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Trial Acronym
CodeBreaK 301
Registration Number
NCT06252649
Scientific 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)
Brief Summary
Key Inclusion Criteria
Key Exclusion Criteria
Trial Locations
Primary Sponsor
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
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
Trial Location Name
Address
Status
Princess Alexandra Hospital (Oncology)
199 Ipswich Road, Woolloongabba QLD 4102, Australia
Recruiting
Primary Contact :
Jill Hung,
jillian.hung@health.qld.gov.au
, 07 3176 9289
Secondary Contact :
Wanyi Jiang,
wanyi.jiang@health.qld.gov.au
, 07 3176 8295
The Queen Elizabeth Hospital (Haematology and Oncology)
28 Woodville Rd, Woodville South SA 5011, Australia
Recruiting
Primary Contact :
Pamela Cooper,
Pamela.cooper@sa.gov.au
, 08 8222 6410
Secondary Contact :
Tamara Olszowka,
Tamara.Olszowka@sa.gov.au
, 08 8222 8011
Amgen
Website URL
Link Name
Link URL
N/A
N/A
Secondary IDs
20210081
Study Type
Interventional
Intervention Code
Treatment - Drugs
Phase
Phase 3
Minimum Age
18
Maximum Age
100
Date Registered
09/01/2025
Date Closed
N/A
Status
Open
Enrolment Type
By Specialist and/or Surgeon Referral
Mutation Status and Biomarker
N/A
Is it a Cohort Trial?
No
Is this a Tele-Trial?
No
Can healthy volunteer participate?
No
Discipline
Health Condition
Category
Sub Category
Oncology
Gastrointestinal Lower
Colorectal
Metastatic First line
Metastatic Second + line
Gene Mutation
Somatic
N/A
Trial ID
25010032
