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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000003723
Receipt No. 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 2011/07/05

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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
Middle name
Last name Nakanishi Yoichi
Organization Kyushu University
Division name Research institute for diseases of the chest
Zip code
Address Fukuoka city HIgashi-ku Maidashi 3-1-1
TEL 092-642-5378
Email

Public contact
Name of contact person
1st name
Middle name
Last name Shiraishi Yoshimasa
Organization Kyushu University
Division name Research institute for diseases of the chest
Zip code
Address Maidashi 3-1-1, HIgashi-ku, Fukuoka city
TEL 092-642-5378
Homepage URL
Email shiraish@kokyu.med.kyushu-u.ac.jp

Sponsor
Institute Research institute for diseases of the chest, Kyushu University
Institute
Department

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
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 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
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 Open public recruiting
Date of protocol fixation
2009 Year 06 Month 30 Day
Date of IRB
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
2011 Year 07 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004504

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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