♦Basic information
JapicCTI-No. JapicCTI-142483
♦Title of the study
Title of the study A phase II dose-response study of NETU in patients receiving highly emetogenic chemotherapy
Public title of the study
Primary sponsor Taiho Pharmaceutical Co., Ltd.
Secondary sponsor  
Study Type interventional (drug)
Summary To investigate dose-response relationship in terms of complete response (CR) rate after a single oral dose of NETU in patients receiving HEC.
♦Details of the study
Disease or condition Chemotherapy-induced nausea and vomiting
Intervention
Intervention name NETU
Classification name(code) of the intervention 239 (other agents affecting digestive organs)
Dosage And administration of the intervention Each subject should orally take NETU (30, 100, or 300 mg) tablet before the start of administration of HEC.
Control intervention name  
Classification name(code) of the control intervention  
Dosage And administration of the control intervention  
Objectives of the study To investigate dose-response relationship in terms of complete response (CR) rate after a single oral dose of NETU in patients receiving HEC.
Study phase Phase 2
Study design
Target sample size 400
Inclusion Criteria Patients who are able to orally take the study drug
Patients who are scheduled to receive chemotherapy including the following HEC agents
Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 to 1
Patients who have provided written informed consent


AgeF     20years old or more
SexF     Both
Exclusion Criteria Patients with any severe or difficult-to-control coexisting condition
Patients with infection, diabetes mellitus, or other disease to whom the investigator (or subinvestigator) judges it difficult to administer steroids during the study period
Patients who are unable or unwilling to cooperate in the implementation of study procedures


Outcome
Primary Outcome CR rate during the first 120 hours after the start of administration of an HEC
Timepoints
Secondary Outcome Efficacy
Safety
Pharmacokinetics
Timepoints
Institutions
Duration of the study 2014-3-1  `  2015-12-31
Study status Completed
recruitment status Study Completed
Region Japan
♦Secondary ID
Related ID Name  
Related ID number  
♦Related information
Name of URL  
URL address  
Description of URL  
♦Contact information
Organization Taiho Pharmaceutical Co., Ltd.
Division Clinical Trial Registration Contact.
Contact person or e-mail address etc. toiawase@taiho.co.jp
Organization@(Scientific) Taiho Pharmaceutical Co., Ltd.
Division@(Scientific) Clinical Development Dept.
Contact person or e-mail address etc.@(Scientific) toiawaseCD1@taiho.co.jp
♦Other
Source funded Taiho Pharmaceutical Co., Ltd.
Name of research funds
Other
♦History
History
2016/3/24   revised
2015/8/13   revised
2015/1/23   revised
2014/8/18   revised
2014/3/25   application date