UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001001 |
|---|---|
| Receipt number | R000001207 |
| Scientific Title | Phase I study in the continual administration of BK-UM against HB-EGF for patients with advanced or recurrent ovarian cancer |
| Date of disclosure of the study information | 2008/02/04 |
| Last modified on | 2011/08/01 08:16:25 |
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Basic information
Public title
Phase I study in the continual administration of BK-UM against HB-EGF for patients with advanced or recurrent ovarian cancer
Acronym
Phase I study in the continual administration of BK-UM against HB-EGF for patients with recurrent ovarian cancer
Scientific Title
Phase I study in the continual administration of BK-UM against HB-EGF for patients with advanced or recurrent ovarian cancer
Scientific Title:Acronym
Phase I study in the continual administration of BK-UM against HB-EGF for patients with recurrent ovarian cancer
Region
| Japan |
Condition
Condition
Patients with recurrent ovarian cancer
Classification by specialty
| Obstetrics 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
Investigation of safety in continual administration of BK-UM in the same patient with recurrent ovarian cancer
Key secondary outcomes
1. Evaluation for efficacy of therapy
2. Screening the predictive markers for
efficacy of therapy
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 agent
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
| Not applicable |
Gender
Female
Key inclusion criteria
1. Patients who have been already
treated with BK-UM and have had no
serious adverse effects in clinical
trial using BK-UM (Phase I study).
2. Patients who have 0 or 1 grade as
performance status in ECOG.
3. Patients who have enough restoring poteintial to keep various organs ordinary coodition.
The data are acceptable within one week before the entry of clinical trial.
(1) WBC: more than 3000/mmm3
Neutrophil: more than 1000/mm3
(2) Platelet: more than 100,000/mm3
(3) Hemoglobin: more than 8.0 g/dl
(4) AST, ALT: more than 2.5 times of
normal limit in Fukuoka university
hospital (less than 5 times in a
patient with liver metastasis)
(5) Toal bilirubin: less than 1.5 mg/dl
(6) Serum creatinie: less than 1.5 mg/dl
(7) No difinite cardiac dysfunction
No abnormal finding in ECG: abnormal findings as follows: elevation of ST, abnormalities in T wave, low voltage in QRS, elogantion og QT, arrythmia(ventricular tachcardia, severe bradycardia, atrial-vetricular block)
(8) Patients who do not have morethan grade 3 in neurotoxicity.
4. Patients who agree to attending this clinical trial by theri own free will.
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 progression of disease in clinical
trial using BK-UM (Phase I study).
3. exclude the patients who have pregnancy or nursing or have possiblity to be pregnant
4. 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 University 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
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
kenji0715@adm.fukuoka-u.ac.jp
Sponsor or person
Institute
Fukuoka 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
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
Other administrative information
Date of disclosure of the study information
| 2008 | Year | 02 | Month | 04 | 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
Preinitiation
Date of protocol fixation
| 2008 | Year | 01 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 02 | 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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001207
