UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016952 |
|---|---|
| Receipt number | R000019664 |
| Scientific Title | Evaluation of intraindividual variability in hepatic CYP3A4 enzyme activity using endogenous markers in lung cancer patients treated with chemotherapeutic drugs and aprepitant |
| Date of disclosure of the study information | 2015/03/27 |
| Last modified on | 2021/04/11 11:22:12 |
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Basic information
Public title
Evaluation of intraindividual variability in hepatic CYP3A4 enzyme activity using endogenous markers in lung cancer patients treated with chemotherapeutic drugs and aprepitant
Acronym
Evaluation of intraindividual variability in hepatic CYP3A4 enzyme activity using endogenous markers in lung cancer patients treated with chemotherapeutic drugs and aprepitant
Scientific Title
Evaluation of intraindividual variability in hepatic CYP3A4 enzyme activity using endogenous markers in lung cancer patients treated with chemotherapeutic drugs and aprepitant
Scientific Title:Acronym
Evaluation of intraindividual variability in hepatic CYP3A4 enzyme activity using endogenous markers in lung cancer patients treated with chemotherapeutic drugs and aprepitant
Region
| Japan |
Condition
Condition
Lung cancer patients treated with chemotherapeutic drugs and aprepitant
Classification by specialty
| Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To investigate intraindividual variability in hepatic CYP3A4 enzyme activity using endogenous markers in lung cancer patients treated with chemotherapeutic drugs and aprepitant
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
CYP3A endogenous markers
Key secondary outcomes
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
| Other |
Interventions/Control_1
Chemotherapeutic drugs and aprepitant to lung cancer
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Lung cancer patients
2)Patients aged > 20 years
3)PS(ECOG) of 0 to 2
4)Patients receiving 1st line chemotherapy to non-small cell lung cancer
5)Patients receiving highly emetogenic agent
6)Fulfill all following conditions
T.Bil < 1.5 mg/dL
AST (GOT) < 100 IU/L
ALT (GPT) < 100 IU/L
Cre < 1.5 mg/dL
SpO2 > = 90%
7)Written informed consent from the patients
Key exclusion criteria
1)Patients who required other chemotherapy
2)Patients who qre actively receiving inducer or inhibitor of CYP3A4
3)Patients who qre actively receiving androgen or estrogen preparation
4)Patients who qre actively receiving adrenal cortex hormone preparation without dexamethasone
5)Patients who qre actively receiving blood transfusion
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Hisakazu |
| Middle name | |
| Last name | Otani |
Organization
Keio University
Division name
Faculty of Pharmacy
Zip code
105-8512
Address
Shibakoen 1-5-30, Minatoku, Tokyo, Japan
TEL
03-5400-2493
ohtani-hs@pha.keio.ac.jp
Public contact
Name of contact person
| 1st name | Hideyuki |
| Middle name | |
| Last name | Hibino |
Organization
Keio University
Division name
Faculty of Pharmacy
Zip code
105-8512
Address
Shibakoen 1-5-30, Minatoku, Tokyo, Japan
TEL
03-5400-2493
Homepage URL
sun-light-field@z7.keio.jp
Sponsor or person
Institute
Keio University Faculty of Pharmacy
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
National Cancer Center Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University
Address
Shibakoen 1-5-30, Minatoku, Tokyo, Japan
Tel
03-5400-2493
skc-soumu@adst.keio.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
2014-140
Org. issuing International ID_1
National Cancer Center Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 03 | Month | 27 | 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
Completed
Date of protocol fixation
| 2015 | Year | 01 | Month | 06 | Day |
Date of IRB
| 2014 | Year | 09 | Month | 24 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 24 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 03 | Month | 27 | Day |
Last modified on
| 2021 | Year | 04 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019664
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