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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000022956
Receipt No. 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 2017/01/04

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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
Middle name
Last name Yasuyuki Seto
Organization The University of Tokyo
Division name Department of Gastrointestinal Surgery
Zip code
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
Middle name
Last name Yasuyoshi Sato
Organization The University of Tokyo
Division name Department of Gastrointestinal Surgery
Zip code
Address 7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL 03-3815-5411
Homepage URL
Email yasuyoshi_s@hotmail.com

Sponsor
Institute The University of Tokyo
Institute
Department

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
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

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 Open public recruiting
Date of protocol fixation
2016 Year 04 Month 04 Day
Date of IRB
Anticipated trial start date
2016 Year 07 Month 01 Day
Last follow-up date
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
2017 Year 01 Month 04 Day


Link to view the page
URL(English) https://upload.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


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