UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000013388
Receipt number R000013307
Scientific Title Investigation of interindividual factors in erlotinib and its metabolites pharmacokinetics, clinical responses and adverse reactions in Japanese non-small cell lung cancer patients receiving oral erlotinib.
Date of disclosure of the study information 2014/03/12
Last modified on 2014/03/11 09:34:40

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Basic information

Public title

Investigation of interindividual factors in erlotinib and its metabolites pharmacokinetics, clinical responses and adverse reactions in Japanese non-small cell lung cancer patients receiving oral erlotinib.

Acronym

Investigation of interindividual factors in erlotinib and its metabolites pharmacokinetics, clinical responses and adverse reactions in Japanese non-small cell lung cancer patients receiving oral erlotinib.

Scientific Title

Investigation of interindividual factors in erlotinib and its metabolites pharmacokinetics, clinical responses and adverse reactions in Japanese non-small cell lung cancer patients receiving oral erlotinib.

Scientific Title:Acronym

Investigation of interindividual factors in erlotinib and its metabolites pharmacokinetics, clinical responses and adverse reactions in Japanese non-small cell lung cancer patients receiving oral erlotinib.

Region

Japan


Condition

Condition

non-small cell lung cancer

Classification by specialty

Pneumology Chest surgery

Classification by malignancy

Malignancy

Genomic information

YES


Objectives

Narrative objectives1

This study evaluates the plasma dispositions of erlotinib and OSI-420, a major metabolite of erlotinib, and the clinical response to erlotinib based on the genetic variants of drug metabolizing enzymes and transporters in non-small cell lung cancer patients receiving oral erlotinib.

Basic objectives2

PK,PD

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Trough plasma concentrations of erlotinib and OSI-420 before dosing on day 8 or later

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1. Patients receiving oral erlotinib to non-small cell lung cancer
2. Patients receiving written informed consent

Key exclusion criteria

1. Patients discontinued receiving treatment of oral erlotinib
2. Patients having severe kidney dysfunction or liver dysfunction
3. Patients who are judged by physicians as inappropriate for study enrollment

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Junichi Kawakami

Organization

Hamamatsu University School of Medicine

Division name

Department of Hospital Pharmacy

Zip code


Address

1-20-1 Handayama, Hamamatsu, Shizuoka 431-3192, Japan

TEL

053-435-2623

Email

pharmacyham-adm@umin.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Takafumi Naito

Organization

Hamamatsu University School of Medicine

Division name

Department of Hospital Pharmacy

Zip code


Address

1-20-1 Handayama, Hamamatsu, Shizuoka 431-3192, Japan

TEL

053-435-2623

Homepage URL


Email

pharmacyham-adm@umin.ac.jp


Sponsor or person

Institute

Department of Hospital Pharmacy
Hamamatsu University School of Medicime

Institute

Department

Personal name



Funding Source

Organization

Department of Hospital Pharmacy
Hamamatsu University School of Medicime

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



Other administrative information

Date of disclosure of the study information

2014 Year 03 Month 12 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

Enrolling by invitation

Date of protocol fixation

2010 Year 11 Month 19 Day

Date of IRB


Anticipated trial start date

2011 Year 01 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

To evaluate the plasma dispositions of and the clinical response to
erlotinib and its active metabolites based on the cachexia stage and genetic variants of drug metabolizing enzymes and drug transporters and drug receptors


Management information

Registered date

2014 Year 03 Month 11 Day

Last modified on

2014 Year 03 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013307


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name