UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012831 |
|---|---|
| Receipt number | R000014990 |
| Scientific Title | To evaluate the relationships between the serum concentration of Erlotinib and the effects and toxicities of them |
| Date of disclosure of the study information | 2014/01/12 |
| Last modified on | 2014/04/03 21:34:31 |
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Basic information
Public title
To evaluate the relationships between the serum concentration of Erlotinib and the effects and toxicities of them
Acronym
To evaluate the relationships between the serum concentration of Erlotinib and the effects and toxicities of them
Scientific Title
To evaluate the relationships between the serum concentration of Erlotinib and the effects and toxicities of them
Scientific Title:Acronym
To evaluate the relationships between the serum concentration of Erlotinib and the effects and toxicities of them
Region
| Japan |
Condition
Condition
non-squamous non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluate efficacy and safety of erlotinib fractionated administration therapy and blood concentration analysis of erlotinib in erlotinib fractionated administration therapy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Safety
Key secondary outcomes
Response Rate, Overall survival, Progression-free survival, QOL
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) non squamous non small cell lung cancer harboring EGFR mutation
2) StageIIIB or VI
3) EGFR-TKI naive
4) ECOG PS 0-2
5) Measurable lesions (RECIST)
6) Age>=20years
7) Adequate function of main organ
8) Provided written informed consent
Key exclusion criteria
1) severe cardiac effusion
2) severe SVC syndrome
3) severe complications
4) severe cardiac diseases
5) severe diabetes mellitus or hypertension
6) severe infections
7) Interstitial pneumonia or pulmonary fibrosis on chest CT scans
8)history of drug allergy
9)pregnant or or lactating women or those who declined contraception
10)those judged not suitable by the attending physician
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoichi Nakamura |
Organization
Nagasaki University Hospital
Division name
Second department of Internal Medecine
Zip code
Address
1-7-1,Sakamoto Nagasaki Japan
TEL
095-819-7273
yi-nakamu@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takaya Ikeda |
Organization
Nagasaki Thoracic Oncology Group
Division name
Nagasaki Thoracic Oncology Group
Zip code
Address
9-3 Hirase Sasebo Nagasaki Japan
TEL
0956-24-1515
Homepage URL
ikedat@hospital.sasebo.nagasaki.jp
Sponsor or person
Institute
Nagasaki Thoracic Oncology Group
Institute
Department
Personal name
Funding Source
Organization
Nagasaki Thoracic Oncology Group
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
| 2014 | Year | 01 | Month | 12 | 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
Enrolling by invitation
Date of protocol fixation
| 2014 | Year | 01 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 01 | Month | 12 | 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
| 2014 | Year | 01 | Month | 12 | Day |
Last modified on
| 2014 | Year | 04 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014990
