臨床研究等提出・公開システム

Phase 3 Multicenter, Randomized, Open-label, Active-controlled Study of Sotorasib, Panitumumab and FOLFIRI Versus FOLFIRI With or Without Bevacizumab-awwb for Treatment-naive Subjects With Metastatic Colorectal Cancer With KRAS p.G12C Mutation (CodeBreaK 301)

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)

Nakatani Iwami

Amgen K.K.

Midtown Tower 9-7-1 Akasaka, Minato-ku, Tokyo

clinicaltrials_japan@amgen.com

Local Contact

Amgen K.K.

Midtown Tower 9-7-1 Akasaka, Minato-ku, Tokyo

+81-80-7217-8592

clinicaltrials_japan@amgen.com

Recruiting

April. 30, 2024

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

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.

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

Both

Metastatic Colorectal Cancer

- 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

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

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)]

+81-92-541-3231

Jan. 11, 2024

Yes

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

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