Spots Global Cancer Trial Database for Sotorasib and Panitumumab Versus Investigator's Choice for Participants With Kirsten Rat Sarcoma (KRAS) p.G12C Mutation
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Trial Identification
Brief Title: Sotorasib and Panitumumab Versus Investigator's Choice for Participants With Kirsten Rat Sarcoma (KRAS) p.G12C Mutation
Official Title: A Phase 3 Multicenter, Randomized, Open-label, Active-controlled Study of Sotorasib and Panitumumab Versus Investigator's Choice (Trifluridine and Tipiracil, or Regorafenib) for the Treatment of Previously Treated Metastatic Colorectal Cancer Subjects With Kirsten Rat Sarcoma (KRAS) p.G12C Mutation
Study ID: NCT05198934
Conditions
Study Description
Brief Summary: The aim of the study is to compare progression-free survival (PFS) in previously treated participants with Kirsten rat sarcoma (KRAS) p.G12C mutated colorectal cancer (CRC) receiving sotorasib 240 mg once daily (QD) and panitumumab vs investigator's choice (trifluridine and tipiracil, or regorafenib), and sotorasib 960 mg QD and panitumumab vs investigator's choice (trifluridine and tipiracil, or regorafenib).
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Central Alabama Research, Birmingham, Alabama, United States
City of Hope National Medical Center, Duarte, California, United States
University of California Irvine, Orange, California, United States
Johns Hopkins University School of Medicine, Washington, District of Columbia, United States
Cancer Specialists of North Florida, Jacksonville, Florida, United States
Lakes Research LLC, Miami Lakes, Florida, United States
Northwest Georgia Oncology Centers PC, Marietta, Georgia, United States
University of Michigan, Ann Arbor, Michigan, United States
Revive Research Institute, Farmington Hills, Michigan, United States
Sparrow Clinical Research Institute, Lansing, Michigan, United States
Revive Research Institute, Sterling Heights, Michigan, United States
Upstate University Hospital, Syracuse, New York, United States
White Plains Hospital Center for Cancer Care, White Plains, New York, United States
Moses H Cone Memorial Hospital, Greensboro, North Carolina, United States
The Mark H Zangmeister Center, Columbus, Ohio, United States
Lancaster General Hospital Ann B Barshinger Cancer Institute, Lancaster, Pennsylvania, United States
Sarah Cannon Research Institute, Nashville, Tennessee, United States
Kelsey Research Foundation, Houston, Texas, United States
Best Cancer Care & Hematology, Houston, Texas, United States
Lumi Research, Kingwood, Texas, United States
Chris OBrien Lifehouse, Camperdown, New South Wales, Australia
GenesisCare -North Shore (Oncology), St Leonards, New South Wales, Australia
Westmead Hospital, Westmead, New South Wales, Australia
The Queen Elizabeth Hospital, Woodville South, South Australia, Australia
Centre Hospitalier Universitaire de Lyon - Hopital Edouard Herriot, Lyon Cédex 3, , France
Institut regional du Cancer Montpellier, Montpellier Cedex 5, , France
Hôpital Européen Georges Pompidou, Paris, , France
Hôpital Haut -lévêque, Pessac, , France
Charite Universitaetsmedizin Berlin, Charité Campus Virchow-Klinikum, Berlin, , Germany
Universitaetsklinikum Carl Gustav Carus an der Technischen Universitaet Dresden, Dresden, , Germany
Universitaetsmedizin Goettingen - Georg-August-Universitaet, Goettingen, , Germany
Klinikum der Universitaet Muenchen Campus Grosshadern, Muenchen, , Germany
Universitaetsklinikum der Eberhard Karls Universitaet Tuebingen, Tuebingen, , Germany
General Hospital of Athens Laiko, Athens, , Greece
Evgenidio Hospital I Agia Trias, Athens, , Greece
Hygeia Hospital, Athens, , Greece
University Hospital of Heraklion, Heraklion - Crete, , Greece
