Program Status
Active, not recruitingPhase
Phase 3Prior Immunotherapy Allowed
YesCRC-directed Trial
YesTags
MSI-H/ MMRd, MSS/ MMRpComments
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.
Helpful Links
https://pubmed.ncbi.nlm.nih.gov/37870968/Location | Location Status |
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United States | |
Central Alabama Research Birmingham, Alabama 35209 |
Active, not recruiting |
City of Hope National Medical Center Duarte, California 91010 |
Active, not recruiting |
University of California Irvine Orange, California 92868 |
Active, not recruiting |
Johns Hopkins University School of Medicine Washington, District of Columbia 20016 |
Active, not recruiting |
Cancer Specialists of North Florida Jacksonville, Florida 32256 |
Active, not recruiting |
Lakes Research LLC Miami Lakes, Florida 33014 |
Active, not recruiting |
Northwest Georgia Oncology Centers PC Marietta, Georgia 30060 |
Active, not recruiting |
University of Michigan Ann Arbor, Michigan 48106-0995 |
Active, not recruiting |
Revive Research Institute Farmington Hills, Michigan 48334 |
Active, not recruiting |
Sparrow Clinical Research Institute Lansing, Michigan 48912 |
Active, not recruiting |
Revive Research Institute Sterling Heights, Michigan 48314 |
Active, not recruiting |
Upstate University Hospital Syracuse, New York 13210 |
Active, not recruiting |
White Plains Hospital Center for Cancer Care White Plains, New York 10601 |
Active, not recruiting |
Moses H Cone Memorial Hospital Greensboro, North Carolina 27403 |
Active, not recruiting |
The Mark H Zangmeister Center Columbus, Ohio 43210 |
Active, not recruiting |
Lancaster General Hospital Ann B Barshinger Cancer Institute Lancaster, Pennsylvania 17601 |
Active, not recruiting |
Sarah Cannon Research Institute Nashville, Tennessee 37203 |
Active, not recruiting |
Kelsey Research Foundation Houston, Texas 77025 |
Active, not recruiting |
Best Cancer Care & Hematology Houston, Texas 77089 |
Active, not recruiting |
Lumi Research Kingwood, Texas 77339 |
Active, not recruiting |
Australia | |
Chris OBrien Lifehouse Camperdown, New South Wales 2050 |
Active, not recruiting |
GenesisCare -North Shore (Oncology) St Leonards, New South Wales 2065 |
Active, not recruiting |
Westmead Hospital Westmead, New South Wales 2145 |
Active, not recruiting |
The Queen Elizabeth Hospital Woodville South, South Australia 5011 |
Active, not recruiting |
France | |
Centre Hospitalier Universitaire de Lyon - Hopital Edouard Herriot Lyon Cédex 3 69437 |
Active, not recruiting |
Institut regional du Cancer Montpellier Montpellier Cedex 5 34298 |
Active, not recruiting |
Hôpital Européen Georges Pompidou Paris 75015 |
Active, not recruiting |
Hôpital Haut -lévêque Pessac 33604 |
Active, not recruiting |
Germany | |
Charite Universitaetsmedizin Berlin, Charité Campus Virchow-Klinikum Berlin 13353 |
Active, not recruiting |
Universitaetsklinikum Carl Gustav Carus an der Technischen Universitaet Dresden Dresden 01307 |
Active, not recruiting |
Universitaetsmedizin Goettingen - Georg-August-Universitaet Goettingen 37075 |
Active, not recruiting |
Klinikum der Universitaet Muenchen Campus Grosshadern Muenchen 81377 |
Active, not recruiting |
Universitaetsklinikum der Eberhard Karls Universitaet Tuebingen Tuebingen 72076 |
Active, not recruiting |
Greece | |
General Hospital of Athens Laiko Athens 11527 |
Active, not recruiting |
Evgenidio Hospital I Agia Trias Athens 11528 |
