UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006634 |
|---|---|
| Receipt number | R000007848 |
| Scientific Title | Pharmacokinetics and pharmacogenomics study with erlotinib in the treatment of advanced non-small cell lung cancer (NSCLC) |
| Date of disclosure of the study information | 2011/11/01 |
| Last modified on | 2013/06/08 10:21:58 |
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Basic information
Public title
Pharmacokinetics and pharmacogenomics study with erlotinib in the treatment of advanced non-small cell lung cancer (NSCLC)
Acronym
PK/PG study with erlotinib in NSCLC
Scientific Title
Pharmacokinetics and pharmacogenomics study with erlotinib in the treatment of advanced non-small cell lung cancer (NSCLC)
Scientific Title:Acronym
PK/PG study with erlotinib in NSCLC
Region
| Japan |
Condition
Condition
Non-small cell lung cancer
Classification by specialty
| Pneumology | Adult |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
The efficacy, safety, pharmacokinetics of erlotinib for advanced non-small cell lung cancer and its relation to pharmacogenomics (SNP) of drug metabolism related genes
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Safety, Efficacy
Key secondary outcomes
Pharmacokinetics
SNP of drug metabolism related genes
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
erlotinib
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. Advanced non-small cell lung cancer
2. Treatment with erlotinib is planned
3. Adequate organ functions, PS0-2
4. Written informed concent
Key exclusion criteria
Without concent
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Katsuhiko Naoki |
Organization
School of Medicine, Keio University
Division name
Department of Respiratory Medicine / Keio Cancer Center
Zip code
Address
35 Shinanomachi, Shinjuku, Tokyo, 160-8582, JAPAN
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
School of Medicine, Keio University
Division name
Department of Respiratory Medicine / Keio Cancer Center
Zip code
Address
35 Shinanomachi, Shinjuku, Tokyo, 160-8582, JAPAN
TEL
Homepage URL
knaoki@pg7.so-net.ne.jp
Sponsor or person
Institute
Department of Respiratory Medicine / Keio Cancer Center, School of Medicine, Keio University
Institute
Department
Personal name
Funding Source
Organization
Japan Research Foundation for Clinical pharmacology
Organization
Division
Category of Funding Organization
Non profit foundation
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
| 2011 | Year | 11 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2011 | Year | 09 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 11 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 10 | Month | 31 | Day |
Last modified on
| 2013 | Year | 06 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007848
