臨床研究等提出・公開システム

Date of registration	May. 17, 2013
Last modified on	Dec. 17, 2018
Trial ID	jRCT2080222084

Scientific Title	Phase I study of YHI-1003 monotherapy in patients with relapsed or refractory neuroblastoma
Public Title	Phase I trial of YHI-1003

Completion Date or Terminated date
Actual Enrolled Number
Baseline Characteristics
Participant flow
Adverse events
Primary Outcome Measures
Secondary Outcome Measures
Brief summary
Posting of journal publication
Date of the first journal publication of results
URL hyperlink(s) related to results and publications

Plan to share IPD
Plan description
URL link to protocol file(s)
Version of protocol file(s)	version: date:

Contact for Scientific Queries	Name
	Contact Name for Scientific Queries
	Address
	Phone Number
	E-mail Address

Contact for Public Queries	Name
	Contact Name for Public Queries	Yakult Honsha Co., Ltd.
	Address	TEL: +81-3-5550-8966, FAX: +81-3-3248-5502
	Phone Number
	E-mail Address

Recruitment Status

Date of First Enrolment
Target Sample Size		18
Study Type		Interventional
Study Design	Study Design	open-label, multicenter trial
Study Design	Objective
Phase		1
Key inclusion & exclusion criteria	Inclusion Criteria	(1)Patients were previously diagnosed with neuroblastoma (2)Patients must have relapsed or refracted against the standard therary
	Exclusion Criteria	(1)Patients were previously treated with Perifosine.
	Minimum Age	2age old over
	Maximum Age	No limit
	Gender	Both
Health Condition or Problem Studied		relapsed or refractory neuroblastoma
Intervention(s)		investigational material(s) Generic name etc : YHI-1003 INN of investigational material : Perifosine Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : oral
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		safety CTCAE v.4.0
Secondary Outcome		efficacy and pharmacokinetic profile

Primary Sponsor	Yakult Honsha Co., Ltd.
Secondary Sponsor

Name of Funding Organization
Name of Research Funding

Name of IRB
Address of IRB
Phone Number of IRB
E-mail Address of IRB
Status of IRB Review
Date of Approval by IRB

Secondary ID No.	JapicCTI-132130
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
9	Dec. 17, 2018	(this page)	Changes
8	Mar. 06, 2017	Detail	Changes
7	Mar. 06, 2017	Detail	Changes
6	June. 10, 2016	Detail	Changes
5	June. 10, 2016	Detail	Changes
4	May. 01, 2014	Detail	Changes
3	May. 01, 2014	Detail	Changes
2	May. 17, 2013	Detail	Changes
1	May. 17, 2013	Detail

List of change history