Active, not recruiting |
Hygeia Hospital Athens 15123 |
Active, not recruiting |
University Hospital of Heraklion Heraklion - Crete 71500 |
Active, not recruiting |
University Hospital of Patras Patra 26504 |
Active, not recruiting |
Theagenion Anticancer Hospital Thessaloniki 54007 |
Active, not recruiting |
Agios Loukas Clinic Thessaloniki 55236 |
Active, not recruiting |
Italy | |
Istituto Ospedaliero Fondazione Poliambulanza Brescia 25124 |
Active, not recruiting |
Azienda Ospedaliera Rilievo Nazionale e Alta Specializzazione Garibaldi Nesima Catania 95122 |
Active, not recruiting |
Azienda Ospedaliera Santa Croce e Carle Confreria (CN) 12100 |
Active, not recruiting |
Azienda Ospedaliera Universitaria Careggi Firenze 50134 |
Active, not recruiting |
Ospedale Policlinico San Martino IRCCS Genova 16132 |
Active, not recruiting |
Azienda Sanitaria Locale 5 Spezzino Ospedale S Andrea La Spezia 19100 |
Active, not recruiting |
Azienda Unita Sanitaria Locale LE Presidio Ospedaliero Vito Fazzi Polo Oncologico Giovanni Paolo II Lecce 73100 |
Active, not recruiting |
Fondazione IRCCS Istituto Nazionale dei Tumori Milano 20133 |
Active, not recruiting |
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda Milano 20162 |
Active, not recruiting |
Azienda Ospedaliero Universitaria di Cagliari Policlinico Duilio Casula Monserrato CA 09042 |
Active, not recruiting |
Azienda Ospedaliero Universitaria Luigi Vanvitelli Napoli 80131 |
Active, not recruiting |
Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione Giovanni Pascale Napoli 80131 |
Active, not recruiting |
Azienda Ospedaliero Universitaria Maggiore della Carita Novara 28100 |
Active, not recruiting |
Istituto Oncologico Veneto IRCCS Padova 35128 |
Active, not recruiting |
Azienda Ospedaliera Universitaria Pisana Ospedale Santa Chiara Pisa 56126 |
Active, not recruiting |
Azienda Ospedaliera San Carlo Potenza 85100 |
Active, not recruiting |
Azienda Unita Sanitaria Locale di Reggio Emilia Arcispedale Santa Maria Nuova Reggio Emilia 42100 |
Active, not recruiting |
Fondazione Policlinico Tor Vergata Roma (RM) 00133 |
Active, not recruiting |
Policlinico Universitario Agostino Gemelli Roma 00168 |
Active, not recruiting |
Azienda Ospedaliera San Giovanni Addolorata Roma 00184 |
Active, not recruiting |
Azienda Ospedaliera Cardinale Giovanni Panico Tricase 73039 |
Active, not recruiting |
Azienda Unita Locale Socio Sanitaria Berica 8 Vicenza 36100 |
Active, not recruiting |
Japan | |
Aichi Medical University Hospital Nagakute-shi, Aichi 480-1195 |
Active, not recruiting |
Chiba Cancer Center Chiba-shi, Chiba 260-8717 |
Active, not recruiting |
National Cancer Center Hospital East Kashiwa-shi, Chiba 277-8577 |
Active, not recruiting |
National Hospital Organization Shikoku Cancer Center Matsuyama-shi, Ehime 791-0280 |
Active, not recruiting |
National Hospital Organization Kyushu Cancer Center Fukuoka-shi, Fukuoka 811-1395 |
Active, not recruiting |
Hokkaido University Hospital Sapporo, Hokkaido 060-8648 |
Active, not recruiting |
Hyogo Cancer Center Akashi-shi, Hyogo 673-8558 |
Active, not recruiting |
St Marianna University Hospital Kawasaki-shi, Kanagawa 216-8511 |
Active, not recruiting |
Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center Yokohama-shi, Kanagawa 241-8515 |
Active, not recruiting |
National Hospital Organization Osaka National Hospital Osaka-shi, Osaka 540-0006 |
Active, not recruiting |
Osaka University Hospital Suita-shi, Osaka 565-0871 |
