Study endpoints
tumor
DISEASE, TUMOR
Primary study endpoints are:Anti-tumor activity, defined as objective response, at 16 weeks assessed by disease specific response criteriaStable disease at 16 weeksTreatment-related and serious adverse eventsSecondary study endpoints are:Duration of response, progression-free survival and overall survivalDuration of study treatment (time on drug)Percentage of screened patients treated based on their molecular tumor profileExploratory study endpoints:Description of concordance between genomic tumor profile of pre-treatment tumor biopsies and genomic tumor profile according to tumor profiling tests that were used to enroll patientsIdentification of patterns of resistance based on serial tumor biopsies and liquid biopsies