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
- 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.
Maximum Plasma Concentration (Cmax) of Sotorasib Day 1 (pre-dose) to week 4 (post dose) on cycle 2 (one cycle = 28 days) 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 exist...
Pre-dose (Ctrough) Concentrations of Sotorasib Day 1 (pre-dose) to week 4 (post dose) on cycle 2 (one cycle = 28 days)
Trial Locations
- Locations (85)
Orchard Healthcare Research Inc
🇺🇸Skokie, Illinois, United States
Pikeville Medical Center
🇺🇸Pikeville, Kentucky, United States
Cancer and Hematology Centers of Western Michigan
🇺🇸Grand Rapids, Michigan, United States
Saint Louis Cancer Care West County
🇺🇸Bridgeton, Missouri, United States
Minniti Center for Medical Oncology and Hematology
🇺🇸Mickleton, New Jersey, United States
Duke Cancer Center
🇺🇸Durham, North Carolina, United States
FirstHealth Cancer Center
🇺🇸Pinehurst, North Carolina, United States
Thomas Jefferson University
🇺🇸Philadelphia, Pennsylvania, United States
Carolina Blood and Cancer Care
🇺🇸Rock Hill, South Carolina, United States
Hospital Universitario Fundacion Favaloro
🇦🇷Caba, Buenos Aires, Argentina
Instituto Argentino de Diagnóstico y Tratamiento
🇦🇷Caba, Buenos Aires, Argentina
Cemic
🇦🇷Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
Sanatorio Británico de Rosario
🇦🇷La Plata, Buenos Aires, Argentina
Liga Norte-Riograndense Contra O Cancer
🇧🇷Natal, Rio Grande Do Norte, Brazil
Fundacao Antonio Prudente AC Camargo Cancer Center
🇧🇷Sao Paulo, São Paulo, Brazil
Oncologia Rede D Or
🇧🇷Sao Paulo, São Paulo, Brazil
Hospital de Base de Sao Jose do Rio Preto
🇧🇷São José do Rio Preto, São Paulo, Brazil
Gazi Universitesi Saglik Arastirma ve Uygulama Merkezi Gazi Hastanesi
🇹🇷Ankara, Turkey
Bezmialem Vakif Universitesi Hastanesi
🇹🇷Istanbul, Turkey
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
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
Hope and Healing Cancer Services
🇺🇸Hinsdale, Illinois, United States
Universitaetsspital Zuerich
🇨🇭Zuerich, Switzerland
China Medical University Hospital
🇨🇳Taichung, Taiwan
Taichung Veterans General Hospital
🇨🇳Taichung, Taiwan
Taipei Veterans General Hospital
🇨🇳Taipei, Taiwan
Linkou Chang Gung Memorial Hospital of Chang Gung Medical Foundation
🇨🇳Taoyuan, Taiwan
Hacettepe Universitesi Tip Fakultesi Hastanesi
🇹🇷Ankara, Turkey
Ankara Bilkent Sehir Hastanesi
🇹🇷Ankara, Turkey
Trakya Universitesi Saglik Arastirma ve Uygulama Merkezi
🇹🇷Edirne, Turkey
Bagcilar Medipol Mega Universite Hastanesi
🇹🇷Istanbul, Turkey
Necmettin Erbakan Universitesi Tip Fakultesi Hastanesi
🇹🇷Konya, Turkey
Inonu Universitesi Turgut Ozal Tip Merkezi
🇹🇷Malatya, Turkey
Instituto de Investigaciones clinicas de Mar del Plata
🇦🇷Mar Del Plata, Buenos Aires, Argentina
Sanatorio Allende
🇦🇷Cordoba, Córdoba, Argentina
Clinica Universitaria Privada Reina Fabiola
🇦🇷Cordoba, Córdoba, Argentina
Clinica Viedma
🇦🇷Viedma, Río Negro, Argentina
Exelsus Oncologia Clinica
🇦🇷San Miguel de Tucuman, Tucuman, Argentina
Hospital Britanico de Buenos Aires
🇦🇷Buenos Aires, Argentina
Chris OBrien Lifehouse
🇦🇺Camperdown, New South Wales, Australia
Toowoomba Hospital
🇦🇺Toowoomba, Queensland, Australia
Flinders Medical Centre
🇦🇺Bedford Park, South Australia, Australia
The Queen Elizabeth Hospital
🇦🇺Woodville South, South Australia, Australia
Austin Health, Austin Hospital
🇦🇺Heidelberg, Victoria, Australia
Hospital Sirio Libanes
🇧🇷Brasilia, Distrito Federal, Brazil
Hospital Evangelico de Cachoeiro de Itapemirim
🇧🇷Cachoeiro de Itapemirim, Espírito Santo, Brazil
Vencer e Oncoclinica
🇧🇷Teresina, Piauí, Brazil
Oncosite Centro de Pesquisa Clinica Em Oncologia Ltda
🇧🇷Ijui, Rio Grande Do Sul, Brazil
Irmandade da Santa Casa de Misericordia de Porto Alegre
🇧🇷Porto Alegre, Rio Grande Do Sul, Brazil
Clinica de Neoplasias Litoral
🇧🇷Itajai, Santa Catarina, Brazil
Institucion Prestadora de Servicios de Salud Sociedad Médica Rionegro SA Somer SA
🇨🇴Rionegro, Antioquia, Colombia
Queen Mary Hospital / HKU
🇭🇰Hong Kong, Hong Kong
Princess Margaret Hospital
🇭🇰Kowloon, Hong Kong
Aichi Cancer Center
🇯🇵Nagoya-shi, Aichi, Japan
Chiba Cancer Center
🇯🇵Chiba-shi, Chiba, Japan
National Cancer Center Hospital East
🇯🇵Kashiwa-shi, Chiba, Japan
National Hospital Organization Shikoku Cancer Center
🇯🇵Matsuyama-shi, Ehime, Japan
National Hospital Organization Kyushu Cancer Center
🇯🇵Fukuoka-shi, Fukuoka, Japan
Hokkaido University Hospital
🇯🇵Sapporo, Hokkaido, Japan
Hyogo Cancer Center
🇯🇵Akashi-shi, Hyogo, Japan
St Marianna University Hospital
🇯🇵Kawasaki-shi, Kanagawa, Japan
Yokohama City University Medical Center
🇯🇵Yokohama-shi, Kanagawa, Japan
Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center
🇯🇵Yokohama-shi, Kanagawa, Japan
Niigata Cancer Center Hospital
🇯🇵Niigata-shi, Niigata, Japan
Kansai Medical University Hospital
🇯🇵Hirakata-shi, Osaka, Japan
National Hospital Organization Osaka National Hospital
🇯🇵Osaka-shi, Osaka, Japan
Osaka University Hospital
🇯🇵Suita-shi, Osaka, Japan
Saitama Cancer Center
🇯🇵Kitaadachi-gun, Saitama, Japan
Shizuoka Cancer Center
🇯🇵Sunto-gun, Shizuoka, Japan
National Cancer Center Hospital
🇯🇵Chuo-ku, Tokyo, Japan
The Cancer Institute Hospital of Japanese Foundation for Cancer Research
🇯🇵Koto-ku, Tokyo, Japan
National Cancer Center
🇰🇷Goyang-si Gyeonggi-do, Korea, Republic of
Korea University Anam Hospital
🇰🇷Seoul, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Severance Hospital Yonsei University Health System
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
The Catholic University of Korea Seoul St Marys Hospital
🇰🇷Seoul, Korea, Republic of
Korea University Guro Hospital
🇰🇷Seoul, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of