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UMIN ID:

Recruitment status
Unique ID issued by UMIN C000000142
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Department of Medical Oncology Kinki University School of Medicine
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000204

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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