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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
21/11/2024

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
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)
Secondary ID [1] 0 0
20210081
Universal Trial Number (UTN)
Trial acronym
CodeBreaK 301
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metastatic Colorectal Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
PFS per Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
Timepoint [1] 0 0
Up to Approximately 3 Years
Secondary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
Up to Approximately 5 Years
Secondary outcome [2] 0 0
Objective Response (OR) per RECIST v1.1
Timepoint [2] 0 0
Up to Approximately 3 Years
Secondary outcome [3] 0 0
Duration of Response (DOR) per RECIST v1.1
Timepoint [3] 0 0
Up to Approximately 3 Years
Secondary outcome [4] 0 0
Disease Control Rate (DCR) per RECIST v1.1
Timepoint [4] 0 0
up to Approximately 3 Years
Secondary outcome [5] 0 0
Time to Response (TTR) per RECIST v1.1
Timepoint [5] 0 0
Up to approximately 3 Years
Secondary outcome [6] 0 0
Depth of Response per RECIST v1.1
Timepoint [6] 0 0
Up to Approximately 3 Years
Secondary outcome [7] 0 0
Time to Early Tumor Shrinkage (ETS) per RECIST v1.1
Timepoint [7] 0 0
Up to Approximately 3 Years
Secondary outcome [8] 0 0
PFS Based on Investigator's Assessment per RECIST v1.1
Timepoint [8] 0 0
Up to Approximately 3 Years
Secondary outcome [9] 0 0
Objective Response Rate (ORR) Based on Investigator's Assessment per RECIST v1.1
Timepoint [9] 0 0
Up to Approximately 3 years
Secondary outcome [10] 0 0
DOR Based on Investigator's Assessment per RECIST v1.1
Timepoint [10] 0 0
up to Approximately 3 Years
Secondary outcome [11] 0 0
DCR Based on Investigator's Assessment per RECIST v1.1
Timepoint [11] 0 0
Up to Approximately 3 Years
Secondary outcome [12] 0 0
TTR Based on Investigator's Assessment per RECIST v1.1
Timepoint [12] 0 0
Up to Approximately 3 Years
Secondary outcome [13] 0 0
Depth of Response Based on Investigator's Assessment per RECIST v1.1
Timepoint [13] 0 0
Up to Approximately 3 Years
Secondary outcome [14] 0 0
Time to ETS Based on Investigator's Assessment per RECIST v1.1
Timepoint [14] 0 0
Up to Approximately 3 Years
Secondary outcome [15] 0 0
Number of Participants Experiencing Adverse Events (AEs)
Timepoint [15] 0 0
Up to Approximately 3 Years
Secondary outcome [16] 0 0
Pre-dose (Ctrough) Concentrations of Sotorasib
Timepoint [16] 0 0
Day 1 (pre-dose) to week 4 (post dose) on cycle 2 (one cycle = 28 days)
Secondary outcome [17] 0 0
Maximum Plasma Concentration (Cmax) of Sotorasib
Timepoint [17] 0 0
Day 1 (pre-dose) to week 4 (post dose) on cycle 2 (one cycle = 28 days)

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
17/07/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/04/2031
Actual
Sample size
Target
450
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Chris OBrien Lifehouse - Camperdown
Recruitment hospital [2] 0 0
Toowoomba Hospital - Toowoomba
Recruitment hospital [3] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [4] 0 0
The Queen Elizabeth Hospital - Woodville South
Recruitment hospital [5] 0 0
Austin Health, Austin Hospital - Heidelberg
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
4350 - Toowoomba
Recruitment postcode(s) [3] 0 0
5042 - Bedford Park
Recruitment postcode(s) [4] 0 0
5011 - Woodville South
Recruitment postcode(s) [5] 0 0
3084 - Heidelberg
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
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United States of America
State/province [2] 0 0
California
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United States of America
State/province [3] 0 0
Connecticut
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United States of America
State/province [4] 0 0
Florida
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United States of America
State/province [5] 0 0
Illinois
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United States of America
State/province [6] 0 0
Kentucky
Country [7] 0 0
United States of America
State/province [7] 0 0
Michigan
Country [8] 0 0
United States of America
State/province [8] 0 0
Missouri
Country [9] 0 0
United States of America
State/province [9] 0 0
New Jersey
Country [10] 0 0
United States of America
State/province [10] 0 0
North Carolina
Country [11] 0 0
United States of America
State/province [11] 0 0
Pennsylvania
Country [12] 0 0
United States of America
State/province [12] 0 0
South Carolina
Country [13] 0 0
Argentina
State/province [13] 0 0
Buenos Aires
Country [14] 0 0
Argentina
State/province [14] 0 0
Córdoba
Country [15] 0 0
Argentina
State/province [15] 0 0
Río Negro
Country [16] 0 0
Argentina
State/province [16] 0 0
Tucuman
Country [17] 0 0
Brazil
State/province [17] 0 0
Piauí
Country [18] 0 0
Brazil
State/province [18] 0 0
Rio Grande Do Sul
Country [19] 0 0
Brazil
State/province [19] 0 0
Santa Catarina
Country [20] 0 0
Colombia
State/province [20] 0 0
Antioquia
Country [21] 0 0
Hong Kong
State/province [21] 0 0
Hong Kong
Country [22] 0 0
Hong Kong
State/province [22] 0 0
Kowloon
Country [23] 0 0
Japan
State/province [23] 0 0
Aichi
Country [24] 0 0
Japan
State/province [24] 0 0
Chiba
Country [25] 0 0
Japan
State/province [25] 0 0
Ehime
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Japan
State/province [26] 0 0
Fukuoka
Country [27] 0 0
Japan
State/province [27] 0 0
Hokkaido
Country [28] 0 0
Japan
State/province [28] 0 0
Hyogo
Country [29] 0 0
Japan
State/province [29] 0 0
Kanagawa
Country [30] 0 0
Japan
State/province [30] 0 0
Niigata
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Japan
State/province [31] 0 0
Osaka
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Japan
State/province [32] 0 0
Saitama
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Japan
State/province [33] 0 0
Shizuoka
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Japan
State/province [34] 0 0
Tokyo
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Korea, Republic of
State/province [35] 0 0
Goyang-si Gyeonggi-do
Country [36] 0 0
Korea, Republic of
State/province [36] 0 0
Seoul
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Taiwan
State/province [37] 0 0
Taichung
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Taiwan
State/province [38] 0 0
Taipei
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Taiwan
State/province [39] 0 0
Taoyuan
Country [40] 0 0
Turkey
State/province [40] 0 0
Ankara
Country [41] 0 0
Turkey
State/province [41] 0 0
Edirne
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Turkey
State/province [42] 0 0
Istanbul
Country [43] 0 0
Turkey
State/province [43] 0 0
Konya
Country [44] 0 0
Turkey
State/province [44] 0 0
Malatya

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Amgen
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT06252649
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
MD
Address 0 0
Amgen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Amgen Call Center
Address 0 0
Country 0 0
Phone 0 0
866-572-6436
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06252649