臨床研究等提出・公開システム

Date of registration	June. 05, 2017
Last modified on	Dec. 01, 2025
Trial ID	jRCT2080223552

Scientific Title	Phase I Study of Cobimetinib as a Single Agent or in Combination with other Anticancer Agents in Patients with Advanced Solid Tumors
Public Title	Phase I Study of Cobimetinib as a Single Agent or in Combination with other Anticancer Agents in Patients with Advanced Solid Tumors

Contact for Scientific Queries	Name
	Contact Name for Scientific Queries	Chugai Pharmaceutical Co., Ltd.
	Address	1-1 NIHONBASHI-MUROMACHI 2-CHOME, CHUO-KU, Tokyo
	Phone Number	+81-120-189-706
	E-mail Address	clinical-trials@chugai-pharm.co.jp

Contact for Public Queries	Name
	Contact Name for Public Queries	Chugai Pharmaceutical Co., Ltd.
	Address	1-1 NIHONBASHI-MUROMACHI 2-CHOME, CHUO-KU, Tokyo
	Phone Number	+81-120-189-706
	E-mail Address	clinical-trials@chugai-pharm.co.jp

Recruitment Status	completed

Date of First Enrolment		July. 18, 2017
Target Sample Size		42
Study Type		Interventional
Study Design	Study Design	Open-label, dose escalation
Study Design	Objective	treatment purpose
Phase		1
Key inclusion & exclusion criteria	Inclusion Criteria	- Advanced or recurrent cancer that is refractory or ineligible to standard therapy or for which no standard therapy exists. - Histologically or cytologically confirmed solid tumor. - ECOG PS of 0 or 1. - Life expectancy >=12 weeks from the date of enrollment. - Major organ function meets all criteria.
	Exclusion Criteria	- Unable to take oral drugs or has a gastrointestinal disorder that would affect gastrointestinal drug absorption. - Pregnant or lactating woman. - Current or previous autoimmune disease. - Positive test result for human immunodeficiency virus (HIV) antibody, hepatitis B surface (HBs) antigen, HBs antibody, hepatitis B core (HBc) antibody, or hepatitis C virus (HCV) antibody (eligible if HCV-RNA-negative). - Current or previous clinically significant liver disease. - Current or previous ophthalmologic findings that indicate a risk of retinal detachment, central serous chorioretinopathy, retinal vein occlusion, or macular degeneration. - History of treatment with immune checkpoint inhibitors.
	Minimum Age	20age old over
	Maximum Age	No limit
	Gender	Both
Health Condition or Problem Studied		Solid tumors
Intervention(s)		investigational material(s) Generic name etc : Cobimetinib INN of investigational material : Cobimetinib Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : Cobimetinib 40mg or 60 mg will be administered orally once daily for Days 1-21 of each 28-day cycle Generic name etc : Atezolizumab INN of investigational material : Atezolizumab Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : Atezolizumab 840 mg will be administered by IV infusion on Days 1 and 15 of each 28-day cycle
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		safety pharmacokinetics NCI CTCAE
Secondary Outcome		efficacy RECIST

Primary Sponsor	CHUGAI PHARMACEUTICAL CO., LTD
Secondary Sponsor	-

Name of Funding Organization	-
Name of Research Funding	-

Name of IRB	National Cancer Ctr IRB #2-J
Address of IRB	5-1-1 Tsukiji, Chuo-ku: Tokyo
Phone Number of IRB
E-mail Address of IRB
Status of IRB Review	approved
Date of Approval by IRB	June. 28, 2017

Secondary ID No.	JapicCTI-173607
Name of Other Registries

Countries / Regions of Recruitment	Japan

History of Changes

No	Publication date
14	Dec. 01, 2025	(this page)	Changes
13	Mar. 31, 2023	Detail	Changes
12	Mar. 17, 2022	Detail	Changes
11	April. 05, 2021	Detail	Changes
10	April. 01, 2020	Detail	Changes
9	Feb. 25, 2019	Detail	Changes
8	Dec. 17, 2018	Detail	Changes
7	Sept. 10, 2018	Detail	Changes
6	April. 10, 2018	Detail	Changes
5	April. 10, 2018	Detail	Changes
4	Oct. 04, 2017	Detail	Changes
3	Oct. 04, 2017	Detail	Changes
2	June. 05, 2017	Detail	Changes
1	June. 05, 2017	Detail

List of change history