UMIN-CTR Clinical Trial

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
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	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000026318