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Study of Sotorasib, Panitumumab and FOLFIRI Versus FOLFIRI With or Without Bevacizumab-awwb in Treatment-naïve Participants With Metastatic Colorectal Cancer With KRAS p.G12C Mutation

RECRUITINGPhase 3Sponsored by Amgen
Actively Recruiting
PhasePhase 3
SponsorAmgen
Started2024-07-17
Est. completion2028-01-31
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations26 sites
View on ClinicalTrials.gov →

NCT06252649

Summary

The aim of this study is to compare progression free survival (PFS) in treatment-naïve participants with KRAS p.G12C mutated metastatic colorectal cancer (mCRC) receiving sotorasib, panitumumab and FOLFIRI vs FOLFIRI with or without bevacizumab-awwb.

Eligibility

Age: 18 Years+Healthy volunteers accepted
Inclusion Criteria:

* Pathologically documented metastatic colorectal adenocarcinoma with KRAS p.G12C mutation by a locally validated assay.
* Central laboratory detection of KRAS p.G12C mutation.
* Measurable metastatic disease per RECIST v1.1 criteria.
* Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1.
* Adequate organ function.

Exclusion Criteria:

* Active, untreated brain metastases.
* Leptomeningeal disease
* Previous treatment with a KRAS p.G12C inhibitor
* History of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial pneumonitis or pulmonary fibrosis on baseline CT scan

Conditions2

CancerMetastatic Colorectal Cancer

Interventions4

Bevacizumab-AwwbFOLFIRI RegimenPanitumumabSotorasib

Locations26 sites

Ironwood Cancer and Research Centers Scottsdale
Chandler, Arizona, 85224
Providence Saint Jude Medical Center
Fullerton, California, 92835
City of Hope National Medical Center
Long Beach, California, 90813
Cancer and Blood Research Center, LLC
Los Alamitos, California, 90720
California Research Institute
Los Angeles, California, 90027

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