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Sotorasib and Panitumumab Versus Investigator’s Choice for Participants With Kirsten Rat Sarcoma (KRAS) p.G12C Mutation (CodeBreak 300)

Program Status

Recruiting

Phase

Phase 3

Immunotherapy-centered Trial

No

Prior Immunotherapy Allowed

Yes

CRC-directed Trial

Yes

Tags

MSS/ pMMR

Comments

Phase 3 trial for stage IV colorectal patients with a KRAS G12C mutation. This trial compares the standard of care treatment (trifluridine and tipiracil (Lonsurf), or regorafenib (Stivarga)) vs two different doses of the novel KRAS G12C inhibitor (Sotorasib, formerly ANG 510) plus panitumumab (Vectibix, a EGFR inhibitor). KRAS mutant patients usually don’t respond to EGFR inhibitors; the addition of the experimental Sotorasib aims to change that situation.

Location Location Status
United States
Central Alabama Research
Birmingham, Alabama 35209
Recruiting
City of Hope National Medical Center
Duarte, California 91010
Recruiting
Johns Hopkins University School of Medicine
Washington, District of Columbia 20016
Recruiting
Cancer Specialists of North Florida
Jacksonville, Florida 32256
Recruiting
Lakes Research LLC
Miami Lakes, Florida 33014
Recruiting
Northwest Georgia Oncology Centers PC
Marietta, Georgia 30060
Recruiting
University of Michigan
Ann Arbor, Michigan 48106-0995
Recruiting
Revive Research Institute
Farmington Hills, Michigan 48334
Recruiting
Sparrow Clinical Research Institute
Lansing, Michigan 48912
Recruiting
Revive Research Institute
Sterling Heights, Michigan 48314
Recruiting
Moses H Cone Memorial Hospital
Greensboro, North Carolina 27403
Recruiting
The Mark H Zangmeister Center
Columbus, Ohio 43210
Recruiting
Sarah Cannon Research Institute
Nashville, Tennessee 37203
Recruiting
Kelsey Research Foundation
Houston, Texas 77025
Recruiting
Lumi Research
Kingwood, Texas 77339
Recruiting
Australia
Chris OBrien Lifehouse
Camperdown, New South Wales 2050
Recruiting
GenesisCare -North Shore (Oncology)
St Leonards, New South Wales 2065
Recruiting
Westmead Hospital
Westmead, New South Wales 2145
Recruiting
The Queen Elizabeth Hospital
Woodville South, South Australia 5011
Recruiting
France
Centre Hospitalier Universitaire de Lyon - Hopital Edouard Herriot
Lyon Cédex 3 69437
Recruiting
Hôpital Européen Georges Pompidou
Paris 75015
Recruiting
Hôpital Haut -lévêque
Pessac 33600
Recruiting
Germany
Charite Universitätsmedizin Berlin, Charité Campus Virchow-Klinikum
Berlin 13353
Recruiting
Universitaetsklinikum Carl Gustav Carus an der Technischen Universitaet Dresden
Dresden 01307
Recruiting
Universitätsmedizin Göttingen - Georg-August-Universität
Göttingen 37075
Recruiting
Klinikum der Universität München Campus Grosshadern
München 81377
Recruiting
Universitaetsklinikum der Eberhard Karls Universitaet Tuebingen
Tübingen 72076
Recruiting
Greece
General Hospital of Athens Laiko
Athens 11527
Recruiting
Evgenidio Hospital I Agia Trias
Athens 11528
Recruiting
Hygeia Hospital
Athens 15123
Recruiting
University Hospital of Heraklion
Heraklion - Crete 71500
Recruiting
University Hospital of Patras
Patra 26504
Recruiting
Theagenion Anticancer Hospital
Thessaloniki 54007
Recruiting
Agios Loukas Clinic
Thessaloniki 55236
Recruiting
Italy
Istituto Ospedaliero Fondazione Poliambulanza
Brescia 25124
Recruiting
Azienda Ospedaliera Santa Croce e Carle
Confreria (CN) 12100
Recruiting
Azienda Ospedaliera Universitaria Careggi
Firenze 50134
Recruiting
Ospedale Policlinico San Martino IRCCS
Genova 16132
Recruiting
Azienda Sanitaria Locale 5 Spezzino Ospedale S Andrea
La Spezia 19100
Recruiting
Fondazione IRCCS Istituto Nazionale dei Tumori
Milano 20133
Recruiting
