臨床研究等提出・公開システム

Date of registration	Sept. 27, 2013
Last modified on	Dec. 17, 2018
Trial ID	jRCT2080222238

Scientific Title	Phase II trial of YHI-1003 monotherapy in patients with advanced or relapsed gynecologic cancer
Public Title	Phase II 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		96
Study Type		Interventional
Study Design	Study Design	open-label, multicenter trial
Study Design	Objective
Phase		2
Key inclusion & exclusion criteria	Inclusion Criteria	(1)Patients with a histologically-diagnosed ovarian , endometric or cervical cancer (2)Patients with a history of treatment with platinum-based chemotherary (3)Patients who have agreed with the investigation of biomarkers (4)Patients who can be treated with oral medications (5)Patients with at least one measurable disease
	Exclusion Criteria	(1)Patients with a history of treatment with PI3K, AKT or mTOR inhibitor (2)Patients with uncontrolled intercurrent illness (3)Patients with brain metastases or suspected brain metastases
	Minimum Age	20age old over
	Maximum Age	No limit
	Gender	Female
Health Condition or Problem Studied		advanced or relapsed gynecologic cancer (ovarian, endometric or cervical cancer)
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		Disease Control Rate RECIST ver1.1
Secondary Outcome		efficacy,safety and biomarker RECIST ver1.1, CTCAE v.4.0

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-132287
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
9	Dec. 17, 2018	(this page)	Changes
8	Mar. 30, 2016	Detail	Changes
7	Mar. 30, 2016	Detail	Changes
6	Oct. 13, 2015	Detail	Changes
5	Oct. 13, 2015	Detail	Changes
4	Oct. 10, 2014	Detail	Changes
3	Oct. 10, 2014	Detail	Changes
2	Oct. 10, 2013	Detail	Changes
1	Sept. 27, 2013	Detail

List of change history