臨床研究等提出・公開システム

Date of registration	Oct. 18, 2011
Last modified on	Dec. 17, 2018
Trial ID	jRCT2080221624

Scientific Title	An Open-label, Multi-center, Phase 2 Study of AMG 162 (denosumab) in Subjects with Giant Cell Tumor of Bone
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	DAIICHI SANKYO Co.,Ltd.
	Address	http://www.daiichisankyo.co.jp/corporate/rd/measure/clinical/index.html
	Phone Number
	E-mail Address

Recruitment Status

Date of First Enrolment
Target Sample Size		10
Study Type		Interventional
Study Design	Study Design	An open-label, multi-center study
Study Design	Objective
Phase		2
Key inclusion & exclusion criteria	Inclusion Criteria	Subjects with surgically unsalvageable Giant Cell Tumor of Bone or with surgically salvageable Giant Cell Tumor of Bone whose planned surgical procedure resulting in severe morbidity
	Exclusion Criteria	Currently receiving other specific treatment for Giant Cell Tumor of Bone
	Minimum Age	12age old over
	Maximum Age	No limit
	Gender	Both
Health Condition or Problem Studied		Giant Cell Tumor of Bone
Intervention(s)		investigational material(s) Generic name etc : AMG 162 INN of investigational material : denosumab Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : AMG 162 120 mg administered subcutaneously every 4 week with a loading dose on study days 8 and 15
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		tumor response rate Radiographic assessment
Secondary Outcome		Durability of response Time to response Radiographic assessment

Primary Sponsor	DAIICHISANKYO 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-111665
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
9	Dec. 17, 2018	(this page)	Changes
8	Oct. 01, 2015	Detail	Changes
7	Oct. 01, 2015	Detail	Changes
6	April. 21, 2015	Detail	Changes
5	April. 21, 2015	Detail	Changes
4	Jan. 20, 2012	Detail	Changes
3	Jan. 20, 2012	Detail	Changes
2	Oct. 18, 2011	Detail	Changes
1	Oct. 18, 2011	Detail

List of change history