For the purpose of this guidance, an FIH multiple expansion cohort trial is an FIH trial with a single protocol with an initial dose-escalation phase followed by three or more additional...

In this study, we propose a simple statistical frame-work to guide the design of DECs for phase 1 cancer tri-als. In retaining the currently popular framework for such studies, the key to our approach is the …

During an expansion As consumers demand more output (goods and services), businesses produce more output to meet this increased demand, but they will eventually reach their productive capacity …

The urgent need for drug development for cancer patients and the complexity of novel therapies have led to the increasing importance of expansion cohorts (EC) within phase 1 trial design.

Approximately a quarter of Phase I trials observed in this review included at least an expansion cohort, and the rate of expansion cohort utilization increased from 12 to 38% over this time period.

The examples shown of the phase function versus the scattering angle all show a strong forward peak. If we were to plot the phase function versus the cosine of the scattering angle - the unit actually used in …

In the dose-expansion phase, ~80 patients will receive RYZ401 at the RP2D: 40 patients with well-differentiated GEP-NETs (cohort A) and 40 with other SSTR+ tumors including non-GEP-NETs …