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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000023783
Receipt No. R000026195
Scientific Title Pharmacokinetics and toxicity of irinotecan hydrochloride: effects of polymorphisms in transporter genes
Date of disclosure of the study information 2016/09/01
Last modified on 2016/08/26

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Basic information
Public title Pharmacokinetics and toxicity of irinotecan hydrochloride: effects of polymorphisms in transporter genes
Acronym PK/PD study of irinotecan hydrochloride.
Scientific Title Pharmacokinetics and toxicity of irinotecan hydrochloride: effects of polymorphisms in transporter genes
Scientific Title:Acronym PK/PD study of irinotecan hydrochloride.
Region
Japan

Condition
Condition malignant solid tumor (pancreatic cancer, colorectal cancer, gastric cancer, lung cancer, ovarian cancer,breast cancer, neuroendocrine carcinoma)
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 We elucidate the genetic polymorphism of the transporter and pharmacokinetics of the irinotecan hydrochloride and toxic relations.
Basic objectives2 PK,PD
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes We analyze genetic polymorphism of OATP1B1, ABCG2 and OATP2B1 and Pharmacokinetics/Pharmacodynamics of the irinotecan and metabolite and toxicity expression relations of the irinotecan hydrochloride.
Key secondary outcomes (1) We analyze about genetic polymorphism(OATP1B3, ABCB1, ABCC2 and CES2 which participates in activation of irinotecan, CYP3A4 which participates in inactivation of irinotecan) and a relation between PK/PD and toxicity.
(2) We analyze the genetic seasonal polymorphism to encode microRNA (miRNA) and the genetic polymorphism of an enzyme participating in processing of miRNA and PK/PD of the irinotecan hydrochloride and relations with the toxicity.
(3) We measure the plasma concentration of an internal compound becoming the OATP substrate and evaluate OATP inhibition by SN-38 and get grounds to estimate the interaction risk between the drug in the irinotecan hydrochloride dosage.
(4) We perform meta genome analysis of the enterobacterial flora and analyze a relation between toxicity of irinotecan hydrochloride (including the diarrhea) and enterobacterial flora.

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
75 years-old >=
Gender Male and Female
Key inclusion criteria 1) Aged 20 to <75 years at the time of informed consent.
2) Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1.
3) Patients who was not treated with the irinotecan hydrochloride in the past.
4) Patients with at least 3 months of life-expectancy.
5) Adequate organ function, evidenced by following laboratory results within 14 days prior to starting chemotherapy.
Absolute neutrophil count >= 1,500/mm3
Platelet count >= 100,000/mm3
Hemoglobin >= 8.5g/dL
AST and ALT <= 2.5 times the upper limit of normal(ULN) (<= 5 times the ULN if liver metastases are present)
Total bilirubin <= 1.5 times the ULN
6) Signed, written informed concent is obtained.
Key exclusion criteria 1) Severe active infection.
2) Sever diarrhea.
3) Gastrointestinal paresthesia and bowel obstruction.
4) Interstitial pneumonia, pulmonary fibrosis.
5) Jaundice.
6) Patient who need drainage of peritoneal, pleural or pericardial effusion.
7) Unstable angina, myocardial infarction or heart failure within 3 months.

8) Severe complication (e.g., uncontrollable diabetis mellitus, liver disease).
9) Serological positive for HBs-antigen or HCV-antibody.
10) Intestinal resection within 4 weeks prior to enrollment or colostomy within 2 weeks prior to enrollment.
11) Patients who received chemotherapy not to include irinotecan hydrochloride, or radiation therapy within two weeks.
12) Severe hypersensitivity to medicine.
13) Patients who has difficulty in getting the understanding for the study.
14) Pregnant or lactating women, or men and women without wanting pregnancy.
15) Patients who were judged inappropriate for the study.
Target sample size 100

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Yutaro Kubota
Organization Showa university school of medicine
Division name Department of internal medicine, Division of medical oncology
Zip code
Address 1-5-8 Hatanodai, Shinagawa-ku, Tokyo, Japan
TEL 03-3784-8402
Email yutaro1008@hotmail.co.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Yutaro Kubota
Organization Showa university school of medicine
Division name Department of internal medicine, Division of medical oncology
Zip code
Address 1-5-8 Hatanodai, Shinagawa-ku, Tokyo, Japan
TEL 03-3784-8402
Homepage URL
Email yutaro1008@hotmail.co.jp

Sponsor
Institute Showa university school of medicine
Institute
Department

Funding Source
Organization Showa University institute of molecular oncology
Showa University School of Medicine, Division of Medical Oncology, Department of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Drug Metabolism and Toxicology, Faculty of Pharmaceutical Sciences, Kanazawa University
Laboratory of Molecular Pharmacokinetics, Graduate School of Pharmaceutical Sciences, The University of Tokyo
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 昭和大学病院(東京都)
昭和大学江東豊洲病院(東京都)
昭和大学横浜市北部病院(神奈川)

Other administrative information
Date of disclosure of the study information
2016 Year 09 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 Preinitiation
Date of protocol fixation
2016 Year 06 Month 18 Day
Date of IRB
Anticipated trial start date
2016 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We analyze genetic polymorphism of OATP1B1, ABCG2 and OATP2B1 and Pharmacokinetics/Pharmacodynamics of the irinotecan and metabolite and toxicity expression relations of the irinotecan hydrochloride.

Management information
Registered date
2016 Year 08 Month 26 Day
Last modified on
2016 Year 08 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026195

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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