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UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000001594
Receipt No. R000001913
Scientific Title Phase I trial to assess safety and pharmacokinetics of Gefitinib plus S-1 combination therapy in patients with advanced adenocarcinoma lung
Date of disclosure of the study information 2008/12/22
Last modified on 2011/12/29

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Basic information
Public title Phase I trial to assess safety and pharmacokinetics of Gefitinib plus S-1 combination therapy in patients with advanced adenocarcinoma lung
Acronym Phase I trial of Gefitinib plus S-1 combination therapy for advanced adenocarcinoma of the lung
Scientific Title Phase I trial to assess safety and pharmacokinetics of Gefitinib plus S-1 combination therapy in patients with advanced adenocarcinoma lung
Scientific Title:Acronym Phase I trial of Gefitinib plus S-1 combination therapy for advanced adenocarcinoma of the lung
Region
Japan

Condition
Condition Lung Cancer
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To assess safety and recommended dose of Gefitinib and S-1 combination therapy.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase I

Assessment
Primary outcomes Recommended dose of Gefitinib and S-1 combination therapy
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 a
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
75 years-old >
Gender Male and Female
Key inclusion criteria a
Key exclusion criteria a
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuhiko Nakagawa
Organization Kinki University School of Medicine
Division name Department of Medical Oncology
Zip code
Address 377-2 Ohno-higashi, Osaka-Sayama, Osaka 589-8511, 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
Homepage URL
Email hidemikiyota@yahoo.co.jp

Sponsor
Institute Kinki University School of Medicine
Institute
Department

Funding Source
Organization 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 近畿大学医学部附属病院(大阪府)、大阪市立総合医療センター(大阪府)、静岡県立静岡がんセンター(静岡県)

Other administrative information
Date of disclosure of the study information
2008 Year 12 Month 22 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
2008 Year 05 Month 30 Day
Date of IRB
Anticipated trial start date
2008 Year 07 Month 01 Day
Last follow-up date
2011 Year 07 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
2008 Year 12 Month 21 Day
Last modified on
2011 Year 12 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001913

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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