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
- Conditions
- Metastatic Colorectal Cancer
- Interventions
- Registration Number
- NCT06252649
- Lead Sponsor
- Amgen
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 450
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm A: Sotorasib + Panitumumab + FOLFIRI FOLFIRI Regimen Sotorasib was taken daily (QD) as an oral tablet. Panitumumab and FOLFIRI were received every 2 weeks (Q2W) via intravenous infusion (IV). Arm B: FOLFIRI with or Without Bevacizumab-awwb FOLFIRI Regimen Participants received FOLFIRI Q2W with or without bevacizumab-awwb. Arm A: Sotorasib + Panitumumab + FOLFIRI Sotorasib Sotorasib was taken daily (QD) as an oral tablet. Panitumumab and FOLFIRI were received every 2 weeks (Q2W) via intravenous infusion (IV). Arm A: Sotorasib + Panitumumab + FOLFIRI Panitumumab Sotorasib was taken daily (QD) as an oral tablet. Panitumumab and FOLFIRI were received every 2 weeks (Q2W) via intravenous infusion (IV). Arm B: FOLFIRI with or Without Bevacizumab-awwb Bevacizumab-awwb Participants received FOLFIRI Q2W with or without bevacizumab-awwb.
- Primary Outcome Measures
Name Time Method PFS per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) Up to Approximately 3 Years
- Secondary Outcome Measures
Name Time Method Overall Survival (OS) Up to Approximately 5 Years Objective Response (OR) per RECIST v1.1 Up to Approximately 3 Years Duration of Response (DOR) per RECIST v1.1 Up to Approximately 3 Years Disease Control Rate (DCR) per RECIST v1.1 up to Approximately 3 Years Time to Response (TTR) per RECIST v1.1 Up to approximately 3 Years Depth of Response per RECIST v1.1 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.
Time to Early Tumor Shrinkage (ETS) per RECIST v1.1 Up to Approximately 3 Years PFS Based on Investigator's Assessment per RECIST v1.1 Up to Approximately 3 Years Objective Response Rate (ORR) Based on Investigator's Assessment per RECIST v1.1 Up to Approximately 3 years DOR Based on Investigator's Assessment per RECIST v1.1 up to Approximately 3 Years DCR Based on Investigator's Assessment per RECIST v1.1 Up to Approximately 3 Years TTR Based on Investigator's Assessment per RECIST v1.1 Up to Approximately 3 Years Depth of Response Based on Investigator's Assessment per RECIST v1.1 Up to Approximately 3 Years Time to ETS Based on Investigator's Assessment per RECIST v1.1 Up to Approximately 3 Years Number of Participants Experiencing Adverse Events (AEs) 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, 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)
Trial Locations
- Locations (254)
Ironwood Cancer and Research Centers Scottsdale
🇺🇸Chandler, Arizona, United States
Providence Saint Jude Medical Center
🇺🇸Fullerton, California, United States
Cancer and Blood Specialty Clinic
🇺🇸Los Alamitos, California, United States
California Research Institute
🇺🇸Los Angeles, California, United States
Norwalk Hospital
🇺🇸Norwalk, Connecticut, United States
Cancer Specialists of North Florida
🇺🇸Jacksonville, Florida, United States
D and H Cancer Research Center
🇺🇸Margate, Florida, United States
Mid Florida Hematology and Oncology Centers PA
🇺🇸Orange City, Florida, United States
Boca Raton Clinical Research Medical Center Inc
🇺🇸Plantation, Florida, United States
Georgia Cancer Specialists
🇺🇸Atlanta, Georgia, United States
Scroll for more (244 remaining)Ironwood Cancer and Research Centers Scottsdale🇺🇸Chandler, Arizona, United States