UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Pharmacokinetics and pharmacodymanics study of doctaxel in patients with non-small cell lung cancer
Title of the study (Brief title)	PK/PD study of doctaxel in patients with NSCLC
Region	Japan

Condition
Condition	Advanced non-small cell lung cancer
Classification by specialty	Pneumology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To determine the relationship between free plasma concentration of docetaxel and age
Basic objectives2	PK,PD
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Correlation between unbound docetaxel concentration and age
Key secondary outcomes

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) Pathologically confirmation of non small cell lung cancer 2) Administration of docetaxel is planned 3) Aged 20 or more 4) Written informed consent
Key exclusion criteria	Patients with interstitial pneumonitis identified by chest X-ray
Target sample size	50

Research contact person
Name of lead principal investigator	Toshiaki Takahashi
Organization	Shizuoka cancer center
Division name	Division of Thoracic Oncology
Address	1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka 411-8777, Japan.
TEL	055-989-5222
Email	t.takahashi@scchr.jp

Public contact
Name of contact person	Hirotsugu Kenmotsu
Organization	Shizuoka cancer center
Division name	Division of Thoracic Oncology
Address	1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka 411-8777, Japan.
TEL	055-989-5222
Homepage URL
Email	h.kenmotsu@scchr.jp

Sponsor
Institute	Shizuoka cancer center
Institute
Department

Funding Source
Organization	Shizuoka cancer center
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Pharmaceutics, school of medicine, Keio University
Name of secondary funｄer(s)

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	静岡県立静岡がんセンター(静岡県)

Other administrative information
Date of disclosure of the study information	2014 Year 07 Month 31 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2014 Year 03 Month 05 Day
Anticipated trial start date	2014 Year 08 Month 11 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information	Blood sampling for pharmacokinetic analysis was carried out before an infusion, at the end of the docetaxel infusion, and 3 points before 24 h after the end of infusion.

Management information
Registered date	2014 Year 07 Month 29 Day
Last modified on	2018 Year 01 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017088