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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000015812
Receipt No. R000018397
Scientific Title 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.
Date of disclosure of the study information 2015/01/15
Last modified on 2016/04/13

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Basic information
Public title 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.
Acronym Phase I/II study of BK-UM and Paclitaxel combination therapy as second line treatment in gastric cancer with peritoneal metastasis refractory.
Scientific Title 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.
Scientific Title:Acronym 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

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

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
1st name
Middle name
Last name Eiji Oki
Organization Kyushu University Hospital
Division name Gastrointestinal Surgery (2)
Zip code
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
1st name
Middle name
Last name Makiko Uchiyama
Organization Kyusyu University
Division name Center for Clinical and Translational Research
Zip code
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

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)

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 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

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 Terminated
Date of protocol fixation
2014 Year 12 Month 01 Day
Date of IRB
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

Other
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

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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