Trial Design: Overview of Study Designs (Phase I, II, III, IV, Factorial Design)Fundamental to all intellectual inquiry is a scientific method for answering research questions. For the majority of medical and surgical questions that seek to determine if one intervention is......
Trial design This open-label, phase 2 study will enroll 370 patients (pts) ≥18 y with previously treated, histologically/cytologically confirmed HRRm/HRD+(per Lynparza HRR-HRD assay) advanced solid tumors who failed/are intolerant to/ineligible for available SOC and have no PD during prior ...
FOLFIRINOX-R study design: a phase I/II trial of FOLFIRINOX plus regorafenib as first line therapy in patients with unresectable RAS-mutated metastatic colorectal cancer Antoine Adenis, Thibault Mazard, Julien Fraisse, Patrick Chalbos, Brice Pastor, Ludovic Evesque, Francois Ghiringhelli...
The Simon two-stage optimal design is often used for phase II cancer clinical trials. A study proceeds to the second stage unless the null hypothesis, that... AP Mander,SG Thompson - 《Contemporary Clinical Trials》 被引量: 59发表: 2010年 Optimal and minimax three-stage designs for phase ...
Study design and treatment This was an open-label, single-arm, multicentre, phase II study investigating the efficacy and safety of necitumumab in combination with mFOLFOX6 in the first-line treatment of locally advanced CRC or mCRC. A treatment cycle was defined as 2 weeks. On day 1 of ...
A Phase III Study of Durvalumab (MEDI4736) With or Without Tremelimumab for Previously Treated Patients With Advanced NSCLC: Rationale and Protocol Design ... Anti-programmed cell death-1 and anti-programmed cell death ligand-1 (PD-L1) monotherapies have shown promising clinical activity in advanc...
The comparison among designs becomes more favorable to the Bayesian basket design as the number of strata increases. For this study, posterior probabilities of activity could be computed as a function of histologic subset although the study would not be powered for any formal evaluation within a ...
A Simon minimax two-stage design was used to estimate the sample size, with a one-sided alpha of 5% and power of 80%. The null hypothesis (P0) was set as an ORR of 50%, referring to the ORR of pyrotinib monotherapy in HER2-positive ABC patients in a phase I study31. Since the...
Patients and study design In this phase Ib/IIa randomized, double-blinded, placebo-controlled, multiple-dose trial, a total of 95 patients with NAFLD were recruited and screened for eligibility in the First Hospital of Jilin University (Changchun, Jilin, China) and another two medical centers in...
The study design is summarized in Fig.1a. The study was designed to evaluate the activity of ruxolitinib in two cohorts: Cohort A, pSTAT3H-score 5 or higher, and Cohort B, pSTAT3T-score 3–4, and to distinguish between a response rate of 5% vs. 20% in each cohort separately. There...