臨床研究等提出・公開システム

Date of registration	April. 26, 2012
Last modified on	Dec. 17, 2018
Trial ID	jRCT2080221781

Scientific Title	A Phase 3 Randomized, Double-blind, Placebo-controlled, Multicenter Study of AMG 386 With Paclitaxel and Carboplatin as First-line Treatment of Subjects With FIGO Stage III-IV Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancers
Public Title	AMG 386 1st Ovarian cancer Global Phase 3 clinical trial

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	Takeda Pharmaceutical Company Limited
	Address	https://www.takeda.co.jp/contact/form/jp/form/
	Phone Number
	E-mail Address

Recruitment Status

Date of First Enrolment
Target Sample Size		2000
Study Type		Interventional
Study Design	Study Design	Randomized, Double-Blinded, Placebo-controlled
Study Design	Objective
Phase		3
Key inclusion & exclusion criteria	Inclusion Criteria	-Female subjects 18 years of age or older with FIGO Stages III-IV epithelial ovarian, primary peritoneal or fallopian tube cancer with an indication for first-line treatment with paclitaxel and carboplatin x 6 cycles (Subjects with pseudomyxoma, mesothelioma, adenocarcinoma with an unknown primary tumour, carcinosarcoma, sarcoma, mucinous or neuroendocrine histology are excluded -Subjects with FIGO Stage IIIA or IIIB disease must have undergone PDS for ovarian, primary peritoneal or fallopian tube cancer within 12 weeks prior to randomization -Subjects with FIGO Stage IIIC or IV disease must either: Undergo PDS for epithelial ovarian, primary peritoneal or fallopian tube cancer within 12 weeks prior to randomization or Plan to have IDS following 3 cycles of paclitaxel and carboplatin plus AMG 386 or AMG 386 placebo for biopsy proven epithelial ovarian, primary peritoneal or fallopian tube cancer -ECOG performance status of 0 or 1 -Adequate bone marrow, renal and hepatic function
	Exclusion Criteria	-Prior use of any anticancer therapy or experimental therapy for epithelial ovarian, primary peritoneal or fallopian tube cancer -Previous abdominal and/or pelvic external beam radiotherapy -History of central nervous metastasis -History of arterial or venous thromboembolism within 12 months prior to randomization -Clinically significant cardiovascular disease within 12 months prior to randomization
	Minimum Age	18age old over
	Maximum Age	No limit
	Gender	Female
Health Condition or Problem Studied		First-line treatment of subjects with International Federation of Gynecology and Obstetrics (FIGO) Stage III-IV epithelial ovarian, primary peritoneal or fallopian tube cancers
Intervention(s)		investigational material(s) Generic name etc : AMG 386 INN of investigational material : Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : Intravenous control material(s) Generic name etc : Placebo INN of investigational material : Therapeutic category code : --- Other Dosage and Administration for Investigational material : Intravenous
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		PFS Intergroup trial
Secondary Outcome		OS Intergroup trial

Primary Sponsor	Takeda Pharmaceutical Company Limited
Secondary Sponsor	Amgen Inc., U.S.A.

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-121823
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
9	Dec. 17, 2018	(this page)	Changes
8	July. 18, 2017	Detail	Changes
7	July. 18, 2017	Detail	Changes
6	June. 11, 2015	Detail	Changes
5	June. 11, 2015	Detail	Changes
4	April. 03, 2014	Detail	Changes
3	April. 03, 2014	Detail	Changes
2	April. 26, 2012	Detail	Changes
1	April. 26, 2012	Detail

List of change history