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 2011/07/05 10:32:24

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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 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


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

Value
https://center6.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