Trial Title:
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
NCT ID:
NCT06252649
Condition:
Metastatic Colorectal Cancer
Conditions: Official terms:
Colorectal Neoplasms
Bevacizumab
Panitumumab
Sotorasib
Conditions: Keywords:
Sotorasib
Panitumumab
FOLFIRI
Bevacizumab-awwb
Oncology
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
FOLFIRI Regimen
Description:
Combination of irinotecan, leucovorin, and 5-fluorouracil given intravenously Q2W.
Arm group label:
Arm A: Sotorasib + Panitumumab + FOLFIRI
Arm group label:
Arm B: FOLFIRI with or Without Bevacizumab-awwb
Intervention type:
Drug
Intervention name:
Sotorasib
Description:
Immediate-release solid dosage form administered PO.
Arm group label:
Arm A: Sotorasib + Panitumumab + FOLFIRI
Other name:
AMG 510
Other name:
Lumakras
Other name:
Lumykras
Intervention type:
Drug
Intervention name:
Panitumumab
Description:
Administered IV Q2W.
Arm group label:
Arm A: Sotorasib + Panitumumab + FOLFIRI
Other name:
Vectibix
Intervention type:
Drug
Intervention name:
Bevacizumab-awwb
Description:
Administered IV Q2W.
Arm group label:
Arm B: FOLFIRI with or Without Bevacizumab-awwb
Other name:
MVASI
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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.
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Ironwood Cancer and Research Centers Scottsdale
Address:
City:
Chandler
Zip:
85224
Country:
United States
Status:
Recruiting
Facility:
Name:
Providence Saint Jude Medical Center
Address:
City:
Fullerton
Zip:
92835
Country:
United States
Status:
Recruiting
Facility:
Name:
Cancer and Blood Specialty Clinic
Address:
City:
Los Alamitos
Zip:
90720
Country:
United States
Status:
Recruiting
Facility:
Name:
Norwalk Hospital
Address:
City:
Norwalk
Zip:
06856
Country:
United States
Status:
Recruiting
Facility:
Name:
Cancer Specialists of North Florida
Address:
City:
Jacksonville
Zip:
32256
Country:
United States
Status:
Recruiting
Facility:
Name:
D and H Cancer Research Center
Address:
City:
Margate
Zip:
33063
Country:
United States
Status:
Recruiting
Facility:
Name:
Mid Florida Hematology and Oncology Centers PA
Address:
City:
Orange City
Zip:
32763
Country:
United States
Status:
Recruiting
Facility:
Name:
Boca Raton Clinical Research Medical Center Inc
Address:
City:
Plantation
Zip:
33322
Country:
United States
Status:
Recruiting
Facility:
Name:
Hope and Healing Cancer Services
Address:
City:
Hinsdale
Zip:
60521
Country:
United States
Status:
Recruiting
Facility:
Name:
Orchard Healthcare Research Inc
Address:
City:
Skokie
Zip:
60076
Country:
United States
Status:
Recruiting
Facility:
Name:
Pikeville Medical Center
Address:
City:
Pikeville
Zip:
41501
Country:
United States
Status:
Recruiting
Facility:
Name:
Cancer and Hematology Centers of Western Michigan
Address:
City:
Grand Rapids
Zip:
49503
Country:
United States
Status:
Recruiting
Facility:
Name:
Saint Louis Cancer Care West County
Address:
City:
Bridgeton
Zip:
63044
Country:
United States
Status:
Recruiting
Facility:
Name:
Minniti Center for Medical Oncology and Hematology
Address:
City:
Mickleton
Zip:
08056
Country:
United States
Status:
Recruiting
Facility:
Name:
Duke Cancer Center
Address:
City:
Durham
Zip:
27710
Country:
United States
Status:
Recruiting
Facility:
Name:
FirstHealth Cancer Center
Address:
City:
Pinehurst
Zip:
28374
Country:
United States
Status:
Recruiting
Facility:
Name:
