UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000001002
Receipt number 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 08:16:48

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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

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

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 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


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

Value
https://center6.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