UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003723 |
|---|---|
| Receipt number | R000004504 |
| Scientific Title | Investigation of influence of genetic polymorphisms of drug metabolizing enzymes and transporters, including SLCO1B3 and ABCC2, on Docetaxel Pharmacokinetics in advanced Non Small Cell Lung Cancer Patients |
| Date of disclosure of the study information | 2010/06/07 |
| Last modified on | 2025/12/18 19:03:05 |
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Basic information
Public title
Investigation of influence of genetic polymorphisms of drug metabolizing enzymes and transporters, including SLCO1B3 and ABCC2, on Docetaxel Pharmacokinetics in advanced Non Small Cell Lung Cancer Patients
Acronym
influence of polymorphisms of drug metabolizing enzymes and transporters on Docetaxel Pharmacokinetics
Scientific Title
Investigation of influence of genetic polymorphisms of drug metabolizing enzymes and transporters, including SLCO1B3 and ABCC2, on Docetaxel Pharmacokinetics in advanced Non Small Cell Lung Cancer Patients
Scientific Title:Acronym
influence of polymorphisms of drug metabolizing enzymes and transporters on Docetaxel Pharmacokinetics
Region
| Japan |
Condition
Condition
Non-Small Cell Lung Cancer
Classification by specialty
| Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To describe the population pharmacokinetics of docetaxel in patients with NSCLC, and assess the relationship between docetaxel disposition and genetic polymorphisms , including SLCO1B3 and ABCC2.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
the relation between genetic polymorphisms and docetaxel pharmacokinetics
Key secondary outcomes
the association between polymorphisms and toxicity in NSCLC patients receiving docetaxel chemotherapy
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Histologically or cytologically confirmed NSCLC
2)Patients with progression or recurrence after platinum-doublet chemotherapy or patients who cannot tolerate first-line platinum-doublet chemotherapy
3)20 years of age or older
4)Presence of at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria
5)Performance Status (ECOG) 0-2
6)Patients who are able to stay in hospital at least for the first two weeks of therapy in principle
7)Adequate organ function obtained within 2 weeks prior to registration. Laboratory values must be as follows;
WBC count >= 3,000 /mm3, and <= 12,000 /mm3
absolute neutrophil count >= 1,500 /mm3, and <= 5,000 /mm3
platelet count >= 100,000 /mm3
hemoglobin >= 9.0 g/dL
AST(SGOT)/ALT(SGPT) <= 2 X institutional upper limit of normal
Total bilirubin less than or equal to 1.5 mg/dL
serum creatinine within 1.5 times the upper limit of normal
SpO2 greater than or equal to 90 % in room air
8) Estimated life expectancy more than 3 months
9) No prior chemotherapy within 4 weeks before enrollment
No prior thoracic radiotherapy within 12 weeks and no prior radiotherapy for metastatic lesions within 2 weeks before enrollment
No prior surgery within 4weeks before enrollment
10) Signed informed consent
Key exclusion criteria
1)History of poorly controlled pleural effusion, pericardial effusion and ascites.
2)Active infection
3)Previous severe drug allergy
4)Hoped to be pregnant/nursing.
5)Symptomatic brain metastasis
6)Active concomitant malignancy
7)History of poorly controlled diabetes mellitus
8)History of severe complicating disease
9)simultaneous use of other anti-cancer drugs
10)Those judged to be not suitable by the attending physician
11)History of bone-marrow transplantation
12)Those who received a white blood cell transfusion within 30 days before registration
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yoichi |
| Middle name | |
| Last name | Nakanishi |
Organization
Kyushu University
Division name
Research institute for diseases of the chest
Zip code
812-8582
Address
Fukuoka city HIgashi-ku Maidashi 3-1-1
TEL
092-642-5378
shiraishi.yoshimasa.258@m.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoshimasa |
| Middle name | |
| Last name | Shiraishi |
Organization
Kyushu University
Division name
Research institute for diseases of the chest
Zip code
812-8582
Address
Maidashi 3-1-1, HIgashi-ku, Fukuoka city
TEL
092-642-5378
Homepage URL
shiraish@kokyu.med.kyushu-u.ac.jp
Sponsor or person
Institute
Research institute for diseases of the chest, Kyushu University
Institute
Department
Personal name
Funding Source
Organization
Research institute for diseases of the chest, Kyushu University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Boards / Ethics Committees of Kyushu University
Address
Maidashi 3-1-1, HIgashi-ku, Fukuoka city, Fukuoka, Japan
Tel
0926426772
ijkseimei@jimu.kyushu-u.ac.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
九州大学病院呼吸器科
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 06 | Month | 07 | Day |
Related information
URL releasing protocol
None
Publication of results
Published
Result
URL related to results and publications
https://link.springer.com/article/10.1007/s00280-016-3157-9
Number of participants that the trial has enrolled
47
Results
A three-compartment model was employed to describe PK data, and the PK model adequately described the docetaxel concentrations observed. Serum albumin (ALB) was detected as a covariate of clearance. The covariate selection indicated that a1-acid glycoprotein (AAG) was a predictor of neutropenia. The model-based simulation also showed that ALB and AAG negatively correlated with the development of neutropenia and that the time course of neutrophil counts was predictable.
Results date posted
| 2025 | Year | 12 | Month | 18 | Day |
Results Delayed
Results Delay Reason
I had forgotten.
Date of the first journal publication of results
| 2016 | Year | 10 | Month | 05 | Day |
Baseline Characteristics
47 Japanese patients with progressive or recurrent NSCLC scheduled to initiate docetaxel monotherapy
Participant flow
Obtain written consent from participants prior to treatment initiation.
Adverse events
No adverse events related to the research were reported.
Outcome measures
Blood samples will be collected at each time point to measure the blood concentration of docetaxel.
Evaluate the pharmacokinetics of docetaxel.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2009 | Year | 06 | Month | 30 | Day |
Date of IRB
| 2009 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2009 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Patients with platinum-refractory non-small cell lung carcinoma or patients who cannot tolerate platinum-doublet chemotherapy are administered single agent docetaxel chemotherapy (standard therapy). Blood samples are collected before and 0, 0.17, 1, 5, 10 and 24 hours after Docetaxel infusion.
Management information
Registered date
| 2010 | Year | 06 | Month | 07 | Day |
Last modified on
| 2025 | Year | 12 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004504
