UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006095 |
|---|---|
| Receipt number | R000007213 |
| Scientific Title | A phase I study of irinotecan for previously treated lung cancer patients with UGT1A1*28 or *6 polymorphism |
| Date of disclosure of the study information | 2011/08/01 |
| Last modified on | 2021/02/17 20:24:05 |
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Basic information
Public title
A phase I study of irinotecan for previously treated lung cancer patients with UGT1A1*28 or *6 polymorphism
Acronym
Irinotecan PI for UGT1A1*28*6 lung cancer
Scientific Title
A phase I study of irinotecan for previously treated lung cancer patients with UGT1A1*28 or *6 polymorphism
Scientific Title:Acronym
Irinotecan PI for UGT1A1*28*6 lung cancer
Region
| Japan |
Condition
Condition
lung cancer
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To determine the recommended dose of irinotecan for lung cancer patients with UGT1A1*28 or UGT1A1*6 polymorphism
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
recommended dose
Key secondary outcomes
dose limiting toxicity, maximum tolerated dose
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
Irinotecan
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
| Not applicable |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
histologically confirmed lung cancer
previously treated by agents except irinotecan
UGT1A1*28 or UGT1A1*6 polymorphism
PS 0-1
adequate organ function
written informed consent
Key exclusion criteria
Interstitial pneumonia detected by Chest X-ray
cardiac and pleural effusion, SVC syndrome, and brain metastasis for necessary treatment
active duplicative cancer for necessary chemotherapy
pregnant or possible pregnant women
difficult to attend study by psychiatric illness
high fever more than 38 degrees
severe complication (myocardial infarction within 3 months, difficult to control angina, heart failure, diabetes, and hypertension )
diarrhea
bowel paralysis or ileus
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Yukito |
| Middle name | |
| Last name | Ichinose |
Organization
National Kyusyu Cancer Center
Division name
Division of respiratory diseases
Zip code
811-1395
Address
3-1-1 Notame, Minami-ku, Fukuoka 811-1395, Japan
TEL
092-541-3231
yichinos@nk-cc.go.jp
Public contact
Name of contact person
| 1st name | Minoru |
| Middle name | |
| Last name | Fukuda |
Organization
Japanese red cross nagasaki genbaku hospital
Division name
Division of chemotherapy
Zip code
852-8511
Address
3-15 Mori-machi, Nagasaki, 852-8511, Japan
TEL
095-819-7779
Homepage URL
mifukuda258@nifty.com
Sponsor or person
Institute
Lung Oncology Group in Kyusyu, Japan (LOGiK)
Institute
Department
Personal name
Funding Source
Organization
Lung Oncology Group in Kyusyu, Japan (LOGiK)
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagasaki Genbaku Hospital
Address
3-15 mori, Nagasaki
Tel
095-847-1511
www.nagasaki-med.jrc.or.jp/
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
| 2011 | Year | 08 | Month | 01 | Day |
Related information
URL releasing protocol
https://onlinelibrary.wiley.com/doi/full/10.1111/1759-7714.12407
Publication of results
Published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/full/10.1111/1759-7714.12407
Number of participants that the trial has enrolled
4
Results
Four patients were enrolled in this trial. Two patients were determined to be ineligible. The remaining two patients, who belonged to group B, received an initial irinotecan dose of 60mg/m2, but did not complete the planned treatment because of diarrhea and leukopenia. Thus, in group B patients, 60mg/m2 was considered to be the MTD of irinotecan. The study was terminated in group A because of poor case recruitment.
Results date posted
| 2021 | Year | 02 | Month | 17 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2016 | Year | 10 | Month | 12 | Day |
Baseline Characteristics
63 male 28/- adeno
65 male 28/- small
Participant flow
Four patients were enrolled in this trial between December 2011 and November 2012. Two were eligible.
Adverse events
The only grade 3-4 hematological toxicity experienced by the patients was anemia, which occurred in the first patient.
Outcome measures
60mg/m2 is considered to be the MTD of irinotecan for previously treated lung cancer patients that are heterozygous for the UGT1A1*28 or UGT1A1*6 gene polymorphism.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2011 | Year | 04 | Month | 18 | Day |
Date of IRB
| 2011 | Year | 07 | Month | 28 | Day |
Anticipated trial start date
| 2011 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 08 | Month | 01 | Day |
Last modified on
| 2021 | Year | 02 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007213
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
