UMIN-CTR Clinical Trial

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