UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022956
Receipt number R000026318
Scientific Title A Phase II study of Ramucirumab beyond disease progression in combination with Irinotecan after failure of weekly Paclitaxel plus Ramucirumab in advanced gastric cancer patients previously treated with fluoropyrimidine and platinum
Date of disclosure of the study information 2016/07/01
Last modified on 2022/11/13 17:00:00

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Basic information

Public title

A Phase II study of Ramucirumab beyond disease progression in combination with Irinotecan after failure of weekly Paclitaxel plus Ramucirumab in advanced gastric cancer patients previously treated with fluoropyrimidine and platinum

Acronym

A Phase II study of Ramucirumab beyond disease progression in combination with Irinotecan after failure of weekly Paclitaxel plus Ramucirumab in advanced gastric cancer patients

Scientific Title

A Phase II study of Ramucirumab beyond disease progression in combination with Irinotecan after failure of weekly Paclitaxel plus Ramucirumab in advanced gastric cancer patients previously treated with fluoropyrimidine and platinum

Scientific Title:Acronym

A Phase II study of Ramucirumab beyond disease progression in combination with Irinotecan after failure of weekly Paclitaxel plus Ramucirumab in advanced gastric cancer patients

Region

Japan


Condition

Condition

Gastric cancer

Classification by specialty

Gastroenterology Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate safety and efficacy of Ramucirumab beyond disease progression in combination with Irinotecan after failure of weekly Paclitaxel plus Ramucirumab in advanced gastric cancer patients previously treated with fluoropyrimidine and platinum.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Progression free survival

Key secondary outcomes

Achievement ratio of second registration
Treatment continuation rate at eight weeks after second registration
Response rate
Overall survival
Safety
Quality of life


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

Second-line therapy
Ramucirumab(8mg/kg) day 1,15 DIV
Paclitaxel(80mg/m2) day 1,8,15 DIV
every 28 days

Study therapy
Ramucirumab(8mg/kg) day 1,15 DIV
Irinotecan(150mg/m2) day 1 DIV
every 14 days

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)histrologically proven gastric/esophagogastric junction adenocarcinoma
2)advanced/recurrence
3)age =>20
4)ECOG PS 0 or 1
5)with evaluable lesions
6)previously treated with fluoropyrimidine and platinum
7)within 42 days after failure of fluoropyrimidine and platinum therapy
8)more than 14 days after last infusion of chemotherpy
9)adequate organ functions(according to the labo-data which was taken within 2weeks before registration)
1.WBC =>3,000/mm3
2.neutrophil=>1,500/mm3
3.hemoglobin=>8.0g/dL
4.platelet=>100,000/mm3
5.Total bililubin =<1.5mg/dL
6.AST=<100 IU/l
7.ALT=<100 IU/l
8. Creatinine=<1.5mg/dL or eGFR=>Total bililubin =<1.5mg/dL
10) with written Informed Consent

Key exclusion criteria

1)with active double cancers excluding carcinoma in situ
2)with pleural fluid, ascites or pericardial effusion that requires drainage
3)with ileus or constipation (>=grade 3)
4)with a histroy of uncontrollable hypertension or acute coronary syndrome in 6 months
5)with active gastrointestinal bleeding in 14 days
6)with severe or uncotrollable complications such as diabetes mellitus, bowel obstruction, jaundice, liver dysfunction, psychological illness and severe infectious disease.
7)with active hepatitis B or C
8)with HIV infection
9)with a history of interstitial pneumonia, pulmonary fibrosis or irradiation pneumonitis
10)with hemorrhagic diathesis or blood coagulation disorder
11)within 28 days after open abdominal or chest surgery or with unrecoverd surgical wounds
12)pregnant and/or nursing women or men who wish to have children in future
13)judged to be unfit to participate in this study by investigater

Target sample size

53


Research contact person

Name of lead principal investigator

1st name Yasuyuki
Middle name
Last name Seto

Organization

The University of Tokyo

Division name

Department of Gastrointestinal Surgery

Zip code

113-8655

Address

7-3-1, Hongo, Bunkyo-ku, Tokyo

TEL

03-3815-5411

Email

seto-tky@umin.ac.jp


Public contact

Name of contact person

1st name Yasuyoshi
Middle name
Last name Sato

Organization

The University of Tokyo

Division name

Department of Gastrointestinal Surgery

Zip code

113-8655

Address

7-3-1, Hongo, Bunkyo-ku, Tokyo

TEL

03-3815-5411

Homepage URL


Email

yasuyoshi_s@hotmail.com


Sponsor or person

Institute

The University of Tokyo

Institute

Department

Personal name



Funding Source

Organization

self funding

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

The University of Tokyo

Address

7-3-1, Hongo, Bunkyo-ku, Tokyo

Tel

03-5800-8743

Email

crctky-office@umin.ac.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



Other administrative information

Date of disclosure of the study information

2016 Year 07 Month 01 Day


Related information

URL releasing protocol


Publication of results

Unpublished


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

Completed

Date of protocol fixation

2016 Year 04 Month 04 Day

Date of IRB

2017 Year 06 Month 21 Day

Anticipated trial start date

2016 Year 07 Month 01 Day

Last follow-up date

2019 Year 03 Month 21 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 06 Month 30 Day

Last modified on

2022 Year 11 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026318


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name