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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000025560
Receipt No. R000029360
Scientific Title A multicenter, phase 1/2 study of Ramucirumab plus Nivolumab as second-line therapy in participants with gastric or GEJ cancer
Date of disclosure of the study information 2017/01/06
Last modified on 2019/01/11

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Basic information
Public title A multicenter, phase 1/2 study of Ramucirumab plus Nivolumab as second-line therapy in participants with gastric or GEJ cancer
Acronym A multicenter, phase 1/2 study of Ramucirumab plus Nivolumab as second-line therapy in participants with gastric or GEJ cancer
Scientific Title A multicenter, phase 1/2 study of Ramucirumab plus Nivolumab as second-line therapy in participants with gastric or GEJ cancer
Scientific Title:Acronym A multicenter, phase 1/2 study of Ramucirumab plus Nivolumab as second-line therapy in participants with gastric or GEJ cancer
Region
Japan

Condition
Condition Advanced or recurrent unresectable gastric or GEJ cancer
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 Phase 1
To estimate maximum tolerated dose (MTD) and dose limiting toxicity (DLT) and to determine of combination therapy of Ramucirumab and Nivolumab and to determine recommended dose (RD) of the therapy.


Phase 2
To assess safety and efficacy of the combination therapy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase I,II

Assessment
Primary outcomes Phase 1
Number of participants with dose limiting toxicities (DLTs) for 28 days from first administration

Phase 2
Progression free survival rate after 6 months
Key secondary outcomes Phase 1
Number of participants with adverse events

Phase 2
Overall response rate (ORR)
Disease control rate (DCR)
Progression-free survival (PFS)
Overall survival (OS)
Number of participants with adverse events

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Phase 1 (Level 1)
Ramucirumab: 8 mg/kg, every 2 weeks
Nivolumab: 3 mg/kg, every 2 weeks
Interventions/Control_2 Phase 1 (Level 0)
Ramucirumab: 8 mg/kg, every 2 weeks
Nivolumab: 1 mg/kg, every 2 weeks
Interventions/Control_3 Phase 2
Ramucirumab: 8 mg/kg, every 2 weeks
Nivolumab: recommended dose established in the phase 1 (3 mg/kg or 1 mg/kg), every 2 weeks
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 - Advanced or recurrent unresectable gastric or GEJ cancer
- Histologically confirmed adenocarcinoma (papillary adenocarcinoma, tubular adenocarcinoma or poorly differentiated adenocarcinoma), signet-ring cell carcinoma, mucinous adenocarcinoma or hepatoid adnocarcinoma
- Patients with normal oral intake
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Patients who have measurable target lesion
- Patients has a refractory or intolerant pretreatment by pyrimidine fluoride anticancer agent and platinum-based anticancer agent
- Patients with no pretreatment history including ramucirumab, nivolumab or other therapies targeting control of T cells
- Patients with written informed consent
Key exclusion criteria - Patients have double cancer
- Patients have infection required systemic therapy
- Known central nervous system (CNS) metastasis
- Patients with history of pneumonitis or pulmonary fibrosis
- Patients with history of serious anaphylaxis induced by antibody preparation
- Patients who have known active autoimmune disease or history of chronic recurrent autoimmune disease
- Female who is pregnant, lactating or suspected pregnancy
- Patients with psychosis or dementia to interfere to obtain informed consent appropriately
Target sample size 44

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ken Kato
Organization National Cancer Center Japan Hospital
Division name Department of Gastrointestinal Medical Oncology
Zip code
Address 5-1-1, Tsukiji, Chuo-ku, Tokyo 104-0045, Japan
TEL 03-3542-2511
Email kenkato@ncc.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hirokazu Shoji
Organization National Cancer Center Japan Hospital
Division name Department of Gastrointestinal Medical Oncology
Zip code
Address 5-1-1, Tsukiji, Chuo-ku, Tokyo 104-0045, Japan
TEL 03-3542-2511
Homepage URL
Email hshouji@ncc.go.jp

Sponsor
Institute Department of Gastrointestinal Medical Oncology, National Cancer Center Japan Hospital
Institute
Department

Funding Source
Organization Ono Pharmaceutical Co. Ltd.
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 YES
Study ID_1 NCT02999295
Org. issuing International ID_1 ClinicalTrials.gov
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 国立研究開発法人国立がん研究センター中央病院(東京都)、公益財団法人 がん研究会有明病院(東京都)、埼玉県立がんセンター(埼玉県)、静岡県立静岡がんセンター(静岡県)、独立行政法人国立病院機構 九州がんセンター(福岡県)

Other administrative information
Date of disclosure of the study information
2017 Year 01 Month 06 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 No longer recruiting
Date of protocol fixation
2016 Year 11 Month 04 Day
Date of IRB
Anticipated trial start date
2017 Year 01 Month 12 Day
Last follow-up date
2019 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2020 Year 06 Month 30 Day

Other
Other related information

Management information
Registered date
2017 Year 01 Month 06 Day
Last modified on
2019 Year 01 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029360

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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