UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase I/II study of HB-EGF-specific inhibitor BK-UM plus weekly paclitaxel therapy in gastric cancer with peritoneal metastasis after failure of first line treatment.
Title of the study (Brief title)	Phase I/II study of BK-UM and Paclitaxel combination therapy as second line treatment in gastric cancer with peritoneal metastasis refractory.
Region	Japan

Condition
Condition	advanced and/or recurrent gastric cancer with peritoneal metastasis
Classification by specialty	Gastroenterology Hematology and clinical oncology Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	One-year overall survival
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase I,II

Assessment
Primary outcomes	One-year progression-free survival
Key secondary outcomes	1)response rate 2)Exploration of biomarker predicting treatment response 3)Safty

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	BK-UM+Paclitaxel
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	75 years-old >
Gender	Male and Female
Key inclusion criteria	1)Patients with histologically proven gastric adenocarcinoma. 2)Patients with unresectable gastric cancer or recurrent gastric cancer. 3)Patients with peritoneal metastasis. 4)ECOG performance status: 0-2 grade. 5)Patients with satisfy any or all of the following items. 1.Tumor progression during 5-FU contained adjuvant chemotherapy or within 24 weeks after adjuvant chemotherapy. 2.Tumor progression during 5-FU contained chemotherapy or within 4 weeks after prior chemotherapy which continued at least 4 weeks. 6)Patients who can place a port into the abdominal cavity. 7)Patients with following adequate organ function. 1.WBC: >= 3,000/ mm3 Neutrophil: >= 1,000/ mm3 <=12,000/ mm3 2.Platelet: >= 100,000/ mm3 3.Hemoglobin: >= 8.0 g/dL 4.AST, ALT: <=100 IU/mL 5.Total biirubin: <=1.5 mg/dL 6.Serum creatinine: <=1.5 mg/dL 7.serum creatinine <=1.5 mg/dL 8.CRP <=10mg/dL 9.Patient without cardiovascular disease requiring continuous treatment. 10.Patient without the neuropathy more than grade 3. 8)Age:20 years old or older, and under 75 years old. 9)Patients without the prior of chemotherapy or the radiotherapy for other malignant disease. 10)Patients who agree with attend this clinical trial by their own will.
Key exclusion criteria	1)Patients who have serious illness or suspect to have serious illness. 2)Patients with serious drug hypersensitivity. 3)Pregnant women, nursing mothers, or patients with chance of pregnancy. 4)Patients with a history of antiserum use 5)Patients with HBsAg-positive or HCVAb-positive. 6)Patients with a history of taxane use. 7)Patients with symptomatic central nervous system metastasis. 8)Patients with large amounts of pleural effusion. 9)Patients with chemotherapy untreatable large amounts ascites. 10)Patient with synchronous or metachronous malignancies within 5 years. 11)Patients within 14 days from prior chemotherapy on the first treatment day. 12)Patients who received the blood transfusion within 21 day from registration. 13)Patients who received the other investigational drug 28 days before agreement. 14)Patients have received BK-UM treatment. 15)Patients who is judged inappropriate for the entry into this study by the principal investigator or sub investigators.
Target sample size	42

Research contact person
Name of lead principal investigator	Eiji Oki
Organization	Kyushu University Hospital
Division name	Gastrointestinal Surgery (2)
Address	3-1-1, Maidashi, Higashi-ku,
TEL	092-642-5464
Email	okieiji@surg2.med.kyushu-u.ac.jp

Public contact
Name of contact person	Makiko Uchiyama
Organization	Kyusyu University
Division name	Center for Clinical and Translational Research
Address	3-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582, JAPAN
TEL	092-642-6291
Homepage URL
Email	bkum@med.kyushu-u.ac.jp

Sponsor
Institute	Kyushu 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	Japan Science and Technology agency
Organization
Division
Category of Funding Organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	The research foundation for Microbial Diseases of Osaka University
Name of secondary funｄer(s)

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	九州大学病院（福岡県）、福岡大学病院（福岡県）、済生会福岡総合病院（福岡県）、九州医療センター（福岡県）、九州がんセンター（福岡県）、神戸市立医療センター中央市民病院（兵庫県）、愛知県がんセンター中央病院（愛知県）、東京大学医科学研究所附属病院（東京都）

Other administrative information
Date of disclosure of the study information	2015 Year 01 Month 15 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2014 Year 12 Month 01 Day
Anticipated trial start date	2015 Year 03 Month 05 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	2014 Year 12 Month 01 Day
Last modified on	2016 Year 04 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018397