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To determine the objective response rate in pediatric patients treated with ensartinib with advanced solid tumors, non-Hodgkin lymphomas, or histiocytic disorders that have ALK or ROS1 fusions or that have ALK missense mutations, it is important to determine the true response rate in pediatric patients treated with ensartinib with advanced solid tumors, non-Hodgkin lymphomas or histiocy To determine the progression-free survival in pediatric patients treated with ensartinib with advanced solid tumors, non-Hodgkin lymphomas, or histiocytic disorders that harbor ALK or ROS1 fusions or that harbor ALK missense mutations, see the following links: ALK or ROS1 fusions or ALK missense mutations. By testing of circulating tumor deoxyribonucleic acid, it's possible to investigate how tumor genomics will change over time.
Source link: https://clinicaltrials.gov/ct2/show/NCT03213652
The pediatric RP2D for this age group will first be determined by age 12 years old, and subjects 12 years old will be enrolled in Phase 1 to determine the pediatric RP2D for this age group; once the pediatric RP2D is determined, subjects aged 12 years old will be enrolled in Phase 1; subjects aged 12 years old will be enrolled in Phase 1 of the study. Subjects aged 12 to 25, which will be automatically enrolled in the Phase 2 program concurrent with Phase 1 enrollment, will be eligible for Phase 2 registration. As follows: Cohort 1: approximately 10-20 patients with solid tumors characterized by NTRK fusion, TRK tyrosine kinase inhibitor nau00efve, and centrally diagnosed measurable disease at baseline, and prospectively reported measurable disease at baseline. About 20 subjects with solid tumors or ALCL characterized by other ALK/NTRK alterations or NTRK fusions without centrally reported measurable disease are not eligible for Cohort 1 or 2.
Source link: https://clinicaltrials.gov/ct2/show/NCT04094610
This report is designed to assess TGRX-678's safety profile, as well as other safety aspects of the investigational drug, such as adverse events and abnormal clinical outcomes.
Source link: https://clinicaltrials.gov/ct2/show/NCT05441956
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