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History of Changes for Study: NCT05162443
Expanded Access of Adagrasib (MRTX849) in Patients With Advanced Solid Tumors Who Have a KRAS G12C Mutation
Latest version (submitted January 19, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 December 3, 2021 None (earliest Version on record)
2 January 19, 2022 Study Status and Contacts/Locations
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Study NCT05162443
Submitted Date:  December 3, 2021 (v1)

Open or close this module Study Identification
Unique Protocol ID: 849-EAP-001
Brief Title: Expanded Access of Adagrasib (MRTX849) in Patients With Advanced Solid Tumors Who Have a KRAS G12C Mutation
Official Title: Expanded Access Use of Adagrasib (MRTX849) for the Treatment of Patients With Advanced Solid Tumors With a KRAS G12C Mutation
Secondary IDs:
Open or close this module Study Status
Record Verification: December 2021
Expanded Access Status: Available
Open or close this module Sponsor/Collaborators
Sponsor: Mirati Therapeutics Inc.
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
Open or close this module Study Description
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:
Open or close this module Conditions
Conditions: Advanced Cancer
Metastatic Cancer
Malignant Neoplasm
Keywords: adagrasib
expanded access
Open or close this module Study Design
Study Type: Expanded Access
Intermediate-size Population
Open or close this module Interventions
Interventions: Drug: adagrasib (MRTX849)
adagrasib (MRTX849) will be administered orally twice daily in a continuous regimen
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
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
Open or close this module Contacts/Locations
Central Contact Person: Early Access Care (EAC)
Telephone: (475) 522-2200
Email: Mirati.ExpandedAccess@earlyaccesscare.com
Locations:
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Citations:
Links:

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