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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000003215
Receipt No. R000003807
Scientific Title A Phase II Study for the efficacy and safety of Erlotinib for Patients previously treated Non-small cell Lung Cancer Patients with EGFR Mutations
Date of disclosure of the study information 2010/02/20
Last modified on 2010/02/19

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Basic information
Public title A Phase II Study for the efficacy and safety of Erlotinib for Patients previously treated Non-small cell Lung Cancer Patients with EGFR Mutations
Acronym A Phase II Study for the efficacy and safety of Erlotinib for Patients previously treated Non-small cell Lung Cancer Patients with EGFR Mutations
Scientific Title A Phase II Study for the efficacy and safety of Erlotinib for Patients previously treated Non-small cell Lung Cancer Patients with EGFR Mutations
Scientific Title:Acronym A Phase II Study for the efficacy and safety of Erlotinib for Patients previously treated Non-small cell Lung Cancer Patients with EGFR Mutations
Region
Japan

Condition
Condition Non-small cell lung cancer
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 Objective of the study is to investigate the efficacy and safety of Erlotinib for patients previously treated with chemotherapy career of 1-3 regimens Non-small cell Lung Cancer with EGFR mutation.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes rseponse rate
Key secondary outcomes Evaluation of safety, Progression free survival, Median survival time

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 Single agent chemotherapy with Erlotinib
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) Patients having EGFR mutation, stage IIIB, IV or relapsed NSCLC previously treated with 1-3 regimens of chemotherapy.
2) Patients who has measurable lesion.
3) ECOG performance status (PS): 1 or less
4) Patients aged 20 years or older.
5) Sufficient function of main organ and bone marrow filled the following criteria.
WBC >=3,000/mm3
Neu >=1,500/mm3
PLT >=10x104/mm3
Hb >=9.0g/dL
sCr <=1.5mg/dL
GOT,GPT x 2.5 of upper limit of normal or less
T-Bil <=1.5mg/dL
PaO2 >=70torr
6) Patients who are considered to survive for more than 3 months.
7) Patients providing written informed consent.
Key exclusion criteria 1)Active infection (fever)
2)Cases with past history of EGFR-TKI
3)Presence of active interstitial lung disease or pulmonary fibrosis
4)Patients with massive pleural or prericardial effusion or ascites
5)Patients with uncontrollable complications
6)Patients with active double cancer
7)Pregnancy or lactation.
8)Patients whose participation in the trial is judged to be inappropriate by the attending doctor.
Target sample size 28

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroki Sakakibara
Organization Fujita Health Universty Hospital
Division name Division of Respirology and Allergology
Zip code
Address 1-98 Dengakugakubo,Kutsukake-cho,Toyoake,Aichi.470-1192
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hiroki Sakakibara, Yuji Saito, Yoshitaka Totani
Organization Fujita Health Universty Hospital
Division name Division of Respirology and Allergology
Zip code
Address
TEL 0562-93-9241
Homepage URL
Email

Sponsor
Institute Fujita Health Universty Hospital Division of Respirology and Allergology
Institute
Department

Funding Source
Organization none
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
2010 Year 02 Month 20 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
2009 Year 09 Month 02 Day
Date of IRB
Anticipated trial start date
2009 Year 11 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 02 Month 19 Day
Last modified on
2010 Year 02 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003807

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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