臨床研究等提出・公開システム

Date of registration	Sept. 03, 2010
Last modified on	Dec. 17, 2018
Trial ID	jRCT2080221233

Scientific Title	Phase I Clinical Study of E7389 in Patients With Solid Tumors
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	Eisai Co., Ltd.
	Address	https://wcs.eisai.co.jp/i_005/wcat/p0201
	Phone Number
	E-mail Address

Recruitment Status

Date of First Enrolment
Target Sample Size		24
Study Type		Interventional
Study Design	Study Design	Open-Label study
Study Design	Objective
Phase		1
Key inclusion & exclusion criteria	Inclusion Criteria	-Patients with histologically or cytologically confirmed solid tumors. -Patients who have progressed on or following standard therapy and with no other treatment options. -Patients having a performance status (PS) of Eastern Cooperative Oncology Group (ECOG) 0 or 1.
	Exclusion Criteria	-Patients with systemic infection with a fever (38°C). -Patients with a large amount of pleural effusion, ascites and pericardial fluid requiring drainage. -Patients with brain metastasis with clinical symptoms.
	Minimum Age	20age old over
	Maximum Age	75age old under
	Gender	Both
Health Condition or Problem Studied		Solid Tumors
Intervention(s)		investigational material(s) Generic name etc : E7389 INN of investigational material : Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : Injection
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		Dose limiting toxicity (DLT) and maximum tolerated dose (MTD)
Secondary Outcome

Primary Sponsor	Eisai 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-101270
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
4	Dec. 17, 2018	(this page)	Changes
3	Nov. 25, 2013	Detail	Changes
2	Sept. 03, 2010	Detail	Changes
1	Sept. 03, 2010	Detail

List of change history