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NCT05162443 Clinical Trial

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

Metastatic Cancer Clinical Trial

Official title:
Expanded Access Use of Adagrasib (MRTX849) for the Treatment of Patients With Advanced Solid Tumors With a KRAS G12C Mutation

Clinical Trial Details — Status: Approved for marketing

Administrative data
NCT number NCT05162443
Other study ID # 849-EAP-001
Secondary ID
Status Approved for marketing
Phase
First received
Last updated

Study information
Verified date May 2023
Source Mirati Therapeutics Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Expanded Access

Clinical Trial 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.

Recruitment information / eligibility
Status Approved for marketing
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• adagrasib (MRTX849)
adagrasib (MRTX849) will be administered orally twice daily in a continuous regimen

Locations
Country Name City State
United States Lehigh Valley Cancer Institute Allentown Pennsylvania
United States Piedmont Cancer Institute Atlanta Georgia
United States Hartford Hospital Hartford Connecticut
United States Lumi Research Kingwood Texas
United States Renown Health Reno Nevada
United States Seattle Integrative Cancer Center Renton Washington
United States Virginia Cancer Institute Richmond Virginia
United States Mayo Clinic - Rochester Rochester Minnesota
United States California Pacific Medical Center San Francisco California
United States Providence Medical Group Santa Rosa - Cancer Center Santa Rosa California
United States Swedish Cancer Institute Seattle Washington

Sponsors (1)
Lead Sponsor Collaborator
Mirati Therapeutics Inc.

Country where clinical trial is conducted

United States, 

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