臨床研究等提出・公開システム

Date of registration	Sept. 10, 2010
Last modified on	Dec. 17, 2018
Trial ID	jRCT2080221239

Scientific Title	Phase 2 Trial of BMS-690514 in Non-Small Cell Lung Cancer Subjects Who Have Been Treated With Gefitinib or Erlotinib and Are Genotypically EGFR Mutation Positive or Who Have Had a Prior Response
Public Title	Clinical Trial of BMS-690514 in Non-Small Cell Lung Cancer Subjects

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	Bristol-Myers K.K.
	Address	jp-clinical-trial@bms.com
	Phone Number
	E-mail Address

Recruitment Status

Date of First Enrolment
Target Sample Size		56
Study Type		Interventional
Study Design	Study Design	The study design is a single arm open label study to evaluate the efficacy and safety of BMS-690514 in NSCLC subjects.
Study Design	Objective
Phase		2
Key inclusion & exclusion criteria	Inclusion Criteria	Subjects must have recurrent, metastatic or progressive NSCLC Pathologically confirmed NSCLC Previously received treatment with single agent Gefitinib or Erlotinib Any one of the following: - A tumor that harbors an EGFR mutation - Objective clinical benefit from treatment with Gefitinib or Erlotinib - Progression of NSCLC while on continuous treatment with gefitinib or erlotinib as noted by CT/MRI increase in disease within 3 months of study enrollment
	Exclusion Criteria	- Symptomatic brain metastasis - Adequate organ function and performance status
	Minimum Age	20age old over
	Maximum Age	No limit
	Gender	Both
Health Condition or Problem Studied		Non-Small-Cell Lung Carcinoma
Intervention(s)		investigational material(s) Generic name etc : BMS-690514 INN of investigational material : Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : Tablets,Oral,200 mg.once daily
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		- To estimate objective response rate of BMS-690514 in NSCLC subjects
Secondary Outcome		- To estimate progression free survival of BMS-690514 - To evaluate safety and tolerability of BMS-690514

Primary Sponsor	Bristol-Myers K.K.
Secondary Sponsor

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Name of Research Funding

Name of IRB
Address of IRB
Phone Number of IRB
E-mail Address of IRB
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Date of Approval by IRB

Secondary ID No.	JapicCTI-101276
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
9	Dec. 17, 2018	(this page)	Changes
8	Feb. 13, 2012	Detail	Changes
7	Feb. 13, 2012	Detail	Changes
6	Dec. 15, 2010	Detail	Changes
5	Dec. 15, 2010	Detail	Changes
4	Sept. 29, 2010	Detail	Changes
3	Sept. 29, 2010	Detail	Changes
2	Sept. 10, 2010	Detail	Changes
1	Sept. 10, 2010	Detail

List of change history