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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000012862
Receipt No. R000015023
Scientific Title Efficacy and pharmacokinetics study of erlotinib in patients with non-small cell lung cancer
Date of disclosure of the study information 2014/01/16
Last modified on 2016/05/09

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Basic information
Public title Efficacy and pharmacokinetics study of erlotinib in patients with non-small cell lung cancer
Acronym Efficacy and pharmacokinetics study of erlotinib in patients with non-small cell lung cancer
Scientific Title Efficacy and pharmacokinetics study of erlotinib in patients with non-small cell lung cancer
Scientific Title:Acronym Efficacy and pharmacokinetics study of erlotinib in patients with non-small cell lung cancer
Region
Japan

Condition
Condition Advanced non-small cell lung cancer
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To determine the correlation between erlotinib pharmacokinetics and clinical response in non-small cell lung cancer
Basic objectives2 PK,PD
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Correlation between erlotinib exposure and clinical response
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) No prior therapy of EGFR-TKI
3) Administration of erlotinib is planned
4) EGFR gene mutation has been examined
5) Measurable lesions based on RECIST ver1.1
6) Aged 20 or more
7) Expected survival over 12 weeks
8) Adequate organ functions
9) Written informed consent
Key exclusion criteria Patients with interstitial pneumonitis identified by chest X-ray
Target sample size 70

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshiaki Takahashi
Organization Shizuoka cancer center
Division name Devision of Thoracic Oncology
Zip code
Address 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka 411-8777, Japan.
TEL (+81)055-989-5222
Email t.takahashi@scchr.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kenmotsu Hirotsugu
Organization Shizuoka cancer center
Division name Division of Thoracic Oncology
Zip code
Address 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka 411-8777, Japan.
TEL (+81)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

Other related organizations
Co-sponsor 1) Pharmaceutics, school of medicine, Keio University
2) RIKEN Center for Genomic Medicine
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

Other administrative information
Date of disclosure of the study information
2014 Year 01 Month 16 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 No longer recruiting
Date of protocol fixation
2013 Year 10 Month 15 Day
Date of IRB
Anticipated trial start date
2014 Year 03 Month 19 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Blood samples are collected before and 0,2,4,6,12 and 24 hour after Erlotinib Administration. Samples are collected before taking erlotinib.

Management information
Registered date
2014 Year 01 Month 15 Day
Last modified on
2016 Year 05 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015023

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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