UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000151 |
|---|---|
| Receipt number | 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 15:52:46 |
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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
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
datacenter@wjog.jp
Sponsor or person
Institute
West Japan Oncology Group
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000217
