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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000002353
Receipt No. R000002890
Scientific Title dose finding study of irinotecan for UGT1A1 homozygnous group
Date of disclosure of the study information 2009/10/01
Last modified on 2013/03/26

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Basic information
Public title dose finding study of irinotecan for UGT1A1 homozygnous group
Acronym dose finding study of irinotecan for UGT1A1 homozygnous group
Scientific Title dose finding study of irinotecan for UGT1A1 homozygnous group
Scientific Title:Acronym dose finding study of irinotecan for UGT1A1 homozygnous group
Region
Japan

Condition
Condition gastric cancer,colorectal cancer,lung cancer,ovarian cancer,cervical cancer and
brest cancer
Classification by specialty
Not applicable
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To estimate optimum dose of irinotecan for UGT1A1 homozygous group
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes adverse events
Key secondary outcomes

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 Gene
Interventions/Control_1 Administraion of irinotecan is twice for 4 weeks . Adjusted dosage is determined from 100or125 mg/sqm in the heterozygous group .
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 Male and Female
Key inclusion criteria 1)Histologically confirmed cancer
2)Testing confirmed UGT1A1*28 and UGT1A1*6 polymorphisms
3)Having prior chemotherapy as standard regimens
4)No prior irinotecan containing treatment
5)Age:>=20 years old at wiritten informed concent
6)PS(ECOG):0 to 1
Key exclusion criteria 1)History of serious drug allergy
2)Active concomitant malignancy
3)Prior extensively irradiation for abdominal or bowel bone marrow
4)Symptomatic brain metastasis
5)Systemic continual use of steroids
6)Active infection
7)Persistent diarrhea (watery stool)
8)Intestinal obstraction or paralytic ileus
9)Interstitial pneumonia or pulmonary fibrosis
10)Massive pleural, pericardial effusion or asites that required drainage
11)Need to treatment with atazanavir sulfate
12)Uncontrolled diabetes mellitus
13)Heart disease deemed to unacceptable by diagnosis of cardiogram within the previous 28 days before enrollment
14)Psychological disease deemed to unacceptable for inclusion to the study
15)Pregnant or lactating women, couple wishing pregnant or no mind of prevent pregnancy
16)Other concominant medical condition deemed to inadequate for inclusion to the study
Target sample size 12

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hironobu Minami
Organization kobe University Hospital and Graduate School of Medicine
Division name Medical Oncology,Department of Medicine
Zip code
Address 7-5-2kusunoki-cho,chuo-ku,kobe,Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hideo Tomioka
Organization kobe University Hospital and Graduate School of Medicine
Division name Medical Oncology,Department of Medicine
Zip code
Address
TEL
Homepage URL
Email tomy705@med.kobe-u.ac.jp

Sponsor
Institute kobe University Hospital and Graduate School of Medicine
Institute
Department

Funding Source
Organization kobe University Hospital and Graduate School of Medicine
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

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
2009 Year 10 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
2009 Year 08 Month 18 Day
Date of IRB
Anticipated trial start date
2009 Year 10 Month 01 Day
Last follow-up date
2012 Year 09 Month 01 Day
Date of closure to data entry
2013 Year 03 Month 31 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 08 Month 20 Day
Last modified on
2013 Year 03 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002890

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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