UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018606 |
|---|---|
| Receipt number | 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 09:14:42 |
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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
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
hsatake@kcho.jp
Sponsor or person
Institute
Kobe City Medical Center General Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021531
