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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000023065
Receipt No. R000026585
Scientific Title An intergroup phase III trial of Ramucirumab plus Irinotecan in third or more line Beyond progression after Ramucirumab for Advanced Gastric cancer.
Date of disclosure of the study information 2016/07/13
Last modified on 2018/07/27

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Basic information
Public title An intergroup phase III trial of Ramucirumab plus Irinotecan in third or more line Beyond progression after Ramucirumab for Advanced Gastric cancer.
Acronym RINDBeRG trial
Scientific Title An intergroup phase III trial of Ramucirumab plus Irinotecan in third or more line Beyond progression after Ramucirumab for Advanced Gastric cancer.
Scientific Title:Acronym RINDBeRG trial
Region
Japan

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

Objectives
Narrative objectives1 This study will evaluate the efficacy and safety of adding RAM to IRI, versus IRI monotherapy, in patients with advanced or recurrent gastric or gastroesophageal cancer who experienced disease progression while receiving a RAM-containing regimen.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase III

Assessment
Primary outcomes overall survival (OS)
Key secondary outcomes progression-free survival (PFS); time to treatment failure (TTF); response rate (RR); disease control rate (DCR); and adverse events (AEs)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Irinotecan alone
IRI 150 mg/m2, day 1 q2w
Interventions/Control_2 Ramucirumab plus irinotecan
RAM 8 mg/kg day1, q2w
IRI 150 mg/m2, day1, q2w
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)Histopathologically confirmed adenocarcinoma of gastric or gastroesophageal junction (GEJ) with inoperable, locally advanced or metastatic disease, not amenable to curative therapy.
2)Documented objective radiographic or clinical disease progression after a ramucirumab-containing chemotherapy.
3)No previous history of IRI administration.


4)Neither tolerates nor responds to treatment with fluoropyrimidines, platinum, or taxanes.
5)Has lesions that can be evaluated on CT or MRI images.
6)Age at enrollment 20 years old <=.
7)ECOG performance status (PS) of 0 or 1 at study entry.
8)Oral intake is possible.
9)Adequate organ function, defined as no severe impairment of bone marrow, heart, lungs, liver or kidneys, and laboratory values at the start of treatment that meet the following criteria.
10)Life expectancy of at least 3 months.
11)Written informed consent obtained prior to any study-specific procedures.
Key exclusion criteria 1)History of another malignancy
2)Previous systemic chemotherapy with an angiogenesis inhibitor, except ramucirumab.
3)History of serious adverse events after treatment with RAM.
4)Uncontrolled arterial hypertension.
5)Uncontrollable diarrhea that interferes with everyday activities even if receiving adequate treatment.
6)Undergoing anticoagulant therapy for the treatment of thromboembolism.
7)Local or systemic active infection that requires treatment.
8)Serious illness or medical condition(s)
9)History of severe allergy or hypersensitivity to any drugs.
10)Transfusion treatment within 2 weeks prior to enrollment.
11)Moderate or large ascites or pleural effusion.
12)Continuous systemic steroid treatment.
13)Evidence of a psychological disorder that is judged to make it difficult to ensure the continuous use of the study drug.
14)Symptomatic evidence of known central nervous system metastases.
15)Daily treatment with atazanavir sulfate, which is incompatible with IRI.
16)Pregnant, possibly pregnant or breastfeeding, or unwilling to practice contraception during the study.
17)17) The patient registered other clinical studies in parallel
18)Any condition that suggests that the patient is, in the investigator's opinion, not an appropriate candidate for the study.
Target sample size 400

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Taroh Satoh
Organization Osaka University Graduate School of Medicine
Division name Department of Frontier Science for Cancer and Chemotherapy
Zip code
Address Yamadaoka 2-2, Suita, Osaka 565-0871, Japan
TEL 06-6879-2641
Email taroh@cfs.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Daisuke Sakai
Organization Osaka University Graduate School of Medicine
Division name Department of Frontier Science for Cancer and Chemotherapy
Zip code
Address Yamadaoka 2-2, Suita, Osaka 565-0871, Japan
TEL 06-4790-7121
Homepage URL
Email dsakai@cfs.med.osaka-u.ac.jp

Sponsor
Institute Osaka Gastrointestinal Cancer Chemotherapy Study Group (OGSG)
Institute
Department

Funding Source
Organization Eli Lilly
Organization
Division
Category of Funding Organization Profit organization
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
2016 Year 07 Month 13 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 Open public recruiting
Date of protocol fixation
2016 Year 07 Month 13 Day
Date of IRB
Anticipated trial start date
2017 Year 02 Month 22 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
2016 Year 07 Month 07 Day
Last modified on
2018 Year 07 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026585

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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