UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023783 |
|---|---|
| Receipt number | 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 17:08:18 |
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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
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
yutaro1008@hotmail.co.jp
Public contact
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
yutaro1008@hotmail.co.jp
Sponsor or person
Institute
Showa university school of medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026195
