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

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)
  • Targeted Therapy
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