臨床研究等提出・公開システム

Date of registration	May. 09, 2011
Last modified on	Dec. 17, 2018
Trial ID	jRCT2080221451

Scientific Title	Phase I Clinical Study of RG7167 in Patients with Advanced Solid Tumors
Public Title	Phase I Clinical Study of RG7167 in Patients with Advanced Solid Tumors

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	Chugai Pharmaceutical Co., Ltd.
	Address	clinical-trials@chugai-pharm.co.jp
	Phone Number
	E-mail Address

Contact for Public Queries	Name
	Contact Name for Public Queries	Chugai Pharmaceutical Co., Ltd.
	Address	clinical-trials@chugai-pharm.co.jp
	Phone Number
	E-mail Address

Recruitment Status

Date of First Enrolment
Target Sample Size		36
Study Type		Interventional
Study Design	Study Design	Single-site unblinded study
Study Design	Objective
Phase		1
Key inclusion & exclusion criteria	Inclusion Criteria	-Histologically or cytologically confirmed solid tumor -Advanced cancer that did not respond to the standard therapy or for which a standard therapy has not been established -PS of 0 to 2
	Exclusion Criteria	-Patients in whom an adverse reaction to the previous treatment persists at Grade 2 or higher -Patients with metastasis to the central nervous system that is accompanied by symptoms or requires treatment -Clinically significant inflammatory condition is observed on the ocular surface -Patients who have been treated with a drug targeting MEK in the past
	Minimum Age	20age old over
	Maximum Age	No limit
	Gender	Both
Health Condition or Problem Studied		Advanced Solid Tumors
Intervention(s)		investigational material(s) Generic name etc : RG7167 INN of investigational material : Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : 1.0 - 17.0 mg/day, once or twice daily administration, orally
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		MTD, Safety, Pharmacokinetics NCI-CTCAE ver. 3.0
Secondary Outcome		Pharmacodynamics, tumor response RECIST Ver. 1

Primary Sponsor	Chugai Pharmaceutical 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-111490
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
9	Dec. 17, 2018	(this page)	Changes
8	Dec. 26, 2013	Detail	Changes
7	Dec. 26, 2013	Detail	Changes
6	Sept. 18, 2013	Detail	Changes
5	Sept. 18, 2013	Detail	Changes
4	Aug. 02, 2012	Detail	Changes
3	Aug. 02, 2012	Detail	Changes
2	May. 09, 2011	Detail	Changes
1	May. 09, 2011	Detail

List of change history