Metastatic Colorectal Cancer
Conditions
Keywords
Sotorasib, Panitumumab, FOLFIRI, Bevacizumab-awwb, Oncology
Brief 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.
Interventions
DRUGFOLFIRI Regimen
Combination of irinotecan, leucovorin, and 5-fluorouracil given via IV infusion Q2W.
DRUGSotorasib
Immediate-release solid dosage form administered orally.
DRUGPanitumumab
Administered via IV infusion Q2W.
DRUGBevacizumab-awwb
Administered via IV infusion Q2W.
Sponsors
Amgen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Pathologically documented metastatic colorectal adenocarcinoma with KRAS p.G12C mutation by a locally validated assay. * Central laboratory detection 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) | Up to Approximately 3 Years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | Up to Approximately 5 Years | — |
| Objective Response Rate (ORR) per RECIST v1.1 | Up to Approximately 5 Years | — |
| Objective Response (OR) per RECIST v1.1 | Up to Approximately 5 Years | — |
| Duration of Response (DOR) per RECIST v1.1 | Up to Approximately 5 Years | — |
| Disease Control Rate (DCR) per RECIST v1.1 | Up to Approximately 5 Years | — |
| Time to Response (TTR) per RECIST v1.1 | Up to Approximately 5 Years | — |
| Depth of Response per RECIST v1.1 | Up to Approximately 5 Years | Depth of response is measured as the percentage of tumor shrinkage calculated as the best percentage change from baseline in lesion sum diameters. |
| Time to Early Tumor Shrinkage (ETS) per RECIST v1.1 | Up to Approximately 5 Years | — |
| PFS Based on Investigator's Assessment per RECIST v1.1 | Up to Approximately 5 Years | — |
| ORR Based on Investigator's Assessment per RECIST v1.1 | Up to Approximately 5 Years | — |
| DOR Based on Investigator's Assessment per RECIST v1.1 | Up to Approximately 5 Years | — |
| DCR Based on Investigator's Assessment per RECIST v1.1 | Up to Approximately 5 Years | — |
| TTR Based on Investigator's Assessment per RECIST v1.1 | Up to Approximately 5 Years | — |
| Depth of Response Based on Investigator's Assessment per RECIST v1.1 | Up to Approximately 5 Years | — |
| Time to ETS Based on Investigator's Assessment per RECIST v1.1 | Up to Approximately 5 Years | — |
| Number of Participants Experiencing Adverse Events (AEs) | Up to Approximately 5 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. |
| Pre-dose (Ctrough) Concentrations of Sotorasib | Day 1 (pre-dose) to week 4 (post dose) on cycle 2 (one cycle = 28 days) | — |
| Maximum Plasma Concentration (Cmax) of Sotorasib | Day 1 (pre-dose) to week 4 (post dose) on cycle 2 (one cycle = 28 days) | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Czechia, Denmark, Estonia, France, Germany, Greece, Hong Kong, Hungary, Italy, Japan, Mexico, Netherlands, Poland, Portugal, Puerto Rico, Romania, Slovakia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey (Türkiye), United Kingdom, United States
Contacts
CONTACTAmgen Call Center
STUDY_DIRECTORMD
Amgen
Outcome results
None listed