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

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ClinicalTrials.gov Identifier: NCT05162443
Expanded Access Status : Approved for marketing
First Posted : December 17, 2021
Last Update Posted : May 19, 2023
Sponsor:
Information provided by (Responsible Party):
Mirati Therapeutics Inc.

Study Description
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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.

Condition or disease Intervention/treatment
Advanced Cancer Metastatic Cancer Malignant Neoplasm Drug: adagrasib (MRTX849)

Study Design
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Study Type : Expanded Access
Expanded Access Type : Intermediate-size Population
  See clinical trials of the intervention/treatment in this expanded access record.
Official Title: Expanded Access Use of Adagrasib (MRTX849) for the Treatment of Patients With Advanced Solid Tumors With a KRAS G12C Mutation

Resource links provided by the National Library of Medicine


Interventions
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Intervention Details:
  • Drug: adagrasib (MRTX849)
    adagrasib (MRTX849) will be administered orally twice daily in a continuous regimen
Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05162443


Locations
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United States, California
California Pacific Medical Center
San Francisco, California, United States, 94115
Providence Medical Group Santa Rosa - Cancer Center
Santa Rosa, California, United States, 95403
United States, Connecticut
Hartford Hospital
Hartford, Connecticut, United States, 06106
United States, Georgia
Piedmont Cancer Institute
Atlanta, Georgia, United States, 30318
United States, Minnesota
Mayo Clinic - Rochester
Rochester, Minnesota, United States, 55905
United States, Nevada
Renown Health
Reno, Nevada, United States, 89502
United States, Pennsylvania
Lehigh Valley Cancer Institute
Allentown, Pennsylvania, United States, 18103
United States, Texas
Lumi Research
Kingwood, Texas, United States, 77339
United States, Virginia
Virginia Cancer Institute
Richmond, Virginia, United States, 23230
United States, Washington
Seattle Integrative Cancer Center
Renton, Washington, United States, 98057
Swedish Cancer Institute
Seattle, Washington, United States, 98104
Sponsors and Collaborators
Mirati Therapeutics Inc.
More Information
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Responsible Party: Mirati Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT05162443    
Other Study ID Numbers: 849-EAP-001
First Posted: December 17, 2021    Key Record Dates
Last Update Posted: May 19, 2023
Last Verified: May 2023
Keywords provided by Mirati Therapeutics Inc.:
adagrasib
expanded access
Additional relevant MeSH terms:
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Neoplasms
Adagrasib
Antineoplastic Agents