臨床研究等提出・公開システム

Date of registration	Aug. 18, 2013
Last modified on	Dec. 17, 2018
Trial ID	jRCT2080222174

Scientific Title	A phase 1 study of K-912, nonrandomized, open label, dose escalation study in Japanese patients with solid tumors.
Public Title	A phase 1 study of K-912, nonrandomized, open label, dose escalation study in Japanese patients with 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	Kowa Co., Ltd.
	Address	ctrdinfo@kowa.co.jp
	Phone Number
	E-mail Address

Contact for Public Queries	Name
	Contact Name for Public Queries	Kowa Co., Ltd.
	Address	ctrdinfo@kowa.co.jp
	Phone Number
	E-mail Address

Recruitment Status

Date of First Enrolment
Target Sample Size		30
Study Type		Interventional
Study Design	Study Design	Single-center, nonrandomized, open label, dose escalation study
Study Design	Objective
Phase		1
Key inclusion & exclusion criteria	Inclusion Criteria	Patients with histologically or cytologically diagnosis of solid tumor Patients with solid tumor which is resistant to standard anti-tumor therapies, or which no appropriate treatment is available Patients with adequate organ functions Patients with 0 to 1 of ECOG Performance Status (P.S.) score Patients with 12 weeks or more life expectancy and so on
	Exclusion Criteria	Patients with the severe complication Patients with brain metastasis accompanying clinical symptoms Patients with hematopoietic tumor Patients with active infections in need of treatment for systemic and so on
	Minimum Age	20age old over
	Maximum Age	74age old under
	Gender	Both
Health Condition or Problem Studied		Solid tumors
Intervention(s)		investigational material(s) Generic name etc : K-912 INN of investigational material : Therapeutic category code : 423 Antitumor antibiotics and preparations Dosage and Administration for Investigational material : Intravenous administration
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		Dose limiting toxicity (DLT) CTCAE ver.4.0
Secondary Outcome		Pharmacokinetics and anti-tumor activity RECIST ver.1.1, Drug concentration measurement

Primary Sponsor	Kowa Co., Ltd.
Secondary Sponsor

Name of Funding Organization	Supplier of study drug NanoCarrier Co., Ltd.
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-132221
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
11	Dec. 17, 2018	(this page)	Changes
10	Oct. 17, 2016	Detail	Changes
9	Oct. 17, 2016	Detail	Changes
8	Sept. 09, 2016	Detail	Changes
7	Sept. 09, 2016	Detail	Changes
6	Dec. 22, 2015	Detail	Changes
5	Dec. 22, 2015	Detail	Changes
4	Nov. 14, 2014	Detail	Changes
3	Nov. 14, 2014	Detail	Changes
2	Aug. 18, 2013	Detail	Changes
1	Aug. 18, 2013	Detail

List of change history