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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000004680
Receipt No. R000005073
Scientific Title A Phase II Study of Erlotinib for previously treated Non-Small Cell Lung Cancer Patients
Date of disclosure of the study information 2010/12/08
Last modified on 2010/12/07

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Basic information
Public title A Phase II Study of Erlotinib for previously treated Non-Small Cell Lung Cancer Patients
Acronym A Phase II Study of Erlotinib for previously treated Non-Small Cell Lung Cancer Patients
Scientific Title A Phase II Study of Erlotinib for previously treated Non-Small Cell Lung Cancer Patients
Scientific Title:Acronym A Phase II Study of Erlotinib for previously treated Non-Small Cell Lung Cancer Patients
Region
Japan

Condition
Condition Objective of the study is to investigate efficacy and safety of Erlotinib for previously treated non-small cell lung cancer patients.
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 Objective of the study is to investigate efficacy and safety of Erlotinib for previously treated non-small cell lung cancer patients.
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 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 single therapy
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) Histologically or cytologically proven stage IIIb or IV non-small cell lung cancer.
2) Patients who have previously treated with one or two chemotherapy.
3) No prior treatment with epidermal growth factor tyrosine kinase inhibitor.
4) Patients who has at least one or more measurable lesion(s) by RECIST.
5) Performance status (ECOG) 0-2
6) Patients who can be hospitalized for at least two weeks after beginning of the treatment or under similar management.
7) Patients aged 20 years or older.
8) Sufficient function of main organ and bone marrow filled the following criteria:
Leukocyte counts, 3,000/mm3 or over -12,000/mm or less.
Neutrophil counts, 1,500/mm3 or over.
Platelets, 100,000/mm3 or over.
AST and alt, x 2 of upper limit of normal (ULN) or less.
Total bilirubin, 1.5mg/dl or less.
Serum creatinin, x 1.5 of ULN or less.
SpO2 90% or above.
9) Patients who are considered to survive for more than 3 months.
10) interval:
(1) Chemotherapy, more than 4 weeks after the last chemotherapy.
(2) Radiation, more than 12 weeks after the thoracic irradiation or more than 2 weeks after the last irradiation to other organs.
(3) Operation, more than 4 weeks after the last operation (including pleurodesis)
11) Patients providing written informed consent.
Key exclusion criteria 1) Patients with active lung disease such as interstitial pneumonia, pneumoconiosis, active radiation pneumonitis, or drug-induced pneumonitis.
2) Patients with massive pleural or pericardial effusion,or ascites.
3) Patients with active severe infections.
4) Cases with past history of administration of HER related agents(gefitinib,trastuzumab,lapatinib,cetuximab).
5) Impossible cases with oral administration.
6) Patients with active opthalmological disease.
7) Pregnancy or lactation.
8) Patients with symptomatic brain metastasis.
9) Patients with active concomitant malignancy.
10) Patients with uncontrollabe diabetes mellitus.
11) Patients with uncontrollable complications.
12) Inappropriate patients for this study judged by the physicians.
Target sample size 27

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Eiji Shimizu
Organization Tottori University, Faculty of Medicine
Division name Division of Medical Oncology and Molecular Respirology Department of Multidisciplinary Internal Medicine
Zip code
Address 36-1 nishi-cho,Yonago,Tottori,683-8504,Japan
TEL 0859-38-6537
Email

Public contact
Name of contact person
1st name
Middle name
Last name Shingo Matsumoto
Organization Tottori University, Faculty of Medicine
Division name Division of Medical Oncology and Molecular Respirology Department of Multidisciplinary Internal Medi
Zip code
Address 36-1 nishi-cho,Yonago,Tottori,683-8504,Japan
TEL 0859-38-6537
Homepage URL
Email watsum@grape.med.tottori-u.ac.jp

Sponsor
Institute Tottori University, Faculty of Medicine,Division of Medical Oncology and Molecular Respirology Department of Multidisciplinary Internal Medicine
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 鳥取大学医学部附属病院、公立八鹿病院、鳥取県立中央病院、米子医療センター、山陰労災病院、済生会境港総合病院、日野病院、松江市立病院、松江医療センター、松江赤十字病院

Other administrative information
Date of disclosure of the study information
2010 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 02 Month 05 Day
Date of IRB
Anticipated trial start date
2009 Year 04 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 07 Day
Last modified on
2010 Year 12 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005073

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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