Preferred Label : Expansion Cohort Trial;
NCIt definition : 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. (FDA Guidance: Expansion Cohorts: Use in First-in-Human Clinical Trials
to Expedite Development of Oncology Drugs and Biologics Guidance for Industry. March
2022);
Alternative definition : CDISC-GLOSS: 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];
NCI Metathesaurus CUI : CL1904859;
Origin ID : C191276;
UMLS CUI : C5784363;
Semantic type(s)
- concept_is_in_subset