Active, not recruiting |
Saitama Cancer Center Kitaadachi-gun, Saitama 362-0806 |
Active, not recruiting |
Shizuoka Cancer Center Sunto-gun, Shizuoka 411-8777 |
Active, not recruiting |
National Cancer Center Hospital Chuo-ku, Tokyo 104-0045 |
Active, not recruiting |
The Cancer Institute Hospital of Japanese Foundation for Cancer Research Koto-ku, Tokyo 135-8550 |
Active, not recruiting |
Korea, Republic of | |
Seoul National University Hospital Seoul 03080 |
Active, not recruiting |
Severance Hospital Yonsei University Health System Seoul 03722 |
Active, not recruiting |
Asan Medical Center Seoul 05505 |
Active, not recruiting |
Samsung Medical Center Seoul 06351 |
Active, not recruiting |
Mexico | |
Superare Centro de Infusion SA de CV Ciudad de Mexico, Distrito Federal 06760 |
Active, not recruiting |
Health Pharma Professional Research SA de CV Mexico City, Distrito Federal 03100 |
Active, not recruiting |
Trials In Medicine SC Ciudad de Mexico 06700 |
Active, not recruiting |
Spain | |
Hospital Universitario Reina Sofia Cordoba, Andalucía 14004 |
Active, not recruiting |
Hospital Universitario Virgen de las Nieves Granada, Andalucía 18014 |
Active, not recruiting |
Hospital Universitario Marques de Valdecilla Santander, Cantabria 39008 |
Active, not recruiting |
Hospital Universitari Vall d Hebron Barcelona, Cataluña 08035 |
Active, not recruiting |
Hospital de la Santa Creu i Sant Pau Barcelona, Cataluña 08041 |
Active, not recruiting |
Hospital General Universitario de Elche Elche, Comunidad Valenciana 03203 |
Active, not recruiting |
Hospital General Universitario de Valencia Valencia, Comunidad Valenciana 46014 |
Active, not recruiting |
Complexo Hospitalario Universitario de Ourense Ourense, Galicia 32005 |
Active, not recruiting |
Hospital Universitario de Navarra Pamplona, Navarra 31008 |
Active, not recruiting |
Hospital Universitario La Paz Madrid 28046 |
Active, not recruiting |
Taiwan | |
Kaohsiung Medical University Chung-Ho Memorial Hospital Kaohsiung 80756 |
Active, not recruiting |
National Cheng Kung University Hospital Tainan 70403 |
Active, not recruiting |
National Taiwan University Hospital Taipei 10002 |
Active, not recruiting |
Taipei Veterans General Hospital Taipei 11217 |
Active, not recruiting |
Linkou Chang Gung Memorial Hospital of Chang Gung Medical Foundation Taoyuan 33305 |
Active, not recruiting |
United Kingdom | |
Beatson West of Scotland Cancer Centre Glasgow G12 0YN |
Active, not recruiting |
Royal Free Hospital London NW3 2QG |
Active, not recruiting |
Royal Marsden Hospital London SW3 6JJ |
Active, not recruiting |
Maidstone Hospital Maidstone ME16 9QQ |
Active, not recruiting |
Mount Vernon Cancer Centre Northwood HA6 2RN |
Active, not recruiting |
Royal Marsden Hospital Sutton SM2 5PT |
Active, not recruiting |
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 prospective central testing, using the analytically validated Qiagen Therascreen KRAS RGQ polymerase chain reaction Kit in CRC as an investigational device demonstrating a KRAS p.G12C mutation is present. Local testing and documentation of KRAS p.G12C mutation should have been previously performed as part of standard of care.
* 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 2 weeks prior to cycle 1 day 1:
* 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, total bilirubin or direct bilirubin needs to be ≤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.