UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012862
Receipt number 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 19:06:08

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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 or person

Institute

Shizuoka cancer center

Institute

Department

Personal name



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

Value
https://center6.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