Carolina Blood and Cancer Care
Address:
City:
Rock Hill
Zip:
29732
Country:
United States
Status:
Recruiting
Facility:
Name:
Hospital Universitario Fundacion Favaloro
Address:
City:
Caba
Zip:
C1093AAS
Country:
Argentina
Status:
Recruiting
Facility:
Name:
Instituto Argentino de Diagnóstico y Tratamiento
Address:
City:
Caba
Zip:
C1093AAS
Country:
Argentina
Status:
Recruiting
Facility:
Name:
Cemic
Address:
City:
Ciudad Autonoma de Buenos Aires
Zip:
C1431FWO
Country:
Argentina
Status:
Recruiting
Facility:
Name:
Sanatorio Británico de Rosario
Address:
City:
La Plata
Zip:
1900
Country:
Argentina
Status:
Recruiting
Facility:
Name:
Sanatorio Allende
Address:
City:
Cordoba
Zip:
X5000JHQ
Country:
Argentina
Status:
Recruiting
Facility:
Name:
Clinica Universitaria Privada Reina Fabiola
Address:
City:
Cordoba
Zip:
X5004FHP
Country:
Argentina
Status:
Recruiting
Facility:
Name:
Clinica Viedma
Address:
City:
Viedma
Zip:
8500
Country:
Argentina
Status:
Recruiting
Facility:
Name:
Exelsus Oncologia Clinica
Address:
City:
San Miguel de Tucuman
Zip:
T4000
Country:
Argentina
Status:
Recruiting
Facility:
Name:
Hospital Britanico de Buenos Aires
Address:
City:
Buenos Aires
Zip:
C1280AEB
Country:
Argentina
Status:
Recruiting
Facility:
Name:
Chris OBrien Lifehouse
Address:
City:
Camperdown
Zip:
2050
Country:
Australia
Status:
Recruiting
Facility:
Name:
Toowoomba Hospital
Address:
City:
Toowoomba
Zip:
4350
Country:
Australia
Status:
Recruiting
Facility:
Name:
Flinders Medical Centre
Address:
City:
Bedford Park
Zip:
5042
Country:
Australia
Status:
Recruiting
Facility:
Name:
The Queen Elizabeth Hospital
Address:
City:
Woodville South
Zip:
5011
Country:
Australia
Status:
Recruiting
Facility:
Name:
Austin Health, Austin Hospital
Address:
City:
Heidelberg
Zip:
3084
Country:
Australia
Status:
Recruiting
Facility:
Name:
Institucion Prestadora de Servicios de Salud Sociedad Médica Rionegro SA Somer SA
Address:
City:
Rionegro
Zip:
054040
Country:
Colombia
Status:
Recruiting
Facility:
Name:
Queen Mary Hospital / HKU
Address:
City:
Hong Kong
Country:
Hong Kong
Status:
Recruiting
Facility:
Name:
Princess Margaret Hospital
Address:
City:
Kowloon
Country:
Hong Kong
Status:
Recruiting
Facility:
Name:
Aichi Cancer Center
Address:
City:
Nagoya-shi
Zip:
464-8681
Country:
Japan
Status:
Recruiting
Facility:
Name:
Chiba Cancer Center
Address:
City:
Chiba-shi
Zip:
260-8717
Country:
Japan
Status:
Recruiting
Facility:
Name:
National Cancer Center Hospital East
Address:
City:
Kashiwa-shi
Zip:
277-8577
Country:
Japan
Status:
Recruiting
Facility:
Name:
National Hospital Organization Shikoku Cancer Center
Address:
City:
Matsuyama-shi
Zip:
791-0280
Country:
Japan
Status:
Recruiting
Facility:
Name:
National Hospital Organization Kyushu Cancer Center
Address:
City:
Fukuoka-shi
Zip:
811-1395
Country:
Japan
Status:
Recruiting
Facility:
Name:
Hokkaido University Hospital
Address:
City:
Sapporo
Zip:
060-8648
Country:
Japan
Status:
Recruiting
Facility:
Name:
Hyogo Cancer Center
Address:
City:
Akashi-shi
Zip:
673-8558
Country:
Japan
Status:
Recruiting
Facility:
Name:
St Marianna University Hospital
Address:
City:
Kawasaki-shi
Zip:
216-8511
Country:
Japan
Status:
Recruiting
Facility:
Name:
Yokohama City University Medical Center
Address:
City:
Yokohama-shi
Zip:
232-0024
Country:
Japan
Status:
Recruiting
Facility:
Name:
Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center
Address:
City:
Yokohama-shi
Zip:
241-8515
Country:
