BOB Modul2

{ "short_title": "BOB Modul2", "data_mode": "900", "data_mode_number": "000002293", "official_title": "Basket of Baskets: A Modular, Open-label, Phase II, Multicentre Study To Evaluate Targeted Agents in Molecularly Selected Populations With Advanced \r\nSolid Tumours Futibatinib in subjects with FGFR-aberrant solid tumours", "accrual_state": "running", "therapeutic_value": "therapeutic", "therapieansatz_value": "not_applicable", "therapieintervention_value": "not_applicable", "therapielinie_value": "not_applicable", "ctgov_number": "NCT03767075", "eudract_number": "2017-005108-89", "general_contact_email": "ctc-trialsite@ukdd.de", "general_contact_phone": "+49 351-4585119", "hauptpruefer_dd_name": "Dr. med. Christoph Heining", "description_laie_de": "Die vorliegende klinische Studie umfasst zwei Teile: Teil A (I-Profiler) ist der Abschnitt der Studie, in dem Ihr Tumor charakterisiert wurde, und Teil B (I-Basket) ist der Behandlungsteil. Sie werden gefragt, ob Sie Interesse haben, an Modul 2 von Teil B (I-Basket) teilzunehmen nachdem Ihr Tumor in Teil A der Studie untersucht bzw. molekulargenetisch charakterisiert wurde. Die Ergebnisse zeigen,dass Sie an der Studie teilnehmen k\u00f6nnen, um mit dem Medikament Futibatinib behandelt zu werden.", "description_laie_en": "Part A includes a molecular profiling program for subjects with advanced solid tumors (iPROFILER) and a molecular tumor board to select the most appropriate treatment based on the molecular alterations found in the iPROFILER. Part B includes iBASKET, a modular investigator-initiated basket study for subjects with selected molecular alterations.The current protocol contains the Module 2 of iBASKET with the following arms:\r\no Arm 2A: Known pathogenic FGFR1-3 mutations. o Arm 2B: Variants of unknown significance in FGFR1-3 with functional relevance or pathogenic FGFR4 \r\nmutations.o Arm 2C: Highly amplified FGFR1-3 (NGS based CN >= 6) WITH high FGFR1-3 mRNA (above the percentile 95 for general cancer population by \r\nusing Nanostring Gene expression profile in solid tumours (with the exception of gastric and breast cancer) Arm 2D: Highly amplified FGFR1-3 (NGS based CN >= 6) WITHOUT high FGFR1-3 mRNA (above the percentile 95 for general cancer population by using Nanostring Gene expression profile in solid tumours (with the exception of gastric and breast cancer)", "description_expert_de": "Die vorliegende klinische Studie umfasst zwei Teile: Teil A (I-Profiler) ist der Abschnitt der Studie, in dem Ihr Tumor charakterisiert wurde, und Teil B (I-Basket) ist der Behandlungsteil. Sie werden gefragt, ob Sie Interesse haben, an Modul 2 von Teil B (I-Basket) teilzunehmen nachdem Ihr Tumor in Teil A der Studie untersucht bzw. molekulargenetisch charakterisiert wurde. Die Ergebnisse zeigen,dass Sie an der Studie teilnehmen k\u00f6nnen, um mit dem Medikament Futibatinib behandelt zu werden.", "description_expert_en": "Part A includes a molecular profiling program for subjects with advanced solid tumors (iPROFILER) and a molecular tumor board to select the most appropriate treatment based on the molecular alterations found in the iPROFILER. Part B includes iBASKET, a modular investigator-initiated basket study for subjects with selected molecular alterations.The current protocol contains the Module 2 of iBASKET with the following arms:\r\no Arm 2A: Known pathogenic FGFR1-3 mutations. o Arm 2B: Variants of unknown significance in FGFR1-3 with functional relevance or pathogenic FGFR4 \r\nmutations.o Arm 2C: Highly amplified FGFR1-3 (NGS based CN >= 6) WITH high FGFR1-3 mRNA (above the percentile 95 for general cancer population by \r\nusing Nanostring Gene expression profile in solid tumours (with the exception of gastric and breast cancer) Arm 2D: Highly amplified FGFR1-3 (NGS based CN >= 6) WITHOUT high FGFR1-3 mRNA (above the percentile 95 for general cancer population by using Nanostring Gene expression profile in solid tumours (with the exception of gastric and breast cancer)", "rechtsgrundlage_value": "AMG", "phase_amg_value": "II", "main_cat_id": 1, "sub_cat_id": 2 }