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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

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
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
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
Distrito Federal
Country [18] 0 0
Brazil
State/province [18] 0 0
Espírito Santo
Country [19] 0 0
Brazil
State/province [19] 0 0
Piauí
Country [20] 0 0
Brazil
State/province [20] 0 0
Rio Grande Do Norte
Country [21] 0 0
Brazil
State/province [21] 0 0
Rio Grande Do Sul
Country [22] 0 0
Brazil
State/province [22] 0 0
Santa Catarina
Country [23] 0 0
Brazil
State/province [23] 0 0
São Paulo
Country [24] 0 0
Colombia
State/province [24] 0 0
Antioquia
Country [25] 0 0
Hong Kong
State/province [25] 0 0
Hong Kong
Country [26] 0 0
Hong Kong
State/province [26] 0 0
Kowloon
Country [27] 0 0
Japan
State/province [27] 0 0
Aichi
Country [28] 0 0
Japan
State/province [28] 0 0
Chiba
Country [29] 0 0
Japan
State/province [29] 0 0
Ehime
Country [30] 0 0
Japan
State/province [30] 0 0
Fukuoka
Country [31] 0 0
Japan
State/province [31] 0 0
Hokkaido
Country [32] 0 0
Japan
State/province [32] 0 0
Hyogo
Country [33] 0 0
Japan
State/province [33] 0 0
Kanagawa
Country [34] 0 0
Japan
State/province [34] 0 0
Niigata
Country [35] 0 0
Japan
State/province [35] 0 0
Osaka
Country [36] 0 0
Japan
State/province [36] 0 0
Saitama
Country [37] 0 0
Japan
State/province [37] 0 0
Shizuoka
Country [38] 0 0
Japan
State/province [38] 0 0
Tokyo
Country [39] 0 0
Korea, Republic of
State/province [39] 0 0
Goyang-si Gyeonggi-do
Country [40] 0 0
Korea, Republic of
State/province [40] 0 0
Seoul
Country [41] 0 0
Switzerland
State/province [41] 0 0
Zuerich
Country [42] 0 0
Taiwan
State/province [42] 0 0
Taichung
Country [43] 0 0
Taiwan
State/province [43] 0 0
Taipei
Country [44] 0 0
Taiwan
State/province [44] 0 0
Taoyuan
Country [45] 0 0
Turkey
State/province [45] 0 0
Ankara
Country [46] 0 0
Turkey
State/province [46] 0 0
Edirne
Country [47] 0 0
Turkey
State/province [47] 0 0
Istanbul
Country [48] 0 0
Turkey
State/province [48] 0 0
Konya
Country [49] 0 0
Turkey
State/province [49] 0 0
Malatya

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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
medinfo@amgen.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
When will data be available (start and end dates)?
Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
Available to whom?
Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://www.amgen.com/datasharing


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