臨床研究等提出・公開システム

Date of registration	Sept. 22, 2010
Last modified on	Dec. 17, 2018
Trial ID	jRCT2080221248

Scientific Title	EO9 Phase I Study (Intravesical Instillation)
Public Title

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	Nippon Kayaku Co., LTD.
	Address	FAX +81-3-3598-5423
	Phone Number
	E-mail Address

Recruitment Status

Date of First Enrolment
Target Sample Size		6
Study Type		Interventional
Study Design	Study Design	Multicenter, open
Study Design	Objective
Phase		1
Key inclusion & exclusion criteria	Inclusion Criteria	(1) Patients who are clinically diagnosed as having stage Ta, T1, histological grade G1, G2 urothelial carcinoma of the bladder and satisfy both of the following criteria: The maximum number of tumors is 5. Tumor diameter:< 3.5 cm. (2) The functions of the major organs are adequate, and the following test value criteria are satisfied. (These tests will be performed within 4 weeks prior to the present TURBT.) WBC count >-3,000 /uL Platelet count >-10x104 /uL AST, ALT <2.5 times the institutional upper limit of normal Total bilirubin <1.5 times the institutional upper limit of normal Serum creatinine -<1.5 mg /dL Hemoglobin >-9.5 g/dL
	Exclusion Criteria	(1) Patients with a primary and solitary tumor. (2) CIS lesions in the bladder or a history thereof. (3) Grade 3 disease or a history thereof. (4) Patients experiencing recurrence within 3 months following TURBT for prior NMIBC. (5) Patients having stage T1 and high-grade disease. (6) Invasive cancer of T2 or greater, with definite lymph node or other organ metastasis, or a history thereof. (7) Patients who received intravesical chemotherapy treatment within 6 months prior to the present TURBT.
	Minimum Age	20age old over
	Maximum Age	74age old under
	Gender	Both
Health Condition or Problem Studied		Non-muscle invasive bladder carcinoma
Intervention(s)		investigational material(s) Generic name etc : EO9 INN of investigational material : Therapeutic category code : 424 Antineoplastic preparations extracted from plants Dosage and Administration for Investigational material : Intravesical Instillation
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		Safety
Secondary Outcome		Pharmacokinetics

Primary Sponsor	Nippon Kayaku 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-101285
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
9	Dec. 17, 2018	(this page)	Changes
8	April. 26, 2012	Detail	Changes
7	April. 26, 2012	Detail	Changes
6	July. 15, 2011	Detail	Changes
5	July. 15, 2011	Detail	Changes
4	Oct. 13, 2010	Detail	Changes
3	Oct. 13, 2010	Detail	Changes
2	Sept. 22, 2010	Detail	Changes
1	Sept. 22, 2010	Detail

List of change history