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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018606
Receipt No. R000021531
Scientific Title Phase I study of Ramucirumab and Irinotecan for metastatic gastric cancer previously treated with Fluoropyrimidine with/without Platinum and Taxane.
Date of disclosure of the study information 2015/08/11
Last modified on 2019/02/09

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Basic information
Public title Phase I study of Ramucirumab and Irinotecan for metastatic gastric cancer previously treated with Fluoropyrimidine with/without Platinum and Taxane.
Acronym G-IRIRAMstudy
Scientific Title Phase I study of Ramucirumab and Irinotecan for metastatic gastric cancer previously treated with Fluoropyrimidine with/without Platinum and Taxane.
Scientific Title:Acronym 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
1st name
Middle name
Last name Hironaga Satake
Organization Kobe City Medical Center General Hospital
Division name Department of Medical Oncology
Zip code
Address 2-1-1, Minatojima minamimachi,chuo-ku,Kobe
TEL 0783024321
Email takeh1977@gmai.com

Public contact
Name of contact person
1st name
Middle name
Last name Hironaga Satake
Organization Kobe City Medical Center General Hospital
Division name Department of Medical Oncology
Zip code
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)

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
2015 Year 08 Month 11 Day

Related information
URL releasing protocol
Publication of results Published

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
2015 Year 07 Month 29 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000021531

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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