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
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
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
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
