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
| NCT number | NCT05162443 |
| Other study ID # | 849-EAP-001 |
| Secondary ID | |
| Status | Approved for marketing |
| Phase | |
| First received | |
| Last updated |
| Verified date | May 2023 |
| Source | Mirati Therapeutics Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Expanded Access |
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.
| 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 |
| 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 |
| Lead Sponsor | Collaborator |
|---|---|
| Mirati Therapeutics Inc. |
United States,
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