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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001509
Receipt No. R000001821
Scientific Title Phase II study of erlotinib monotherapy for relapsed patients with non-small-cell lung cancer who do not possess any active EGFR gene mutations
Date of disclosure of the study information 2008/11/16
Last modified on 2009/05/16

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Basic information
Public title Phase II study of erlotinib monotherapy for relapsed patients with non-small-cell lung cancer who do not possess any active EGFR gene mutations
Acronym Erlotinib for relapsed non-small-cell lung cancer patients without any
active EGFR gene mutations
Scientific Title Phase II study of erlotinib monotherapy for relapsed patients with non-small-cell lung cancer who do not possess any active EGFR gene mutations
Scientific Title:Acronym Erlotinib for relapsed non-small-cell lung cancer patients without any
active EGFR gene mutations
Region
Japan

Condition
Condition relapsed non-small-cell lung cancer
Classification by specialty
Pneumology Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 The objective of this study is to evaluate antitumor response as the primary endpoint of erlotinib monotherapy for relapsed patients with non-small-cell lung cancer who do not possess any active EGFR gene mutations
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase II

Assessment
Primary outcomes Anti-tumor activity
Key secondary outcomes Adverse events, overall survival, progression-free survival, questionnaire about participation in this study, and molecular analysis using tumor samples (MET gene amplification, PTEN expression, K-ras gene mutation, methylation anlaysis for serum MGMT, RARB, p16, DAPK, RASSF1A, and EGFR)

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Pathologically proven NSCLC
Patients with targeted lesions defined in the RECIST guideline
Patients previously treated with 1 to 3 chemotherapy regimens
Those without any active EGFR mutations in the tumor specimens
Those with no prior therapy within four weeks
Those with ECOG PS of 0 to 2
Those considered to survive for more than two months
Those with adequate organ functions
Those providing written informed consent
Key exclusion criteria Patients without adequate tumor samples for assessing EGFR mutation status
Those with severe co-morbidity including uncontrollable cardiac, cerebral and infectious disease and diabetes mellitus
Those with symptomatic cerebral metastasis
Those with active interstitial pneumonia or massive malignant pleural/pericardial effusion
Pregnant or lactating women
Those previously treated with EGFR-tyrosine kinase inhibitors
Those who need to be treated immediately with radiotherapy
Patients judged as being in inappropriate condition for this study by physician
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mitsune Tanimoto
Organization Okayama University Hospital
Division name Hematology, Oncology, Respiratory Medicine
Zip code
Address 2-5-1 Shikata-cho, Okayama 700-8558
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Okayama Lung Cancer Study Group Coordinating Office
Division name Hematology, Oncology, Respiratory Medicine
Zip code
Address
TEL 086-235-7227
Homepage URL
Email

Sponsor
Institute Okayama Lung Cancer Study Group
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
2008 Year 11 Month 16 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 Completed
Date of protocol fixation
2008 Year 01 Month 15 Day
Date of IRB
Anticipated trial start date
2008 Year 01 Month 01 Day
Last follow-up date
2009 Year 11 Month 01 Day
Date of closure to data entry
2009 Year 12 Month 01 Day
Date trial data considered complete
2009 Year 12 Month 01 Day
Date analysis concluded
2009 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2008 Year 11 Month 16 Day
Last modified on
2009 Year 05 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001821

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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