Japan
Status:
Recruiting
Facility:
Name:
Niigata Cancer Center Hospital
Address:
City:
Niigata-shi
Zip:
951-8566
Country:
Japan
Status:
Recruiting
Facility:
Name:
Kansai Medical University Hospital
Address:
City:
Hirakata-shi
Zip:
573-1191
Country:
Japan
Status:
Recruiting
Facility:
Name:
National Hospital Organization Osaka National Hospital
Address:
City:
Osaka-shi
Zip:
540-0006
Country:
Japan
Status:
Recruiting
Facility:
Name:
Osaka University Hospital
Address:
City:
Suita-shi
Zip:
565-0871
Country:
Japan
Status:
Recruiting
Facility:
Name:
Saitama Cancer Center
Address:
City:
Kitaadachi-gun
Zip:
362-0806
Country:
Japan
Status:
Recruiting
Facility:
Name:
Shizuoka Cancer Center
Address:
City:
Sunto-gun
Zip:
411-8777
Country:
Japan
Status:
Recruiting
Facility:
Name:
National Cancer Center Hospital
Address:
City:
Chuo-ku
Zip:
104-0045
Country:
Japan
Status:
Recruiting
Facility:
Name:
The Cancer Institute Hospital of Japanese Foundation for Cancer Research
Address:
City:
Koto-ku
Zip:
135-8550
Country:
Japan
Status:
Recruiting
Facility:
Name:
National Cancer Center
Address:
City:
Goyang-si Gyeonggi-do
Zip:
10408
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Korea University Anam Hospital
Address:
City:
Seoul
Zip:
02841
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Seoul National University Hospital
Address:
City:
Seoul
Zip:
03080
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Severance Hospital Yonsei University Health System
Address:
City:
Seoul
Zip:
03722
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Samsung Medical Center
Address:
City:
Seoul
Zip:
06351
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
The Catholic University of Korea Seoul St Marys Hospital
Address:
City:
Seoul
Zip:
06591
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Korea University Guro Hospital
Address:
City:
Seoul
Zip:
08308
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Asan Medical Center
Address:
City:
Seoul
Zip:
138-736
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Taichung Veterans General Hospital
Address:
City:
Taichung
Zip:
40705
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
Taipei Veterans General Hospital
Address:
City:
Taipei
Zip:
11217
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
Linkou Chang Gung Memorial Hospital of Chang Gung Medical Foundation
Address:
City:
Taoyuan
Zip:
33305
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
Hacettepe Universitesi Tip Fakultesi Hastanesi
Address:
City:
Ankara
Zip:
06230
Country:
Turkey
Status:
Recruiting
Facility:
Name:
Ankara Bilkent Sehir Hastanesi
Address:
City:
Ankara
Zip:
06800
Country:
Turkey
Status:
Recruiting
Facility:
Name:
Trakya Universitesi Saglik Arastirma ve Uygulama Merkezi
Address:
City:
Edirne
Zip:
22030
Country:
Turkey
Status:
Recruiting
Facility:
Name:
Bagcilar Medipol Mega Universite Hastanesi
Address:
City:
Istanbul
Zip:
34214
Country:
Turkey
Status:
Recruiting
Facility:
Name:
Necmettin Erbakan Universitesi Tip Fakultesi Hastanesi
Address:
City:
Konya
Zip:
42080
Country:
Turkey
Status:
Recruiting
Facility:
Name:
Inonu Universitesi Turgut Ozal Tip Merkezi
Address:
City:
Malatya
Zip:
44280
Country:
Turkey
Status:
Recruiting
Start date:
July 17, 2024
Completion date:
April 30, 2031
Lead sponsor:
Agency:
Amgen
Agency class:
Industry
Source:
Amgen
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06252649
http://www.amgentrials.com
