UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009923 |
|---|---|
| Receipt number | R000011548 |
| Scientific Title | Phase II Trial of BK-UM against HB-EGF in combination with Gemcitabine in Patients with advanced or recurrent ovarian cancer |
| Date of disclosure of the study information | 2013/03/01 |
| Last modified on | 2015/08/03 10:29:29 |
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Basic information
Public title
Phase II Trial of BK-UM against HB-EGF in combination with Gemcitabine in Patients with advanced or recurrent ovarian cancer
Acronym
Phase II Trial of BK-UM against HB-EGF in combination with Gemcitabine
Scientific Title
Phase II Trial of BK-UM against HB-EGF in combination with Gemcitabine in Patients with advanced or recurrent ovarian cancer
Scientific Title:Acronym
Phase II Trial of BK-UM against HB-EGF in combination with Gemcitabine
Region
| Japan |
Condition
Condition
Patients with advanced or recurrent ovarian cancer (include fallopian tube cancer and peritoneal cancer)
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Safety and Efficacy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
progression-free survival rate
Key secondary outcomes
1) observation of curative effect
2) Exploration of biomarker predicting curative effect
3) Plasma CRM197 concentration, plasma gemcitabine concentration (confirmation of the accumulation)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
BK-UM+gemcitabine
Interventions/Control_2
Gemcitabine
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
Female
Key inclusion criteria
1)Patients who are histologically proved ovarian cancer, fallopian tube cancer or peritoneal cancer.
2)ECOG performance status: 0-2 grade.
3)Patients who are platinum-containing drug resistant.
4)Patients with a history of the taxanes (paclitaxel or docetaxel) use.
5)The patient who satisfy any or all of the following items.
1.Patients who have measurable lesions meeting RECIST guideline.
2.Patients who have immeasurable lesions by diagnostic imaging and who have CA125 > 70.
6)Patients who do not have a history of gemcitabine use.
7)Patients who passed in the period when the current chemotherapy does not have any effects.
8)Patients who have ascites or intra-abdominal dissemination/metastasis.
9)Patient who can place a port into the abdominal cavity.
10)Patients who have the acceptable data within 2 weeks before the entry of the clinical trial.
1.WBC: > 3,000/microl Neutrophil > 1,000/microl
2.Platelet: > 100,000/microl
3.Hemoglobin: > 8.0 g/dl
4.AST, ALT: < 100 U/l (IU/l)
5.Total biirubin: < 1.5 mg/dl
6.Serum creatinine: < 1.5 mg/dl
7.No definite cardiac dysfunction: abnormal findings as follows: ST segment elevation, T-wave abnormality, low voltage in QRS, long QT syndrome, arrhythmia (ventricular tachycardia, severe bradycardia, atrioventricular block).
8.Patient without the neuropathy more than grade3.
11)Age: 20 years old or older, and under 75 years old.
12)Patients who agree to attend this clinical trial by their own will.
Key exclusion criteria
1)Patient who have metastasis except for abdominal cavity or have the liver metastasis.
2)Patients who have serious illness or suspect to have serious illness mentioned below.
1.Patients with coronary heart disease or arrhythmia to need treatment.
2.Patient with left ventricle ejection fraction less than 50% in echocardiogram.
3.Patients who have cardiac dysfunction as grade III or IV of NYHA or have cardiac infarction within 6 months.
4. patient with pulmonary embolism.
5.Patients with decompensated cirrhosis.
6.Patients with interstitial pneumonia or pulmonary fibrosis, that is confirmed by chest X-ray and is associated with clinical symptoms.
7.The patients who need psychotic therapy or who take psychiatric medication.
8.Patients with poorly-controlled diabetes.
9.Patients with ileus or subileus.
10.Patients with active or poorly-controlled serious infection.
11.Patients with myelosuppression.
3)Patients with serious drug hypersensitivity.
4)Pregnant women, nursing mothers, or patients with chance of pregnancy.
5)Patients with a history of antiserum use.
6)Patient with multiple malignancies or with those history 5 years before agreement.
7)The patient who have a history of deferred treatment more than 6 weeks by hematotoxicity caused by the taxanes or the platinums use.
8)Patients who received the investigational drug 4 weeks before agreement.
9)Patients with a history of BK-UM use.
10)Patients undergoing radiation therapy to chest.
11)The patient that principal investigator or sub investigators judged the participation in this clinical trial to be inappropriate.
Target sample size
64
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shingo Miyamoto |
Organization
Fukuoka University Hospital
Division name
Department of Obstetrics and Gynecology
Zip code
Address
45-1, 7-chome, Nanakuma, Jyounan-ku, Fukuoka
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Osaka University Hospital
Division name
Department of Medical Innovation
Zip code
Address
2-15, Yamadaoka, Suita, Osaka
TEL
Homepage URL
Sponsor or person
Institute
Osaka University
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
福岡大学病院（福岡県）、大阪大学医学部附属病院（大阪府）、東京大学医科学研究所附属病院（東京都）、東北大学病院（宮城県）、北海道大学病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 03 | Month | 01 | 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
| 2013 | Year | 01 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 05 | Month | 15 | 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
| 2013 | Year | 02 | Month | 01 | Day |
Last modified on
| 2015 | Year | 08 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011548
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