UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015812 |
|---|---|
| Receipt number | 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 21:30:48 |
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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
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
bkum@med.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018397
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