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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05162443
Expanded Access Status : Available
First Posted : December 17, 2021
Last Update Posted : January 20, 2022
Sponsor:
Information provided by (Responsible Party):
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.

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

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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



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

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

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


Contacts
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Contact: Early Access Care (EAC) (475) 522-2200 Mirati.ExpandedAccess@earlyaccesscare.com

Locations
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United States, California
Providence Medical Group Santa Rosa - Cancer Center Available
Santa Rosa, California, United States, 95403
Principal Investigator: Ian C Anderson, MD         
Sponsors and Collaborators
Mirati Therapeutics Inc.
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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: January 20, 2022
Last Verified: January 2022
Keywords provided by Mirati Therapeutics Inc.:
adagrasib
expanded access
Additional relevant MeSH terms:
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Neoplasms
Adagrasib
Antineoplastic Agents