臨床研究等提出・公開システム

Date of registration	Sept. 01, 2016
Last modified on	Dec. 17, 2018
Trial ID	jRCT2080223309

Scientific Title	A Phase 1 Study of LY3039478 in Japanese Patients with Advanced Solid Tumors I6F-JE-JJCC
Public Title

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	completed

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	-Histological or cytological evidence of a diagnosis of solid tumor that is advanced and/or metastatic. -In the judgment of the investigator, participants must be appropriate candidates for experimental therapy after available standard therapies have failed or for whom standard therapy is not appropriate. -Performance status of less than or equal to 1 on the Eastern Cooperative Oncology Group (ECOG) scale. -Adequate organ function, including hematologic, hepatic, and renal. -Estimated life expectancy of more than or equal to 12 weeks.
	Exclusion Criteria	-Received previous therapy for cancer within 14 or 21 days of the initial dose of study drug for a nonmyelosuppressive or myelosuppressive agents, respectively. -Have serious preexisting medical conditions. -Have current or recent (within 3 months of study drug administration) gastrointestinal disease with chronic or intermittent diarrhea. -Have an active bacterial, fungal, and/or known viral infection. -Have known acute or chronic leukemia or current hematologic malignancies that may affect the interpretation of results.
	Minimum Age	20age old over
	Maximum Age	No limit
	Gender	Both
Health Condition or Problem Studied		Advanced Solid Tumor
Intervention(s)		investigational material(s) Generic name etc : LY3039478 INN of investigational material : Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : LY3039478 given orally TIW (3 times per week) in 28 day cycles. Treatment will continue until disease progression, development of unacceptable toxicity, or any other discontinuation criteria are met.
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-163364
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
5	Dec. 17, 2018	(this page)	Changes
4	Oct. 25, 2017	Detail	Changes
3	Oct. 25, 2017	Detail	Changes
2	Sept. 02, 2016	Detail	Changes
1	Sept. 01, 2016	Detail

List of change history