RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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)

Quick Facts

Study Start:2024-07-17
Study Completion:2031-08-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06252649

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Pathologically documented metastatic colorectal adenocarcinoma with KRAS p.G12C mutation by a locally validated assay.
  2. * Central laboratory detection of KRAS p.G12C mutation.
  3. * Measurable metastatic disease per RECIST v1.1 criteria.
  4. * Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1.
  5. * Adequate organ function.
  1. * Active, untreated brain metastases.
  2. * Leptomeningeal disease
  3. * Previous treatment with a KRAS p.G12C inhibitor
  4. * History of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial pneumonitis or pulmonary fibrosis on baseline CT scan

Contacts and Locations

Study Contact

Amgen Call Center
CONTACT
866-572-6436
medinfo@amgen.com

Principal Investigator

MD
STUDY_DIRECTOR
Amgen

Study Locations (Sites)

Ironwood Cancer and Research Centers Scottsdale
Chandler, Arizona, 85224
United States
Providence Saint Jude Medical Center
Fullerton, California, 92835
United States
Cancer and Blood Research Center, LLC
Los Alamitos, California, 90720
United States
California Research Institute
Los Angeles, California, 90027
United States
Norwalk Hospital
Norwalk, Connecticut, 06856
United States
Cancer Specialists of North Florida
Jacksonville, Florida, 32256
United States
D and H Cancer Research Center
Margate, Florida, 33063
United States
Mid Florida Hematology and Oncology Centers PA
Orange City, Florida, 32763
United States
Boca Raton Clinical Research Medical Center Inc
Plantation, Florida, 33322
United States
Georgia Cancer Specialists
Atlanta, Georgia, 30342
United States
Insight Research Institute
Chicago, Illinois, 60616
United States
Hope and Healing Cancer Services
Hinsdale, Illinois, 60521
United States
Orchard Healthcare Research Inc
Skokie, Illinois, 60076
United States
Pikeville Medical Center
Pikeville, Kentucky, 41501
United States
Henry Ford Health System
Detroit, Michigan, 48202
United States
Cancer and Hematology Centers of Western Michigan
Grand Rapids, Michigan, 49503
United States
Saint Louis Cancer Care West County
Bridgeton, Missouri, 63044
United States
Minniti Center for Medical Oncology and Hematology
Mickleton, New Jersey, 08056
United States
Duke Cancer Center
Durham, North Carolina, 27710
United States
FirstHealth Cancer Center
Pinehurst, North Carolina, 28374
United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
United States
Carolina Blood and Cancer Care
Rock Hill, South Carolina, 29732
United States
Tennessee Oncology PLLC - Chattanooga
Nashville, Tennessee, 37203
United States
Tennessee Oncology PLLC
Nashville, Tennessee, 37203
United States

Collaborators and Investigators

Sponsor: Amgen

  • MD, STUDY_DIRECTOR, Amgen

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-17
Study Completion Date2031-08-31

Study Record Updates

Study Start Date2024-07-17
Study Completion Date2031-08-31

Terms related to this study

Keywords Provided by Researchers

  • Sotorasib
  • Panitumumab
  • FOLFIRI
  • Bevacizumab-awwb
  • Oncology

Additional Relevant MeSH Terms

  • Metastatic Colorectal Cancer