UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000001002
Receipt No. R000001202
Scientific Title Phase I study using BK-UM against HB-EGF for patients with advanced or recurrent ovarian cancer
Date of disclosure of the study information 2008/01/30
Last modified on 2011/08/01

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Phase I study using BK-UM against HB-EGF for patients with advanced or recurrent ovarian cancer
Acronym Phase I study using BK-UM for patients with recurrent ovarian cancer
Scientific Title Phase I study using BK-UM against HB-EGF for patients with advanced or recurrent ovarian cancer
Scientific Title:Acronym Phase I study using BK-UM for patients with recurrent ovarian cancer
Region
Japan

Condition
Condition Patients with recurrent ovarian cancer
Classification by specialty
Obsterics and gynecology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Safety
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I

Assessment
Primary outcomes Determination of the recomemded dose after analizing the dose limiting toxicity
Key secondary outcomes 1. Evaluation for efficacy of therapy
2. Screening the predictive markers for
efficacy of therapy
3. Pharmacokinetics

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 Anticancer agents
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 Female
Key inclusion criteria 1. Ovarian cancer or primary mesothelial cancer
2. 0 or 1 grade as performance status in ECOG.
3. Treated with taxian and platinum, and then recurrent.
4.Progression of the disease within 6 months after the day of final course in chemotherapy.
5. No effects of previous chemotherapy
6. Peritoneal fluid fulfill the criteria mentioned below;
(1)3cm of maximum width using CT scanning.
(2)more than 3 ml of peritoneal fluid with more than HB-EGF expression.
Or metastatic lesions in abdominal cavity with HB-EGF expression in blood.
7. Less than 0.1 U/ml of anti-diphtheria toxin antibody as a titer within 4 weeks before entry.
8. Fix the port into the abdomen
9. Keep various organs ordinary condition.
The data are acceptable within one week before the entry of clinical trial.
(1) WBC: > 3000/mmm3
Neutrophil: >1000/mm3
(2) Platelet: >100,000/mm3
(3) Hemoglobin: > 8.0 g/dl
(4) AST, ALT: < 2.5 times of
normal limit in Fukuoka university
hospital (< 5 times in a
patient with liver metastasis)
(5) Toal bilirubin: < 1.5 mg/dl
(6) Serum creatinie: < 1.5 mg/dl
(7) No difinite cardiac dysfunction
(8) <grade 2 in neurotoxicity.
10. 20 to 75 years old
11. Agree to attending this clinical trial
Key exclusion criteria 1. exclude the patients who have serious illness or suspect to have serious illness menthioned below
(1)exclude the patients who have ischemic heart diseases ro arrythmia to give medical treatment
(2)exclude the patients who have less than 50% in ejection fraction using echocardiogram
(3)exclude the patients who have cardiac dysfunction as grade III or IV of NYHA or have cardiac infarction within 6 months
(4)exclude the patients who have liver schirosis beyond medical control
(5)exclude the patients who need the oxigen supplement because of pulmonary intestitial pneumonitis or fiibrosis
(6) exclude the patients who need or do medical treatment for mental diseases
(7) exclude the patients who have serious diabetes beyond medical control
(8) exclude the patients who have ileus or subileus
(9)exclude the patients who have serious infection beyond medical control
2. exclude the patients who have previously had seriuos allergic sensitivity
3. exclude the patients who have pregnancy or nursing or have possiblity to be pregnant
4. exclude the patients who have previoursly had some anti-serum
5. exclude the patients who have serious other malignancy influenced on their survival
6. exclude the patients who have the agent used in other clinical trial within 4 weeks.
7. exclude the patients who are recognized as inadequate patients by doctors wth resposibility in this clinical trial
Target sample size 24

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shingo Miyamoto
Organization Fukuoka Univeristy Hospital
Division name Department of Obstetrics and Gynecology
Zip code
Address 45-1, 7-chome, Nanakuma, Jyounan-ku, Fukuoka city, Fukuoka perfecture
TEL 092-801-1011
Email

Public contact
Name of contact person
1st name
Middle name
Last name Kenji Yamaguchi
Organization Fukuoka University Hospital
Division name Clinical research assist center
Zip code
Address 45-1, 7-chome, Nanakuma, Jyounan-ku, Fukuoka city, Fukuoka perfecture
TEL 092-801-1011
Homepage URL
Email kenji0715@adm.fukuoka-u.ac.jp

Sponsor
Institute Fukuoka 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
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

Other administrative information
Date of disclosure of the study information
2008 Year 01 Month 30 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 Open public recruiting
Date of protocol fixation
2007 Year 11 Month 26 Day
Date of IRB
Anticipated trial start date
2007 Year 12 Month 01 Day
Last follow-up date
2011 Year 03 Month 01 Day
Date of closure to data entry
2011 Year 03 Month 01 Day
Date trial data considered complete
2011 Year 03 Month 01 Day
Date analysis concluded
2011 Year 06 Month 01 Day

Other
Other related information

Management information
Registered date
2008 Year 01 Month 30 Day
Last modified on
2011 Year 08 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001202

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.