UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase I study of Ramucirumab and Irinotecan for metastatic gastric cancer previously treated with Fluoropyrimidine with/without Platinum and Taxane.
Title of the study (Brief title)	G-IRIRAMstudy
Region	Japan

Condition
Condition	gastric cancer
Classification by specialty	Medicine in general Gastroenterology Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To determine the recommended doses of irinotecan plus ramucirumab for patients with metastatic gastric cancer previously treated with fluoropyrimidine with/without platinum and taxane
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Safety DLT DLTobservation period=first course
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	irinotecan/ramucirumab CPT-11:level1 150mg/m2,q2w, level0 120mg/m2,q2w, level-1 100mg/m2,q2w Rumucirumab:8mg/kg,q2w until evidence of progressin, unacceptable toxicity, or patinet refusal
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) histlogically proven gastric adenocarcinoma (including adenocarcinoma of the GEJ) 2) previously teated with fluoropyrimigine with/without platinum and taxane 3) with target lesion(RECIST version1.1) 4) Performance status must be Eastern Cooperative Oncology Group (ECOG) 0, or 1 4) Age >= 20 years 5) Adequate bone marrow, hepatic, renal, cardiac and respiratory functions 7) Written informed consent
Key exclusion criteria	1) active synchronous or metachronous malignancy 2) previously treated with irinotecan 3) uncontrolled hypertension 4) active infection 5) serious coexisting illness 6) intensive surgery within 28 days prior to the registration 7) embolism and thrombosis, or grade 3 or more GI bleeding within 3 months prior to the registration 8) uncontrolled diarrhea 9) severe allergy 10) moderate or more pleural effusion/ascites 11) systemic steroid user 12) severe mental disorders 13) symptomatic central metastasis 14) atazanavir user 15) pregnant or nursing 16) active hepatitis 17) UGT1A1*6/*6, *28/*28, *6/*28 18) other conditions not suitable for this study
Target sample size	18

Research contact person
Name of lead principal investigator	Hironaga Satake
Organization	Kobe City Medical Center General Hospital
Division name	Department of Medical Oncology
Address	2-1-1, Minatojima minamimachi,chuo-ku,Kobe
TEL	0783024321
Email	takeh1977@gmai.com

Public contact
Name of contact person	Hironaga Satake
Organization	Kobe City Medical Center General Hospital
Division name	Department of Medical Oncology
Address	2-1-1, Minatojima minamimachi,chuo-ku,Kobe
TEL	0783024321
Homepage URL
Email	hsatake@kcho.jp

Sponsor
Institute	Kobe City Medical Center General Hospital
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2015 Year 08 Month 11 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 07 Month 29 Day
Anticipated trial start date	2015 Year 08 Month 11 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 08 Month 08 Day
Last modified on	2019 Year 02 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000021531