UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002353 |
|---|---|
| Receipt number | 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 09:38:36 |
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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
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
tomy705@med.kobe-u.ac.jp
Sponsor or person
Institute
kobe University Hospital and Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002890
