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

Metastatic Colorectal Cancer Clinical Trial

— CodeBreaK 301  

Official 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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06252649
• Other study ID #: 20210081
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: June 1, 2024
• Est. completion date: December 21, 2030

Study information

• Verified date: April 2024
• Source: Amgen
• Contact: Amgen Call Center
• Phone: 866-572-6436
• Email: medinfo[@]amgen.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 450
• Est. completion date: December 21, 2030
• Est. primary completion date: May 21, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Metastatic Colorectal Cancer

Intervention

Drug:
• FOLFIRI Regimen
Combination of irinotecan, leucovorin, and 5-fluorouracil given intravenously Q2W.
• Sotorasib
Immediate-release solid dosage form administered PO.
• Panitumumab
Administered IV Q2W.
• Bevacizumab-awwb
Administered IV Q2W.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PFS per Response Evaluation Criteria in Solid Tumors (RECIST v1.1)		Up to Approximately 3 Years
Secondary	Overall Survival (OS)		Up to Approximately 5 Years
Secondary	Objective Response (OR) per RECIST v1.1		Up to Approximately 3 Years
Secondary	Duration of Response (DOR) per RECIST v1.1		Up to Approximately 3 Years
Secondary	Disease Control Rate (DCR) per RECIST v1.1		up to Approximately 3 Years
Secondary	Time to Response (TTR) per RECIST v1.1		Up to approximately 3 Years
Secondary	Depth of Response per RECIST v1.1	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
Secondary	Time to Early Tumor Shrinkage (ETS) per RECIST v1.1		Up to Approximately 3 Years
Secondary	PFS Based on Investigator's Assessment per RECIST v1.1		Up to Approximately 3 Years
Secondary	Objective Response Rate (ORR) Based on Investigator's Assessment per RECIST v1.1		Up to Approximately 3 years
Secondary	DOR Based on Investigator's Assessment per RECIST v1.1		up to Approximately 3 Years
Secondary	DCR Based on Investigator's Assessment per RECIST v1.1		Up to Approximately 3 Years
Secondary	TTR Based on Investigator's Assessment per RECIST v1.1		Up to Approximately 3 Years
Secondary	Depth of Response Based on Investigator's Assessment per RECIST v1.1		Up to Approximately 3 Years
Secondary	Time to ETS Based on Investigator's Assessment per RECIST v1.1		Up to Approximately 3 Years
Secondary	Number of Participants Experiencing Adverse Events (AEs)	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
Secondary	Pre-dose (Ctrough) Concentrations of Sotorasib		Day 1 (pre-dose) to week 4 (post dose) on cycle 2 (one cycle = 28 days)
Secondary	Maximum Plasma Concentration (Cmax) of Sotorasib		Day 1 (pre-dose) to week 4 (post dose) on cycle 2 (one cycle = 28 days)

External Links

•   AmgenTrials clinical trials website