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

Description

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.

Conditions

Metastatic Colorectal Cancer

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Study Overview

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Study Details

Study overview

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.

Phase 3 Multicenter, Randomized, Open-label, Active-controlled Study of Sotorasib, Panitumumab and FOLFIRI Versus FOLFIRI With or Without Bevacizumab-awwb for Treatment-naïve Subjects With Metastatic Colorectal Cancer With KRAS p.G12C Mutation (CodeBreaK 301)

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

Condition
Metastatic Colorectal Cancer
Intervention / Treatment

-

Contacts and Locations

Chandler

Ironwood Cancer and Research Centers Scottsdale, Chandler, Arizona, United States, 85224

Fullerton

Providence Saint Jude Medical Center, Fullerton, California, United States, 92835

Los Alamitos

Cancer and Blood Specialty Clinic, Los Alamitos, California, United States, 90720

Norwalk

Norwalk Hospital, Norwalk, Connecticut, United States, 06856

Jacksonville

Cancer Specialists of North Florida, Jacksonville, Florida, United States, 32256

Margate

D and H Cancer Research Center, Margate, Florida, United States, 33063

Orange City

Mid Florida Hematology and Oncology Centers PA, Orange City, Florida, United States, 32763

Plantation

Boca Raton Clinical Research Medical Center Inc, Plantation, Florida, United States, 33322

Hinsdale

Hope and Healing Cancer Services, Hinsdale, Illinois, United States, 60521

Skokie

Orchard Healthcare Research Inc, Skokie, Illinois, United States, 60076

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Pathologically documented metastatic colorectal adenocarcinoma with KRAS p.G12C mutation by a locally validated assay.
  • * Central confirmation 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.
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Amgen,

MD, STUDY_DIRECTOR, Amgen

Study Record Dates

2031-04-30