臨床研究等提出・公開システム

Date of registration	May. 14, 2014
Last modified on	Dec. 17, 2018
Trial ID	jRCT2080222485

Scientific Title	A Phase 1, Randomized, Open-Label Study of TAK-385, an Oral Gonadotropin-Releasing Hormone (GnRH) Antagonist in Japanese Patients With Androgen Deprivation Treatment-Naive Nonmetastatic Prostate Cancer
Public Title	A Phase 1 study of TAK-385 in Patients With Androgen Deprivation Treatment-Naive Prostate Cancer

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	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		43
Study Type		Interventional
Study Design	Study Design	open-label, multicenter
Study Design	Objective
Phase		1
Key inclusion & exclusion criteria	Inclusion Criteria	1)Patient has histologically or cytologically confirmed prostate adenocarcinoma 2)Patients who have not received androgen deprivation treatment (e.g., GnRH agonist, GnRH antagonist, steroidal antiandrogen, non-steroidal androgen) for prostate cancer. 3)Patients who have not undergone surgical castration 4)Serum testosterone at screening > 150 ng/dL 5)Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
	Exclusion Criteria	1)Patients who have received 5-alpha reductase inhibitors 2)Patients who have received chemotherapy for prostate cancer (including Estramustine) 3)Patients who have received 125I-brachytherapy radiation therapy 4)Diagnosis or treatment for another systemic malignancy within 2 years before the first dose. Patients who diagnosed with another malignancy and any evidence of residual disease. Patients with non-melanoma skin cancer or carcinoma in situ of any type will not be excluded if they have undergone complete resection.
	Minimum Age	20age old over
	Maximum Age	No limit
	Gender	Male
Health Condition or Problem Studied		androgen deprivation treatment-naive nonmetastatic prostate cancer
Intervention(s)		investigational material(s) Generic name etc : TAK-385 INN of investigational material : Therapeutic category code : 249 Other hormone preparations (including antihormone preparations) Dosage and Administration for Investigational material : TAK-385 will be taken orally every morning at least 30 minutes before the first meal of the day. 320-360mg(loading dose), 40-160mg(maintenance dose)
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		DLT, adverse events, clinical laboratory tests, vital signs, and 12-lead ECGs Up to 48 weeks
Secondary Outcome		Plasma concentrations of TAK-385, Serum testosterone concentration, Serum prostate-specific antigen (PSA) Up to 48 weeks

Primary Sponsor	TAKEDA PHARMACEUTICAL COMPANY 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-142536
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
11	Dec. 17, 2018	(this page)	Changes
10	April. 18, 2018	Detail	Changes
9	April. 18, 2018	Detail	Changes
8	June. 01, 2017	Detail	Changes
7	June. 01, 2017	Detail	Changes
6	July. 09, 2015	Detail	Changes
5	July. 09, 2015	Detail	Changes
4	June. 12, 2015	Detail	Changes
3	June. 12, 2015	Detail	Changes
2	May. 14, 2014	Detail	Changes
1	May. 14, 2014	Detail

List of change history