UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000007421
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

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Basic information

Public title

Phase II study of TAS-102 in patients with advanced gastric cancer after progression on 1 or 2 prior systemic chemotherapy

Acronym

TAS-102 Phase II GC

Scientific Title

Phase II study of TAS-102 in patients with advanced gastric cancer after progression on 1 or 2 prior systemic chemotherapy

Scientific Title:Acronym

TAS-102 Phase II GC

Region

Japan


Condition

Condition

advanced gastric cancer

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy and safety of TAS-102 in patients with advanced gastric cancer after progression on 1 or 2 prior systemic chemotherapy.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Phase II


Assessment

Primary outcomes

Disease control rate (DCR)

Key secondary outcomes

Response rate (RR)
Progression free survival (PFS)
Overall survival (OS)
Adverse events
PK parameter


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

TAS-102 (35 mg/m2/dose BID) is administered orally on Day1-5 and Day8-12 in 28-day cycles.

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 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.

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 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.

Target sample size

28


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Toshihiko Doi

Organization

National Cancer Center Hospital East

Division name

Gastrointestinal Oncology Division

Zip code


Address

6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan

TEL

04-7133-1111

Email

tdoi@east.ncc.go.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hideaki, BANDO, M.D.

Organization

National Cancer Center Hospital East

Division name

Gastrointestinal Oncology Division

Zip code


Address

6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan

TEL

04-7133-1111

Homepage URL


Email

hbando@east.ncc.go.jp


Sponsor or person

Institute

National Cancer Center Hospital East

Institute

Department

Personal name



Funding Source

Organization

Health and Labor Sciences Research Grant

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor

Taiho Pharmaceutical Co., Ltd.

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

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)


Other administrative information

Date of disclosure of the study information

2012 Year 03 Month 02 Day


Related information

URL releasing protocol


Publication of results

Published


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

Main results already published

Date of protocol fixation

2011 Year 12 Month 14 Day

Date of IRB


Anticipated trial start date

2012 Year 03 Month 01 Day

Last follow-up date

2014 Year 03 Month 01 Day

Date of closure to data entry

2014 Year 04 Month 30 Day

Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2012 Year 03 Month 01 Day

Last modified on

2017 Year 01 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008700


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name