University Hospital of Patras, Patra, , Greece
Theagenion Anticancer Hospital, Thessaloniki, , Greece
Agios Loukas Clinic, Thessaloniki, , Greece
Istituto Ospedaliero Fondazione Poliambulanza, Brescia, , Italy
Azienda Ospedaliera Rilievo Nazionale e Alta Specializzazione Garibaldi Nesima, Catania, , Italy
Azienda Ospedaliera Santa Croce e Carle, Confreria (CN), , Italy
Azienda Ospedaliera Universitaria Careggi, Firenze, , Italy
Ospedale Policlinico San Martino IRCCS, Genova, , Italy
Azienda Sanitaria Locale 5 Spezzino Ospedale S Andrea, La Spezia, , Italy
Azienda Unita Sanitaria Locale LE Presidio Ospedaliero Vito Fazzi Polo Oncologico Giovanni Paolo II, Lecce, , Italy
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, , Italy
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda, Milano, , Italy
Azienda Ospedaliero Universitaria di Cagliari Policlinico Duilio Casula, Monserrato CA, , Italy
Azienda Ospedaliero Universitaria Luigi Vanvitelli, Napoli, , Italy
Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione Giovanni Pascale, Napoli, , Italy
Azienda Ospedaliero Universitaria Maggiore della Carita, Novara, , Italy
Istituto Oncologico Veneto IRCCS, Padova, , Italy
Azienda Ospedaliera Universitaria Pisana Ospedale Santa Chiara, Pisa, , Italy
Azienda Ospedaliera San Carlo, Potenza, , Italy
Azienda Unita Sanitaria Locale di Reggio Emilia Arcispedale Santa Maria Nuova, Reggio Emilia, , Italy
Fondazione Policlinico Tor Vergata, Roma (RM), , Italy
Policlinico Universitario Agostino Gemelli, Roma, , Italy
Azienda Ospedaliera San Giovanni Addolorata, Roma, , Italy
Azienda Ospedaliera Cardinale Giovanni Panico, Tricase, , Italy
Azienda Unita Locale Socio Sanitaria Berica 8, Vicenza, , Italy
Aichi Medical University Hospital, Nagakute-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
Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center, Yokohama-shi, Kanagawa, 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
Seoul National University Hospital, Seoul, , Korea, Republic of
Severance Hospital Yonsei University Health System, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Superare Centro de Infusion SA de CV, Ciudad de Mexico, Distrito Federal, Mexico
Health Pharma Professional Research SA de CV, Mexico City, Distrito Federal, Mexico
Trials In Medicine SC, Ciudad de Mexico, , Mexico
Hospital Universitario Reina Sofia, Cordoba, Andalucía, Spain
Hospital Universitario Virgen de las Nieves, Granada, Andalucía, Spain
Hospital Universitario Marques de Valdecilla, Santander, Cantabria, Spain
Hospital Universitari Vall d Hebron, Barcelona, Cataluña, Spain
Hospital de la Santa Creu i Sant Pau, Barcelona, Cataluña, Spain
Hospital General Universitario de Elche, Elche, Comunidad Valenciana, Spain
Hospital General Universitario de Valencia, Valencia, Comunidad Valenciana, Spain
Complexo Hospitalario Universitario de Ourense, Ourense, Galicia, Spain
Hospital Universitario de Navarra, Pamplona, Navarra, Spain
Hospital Universitario La Paz, Madrid, , Spain
Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung, , Taiwan
National Cheng Kung University Hospital, Tainan, , Taiwan
National Taiwan University Hospital, Taipei, , Taiwan
Taipei Veterans General Hospital, Taipei, , Taiwan
Linkou Chang Gung Memorial Hospital of Chang Gung Medical Foundation, Taoyuan, , Taiwan
Beatson West of Scotland Cancer Centre, Glasgow, , United Kingdom
Royal Free Hospital, London, , United Kingdom
Royal Marsden Hospital, London, , United Kingdom
Maidstone Hospital, Maidstone, , United Kingdom
Mount Vernon Cancer Centre, Northwood, , United Kingdom
Royal Marsden Hospital, Sutton, , United Kingdom
Contact Details
Name: MD
Affiliation: Amgen
Role: STUDY_DIRECTOR
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