UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000025947
Receipt No. R000029783
Scientific Title Phase I/II multicenter trial of paclitaxel, ramucirumab and nivolumab for metastatic gastric cancer patients who progressed on chemotherapy with fluoropyrimidine plus platinum
Date of disclosure of the study information 2017/02/03
Last modified on 2017/02/01

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Phase I/II multicenter trial of paclitaxel, ramucirumab and nivolumab for metastatic gastric cancer patients who progressed on chemotherapy with fluoropyrimidine plus platinum
Acronym Phase I/II trial of paclitaxel, ramucirumab and nivolumab for advanced gastric cancer patients
Scientific Title Phase I/II multicenter trial of paclitaxel, ramucirumab and nivolumab for metastatic gastric cancer patients who progressed on chemotherapy with fluoropyrimidine plus platinum
Scientific Title:Acronym Phase I/II trial of paclitaxel, ramucirumab and nivolumab for advanced gastric cancer patients
Region
Japan

Condition
Condition Gastric cancer
Classification by specialty
Gastroenterology Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Phase I: To determine Maximum Tolerated Dose: MTD, Dose Limiting Toxicity: DLT, Recommended Dose: RD of paclitaxel, ramucirumab and nivolumab

Phase II: To evaluate efficacy of paclitaxel, ramucirumab and nivolumab at RD level
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase I,II

Assessment
Primary outcomes Phase I: DLT
Phase II: 6 months progression -free survival
Key secondary outcomes Phase I: Safety
Phase II: Overall response rate: ORR, Disease control rate: DCR, Progression-free survival: PFS, Overall survival: OS

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Level1
Paclitaxel: 80 mg/m2 day1, 8, 15
Ramucirumab:8 mg/kg div day1, 15
Nivolumab: 3 mg/kg div day1, 15
28 days 1 course

Level0
Paclitaxel: 80 mg/m2 day1, 8, 15
Ramucirumab:8 mg/kg div day1, 15
Nivolumab: 1 mg/kg div day1, 15
28 days 1 course

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) Histologically diagnosed as adenocarcinoma (papillary adenocarcinoma, tubular adenocarcinoma, poorly differentiated adenocarcinoma), signet ring cell carcinoma, mucinous carcinoma, hepatoid adenocarcinoma.
2) Unresectable gastric cancer including esophago-gastric junctional cancer)
3) No massive ascites that needs drainage.
4) No brain metastasis
5) To be able to take oral intake
6) Aged 20 years or over
7) ECOG PS 0 or 1
8) One or more measurable lesions
9) Prior chemotherapy with fluoropyrimidine and platinum
10) Adequate organ function
1. Neutrophil count: 1,500/mm3 or above
2. Platelet count: 100,000/mm3 or above
3. Hemoglobin: 8.0 g/dL or above
4. AST(GOT):100 IU/L or less
5. ALT(GPT):100 IU/L or less
6. Total bilirubin: 1.5 mg/dL or less
7. Creatinin: 1.5 mg/dL or less
8. PT-INR: 1.5 or less
9. i. Urinary protein (-) or (1+)
ii. Urinary protein (2+) or more : Measure proteinuria for 24 hours and urinary protein 1g or less / 24 hour
11) Blood pressure under control
12) Written informed consent
Key exclusion criteria 1) Prior therapy with anti PD-1/PD-L1/CTLA-4 antibody or treatment targeting T cell
2) Chemotherapy within 14 days prior to enrollment
3) Treatment under investigation within 28 days prior to enrollment
4) Prednisolone 10mg or more/immunosuppressing therapy within 14 days prior to enrollment
5) Other active cancer
6) Active infecton
7) Fever of 38 Centigrade or above
8) Pregnancy
9) HBsAg+ or HCVAb+
10) HIV-1 Ab+ or HIV-2 Ab+ or HTLV-1 Ab+
11) Serious comorbidity
12) Consent to contraception
Target sample size 43

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takako Nakajima
Organization St. Marianna University School of Medicine Hospital
Division name Department of Clinical Oncology
Zip code
Address 2-16-1 Sugao Miyamae-ku Kawasaki Kanagawa
TEL 044-977-8111
Email tnakajima@marianna-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yumiko Kodaira
Organization St. Marianna University School of Medicine
Division name Department of Clinical Oncology
Zip code
Address 2-16-1 Sugao Miyamae-ku Kawasaki Kanagawa
TEL 044-977-8111
Homepage URL
Email y.kodaira@marianna-u.ac.jp

Sponsor
Institute St. Marianna University School of Medicine Hospital
Department of Clinical Oncology
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 NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 聖マリアンナ医科大学病院  腫瘍内科 
千葉県がんセンター 臨床試験推進部 
愛知県がんセンター中央病院 薬物療法部   
独立行政法人国立病院機構四国がんセンター 消化器内科  

Other administrative information
Date of disclosure of the study information
2017 Year 02 Month 03 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 Preinitiation
Date of protocol fixation
2017 Year 01 Month 20 Day
Date of IRB
Anticipated trial start date
2017 Year 02 Month 03 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
2017 Year 02 Month 01 Day
Last modified on
2017 Year 02 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029783

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.