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
Milano 20162
Recruiting
Azienda Ospedaliero Universitaria di Cagliari Policlinico Duilio Casula
Monserrato CA 09042
Recruiting
Azienda Ospedaliero Universitaria Luigi Vanvitelli
Napoli 80131
Recruiting
Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione Giovanni Pascale
Napoli 80131
Recruiting
Azienda Ospedaliero Universitaria Maggiore della Carita
Novara 28100
Recruiting
Istituto Oncologico Veneto IRCCS
Padova 35128
Recruiting
Azienda Ospedaliera Universitaria Pisana Ospedale Santa Chiara
Pisa 56126
Recruiting
Azienda Ospedaliera San Carlo
Potenza 85100
Recruiting
Azienda Unita Sanitaria Locale di Reggio Emilia Arcispedale Santa Maria Nuova
Reggio Emilia 42100
Recruiting
Fondazione Policlinico Tor Vergata
Roma (RM) 00133
Recruiting
Policlinico Universitario Agostino Gemelli
Roma 00168
Recruiting
Azienda Ospedaliera San Giovanni Addolorata
Roma 00184
Recruiting
Azienda Ospedaliera Cardinale Giovanni Panico
Tricase 73039
Recruiting
Japan
Aichi Medical University Hospital
Nagakute-shi, Aichi 480-1195
Recruiting
Chiba Cancer Center
Chiba-shi, Chiba 260-8717
Recruiting
National Cancer Center Hospital East
Kashiwa-shi, Chiba 277-8577
Recruiting
National Hospital Organization Shikoku Cancer Center
Matsuyama-shi, Ehime 791-0280
Recruiting
National Hospital Organization Kyushu Cancer Center
Fukuoka-shi, Fukuoka 811-1395
Recruiting
Hokkaido University Hospital
Sapporo, Hokkaido 060-8648
Recruiting
Hyogo Cancer Center
Akashi-shi, Hyogo 673-8558
Recruiting
St Marianna University Hospital
Kawasaki-shi, Kanagawa 216-8511
Recruiting
Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center
Yokohama-shi, Kanagawa 241-8515
Recruiting
National Hospital Organization Osaka National Hospital
Osaka-shi, Osaka 540-0006
Recruiting
Osaka University Hospital
Suita-shi, Osaka 565-0871
Recruiting
Saitama Cancer Center
Kitaadachi-gun, Saitama 362-0806
Recruiting
Shizuoka Cancer Center
Sunto-gun, Shizuoka 411-8777
Recruiting
National Cancer Center Hospital
Chuo-ku, Tokyo 104-0045
Recruiting
The Cancer Institute Hospital of Japanese Foundation for Cancer Research
Koto-ku, Tokyo 135-8550
Recruiting
Korea, Republic of
Seoul National University Hospital
Seoul 03080
Recruiting
Severance Hospital Yonsei University Health System
Seoul 03722
Recruiting
Asan Medical Center
Seoul 05505
Recruiting
Samsung Medical Center
Seoul 06351
Recruiting
Mexico
Superare Centro de Infusion SA de CV
Ciudad de Mexico, Distrito Federal 06760
Recruiting
Health Pharma Professional Research SA de CV
Mexico City, Distrito Federal 03100
Recruiting
Trials In Medicine SC
Ciudad de Mexico 06700
Recruiting
Spain
Hospital Universitario Reina Sofia
Cordoba, Andalucía 14004
Recruiting
Hospital Universitario Virgen de las Nieves
Granada, Andalucía 18014
Recruiting
Hospital Universitario Marques de Valdecilla
Santander, Cantabria 39008
Recruiting
Hospital Universitari Vall d Hebron
Barcelona, Cataluña 08035
Recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona, Cataluña 08041
Recruiting
Hospital General Universitario de Elche
Elche, Comunidad Valenciana 03203
Recruiting
Hospital General Universitario de Valencia
Valencia, Comunidad Valenciana 46014
Recruiting
Complexo Hospitalario de Ourense
Ourense, Galicia 32005
Recruiting
Complejo Hospitalario de Navarra
Pamplona, Navarra 31008
Recruiting
Hospital Universitario La Paz
Madrid 28046
Recruiting
Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung 80756
Recruiting
National Cheng Kung University Hospital
Tainan 70403
Recruiting
Taipei Veterans General Hospital
Taipei 11217
Recruiting
United Kingdom
Maidstone Hospital
Maidstone ME16 9QQ
Recruiting

