UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028329
Receipt number 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 08:43:15

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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 or person

Institute

National Cancer Center Hospital East

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032420


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name