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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000031285
Receipt No. R000035715
Scientific Title A phase II study of weekly nab-paclitaxel plus ramucirumab in patients with previously treated advanced gastric cancer
Date of disclosure of the study information 2018/02/14
Last modified on 2018/02/13

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Basic information
Public title A phase II study of weekly nab-paclitaxel plus ramucirumab in patients with previously treated advanced gastric cancer
Acronym weekly Nab-Paclitaxel+Ramucirumab for unresectable gastric cancer
Scientific Title A phase II study of weekly nab-paclitaxel plus ramucirumab in patients with previously treated advanced gastric cancer
Scientific Title:Acronym weekly Nab-Paclitaxel+Ramucirumab for unresectable gastric cancer
Region
Japan

Condition
Condition gastric cancer
Classification by specialty
Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate efficacy and safety of weekly nab-Paclitaxel plus Ramucirumab as 2nd line chemotherapy for unresectable gastric cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I,II

Assessment
Primary outcomes Progression-free survival (PFS)
Key secondary outcomes Overall survival (OS)
Response rate (RR)
Disease control rate (DCR)
Safety (Safety)
Relative dose intensity (RDI)

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 nab-Paclitaxel fixed dose
Ramcirmab fixed dose
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. Histopathologically confirmed gastric cancer.
2. Patients resisted first line chemotherapy consisted of fluoropyrimidine for unresectable or reccurent gastric cancer.
3. Patients with measurable lesions or evaluable lesions within 28 days before registration.
4. Patients with advanced/recurrent gastric cancer which are resistant to first line chemotherapy within 28 days before registration.
5. No influence of prior therapy.
6. PS 0-2
7. Age >=20
8. Expected more than 3 months survival
9. Adequate organ functions (within 14 days before registration)
Leu: >=3,000 /mm3, <=12,000 /mm3
Neu: >= 1,500 /mm3
Plt: >= 100,000 /mm3
Hemoglobin: >= 9.0 g/dL
ALT: <=ULNx2.5
AST: <=ULNx2.5
T-bil: =<1.5mg/dl
Scr: >= 1.5 mg/dl
10. With written informed consent
Key exclusion criteria 1. Patients with serious drug allergy
2. Patients with history of receiving paclitaxel treatment
3. Patients with infectious disease and febrile condition (over 38 centigrade)
4. Patiens with any other serious disease.
5. Patients with history of gastrointestinal perforation and fistula
6. Patients with venous thrombosis and fresh bleeding from intestinal tract.
7. Patients with serious heart disease
8. Presence of active multiple primaries. (Active multiple primaries is simultaneous or metachronous with disease-free interval of 5 years or more. But, carcinoma in situ and skin cancer which are judged to be recovery by medical treatment are excluded.)
9. Patients with peripheral neuropathy(=>Grade2)
10. Patients wit psychological illness
11. Pregnant or nursing female
12. Patient with brain metastasis.
13. Patient with mental illness
14. Not appropriate for the study at the physician's assessment
Target sample size 46

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroaki Nagano
Organization Yamaguchi University Graduate School of Medicine
Division name Department of Gastroenterological, Breast and Endocrine Surgeryy
Zip code
Address 1-1-1 Minamikokushi, Ube, Yamaguchi 755-8505, Japan
TEL 0836-22-2264
Email hnagano@yamaguchi-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Michihisa Iida
Organization Yamaguchi University Graduate School of Medicine
Division name Department of Gastroenterological, Breast and Endocrine Surgery
Zip code
Address 1-1-1 Minamikokushi, Ube, Yamaguchi 755-8505, Japan
TEL 0836-22-2264
Homepage URL
Email miida@yamaguchi-u.ac.jp

Sponsor
Institute Department of Gastroenterological, Breast and Endocrine Surgery,Yamaguchi University Graduate School of Medicine
Institute
Department

Funding Source
Organization Department of Gastroenterological, Breast and Endocrine Surgery,Yamaguchi University Graduate School of Medicine
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
2018 Year 02 Month 14 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
2018 Year 02 Month 09 Day
Date of IRB
Anticipated trial start date
2018 Year 02 Month 13 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
2018 Year 02 Month 13 Day
Last modified on
2018 Year 02 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035715

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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