… However, because of the limited sample size, this phase 2 study was not powered adequately
to assess the significance of these differences in AEs among the treatment groups. The …

… the use of randomization in phase II studies, the situations in … in which the use of randomized
designs is preferred. We … and type II error bounds for randomized studies can facilitate …

… The sources of variability influencing the results of phase II trials are reviewed. Randomized
designs for phase II testing are presented and evaluated. Phase II designs with "standard …

… data from a phase 2, randomized, dose‐ranging, placebo‐ and active‐controlled study that
was … In this phase 2 study, RANKL inhibition with denosumab reduced bone turnover and …

… subunit of interleukin 23, in a phase 2 study of patients with UC. … 2 studies with positive
results in which patients with CD were treated with IL23 p19 monoclonal antibodies, in this study, …

… and cogently outlines attractions of the randomized phase II trial, as well as … randomized
phase II study designs, specifically examining phase II selection designs, randomized phase II …

… This multicenter, open-label, randomized phase 2 study evaluated 2 dose regimens of
lenalidomide for relapsed, refractory myeloma. Seventy patients were randomized to receive …

… This was a 2-part randomized phase 2 study. Eligibility criteria included recurrent GBM after
radiotherapy and temozolomide, no other chemotherapy for GBM, and Eastern Cooperative …

… , and phase II/III designs. The barriers to widespread adoption of randomized phase II trials
… We conclude that randomized phase II trials are a worthy investment considering finite …

… in the phase I study included 5 and 7 mg/kg/d. This study defined a recommended phase II
… curve (AUC) 5 on day 6, and etoposide 80 mg/m 2 /d on days 6 through 8, on a 21-day cycle. …