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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000004207
Receipt No. R000005056
Scientific Title A Phase II Study of Erlotinib monotherapy for patients with non-small cell lung cancer wihtout EGFR mutation
Date of disclosure of the study information 2010/09/17
Last modified on 2012/08/01

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Basic information
Public title A Phase II Study of Erlotinib monotherapy for patients with non-small cell lung cancer wihtout EGFR mutation
Acronym A phase II study of Erlotinib for NSCLC wihtout EGFR mutation
Scientific Title A Phase II Study of Erlotinib monotherapy for patients with non-small cell lung cancer wihtout EGFR mutation
Scientific Title:Acronym A phase II study of Erlotinib for NSCLC wihtout EGFR mutation
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 evaluate efficacy and safety of erlotinib in pretreated patients with NSCLC harboring EGFR wlid type tumor
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Disease contorol rate
Key secondary outcomes Response rate
Overall survival
Progression free survival
Safety
Time to treatment failure

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 150 mg/day
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) Hitologically proven NSCLC
2) Patient with recurrent NSCLC of stage IV or after surgery who did not respond to or replapsed prior chemotherapy (<=3).
3) Patients harboring EGFR mutation negative tumor.
4) patients whose tumor tissue are available for EGFR gene copy number, Kras, and cMet.
5) Patients who treated with standard chemotherapy.
6) No prior therapywith EGFR tyrosine kinase inhibitor.
7) ECOG performance status 0-2
8) Patients who have one or more measurable lesion by RECIST.
9) Patiens who ar able to receive treatment by hospitalization for at least 2-4 weeks or under equivalent condition.
10) Age >= 20years at the time ofregestration.
11) adequate organ fuction.
12) Patients who are considered to survive for more than 12 weeks.
13) Patients with written informed consent.
Key exclusion criteria 1) severe interstitial lung disease or pulmonary fibrosis.
2) patient with history of drug-related lung disease.
3) Severe drug allrgy.
4) Patients with complication of infectious disease.
5) patients with Severe diarrhea
6) Patients with clinically significant ball disease.
7) patients with clinically significant opthalmologic disorder.
8) patients with complication or hisotry of gastrointestinal perforation.
9) Uncontrolable GI ulcer.
10) Brain metastasis with symptoms
11) Active multiple cancer.
12) patients with clinically significant heart disease.
13) Patients with clinically siginificant psychologic disease.
14) Patients with lactation or pregnancy.
15) patients who are considered ineligible based on decision of a reasonable investigator.

Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuo Kasahara
Organization Kanazawa University Hospital
Division name Respiratory Medicine
Zip code
Address Takara-machi, 13-1, Kanazawa, Ishikawa ,920-8641,Japan
TEL 076-265-2273
Email

Public contact
Name of contact person
1st name
Middle name
Last name Takashi Sone
Organization Kanazawa University Hospital
Division name Respiratory Medicine
Zip code
Address Takara-machi, 13-1, Kanazawa, Ishikawa ,920-8641,Japan
TEL 076-265-2273
Homepage URL
Email

Sponsor
Institute Hokuriku 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
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
patients are recruiting
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
2010 Year 07 Month 29 Day
Date of IRB
Anticipated trial start date
2010 Year 09 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 09 Month 14 Day
Last modified on
2012 Year 08 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005056

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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