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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06252649
Registration number
NCT06252649
Ethics application status
Date submitted
15/01/2024
Date registered
12/02/2024
Date last updated
14/07/2025
Titles & IDs
Public title
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
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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)
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Secondary ID [1]
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20210081
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Universal Trial Number (UTN)
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Trial acronym
CodeBreaK 301
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Metastatic Colorectal Cancer
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Condition category
Condition code
Cancer
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Bowel - Back passage (rectum) or large bowel (colon)
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - FOLFIRI Regimen
Treatment: Drugs - Sotorasib
Treatment: Drugs - Panitumumab
Treatment: Drugs - Bevacizumab-awwb
Experimental: Arm A: Sotorasib + Panitumumab + FOLFIRI - Sotorasib was taken daily (QD) as an oral tablet. Panitumumab and FOLFIRI were received every 2 weeks (Q2W) via intravenous infusion (IV).
Active comparator: Arm B: FOLFIRI with or Without Bevacizumab-awwb - Participants received FOLFIRI Q2W with or without bevacizumab-awwb.
Treatment: Drugs: FOLFIRI Regimen
Combination of irinotecan, leucovorin, and 5-fluorouracil given intravenously Q2W.
Treatment: Drugs: Sotorasib
Immediate-release solid dosage form administered PO.
Treatment: Drugs: Panitumumab
Administered IV Q2W.
Treatment: Drugs: Bevacizumab-awwb
Administered IV Q2W.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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PFS per Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
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Assessment method [1]
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Timepoint [1]
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Up to Approximately 3 Years
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Secondary outcome [1]
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Overall Survival (OS)
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Assessment method [1]
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Timepoint [1]
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Up to Approximately 5 Years
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Secondary outcome [2]
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Objective Response (OR) per RECIST v1.1
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Assessment method [2]
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Timepoint [2]
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Up to Approximately 3 Years
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Secondary outcome [3]
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Duration of Response (DOR) per RECIST v1.1
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Assessment method [3]
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Timepoint [3]
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Up to Approximately 3 Years
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Secondary outcome [4]
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Disease Control Rate (DCR) per RECIST v1.1
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Assessment method [4]
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Timepoint [4]
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up to Approximately 3 Years
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Secondary outcome [5]
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Time to Response (TTR) per RECIST v1.1
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Assessment method [5]
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Timepoint [5]
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Up to approximately 3 Years
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Secondary outcome [6]
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Depth of Response per RECIST v1.1
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Assessment method [6]
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Depth of response is measured as the percentage of tumor shrinkage calculated as the best percentage change from baseline in lesion sum diameters.
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Timepoint [6]
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Up to Approximately 3 Years
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Secondary outcome [7]
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Time to Early Tumor Shrinkage (ETS) per RECIST v1.1
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Assessment method [7]
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Timepoint [7]
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Up to Approximately 3 Years
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Secondary outcome [8]
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PFS Based on Investigator's Assessment per RECIST v1.1
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Assessment method [8]
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Timepoint [8]
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Up to Approximately 3 Years
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Secondary outcome [9]
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Objective Response Rate (ORR) Based on Investigator's Assessment per RECIST v1.1
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Assessment method [9]
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Timepoint [9]
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Up to Approximately 3 years
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Secondary outcome [10]
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DOR Based on Investigator's Assessment per RECIST v1.1
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Assessment method [10]
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0
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Timepoint [10]
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up to Approximately 3 Years
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Secondary outcome [11]
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DCR Based on Investigator's Assessment per RECIST v1.1
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Assessment method [11]
0
0
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Timepoint [11]
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Up to Approximately 3 Years
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Secondary outcome [12]
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0
TTR Based on Investigator's Assessment per RECIST v1.1
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Assessment method [12]
0
0
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Timepoint [12]
0
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Up to Approximately 3 Years
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Secondary outcome [13]
0
0
Depth of Response Based on Investigator's Assessment per RECIST v1.1
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Assessment method [13]
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0
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Timepoint [13]
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Up to Approximately 3 Years
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Secondary outcome [14]
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Time to ETS Based on Investigator's Assessment per RECIST v1.1
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Assessment method [14]
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Timepoint [14]
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Up to Approximately 3 Years
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Secondary outcome [15]
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Number of Participants Experiencing Adverse Events (AEs)
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Assessment method [15]
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An AE is defined as any untoward medical occurrence in participant or clinical investigation subject administered a pharmaceutical product, which does not necessarily have to have a causal relationship with this treatment. A serious AE is defined as any AE that results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital abnormality/birth defect or important medical events that do not meet the preceding criteria but based on appropriate medical judgment may jeopardize the patient or may require medical or surgical intervention to prevent any of the outcomes listed above.
