UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001594 |
|---|---|
| Receipt number | 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 00:06:08 |
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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
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
hidemikiyota@yahoo.co.jp
Sponsor or person
Institute
Kinki University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001913
