UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000142 |
|---|---|
| Receipt number | R000000204 |
| Scientific Title | PhaseII stady of gefitinib and in patients with relapsed advanced non-small cell lung cancer |
| Date of disclosure of the study information | 2005/09/08 |
| Last modified on | 2005/09/08 16:45:28 |
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Basic information
Public title
PhaseII stady of gefitinib and in patients with relapsed advanced non-small cell lung cancer
Acronym
PhaseII stady of gefitinib and in patients with relapsed advanced non-small cell lung cancer
Scientific Title
PhaseII stady of gefitinib and in patients with relapsed advanced non-small cell lung cancer
Scientific Title:Acronym
PhaseII stady of gefitinib and in patients with relapsed advanced non-small cell lung cancer
Region
| Japan |
Condition
Condition
relapsed advanced non-small cell lung cartinoma
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Determine the response rate and safety in patients with advanced non-small cell lung cancer treated with gefitinib and meloxicam.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Response rate
Key secondary outcomes
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 receive oral gefitinib 250mg and meloxicam 10mg once daily
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)Histologically confirmed non-small lung cancer
(2)With clinical organization object before treatment
(3)Failed 1 or 2 prior treatment regimen for advanced non-small cell lung cancer.
(4)Aged 20 and over.
(5)Eastern Cooperative Oncology Group(ECOG) performance status 0-2
(6)With measurable lesion
(7)Adequate hematologic, hepatic, and renal functions
(8)No prior gefitinib
(9)More than 30days since prior chronic nonsteroidal nanti-inflammatory drugs(NAISDs)
(10)No history of peptic ulcer disease within the past 6 months
(11)More than 2 weeks prior therapy
(12)Life expectancy over 3 months
(13)Provide written informed consent
Key exclusion criteria
(1)Uncontrolled infection, cardiac disease, hepatic disease, and so on
(2)Evidence of interstitial lung disease in chest x-p
(3)Active brain metastases
(4)Other active malignancy
(5)History of bone marrow transplantation
(6)History of peripheral blood stem cell transplantation
(7)Allergy to any drugs
(8)Pregnant or nursing women
(9)Patients don't have will of contraception
(10)Uncontrolled diabetes
(11)Other concurrent serious medical condition
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Asuka Tsuya |
Organization
Kinki University School of Medicine
Division name
Department of Medical Oncology
Zip code
Address
377-2, Ohno-Higashi, Osakasayama city, Osaka, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kinki University School of Medicine
Division name
Department of Medical Oncology
Zip code
Address
TEL
072-366-0221
Homepage URL
Sponsor or person
Institute
Department of Medical Oncology Kinki University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Medical Oncology Kinki University School of Medicine
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 | 08 | 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
Date of protocol fixation
| 2003 | Year | 12 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2004 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2007 | Year | 02 | 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 | 08 | Day |
Last modified on
| 2005 | Year | 09 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000204
