Unique ID issued by UMIN | UMIN000022494 |
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Receipt number | 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 15:03:58 |
Investigator-Initiated Clinical Trials to assess the safety of SK-818 in patients with operable breast cancer
Investigator-Initiated Clinical Trials to assess the safety of SK-818 in patients with operable breast cancer
Investigator-Initiated Clinical Trials to assess the safety of SK-818 in patients with operable breast cancer
Investigator-Initiated Clinical Trials to assess the safety of SK-818 in patients with operable breast cancer
Japan |
Breast cancer
Breast surgery |
Malignancy
NO
To evaluated the safety of SK-818 in patients with operable breast cancer and to determine the tolerated and the recommended dose
Safety
Exploratory
Phase I
Dose limiting toxicity (DLT)
Adverse events
Pharmacokinetic for Propagermanium
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Continuous oral administration of SK-818 from 1 week before operation until 28 days after operation except on operation day
20 | years-old | <= |
70 | years-old | >= |
Female
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
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
18
1st name | |
Middle name | |
Last name | Koshi Mimori |
Kyushu University Beppu Hospital
Surgery
4546 Tsurumibaru, Tsurumi, Beppu-shi, Oita
0977-27-1650
kmimori@beppu.kyushu-u.ac.jp
1st name | |
Middle name | |
Last name | Hisayo Morioka |
EP-CRSU Japan Co. , Ltd
Clinical Research Headquarters
Kogin Bldg, 4-1-1 Koraibashi, Chuo-ku, Osaka
06-6202-5375
prj-sk-818@eps.co.jp
Kyushu University
Japan Agency for Medical Research and Development
Other
NO
・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)
2016 | Year | 06 | Month | 01 | Day |
Unpublished
Completed
2016 | Year | 03 | Month | 11 | Day |
2016 | Year | 06 | Month | 13 | Day |
2017 | Year | 12 | Month | 18 | Day |
2016 | Year | 05 | Month | 27 | Day |
2018 | Year | 03 | Month | 15 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025695
Research Plan | |
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Research case data | |
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