Contacts

Amgen Call Center
Contact
866-572-6436 medinfo@amgen.com

Inclusion Criteria

Inclusion Criteria:

Participant has provided informed consent/assent prior to initiation of any study specific activities/procedures.
Age ≥18 years.
Pathologically documented metastatic colorectal adenocarcinoma with Kirsten rat sarcoma (KRAS) p.G12C mutation as determined by central testing.
Participants will have received at least 1 prior line of therapy for metastatic disease. Participants must have received and progressed or experienced disease recurrence on or after fluoropyrimidine, irinotecan, and oxaliplatin given for metastatic disease unless the participant, in the opinion of the investigator, is not a candidate for fluoropyrimidine, irinotecan, or oxaliplatin, in which case, the participant may be eligible after investigator discussion with Amgen medical monitor provided participant has received at least one prior line of therapy for metastatic disease and provided trifluridine and tipiracil or regorafenib is deemed the appropriate next line of therapy for the participant.
Measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria. Lesions previously radiated are not considered measurable unless they have progressed after radiation.
Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤2.
Life expectancy of >3 months, in the opinion of the investigator.

Adequate hematologic and end-organ function, defined as the following within 10 days prior to randomization:

Absolute neutrophil count (ANC) ≥1.5 x 10^9/L (without granulocyte colony stimulating factor support within 2 weeks of laboratory test used to determine eligibility).
Hemoglobin ≥9.0 g/dL (without transfusion within 2 weeks of laboratory test used to determine eligibility).
Platelet count ≥100 x 10^9/L (without transfusion within 2 weeks of laboratory test used to determine eligibility).
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 times the upper limit of normal (ULN).
Serum bilirubin ≤1.0 x ULN. For participants with Gilbert's disease, direct bilirubin ≤1.0 x ULN.
International normalized ratio (INR) and activated partial thromboplastin time (or partial thromboplastin time) ≤1.5 x ULN. Prothrombin time (PT) ≤1.5 x ULN may be used instead of INR for sites whose labs do not report INR.
Estimated glomerular filtration rate based on Modification of Diet in Renal Disease (MDRD) calculation ≥30 mL/min/1.73 m^2.
Fridericia's Correction Formula (QTcF) ≤470 msec.

Exclusion Criteria

Exclusion Criteria:

Active brain metastases. Participants who have had brain metastases resected or have received radiation therapy ending at least 4 weeks prior to study day 1 are eligible if they meet all of the following criteria: a) residual neurological symptoms grade ≤2; b) on stable doses of dexamethasone or equivalent for at least 2 weeks, if applicable; and c) follow-up magnetic resonance imaging (MRI) performed within 28 days of day 1 shows no progression or new lesions appearing.
History or presence of hematological malignancies unless curatively treated with no evidence of disease ≥2 years.

History of other malignancy within the past 3 years, with the following exceptions:

Malignancy treated with curative intent and with no known active disease present for ≥3 years before enrollment and felt to be at low risk for recurrence by the treating physician.
Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
Adequately treated cervical carcinoma in situ without evidence of disease.
Adequately treated breast ductal carcinoma in situ without evidence of disease.
Prostatic intraepithelial neoplasia without evidence of prostate cancer.
Adequately treated urothelial papillary non-invasive carcinoma or carcinoma in situ.
Leptomeningeal disease.
Significant gastrointestinal (GI) disorder that results in significant malabsorption, requirement for intravenous (IV) alimentation, or inability to take oral medication.
History of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial pneumonitis or pulmonary fibrosis.
Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction within 6 months prior to randomization, unstable arrhythmias or unstable angina.
Previous treatment with a KRAS G12C inhibitor.

NCT ID

NCT05198934

Date Trial Added

2022-01-20

Updated Date

2022-09-29