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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006095
Receipt No. 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

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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
Email 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
Email mifukuda258@nifty.com

Sponsor
Institute Lung Oncology Group in Kyusyu, Japan (LOGiK)
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007213

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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