A Dose-Finding Method Based on Multiple Dosing in Two-Agent Combination Phase I Trials
Yasuyuki Kakurai1, Akihiro Hirakawa, Chikuma Hamada
1a Department of Management Science, Graduate School of Engineering , Tokyo University of Science , Tokyo , Japan.
Abstract:
Here, we developed a new dose-finding method that partitions a cohort of patients based on the number of dose combinations within a prespecified acceptable toxicity range in two-agent combination Phase I trials. In the proposed method, patients in the same cohort are partitioned according to several dose combinations, although most of the existing methods allocate patients in the same cohort according to a single-dose combination. We compared the operating characteristics of the proposed and existing methods through simulation studies.
More Related Videos
12:08Diagonal Method to Measure Synergy Among Any Number of Drugs
Published on: June 21, 2018
08:57Sample Extraction and Simultaneous Chromatographic Quantitation of Doxorubicin and Mitomycin C Following Drug Combination Delivery in Nanoparticles to Tumor-bearing Mice
Published on: October 5, 2017
Related Concept Videos
Determination of Multiple Dosing Parameters: Loading and Maintenance Doses
Bioavailability Study Design: Single Versus Multiple Dose Studies
Dosage Regimen: Multiple Oral Dosage
Clinical Trials: Overview
Dose Size and Dosing Frequency: Determination Methods
Dosage Regimen: Fixed Dose
Fixed-dose regimens can be used for various routes of administration, including intravenous (IV) injections and oral medications. For IV administration, a predetermined amount of the drug is...
