Study of Sotorasib, Panitumumab and FOLFIRI Versus FOLFIRI With or Without Bevacizumab-awwb in Treatment-naive Participants With Metastatic Colorectal Cancer With KRAS p.G12C Mutation (CodeBreaK 301)

JRCT ID: jRCT2071240009

Registered date:25/04/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Metastatic Colorectal Cancer
• Date of first enrollment: 17/07/2024
• Target sample size: 450
• Countries of recruitment: United States,Japan,Korea,Japan,Argentina,Japan,Australia,Japan,Hong Kong,Japan,Taiwan,Japan,Turkey,Japan
• Study type: Interventional

Intervention(s)

- 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).
Interventions:
Drug: FOLFIRI Regimen
Drug: Sotorasib
Drug: Panitumumab

- Active Comparator: Arm B: FOLFIRI with or Without Bevacizumab-awwb
Participants received FOLFIRI Q2W with or without bevacizumab-awwb.
Interventions:
Drug: FOLFIRI Regimen
Drug: Bevacizumab-awwb

Outcome(s)

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

Secondary Outcome

1. Overall Survival (OS) [Time Frame: Up to Approximately 5 Years]
2. Objective Response (OR) per RECIST v1.1 [Time Frame: Up to Approximately 3 Years]
3. Duration of Response (DOR) per RECIST v1.1 [Time Frame: Up to Approximately 3 Years]
4. Disease Control Rate (DCR) per RECIST v1.1 [Time Frame: up to Approximately 3 Years]
5. Time to Response (TTR) per RECIST v1.1 [Time Frame: Up to approximately 3 Years]
6. 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.
7. Time to Early Tumor Shrinkage (ETS) per RECIST v1.1 [Time Frame: Up to Approximately 3 Years]
8. PFS Based on Investigator's Assessment per RECIST v1.1 [Time Frame: Up to Approximately 3 Years]
9. Objective Response Rate (ORR) Based on Investigator's Assessment per RECIST v1.1 [Time Frame: Up to Approximately 3 years]
10. DOR Based on Investigator's Assessment per RECIST v1.1 [Time Frame: up to Approximately 3 Years]
11. DCR Based on Investigator's Assessment per RECIST v1.1 [Time Frame: Up to Approximately 3 Years]
12. TTR Based on Investigator's Assessment per RECIST v1.1 [Time Frame: Up to Approximately 3 Years]
13. Depth of Response Based on Investigator's Assessment per RECIST v1.1 [Time Frame: Up to Approximately 3 Years]
14. Time to ETS Based on Investigator's Assessment per RECIST v1.1 [Time Frame: Up to Approximately 3 Years]
15. 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, isa 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.
16. Pre-dose (Ctrough) Concentrations of Sotorasib [Time Frame: Day 1 (pre-dose) to week 4 (post dose) on cycle 2 (one cycle = 28 days)]
17. Maximum Plasma Concentration (Cmax) of Sotorasib [Time Frame: Day 1 (pre-dose) to week 4 (post dose) on cycle 2 (one cycle = 28 days)]

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Pathologically documented metastatic colorectal adenocarcinoma with KRAS p.G12C mutation by a locally validated assay.
2. Central confirmation of KRAS p.G12C mutation
3. Measurable metastatic disease per RECIST v1.1 criteria.
4. Eastern Cooperative Oncology Group (ECOG) Performance Status of <= 1.
5. Adequate organ function.

Exclude criteria

1. Active, untreated brain metastases.
2. Leptomeningeal disease
3. Previous treatment with a KRAS p.G12C inhibitor
4. History of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial pneumonitis or pulmonary fibrosis on baseline CT scan

Related Information

• Primary Sponsor: Nakatani Iwami
• Secondary ID(s): NCT06252649