UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A phase I trial of biweekly nab-paclitaxel plus ramucirumab in patients with previously treated advanced gastric cancer
Title of the study (Brief title)	Biweekly nab-paclitaxel plus ramucirumab in patients with previously treated advanced gastric cancer
Region	Japan

Condition
Condition	metastatic or recurrent gastric cancer
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The sefety of nab-paclitaxel plus ramucirumab combination as second line therapy in patients with advanced gastric cancer
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase I

Assessment
Primary outcomes	Maximum tolerated dose, recommended dose
Key secondary outcomes	adverse events, overall response rate, disease control rate

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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 is administered 100mg/m2 given intravenously in a 2-week cycle. Ramurcirumab is administered 8mg per body weight intravenously in a 2-week cycle.
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	80 years-old >
Gender	Male and Female
Key inclusion criteria	1)written informed consent got from the patient 2)patient who has histologically or cytologically confirmed gastric adenocarcinoma 3)patient who previously treated with fluorouracil regimens for advanced gastric cancer, and who is refractory or intolerant to them 4)patient with an ECOG Performance Status of between 0 and 1 5)patient is >=20 years old and <80 years old 6)patient who has a life expectancy of at least 90 days 7)patient who has adequate main organ functions in tests within 2 weeks before enrollment a)haemoglobin concentorarion >=8.0 g/dL b)white blood cell(WBC) count >=3,000/mm3 or neutrophil count >=1,500/mm3, and WBC count <=12,000/mm3 c)platelet count >=100,000/mm3 d)serum total bilirubin level <=one and a half times as many as average level baseline e)serum AST and ALT levels two and a half times as many as average level baseline f)serum creatinine <=1.5 mg/dL
Key exclusion criteria	1)patient with allergy of paclitaxel or ramucirumab 2)patient with contraindication for paclitaxel or ramucirumab 3)patient who had previously administered with paclitaxel as first line therapy 4)patient who has a serious infection 5)patient who has serious complications such as heart disease, respitary disorder, cerebrovascular disorder, liver disease and much ascites or pleural effusion 6)patient who has recieved chemotherapy within 2weeks 7)patient who has recieved therapy with blood products 8)patient with other malignat tumor 9)patient with neuropathy (>=grade 2) 10)patient with urinary protein (>=grade 2) 11)patient with brain symptomatic metastasis 12)patient who recieved with steroid 13)patient with psychic disorder 14)patient with pregnancy, lactating or possibility of pregnancy 15)patient who given a dicision of unsuitable for this study by the investigator
Target sample size	10

Research contact person
Name of lead principal investigator	Tetsuji Takayama
Organization	Institute of Biomedical Sciences, Tokushima University Graduate School
Division name	Gastroenterology and Oncology
Address	3-18-15 Kuramoto Tokushima-city, Tokushima Japan
TEL	088-633-7124
Email	takayama@tokushima-u.ac.jp

Public contact
Name of contact person	Tetsuji Takayama
Organization	Institute of Biomedical Sciences, Tokushima University Graduate School
Division name	Gastroenterology and Oncology
Address	3-18-15 Kuramoto Tokushima-city, Tokushima Japan
TEL	088-633-7124
Homepage URL
Email	takayama@tokushima-u.ac.jp

Sponsor
Institute	Tokushima University Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	None
Name of secondary funｄer(s)	None

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	徳島大学病院（徳島県）

Other administrative information
Date of disclosure of the study information	2016 Year 05 Month 23 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 05 Month 23 Day
Anticipated trial start date	2016 Year 05 Month 23 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 04 Month 17 Day
Last modified on	2016 Year 04 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025174