UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000002861
Receipt number R000003492
Scientific Title A phase II study of erlotinib for patients with pretreated non-small cell lung cancer with brain metastasis and sensitive EGFR mutations.
Date of disclosure of the study information 2009/12/08
Last modified on 2013/01/30 13:34:18

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Basic information

Public title

A phase II study of erlotinib for patients with pretreated non-small cell lung cancer with brain metastasis and sensitive EGFR mutations.

Acronym

A phase II study of erlotinib for patients with pretreated non-small cell lung cancer with brain metastasis and sensitive EGFR mutations.

Scientific Title

A phase II study of erlotinib for patients with pretreated non-small cell lung cancer with brain metastasis and sensitive EGFR mutations.

Scientific Title:Acronym

A phase II study of erlotinib for patients with pretreated non-small cell lung cancer with brain metastasis and sensitive EGFR mutations.

Region

Japan


Condition

Condition

Non-small cell lung cancer

Classification by specialty

Pneumology Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

YES


Objectives

Narrative objectives1

To investigate efficacy and safety of Erlotinib for patients with pretreated non-small cell lung cancer with brain metastasis and sensitive EGFR mutations.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

Response rate

Key secondary outcomes

Efficacy for brain metastasis,
Disease Control Rate,
Progression Free Survival,
Overall Survival,
Evaluation of safety


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 monotherapy

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)Non-small cell lung cancer proven by histology and/or cytology
2)Recurrent non-small cell lung cancer already treated with at least one regimens of chemotherapy
3)Patients having EGFR mutation (exon 19 deletion or L858R)
4)No prior treatment with EGFR-TKIs
5)Patients who have at least one measurable lesion, one must be brain lesion, by RECIST.
In the case Stereotactic irradiation such as gammma knives is eligible, those treatment can be priority. After those treatmen, patients are eligible if the measurable brain lesion still remain.
6)Performance status(ECOG):0-3
7)Able to be intensely monitored at least for 2 weeks
8)Patients aged 20 years or older
9)Adequate organ functions, evaluated within 2 weeks before enrollment, as;
a) WBC >= 3,000/mm3
b) Netrophile >= 1,500/mm3
c) Plt >= 100,000/mm3
d) AST/ALT, x 2 of upper limit of normal or less.
e) T. Bil <= 1.5 g/dL
f) Serum creatinine, x 1.5 of upper limit of normal or less.
g) SpO2 >= 90% as room air
10)Patients are excepted to live over 8 weeks.
11)Written informed consent is required to obtain from each patients at each participating institution

Key exclusion criteria

Patients with at least one of the following conditions are ineligible
1) Patients with idiopathic pulmonary fibrosis, other interstitial pneumonia, pneumoconiosis, active radiation pneumonitis, drug induced pulmonary damage
2)Patients with pleural effusion, ascites and/or pericardial effusion requiring drainage
3)Patients with infection requiring iv administration of antibiotics and/or antifungal agents
4)Patients who has received HER modulator medicine in the past
5)Patients unable to be treated with PO drugs
6) Clinically significant eye diseases such as severe dry eye, keratoconjunctivitis
7)Pregnant or breast feeding
8) Active synchronous malignancies
9) Uncontrolled diabetes mellitus
10)Other clinically significant complications
11)Patients judged as being in inappropriate condition for this study by physician

Target sample size

24


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takashi Eto

Organization

Shizuoka General Hospital

Division name

Respiratory center

Zip code


Address

27-1, 4-chome, Kitaandou, Aoi-ku, Shizuoka Japan

TEL

054-247-6111

Email



Public contact

Name of contact person

1st name
Middle name
Last name Yuichirou Shishido

Organization

Shizuoka General Hospital

Division name

Respiratory medicine

Zip code


Address

27-1, 4-chome, Kitaandou, Aoi-ku, Shizuoka Japan

TEL

054-247-6111

Homepage URL


Email

shishido@general-hosp.pref.shizuoka.jp


Sponsor or person

Institute

Shizuoka General Hospital Respiratory center

Institute

Department

Personal name



Funding Source

Organization

Shizuoka General Hospital

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

Shizuoka Cancer Center Division of Thoracic Oncology

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

静岡県立総合病院(静岡県)、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

2009 Year 12 Month 08 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

Open public recruiting

Date of protocol fixation

2009 Year 08 Month 30 Day

Date of IRB


Anticipated trial start date

2009 Year 08 Month 01 Day

Last follow-up date

2011 Year 09 Month 01 Day

Date of closure to data entry

2013 Year 01 Month 30 Day

Date trial data considered complete

2013 Year 01 Month 30 Day

Date analysis concluded

2013 Year 01 Month 30 Day


Other

Other related information



Management information

Registered date

2009 Year 12 Month 08 Day

Last modified on

2013 Year 01 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003492


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name