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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
450
Combination of irinotecan, leucovorin, and 5-fluorouracil given via IV infusion Q2W.
Immediate-release solid dosage form administered orally.
Administered via IV infusion Q2W.
PFS per Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
Time frame: Up to Approximately 3 Years
Overall Survival (OS)
Time frame: Up to Approximately 5 Years
Objective Response Rate (ORR) per RECIST v1.1
Time frame: Up to Approximately 5 Years
Objective Response (OR) per RECIST v1.1
Time frame: Up to Approximately 5 Years
Duration of Response (DOR) per RECIST v1.1
Time frame: Up to Approximately 5 Years
Disease Control Rate (DCR) per RECIST v1.1
Time frame: Up to Approximately 5 Years
Time to Response (TTR) per RECIST v1.1
Time frame: Up to Approximately 5 Years
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.
Time frame: Up to Approximately 5 Years
Time to Early Tumor Shrinkage (ETS) per RECIST v1.1
Time frame: Up to Approximately 5 Years
PFS Based on Investigator's Assessment per RECIST v1.1
Time frame: Up to Approximately 5 Years
ORR Based on Investigator's Assessment per RECIST v1.1
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Administered via IV infusion Q2W.
Ironwood Cancer and Research Centers Scottsdale
Chandler, Arizona, United States
RECRUITINGProvidence Saint Jude Medical Center
Fullerton, California, United States
TERMINATEDCity of Hope National Medical Center
Long Beach, California, United States
RECRUITINGCancer and Blood Research Center, LLC
Los Alamitos, California, United States
RECRUITINGCalifornia Research Institute
Los Angeles, California, United States
TERMINATEDNorwalk Hospital
Norwalk, Connecticut, United States
TERMINATEDCancer Specialists of North Florida - Southpoint
Jacksonville, Florida, United States
RECRUITINGD and H Cancer Research Center
Margate, Florida, United States
TERMINATEDMid Florida Hematology and Oncology Centers PA
Orange City, Florida, United States
TERMINATEDBoca Raton Clinical Research Medical Center Inc
Plantation, Florida, United States
TERMINATED...and 281 more locations
Time frame: Up to Approximately 5 Years
DOR Based on Investigator's Assessment per RECIST v1.1
Time frame: Up to Approximately 5 Years
DCR Based on Investigator's Assessment per RECIST v1.1
Time frame: Up to Approximately 5 Years
TTR Based on Investigator's Assessment per RECIST v1.1
Time frame: Up to Approximately 5 Years
Depth of Response Based on Investigator's Assessment per RECIST v1.1
Time frame: Up to Approximately 5 Years
Time to ETS Based on Investigator's Assessment per RECIST v1.1
Time frame: Up to Approximately 5 Years
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.
Time frame: Up to Approximately 5 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)
Maximum Plasma Concentration (Cmax) of Sotorasib
Time frame: Day 1 (pre-dose) to week 4 (post dose) on cycle 2 (one cycle = 28 days)