Matches in Ubergraph for { <https://frink.apps.renci.org/.well-known/genid/Be623ca384880dd9f0e61a524da28781b> ?p ?o ?g. }
Showing items 1 to 5 of
5
with 100 items per page.
- Be623ca384880dd9f0e61a524da28781b NCIT_P378 "CDISC-GLOSS" @default.
- Be623ca384880dd9f0e61a524da28781b type Axiom @default.
- Be623ca384880dd9f0e61a524da28781b annotatedProperty NCIT_P325 @default.
- Be623ca384880dd9f0e61a524da28781b annotatedSource NCIT_C191276 @default.
- Be623ca384880dd9f0e61a524da28781b annotatedTarget "A predominantly First-in-Human (FIH) trial with a single protocol with an initial dose-escalation phase followed by three or more additional subject cohorts with cohort-specific objectives. NOTE: The objectives of these expansion cohorts can include assessment of antitumor activity in a disease-specific setting, assessment of a dose with acceptable safety in specific populations (e.g., pediatric or elderly subjects, subjects with organ impairment, subjects with specific tumor types), evaluation of alternative doses or schedules, establishment of dose and schedule for the investigational drug administered with another oncology drug, or evaluation of the predictive value of a potential biomarker. In general, comparison of activity between cohorts is not planned except when a prespecified randomization and analysis plan are part of the protocol design. [FDA Guidance: Expansion Cohorts: Use in First-in-Human Clinical Trials to Expedite Development of Oncology Drugs and Biologics Guidance for Industry. March 2022]" @default.