UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000028329
Receipt No. R000032420
Scientific Title Phase II study of TAS-114 in combination with S-1 in patients with advanced gastric cancer refractory to prior chemotherpy.
Date of disclosure of the study information 2017/09/13
Last modified on 2020/08/24 (Ver. 8)

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Basic information
Public title Phase II study of TAS-114 in combination with S-1 in patients with advanced gastric cancer refractory to prior chemotherpy.
Acronym TAS114_GC study
Scientific Title Phase II study of TAS-114 in combination with S-1 in patients with advanced gastric cancer refractory to prior chemotherpy.
Scientific Title:Acronym TAS114_GC study
Region
Japan

Condition
Condition gastric cancer
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety os TAS-114 in combination with S-1 in patients with advanced gastric cancer refractory to prior chemotherapy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Objective Response Rate : ORR
Key secondary outcomes Disease control rate: DCR
Progression free survival: PFS
Overall survival: OS
Adverse Events: AE

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 1 cycle is 21days.
TAS-114(400mg) and S-1(30mg/m2) are administered orally twice daily for 14 days followed by 7days rest.
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

Not applicable
Gender Male and Female
Key inclusion criteria 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 0 or 1
6)Measurable disease 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 as 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 7 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

Key exclusion criteria 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 was administrated within 4 weeks prior to enrollment
4)Prior chemotherapy with TAS-114.
5)Known hypersensitivity to S-1 or excipients.
6)Patients with CNS metastases.
7)Synchronous or asynchronous (within 3 years) other cancer except carcinoma in situ or intramucosal carcinoma.
8)Any severe and/or uncontrolled medical conditions.
9)Active hepatitis
10)Chronic treatment with steroids or another immunosuppressive agent.
11)Patient is unwilling to practice appropriate contraception during the study and the contraception period after the discontinuation of the protocol treatment
12)Patient is unwilling or unable to comply with the protocol
13)Patient is judged by the investigator to be inappropriate for study participation for any reason.
Target sample size 29

Research contact person
Name of lead principal investigator
1st name Kohei
Middle name
Last name Shitara
Organization National Cancer Center Hospital East
Division name Department of Gastrointestinal Oncology
Zip code 277-8577
Address 6-5-1,Kashiwanoha,Kashiwa,Chiba,277-8577,Japan
TEL 04-7133-1111
Email TAS114_GC_core@east.ncc.go.jp

Public contact
Name of contact person
1st name Akihito
Middle name
Last name Kawazoe
Organization National Cancer Center Hospital East
Division name Department of Gastrointestinal Oncology
Zip code 277-8577
Address 6-5-1,Kashiwanoha,Kashiwa,Chiba,277-8577,Japan
TEL 04-7133-1111
Homepage URL
Email TAS114_GC_core@east.ncc.go.jp

Sponsor
Institute National Cancer Center Hospital East
Institute
Department

Funding Source
Organization Taiho Pharmaceutical Co., Ltd
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

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

IRB Contact (For public release)
Organization NCC IRB
Address 6-5-1,Kashiwanoha,Kashiwa,Chiba,277-8577,Japan
Tel 04-7133-1111
Email irboffice@east.ncc.go.jp

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 国立研究開発法人　国立がん研究センター東病院(千葉県）
がん研有明病院（東京都）

Other administrative information
Date of disclosure of the study information
2017 Year 09 Month 13 Day

Related information
URL releasing protocol Not Release
Publication of results Published

Result
URL related to results and publications https://link.springer.com/article/10.1007/s10120-020-01107-y
Number of participants that the trial has enrolled 20
Results 
ORR 5%, DCR 70%
Results date posted
2020 Year 08 Month 24 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics 
Gastric cancer
Participant flow 
informed consent
Adverse events 
anemia, leucopenia, neutropenia, etc.
Outcome measures 
ORR, DCR, PFS, OS, etc
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2017 Year 07 Month 26 Day
Date of IRB
2017 Year 09 Month 13 Day
Anticipated trial start date
2017 Year 10 Month 17 Day
Last follow-up date
2018 Year 12 Month 28 Day
Date of closure to data entry
2019 Year 01 Month 31 Day
Date trial data considered complete
2019 Year 03 Month 01 Day
Date analysis concluded
2020 Year 05 Month 01 Day

Other
Other related information

Management information
Registered date
2017 Year 07 Month 21 Day
Last modified on
2020 Year 08 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032420