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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000022494
Receipt No. R000025695
Scientific Title Investigator-Initiated Clinical Trials to assess the safety of SK-818 in patients with operable breast cancer
Date of disclosure of the study information 2016/06/01
Last modified on 2018/03/15

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Basic information
Public title Investigator-Initiated Clinical Trials to assess the safety of SK-818 in patients with operable breast cancer
Acronym Investigator-Initiated Clinical Trials to assess the safety of SK-818 in patients with operable breast cancer
Scientific Title Investigator-Initiated Clinical Trials to assess the safety of SK-818 in patients with operable breast cancer
Scientific Title:Acronym 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
1st name
Middle name
Last name Koshi Mimori
Organization Kyushu University Beppu Hospital
Division name Surgery
Zip code
Address 4546 Tsurumibaru, Tsurumi, Beppu-shi, Oita
TEL 0977-27-1650
Email kmimori@beppu.kyushu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hisayo Morioka
Organization EP-CRSU Japan Co. , Ltd
Division name Clinical Research Headquarters
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2016 Year 03 Month 11 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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