial Assistance Available

Yes