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

• Conditions: Advanced Cancer; Metastatic Cancer; Malignant Neoplasm

• Registration Number: NCT05162443
• Lead Sponsor: Mirati Therapeutics Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-12-03
• Study First Submitted QC: 2021-12-03
• Study First Posted: 2021-12-17
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-17
• Last Update Posted: 2023-05-19

Recruitment & Eligibility

• Status: APPROVED_FOR_MARKETING
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Histologically or cytologically confirmed diagnosis of an advanced/metastatic solid tumor
• Confirmed presence of a KRASG12C mutation
• Ineligible for an ongoing clinical trial of MRTX849
• No available or not eligible for standard of care treatment
• Adequate organ function
• CNS Metastases (within set parameters) are allowed
• ECOG performance status of ≤ 2

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Exclusion Criteria

• 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
• Prior therapy targeting a KRAS G12C mutation
• Other active cancer

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Study & Design

• Study Type: EXPANDED_ACCESS
• Study Design: Not specified

Trial Locations

Locations (11)

Piedmont Cancer Institute; 🇺🇸 Atlanta, Georgia, United States

Renown Health; 🇺🇸 Reno, Nevada, United States

Lehigh Valley Cancer Institute; 🇺🇸 Allentown, Pennsylvania, United States

Hartford Hospital; 🇺🇸 Hartford, Connecticut, United States

California Pacific Medical Center; 🇺🇸 San Francisco, California, United States

Providence Medical Group Santa Rosa - Cancer Center; 🇺🇸 Santa Rosa, California, United States

Mayo Clinic - Rochester; 🇺🇸 Rochester, Minnesota, United States

Virginia Cancer Institute; 🇺🇸 Richmond, Virginia, United States

Swedish Cancer Institute; 🇺🇸 Seattle, Washington, United States

Lumi Research; 🇺🇸 Kingwood, Texas, United States

Seattle Integrative Cancer Center; 🇺🇸 Renton, Washington, United States