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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000151
Receipt No. R000000217
Scientific Title Phase II study of gefitinib in patients with EGFR mutation positive- advanced non-small cell lung cancer
Date of disclosure of the study information 2005/09/09
Last modified on 2015/08/31

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Basic information
Public title Phase II study of gefitinib in patients with EGFR mutation positive- advanced non-small cell lung cancer
Acronym Phase II study of gefitinib in patients with EGFR mutation positive- advanced non-small cell lung cancer
Scientific Title Phase II study of gefitinib in patients with EGFR mutation positive- advanced non-small cell lung cancer
Scientific Title:Acronym Phase II study of gefitinib in patients with EGFR mutation positive- advanced non-small cell lung cancer
Region
Japan

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

Objectives
Narrative objectives1 To determine the efficacy and safety of gefitinib monotherapy for NSCLC patients with specific EGFR mutation
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes (Primary Endpoint)
Response rate
Key secondary outcomes (Secondary Endpoint)
Overall survival, One year survival, Time to progression, disease control rate, 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 gefitinib 250mg/m2 /day orally
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) Inoperable stage III or stage IV NSCLC
2) Chemonaive or prior 1-2 regimens of chemotherapy
3) Availability of tissue sample for mutation analyses
4) At least one measurable lesion
5) Age 20 years or older
6) Performance status (PS) of 0 to 2
7) Adequate main organ functions
8) No prior treatment of gefitinib or erlotinib
9) Written informed consent
Key exclusion criteria Intestinal pneumonia or lung fibrosis
2) History of severe drug allergic reaction
3) Severe infection and complication (cardio insufficiency or hemorrhage etc.)
4) Severe diarrhea
5) Bowel obstruction,ileus
6) Symptomatic brain metastasis
7) History of other malignancy
8) Pregnant women or women willing child-bearing
9) No regulatory condition because of psychological disease
10) Inadequate condition diagnosed by primary physician
Target sample size 25

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kenji Tamura MD
Organization Kinki University School of Medicine, Nara Hospital
Division name Department of Medical Oncology
Zip code
Address 1248-1, Otoda, Ikoma, Nara, 630-0293, Japan
TEL 0743-77-0880
Email

Public contact
Name of contact person
1st name
Middle name
Last name Shinichiro Nakamura
Organization West Japan Oncology Group
Division name WJOG datacenter
Zip code
Address Namba Plaza Bldg.3F 1-5-7,Motomachi Naniwa-ku,Osaka556-0016 JAPAN
TEL 06-6633-7400
Homepage URL
Email datacenter@wjog.jp

Sponsor
Institute West Japan Oncology 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
2005 Year 09 Month 09 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.ncbi.nlm.nih.gov/pubmed?term=18283321
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
2004 Year 12 Month 24 Day
Date of IRB
Anticipated trial start date
2005 Year 03 Month 01 Day
Last follow-up date
2008 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2005 Year 09 Month 09 Day
Last modified on
2015 Year 08 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000217

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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