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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000002861
Receipt No. 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

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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
Institute Shizuoka General Hospital Respiratory center
Institute
Department

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
URL(English) https://upload.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


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