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 (CodeBreaK 301)

February 8, 2024 updated by: Amgen

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)

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

450

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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).
Drug: FOLFIRI Regimen
Combination of irinotecan, leucovorin, and 5-fluorouracil given intravenously Q2W.
Drug: Sotorasib
Immediate-release solid dosage form administered PO.
Other Names:
  • AMG 510
  • Lumakras
  • Lumykras
Drug: Panitumumab
Administered IV Q2W.
Other Names:
  • Vectibix
Active Comparator: Arm B: FOLFIRI with or Without Bevacizumab-awwb
Participants received FOLFIRI Q2W with or without bevacizumab-awwb.
Drug: FOLFIRI Regimen
Combination of irinotecan, leucovorin, and 5-fluorouracil given intravenously Q2W.
Drug: Bevacizumab-awwb
Administered IV Q2W.
Other Names:
  • MVASI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
PFS per Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
Time Frame: Up to Approximately 3 Years
Up to Approximately 3 Years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: Up to Approximately 5 Years
Up to Approximately 5 Years
Objective Response (OR) per RECIST v1.1
Time Frame: Up to Approximately 3 Years
Up to Approximately 3 Years
Duration of Response (DOR) per RECIST v1.1
Time Frame: Up to Approximately 3 Years
Up to Approximately 3 Years
Disease Control Rate (DCR) per RECIST v1.1
Time Frame: up to Approximately 3 Years
up to Approximately 3 Years
Time to Response (TTR) per RECIST v1.1
Time Frame: Up to approximately 3 Years
Up to approximately 3 Years
Depth of Response per RECIST v1.1
Time Frame: Up to Approximately 3 Years
Depth of response is measured as the percentage of tumor shrinkage calculated as the best percentage change from baseline in lesion sum diameters.
Up to Approximately 3 Years
Time to Early Tumor Shrinkage (ETS) per RECIST v1.1
Time Frame: Up to Approximately 3 Years
Up to Approximately 3 Years
PFS Based on Investigator's Assessment per RECIST v1.1
Time Frame: Up to Approximately 3 Years
Up to Approximately 3 Years
Objective Response Rate (ORR) Based on Investigator's Assessment per RECIST v1.1
Time Frame: Up to Approximately 3 years
Up to Approximately 3 years
DOR Based on Investigator's Assessment per RECIST v1.1
Time Frame: up to Approximately 3 Years
up to Approximately 3 Years
DCR Based on Investigator's Assessment per RECIST v1.1
Time Frame: Up to Approximately 3 Years
Up to Approximately 3 Years
TTR Based on Investigator's Assessment per RECIST v1.1
Time Frame: Up to Approximately 3 Years
Up to Approximately 3 Years
Depth of Response Based on Investigator's Assessment per RECIST v1.1
Time Frame: Up to Approximately 3 Years
Up to Approximately 3 Years
Time to ETS Based on Investigator's Assessment per RECIST v1.1
Time Frame: Up to Approximately 3 Years
Up to Approximately 3 Years
Number of Participants Experiencing Adverse Events (AEs)
Time Frame: Up to Approximately 3 Years
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.
Up to Approximately 3 Years
Pre-dose (Ctrough) Concentrations of Sotorasib
Time Frame: Day 1 (pre-dose) to week 4 (post dose) on cycle 2 (one cycle = 28 days)
Day 1 (pre-dose) to week 4 (post dose) on cycle 2 (one cycle = 28 days)
Maximum Plasma Concentration (Cmax) of Sotorasib
Time Frame: Day 1 (pre-dose) to week 4 (post dose) on cycle 2 (one cycle = 28 days)
Day 1 (pre-dose) to week 4 (post dose) on cycle 2 (one cycle = 28 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amgen

Investigators

  • Study Director: MD, Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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 Major Dates

Study Start (Estimated)

April 30, 2024

Primary Completion (Estimated)

April 27, 2027

Study Completion (Estimated)

November 27, 2030

Study Registration Dates

First Submitted

January 15, 2024

First Submitted That Met QC Criteria

February 8, 2024

First Posted (Actual)

February 12, 2024

Study Record Updates

Last Update Posted (Actual)

February 12, 2024

Last Update Submitted That Met QC Criteria

February 8, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20210081

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

IPD Sharing Time Frame

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.

IPD Sharing Access Criteria

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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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