Studie der Phase 1/2 zur Beurteilung der Mono- und Kombinationstherapie mit AMG 510 bei Patienten mit mutierten fortgeschrittenen soliden Tumoren

Points finaux secondaires (Source de données: WHO)

Secondary: Plasma concentration (Cmax) of sotorasib;Secondary: Plasma concentration (Cmax) of midazolam;Secondary: Time to achieve Cmax (Tmax) of sotorasib;Secondary: Area under the plasma concentration-time curve (AUC) of sotorasib;Secondary: Area under the plasma concentration-time curve (AUC) of midazolam;Secondary: Clearance of midazolam from the plasma;Secondary: Terminal half-life (t1/2) of midazolam;Secondary: Objective response rate (ORR) as assessed by RECIST 1.1 criteria;Secondary: Duration of response (DOR) as assessed by RECIST 1.1 criteria;Secondary: Disease control as assessed by RECIST 1.1 criteria;Secondary: Progression-free survival (PFS) as assessed by RECIST 1.1 criteria;Secondary: Duration of stable disease (SD) as assessed by RECIST 1.1 criteria;Secondary: Depth of response (best percentage change from baseline in lesion sum diameters) as assessed by RECIST 1.1 criteria;Secondary: Time to response (TTR) as assessed by RECIST 1.1 criteria;Secondary: Overall survival (OS);Secondary: sotorasib exposure and QTc interval relationship;Secondary: Progression-free survival (PFS) at 6 months;Secondary: Progression-free survival (PFS) at 12 months;Secondary: Overall survival (OS) at 12 months;Secondary: Number of subjects with treatment-emergent adverse events;Secondary: Number of subjects with grade =3 treatment-emergent adverse events;Secondary: Impact of treatment on disease-related symptoms and health related quality of life (HRQOL) as assessed by EORTC QLQ-C30;Secondary: Impact of treatment on disease-related symptoms and HRQOL as assessed by disease-specific modules Quality-of-Life Questionnaire Lung Cancer Module (QLQ LC13);Secondary: Impact of treatment on disease-related symptoms and HRQOL as assessed by non-small cell lung cancer symptom assessment questionnaire (NSCLC SAQ) for NSCLC;Secondary: Impact of treatment on disease-related symptoms and HRQOL as assessed by Patient Global Impression of Severity (PGIS);Secondary: Impact of treatment on disease-related symptoms and HRQOL as assessed by Patient Global Impression of Change (PGIC) in cough, dyspnea and chest pain for NSCLC;Secondary: Treatment-related symptoms and impact on the subject as assessed by EORTC QLQ-C30;Secondary: Treatment-related symptoms and impact on the subject as assessed by selected questions from the Patient-reported Outcome of the Common Terminology Criteria for Adverse Events (PRO-CTCAE library);Secondary: Treatment-related symptoms and impact on the subject as assessed by a single item about symptom bother, item GP5 of the Functional Assessment of Cancer Therapy - General (FACT-G);Secondary: Change from baseline in physical function as assessed by EORTC QLQ-C30