臨床研究等提出・公開システム

Date of registration	Oct. 16, 2015
Last modified on	Dec. 17, 2018
Trial ID	jRCT2080222989

Scientific Title	A Phase 1 Study of LY3023414 in Japanese Patients with Advanced Malignancies
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	Eli Lilly Japan K.K.
	Address	0120-360-605
	Phone Number
	E-mail Address

Recruitment Status

Date of First Enrolment
Target Sample Size
Study Type		Interventional
Study Design	Study Design
Study Design	Objective
Phase		1
Key inclusion & exclusion criteria	Inclusion Criteria	-Have histological or cytological evidence of a diagnosis of solid tumor that is advanced and/or metastatic and must be, in the judgment of the investigator, an appropriate candidate for experimental therapy after available standard therapies have failed or for whom standard therapy would not be appropriate. -Have the presence of measurable or non-measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. -Have adequate organ and coagulation function. -Have discontinued all previous cancer therapies, and any agents that have not received regulatory approval for any indication, for at least 21 days or 5 half-lives prior to study treatment, whichever is shorter, and recovered from the acute effects of therapy. Participants must have discontinued mitomycin-C or nitrosourea therapy for at least 42 days. -Are able to swallow capsules. -Males must agree to use medically approved barrier contraceptive precautions during the study and for 3 months following the last dose of study drug. -Females with childbearing potential: Must agree to use medically approved contraceptive precautions during the study and for 3 months following the last dose of study drug, must have had a negative serum or urine pregnancy test more than 7 days before the first dose of study drug. -A breastfeeding woman must also not be breastfeeding. If a female who stops breastfeeding enters the study, breastfeeding must cease from the day of the first study drug administration until at least 3 months after the last administration.
	Exclusion Criteria
	Minimum Age	20age old over
	Maximum Age	No limit
	Gender	Both
Health Condition or Problem Studied		Advanced malignancy
Intervention(s)		investigational material(s) Generic name etc : LY3023414 INN of investigational material : Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : LY3023414 administered orally, twice daily in 21-day cycles
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome
Secondary Outcome

Primary Sponsor	Eli Lilly Japan K.K.
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-153043
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
7	Dec. 17, 2018	(this page)	Changes
6	Oct. 31, 2018	Detail	Changes
5	Oct. 31, 2018	Detail	Changes
4	Oct. 25, 2017	Detail	Changes
3	Oct. 25, 2017	Detail	Changes
2	Oct. 16, 2015	Detail	Changes
1	Oct. 16, 2015	Detail

List of change history