UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Investigator-Initiated Clinical Trials to assess the safety of SK-818 in patients with operable breast cancer
Title of the study (Brief title)	Investigator-Initiated Clinical Trials to assess the safety of SK-818 in patients with operable breast cancer
Region	Japan

Condition
Condition	Breast cancer
Classification by specialty	Breast surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluated the safety of SK-818 in patients with operable breast cancer and to determine the tolerated and the recommended dose
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase I

Assessment
Primary outcomes	Dose limiting toxicity (DLT)
Key secondary outcomes	Adverse events Pharmacokinetic for Propagermanium

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Continuous oral administration of SK-818 from 1 week before operation until 28 days after operation except on operation day
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	70 years-old >=
Gender	Female
Key inclusion criteria	1) Women between the age of 20 and 70 at giving informed consent 2) Histologically or cytologically proven invasive ductal breast cancer -Her2/ER/PgR: positive/negative -Synchronous/Heterochrony 3) Stage I ~ III 4) Curative surgery without breast reconstruction 5) eGFR> 30 6) Adequate liver function as follows: a. T-Bil: <=1.5x upper limit of normal (ULN) b. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT): >= 3.0x ULN 7) ECOG Performance Status PS 0-1 8) No neoadjuvant therapy for breast cancer 9) Oral administration 10) Written informed consent
Key exclusion criteria	1) Male 2) Multiple malignancies 3) Jaundice or cirrhosis 4) HBs antigen:positive (HBV testing for HBs antigen, HBs antibody and HBc antibody and HCV testing for HCV antibody should be performed within 3 months before operation) 5) Severe heart disease such as poorly controlled ischemic heart disease, heart failure and arrhythmia 6) Interstitial pneumonitis or pulmonary fibrosis 7) Blood disorders with disturbance of hematopoiesis such as Aplastic anemia or myelodysplastic syndromes 8) Active infection. 9) Severe drug allergy 10) Severe mental illness 11) Women during pregnancy or lactation and women who don't agree with contraception during the clinical trial 12) Participants in other clinical research within 30 days before giving informed consent 13) Patients as deemed appropriate for participation in this trial by medical doctors
Target sample size	18

Research contact person
Name of lead principal investigator	Koshi Mimori
Organization	Kyushu University Beppu Hospital
Division name	Surgery
Address	4546 Tsurumibaru, Tsurumi, Beppu-shi, Oita
TEL	0977-27-1650
Email	kmimori@beppu.kyushu-u.ac.jp

Public contact
Name of contact person	Hisayo Morioka
Organization	EP-CRSU Japan Co. , Ltd
Division name	Clinical Research Headquarters
Address	Kogin Bldg, 4-1-1 Koraibashi, Chuo-ku, Osaka
TEL	06-6202-5375
Homepage URL
Email	prj-sk-818@eps.co.jp

Sponsor
Institute	Kyushu University
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	・公益財団法人　がん研究会有明病院（東京都） ・国立研究開発法人　国立がん研究センター東病院（千葉県）

Other administrative information
Date of disclosure of the study information	2016 Year 06 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 03 Month 11 Day
Anticipated trial start date	2016 Year 06 Month 13 Day
Last follow-up date	2017 Year 12 Month 18 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 05 Month 27 Day
Last modified on	2018 Year 03 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025695