UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004703
Receipt number R000005600
Scientific Title Plasma and cerebrospinal fluid concentrations treated with daily dose and high dose weekly erlotinib in non-small cell lung cancer patients with central nervous system metastases
Date of disclosure of the study information 2010/12/10
Last modified on 2017/05/26 16:30:02

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Basic information

Public title

Plasma and cerebrospinal fluid concentrations treated with daily dose and high dose weekly erlotinib in non-small cell lung cancer patients with central nervous system metastases

Acronym

CSF concentrations treated with high dose weekly erlotinib in patients with CNS metastases

Scientific Title

Plasma and cerebrospinal fluid concentrations treated with daily dose and high dose weekly erlotinib in non-small cell lung cancer patients with central nervous system metastases

Scientific Title:Acronym

CSF concentrations treated with high dose weekly erlotinib in patients with CNS metastases

Region

Japan


Condition

Condition

central nervous system metastases of non-small cell lung cancer with active EGFR mutations treated with daily dosing erlotinib

Classification by specialty

Pneumology Hematology and clinical oncology Adult

Classification by malignancy

Malignancy

Genomic information

YES


Objectives

Narrative objectives1

PK/PD analyses of plasma and CSF in patients treated with daily dosing and high dose weekly erlotinib

Basic objectives2

PK,PD

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

relation of clinical efficacy and CSF penetration rate of erlotinib

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

erlotinib: 150mg daily
Failure with CNS metastases: 1500 mg weekly

erlotinib: 150mg daily
PK/PD analyses in day8 and in day15

erlotinib: 1500mg weekly
PK/PD analyses in day8

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.non-small cell lung cancer
2.nervous system metastases
3.active EGFR mutations
4.obtained informed consents

Key exclusion criteria

1.IIPs
2.drug hypersensitivity reaction
with gefitinib or erlotinib
3.high risk of brain herniation by lumbar puncture
4.unsuitable for treatment

Target sample size

10


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shinzoh Kudoh

Organization

Osaka City University

Division name

Department of Respiratory medicine

Zip code


Address

1-4-3 Asahimachi Abenoku Osaka Japan

TEL

06-6645-3916

Email

kimutats@med.osaka-cu.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Tatsuo Kimura

Organization

Osaka City University

Division name

Department of Respiratory medicine

Zip code


Address

1-1-43, Abenosuji, abeno-ku, Osaka 545-6090 JAPAN

TEL

06-6645-3916

Homepage URL


Email

kimutats@med.osaka-cu.ac.jp


Sponsor or person

Institute

Osaka City University

Institute

Department

Personal name



Funding Source

Organization

Osaka City 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

大阪市立大学


Other administrative information

Date of disclosure of the study information

2010 Year 12 Month 10 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

Terminated

Date of protocol fixation

2010 Year 12 Month 10 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



Management information

Registered date

2010 Year 12 Month 10 Day

Last modified on

2017 Year 05 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005600


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name