Unique ID issued by UMIN | UMIN000007421 |
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Receipt number | R000008700 |
Scientific Title | Phase II study of TAS-102 in patients with advanced gastric cancer after progression on 1 or 2 prior systemic chemotherapy |
Date of disclosure of the study information | 2012/03/02 |
Last modified on | 2017/01/05 18:07:46 |
Phase II study of TAS-102 in patients with advanced gastric cancer after progression on 1 or 2 prior systemic chemotherapy
TAS-102 Phase II GC
Phase II study of TAS-102 in patients with advanced gastric cancer after progression on 1 or 2 prior systemic chemotherapy
TAS-102 Phase II GC
Japan |
advanced gastric cancer
Gastroenterology |
Malignancy
NO
To evaluate the efficacy and safety of TAS-102 in patients with advanced gastric cancer after progression on 1 or 2 prior systemic chemotherapy.
Safety,Efficacy
Exploratory
Phase II
Disease control rate (DCR)
Response rate (RR)
Progression free survival (PFS)
Overall survival (OS)
Adverse events
PK parameter
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
TAS-102 (35 mg/m2/dose BID) is administered orally on Day1-5 and Day8-12 in 28-day cycles.
20 | years-old | <= |
Not applicable |
Male and Female
1) Histologically proven gastric adenocarcinoma or gastro-esophageal junction adenocarcinoma.
2) Inoperable, recurrent or metastatic disease.
3) Tumor progression during prior chemotherapy or within 2 months after prior chemotherapy.
4) >= 20 years old.
5) ECOG performance status of <= 2.
6) Measurable disease without irradiation according to RECIST ver1.1.
7) Prior chemotherapies for advanced gastric cancer are as follows. (In case of progression during adjuvant/neoadjuvant therapy or <= 6 months after the last administration of adjuvant/neoadjuvant therapy, the adjuvant/neoadjuvant therapy will be considered one prior treatment.)
i. Include chemotherapy with 5-FU.
ii. Include chemotherapy with platinum derivative.
iii. Include chemotherapy with taxane or irinotecan.
iv. No. of prior chemotherapies <= 2.
8) Adequate organ function.
9) No blood transfusion within 14 days prior to enrollment.
10) AE related to prior chemotherapy, radiation therapy or surgery must be Grade <= 1 according to CTCAE. (except alopecia, peripheral sensory neuropathy, skin hyperpigmentation and dysgeusia)
11) Women of childbearing potential must have a negative serum pregnancy test within 14 days prior to enrollment.
12) Adequate oral intake.
13) Written informed consent.
1) Administration of chemotherapy within 2 weeks prior to enrollment.
2) Major surgery or radiation therapy within 4 weeks prior to enrollment. Except bowel bypass surgery or enterostomy has passed over 2 weeks.
3) Investigational drugs were administrated within 4 weeks prior to enrollment.
4) Prior chemotherapy with TAS-102.
5) Known hypersensitivity to TAS-102 or excipients.
6) Patients with CNS metastases.
7) Malignant pleural effusion, ascites or cardiac effusion requiring invasive treatment. (such as ascites drainage)
8) Synchronous or asynchronous (within 3 years) other cancer except carcinoma in situ or intramucosal carcinoma.
9) Any severe and/or uncontrolled medical conditions.
10) Positive HBs antigen or HCV antibody. Known positive serology for HIV.
11) Chronic treatment with steroids or another immunosuppressive agent.
12) Not use adequate methods of contraception. (duplex barrier method or intrauterine device)
13) Patient is unwilling or unable to comply with the protocol.
14) Patient is judged by the investigator to be inappropriate for study participation for any reason.
28
1st name | |
Middle name | |
Last name | Toshihiko Doi |
National Cancer Center Hospital East
Gastrointestinal Oncology Division
6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan
04-7133-1111
tdoi@east.ncc.go.jp
1st name | |
Middle name | |
Last name | Hideaki, BANDO, M.D. |
National Cancer Center Hospital East
Gastrointestinal Oncology Division
6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan
04-7133-1111
hbando@east.ncc.go.jp
National Cancer Center Hospital East
Health and Labor Sciences Research Grant
Japanese Governmental office
Japan
Taiho Pharmaceutical Co., Ltd.
NO
独立行政法人国立がん研究センター東病院(千葉県)
静岡県立静岡がんセンター(静岡県)
愛知県がんセンター中央病院(愛知県)
独立行政法人国立病院機構四国がんセンター(愛媛県)
埼玉県立がんセンター(埼玉県)
公益財団法人がん研究会有明病院(東京都)
2012 | Year | 03 | Month | 02 | Day |
Published
Main results already published
2011 | Year | 12 | Month | 14 | Day |
2012 | Year | 03 | Month | 01 | Day |
2014 | Year | 03 | Month | 01 | Day |
2014 | Year | 04 | Month | 30 | Day |
2012 | Year | 03 | Month | 01 | Day |
2017 | Year | 01 | Month | 05 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008700
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