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Timepoint [15]
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Up to Approximately 3 Years
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Secondary outcome [16]
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Pre-dose (Ctrough) Concentrations of Sotorasib
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Assessment method [16]
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Timepoint [16]
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Day 1 (pre-dose) to week 4 (post dose) on cycle 2 (one cycle = 28 days)
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Secondary outcome [17]
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Maximum Plasma Concentration (Cmax) of Sotorasib
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Assessment method [17]
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Timepoint [17]
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Day 1 (pre-dose) to week 4 (post dose) on cycle 2 (one cycle = 28 days)
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Eligibility
Key inclusion 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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
17/07/2024
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
31/08/2031
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Actual
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Sample size
Target
450
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
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Recruitment hospital [1]
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Chris OBrien Lifehouse - Camperdown
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Toowoomba Hospital - Toowoomba
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Flinders Medical Centre - Bedford Park
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The Queen Elizabeth Hospital - Woodville South
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Recruitment hospital [5]
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Austin Health, Austin Hospital - Heidelberg
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2050 - Camperdown
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4350 - Toowoomba
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5042 - Bedford Park
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Recruitment postcode(s) [4]
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5011 - Woodville South
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Recruitment postcode(s) [5]
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3084 - Heidelberg
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Recruitment outside Australia
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Japan
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State/province [109]
0
0
Aichi
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0
0
Japan
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Chiba
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0
Japan
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Ehime
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Japan
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Fukuoka
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Japan
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Hokkaido
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Japan
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Hyogo
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Japan
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Kanagawa
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Japan
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Niigata
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Japan
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Osaka
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Japan
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Saitama
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Japan
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Shizuoka
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Japan
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Tokushima
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Japan
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Tokyo
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Korea, Republic of
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Goyang-si, Gyeonggi-do
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Korea, Republic of
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Seoul
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Mexico
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Distrito Federal
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Mexico
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Nuevo LeĂłn
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Netherlands
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Amsterdam
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Netherlands
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Enschede
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Poland
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Kielce
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Poland
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Opole
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Poland
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Poznan
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Poland
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Warszawa
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Portugal
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Almada
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Portugal
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Coimbra
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Portugal
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Lisboa
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Portugal
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Matosinhos
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Portugal
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Santa Maria da Feira
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Romania
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Bucharest
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Romania
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Bucuresti
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Romania
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Cluj Napoca
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Romania
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Craiova
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Romania
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Iasi
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Romania
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Ploiesti
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Romania
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Timisoara
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Spain
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AndalucĂa
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Spain
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Asturias
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Spain
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Cantabria
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Spain
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Castilla LeĂłn
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Spain
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Cataluña
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Spain
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Comunidad Valenciana
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Spain
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Galicia
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Spain
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Navarra
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Spain
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Madrid
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Sweden
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Stockholm
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Switzerland
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Zuerich
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Taiwan
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Taichung
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Taiwan
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Taipei
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Taiwan
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Taoyuan
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Thailand
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Bangkok
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Country [159]
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Turkey
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Adana
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Country [160]
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Turkey
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Ankara
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Turkey
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Edirne
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Turkey
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Istanbul
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Turkey
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Izmir
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Turkey
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Konya
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Turkey
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Malatya
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United Kingdom
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London
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United Kingdom
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0
Maidstone
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Country [168]
0
0
United Kingdom
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State/province [168]
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0
Northwood
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Amgen
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief 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.
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Trial website
https://clinicaltrials.gov/study/NCT06252649
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
0
0
MD
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Address
0
0
Amgen
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Country
0
0
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Phone
0
0
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Fax
0
0
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Email
0
0
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Contact person for public queries
Name
0
0
Amgen Call Center
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Address
0
0
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Country
0
0
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Phone
0
0
866-572-6436
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Fax
0
0
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Email
0
0
[email protected]
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Contact person for scientific queries
Data sharing statement
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06252649
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