AMG20210081 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

{ "short_title": "AMG20210081 Study of Sotorasib, Panitumumab and FOLFIRI Versus FOLFIRI With or Without Bevacizumab-awwb in Treatment-na\u00efve Participants With Metastatic Colorectal Cancer With KRAS p.G12C Mutation", "data_mode": "900", "data_mode_number": "000002483", "official_title": "Phase 3 Multicenter, Randomized, Open-label, Active-controlled Study of Sotorasib, Panitumumab and FOLFIRI Versus FOLFIRI With or Without Bevacizumab-awwb for Treatment-na\u00efve Subjects With Metastatic Colorectal Cancer With KRAS p.G12C Mutation (CodeBreaK 301)", "accrual_state": "running", "therapeutic_value": "therapeutic", "therapieansatz_value": "palliativ", "therapieintervention_value": "not_applicable", "therapielinie_value": "first", "ctgov_number": "NCT06252649", "eudract_number": null, "general_contact_email": "oncostudy@ukdd.de", "general_contact_phone": "+49 351-4587666", "hauptpruefer_dd_name": "Prof. Dr. med. Gunnar Folprecht", "description_laie_de": "Der oben genannte Sponsor der klinischen Pr\u00fcfung entwickelt eine neue Therapie f\u00fcr Patienten mit \r\neinem Kolorektalkarzinom, das die KRAS p.G12C-Mutation aufweist. Deswegen soll das \r\nStudienpr\u00e4parat mit dem Namen Sotorasib in der Studie getestet werden. Der Sponsor m\u00f6chte die \r\nSicherheit und Vertr\u00e4glichkeit von Sotorasib in Kombination mit Panitumumab und FOLFIRI im \r\nVergleich zu FOLFIRI mit oder ohne Bevacizumab-awwb beurteilen und herausfinden, ob \r\nNebenwirkungen davon verursacht werden.", "description_laie_en": "The above-mentioned sponsor of the clinical trial is developing a new therapy for patients with \r\na colorectal carcinoma that has the KRAS p.G12C mutation. Therefore, the \r\nstudy drug called Sotorasib will be tested in the trial. The sponsor would like to assess the \r\nsafety and tolerability of sotorasib in combination with panitumumab and FOLFIRI in \r\ncomparison to FOLFIRI with or without bevacizumab-awwb and to find out whether \r\nside effects are caused.", "description_expert_de": "Ziel dieser Studie ist der Vergleich des progressionsfreien \u00dcberlebens (PFS) bei therapienaiven Teilnehmern mit metastasiertem kolorektalen Karzinom (mCRC) mit KRAS p.G12C-Mutation, die Totorasib, Panitumumab und FOLFIRI erhalten, mit FOLFIRI mit oder ohne Bevacizumab-awwb.", "description_expert_en": "The aim of this study is to compare progression free survival (PFS) in treatment-na\u00efveParticipants with KRAS p.G12C mutated metastatic colorectal cancer (mCRC) receivingsotorasib, panitumumab and FOLFIRI vs FOLFIRI with or without bevacizumab-awwb.", "rechtsgrundlage_value": "AMG", "phase_amg_value": "III", "main_cat_id": 2, "sub_cat_id": 6 }