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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004227
Receipt No. R000005081
Scientific Title Phase II study of erlotinib as third-line monotherapy in patients with advanced non-small cell lung cancer
Date of disclosure of the study information 2010/09/17
Last modified on 2011/03/17

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Basic information
Public title Phase II study of erlotinib as third-line monotherapy in patients with advanced non-small cell lung cancer
Acronym Phase II study of erlotinib as third-line monotherapy in patients with advanced non-small cell lung cancer
Scientific Title Phase II study of erlotinib as third-line monotherapy in patients with advanced non-small cell lung cancer
Scientific Title:Acronym Phase II study of erlotinib as third-line monotherapy in patients with advanced non-small cell lung cancer
Region
Japan

Condition
Condition advanced non-small cell lung cancer
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of erlotinib monotherapy as third-line chemotherapy
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes overall response rate
Key secondary outcomes overall survival time, safety,progression-free survival

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 Patients started to receive erlotinib (150 mg, p.o.) daily after experiencing recurrence or disease progression after second-line treatment. Treatment was continued until disease progression or unacceptable toxicity occurred. Doses were adjusted to 100 mg per day according to the toxicity.
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 Pathologically confirmed inoperable stage IIIB or stage IV NSCLC
ECOG performance status of 0-2
naive for EGFR tyrosine kinase inhibitors
two prior systemic chemotherapy regimens, one of which was a platinum-containing regimen
Adequate function of the bone marrow, liver and kidney
Key exclusion criteria user of EGFR tyrosine kinase inhibitors
severe complications or active interstitial lung disease
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kingo Chida
Organization Hamamatsu University School of Medicine
Division name Respiratory medicine
Zip code
Address 1-20-1 Handayama, Hamamatsu, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Hamamatsu University School of Medicine
Division name Respiratory medicien
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute Hamamatsu University School of Medicine
Institute
Department

Funding Source
Organization Hamamatsu University School of Medicine
Organization
Division
Category of Funding Organization Other
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 浜松医科大学附属病院

Other administrative information
Date of disclosure of the study information
2010 Year 09 Month 17 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 06 Month 01 Day
Date of IRB
Anticipated trial start date
2009 Year 01 Month 01 Day
Last follow-up date
2010 Year 01 Month 01 Day
Date of closure to data entry
2010 Year 02 Month 01 Day
Date trial data considered complete
2010 Year 02 Month 01 Day
Date analysis concluded
2010 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2010 Year 09 Month 17 Day
Last modified on
2011 Year 03 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005081

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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