UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016441 |
|---|---|
| Receipt number | R000019088 |
| Scientific Title | Dose-escalation Study of Afatinib in Elderly Patients with EGFR mutation for Non-Small Cell Lung Cancer |
| Date of disclosure of the study information | 2015/02/04 |
| Last modified on | 2018/09/02 08:32:18 |
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Basic information
Public title
Dose-escalation Study of Afatinib in Elderly Patients with EGFR mutation for Non-Small Cell Lung Cancer
Acronym
Dose-escalation Study of Afatinib in Elderly Patients with EGFR mutation for Non-Small Cell Lung Cancer
Scientific Title
Dose-escalation Study of Afatinib in Elderly Patients with EGFR mutation for Non-Small Cell Lung Cancer
Scientific Title:Acronym
Dose-escalation Study of Afatinib in Elderly Patients with EGFR mutation for Non-Small Cell Lung Cancer
Region
| Japan |
Condition
Condition
Non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate feasibility, maximum tolerated dose and recommended phase II dose of afatinib therapy in elderly patients with EGFR mutation
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
To conclude maximum tolerated dose and recommended phase II dose.
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
afatinib
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
| 75 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Histologically or cytologically proven non-small cell lung cancer
2)Harboring sensitive EGFR mutation
3)More taan 3 weeks from prior chomotherapy
4)More than 12 weeks from the RT therapy
5)More than 2 weeks from pleurodesis
6)Performance status: 0-1
7)More than 75 years old
8)Adequate organ functions
9)PaO2 >= 60torr or SpO2 >= 95% at room air
10)Life expectancy: over 3 months
11)Written informed consent
Key exclusion criteria
1)Having severe complications
2)Symptomatic brain metastases
3)Interstitial pneumonitis on chest Xray
4)Past history of severe allergic reactions to drugs
5)Pregnant or breastfeeding woman
6)Receiving steroids or immunosuppressants
7)Active infectious disease
8)Uncontrollable pleural effusion or pericardial effusion
9)Active double cancer
10)Patients whose physicians considered as inappropriate for this clinical study
Target sample size
18
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kageaki Taima |
Organization
Hirosaki University Graduate School of Medicine
Division name
Cardiology, Respiratory medicine and Nephrology
Zip code
Address
5 Zaifu-cho Hirosaki city, Aomori Prefecture, JAPAN
TEL
0172-39-5057
taima0305@hotmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hisashi Tanaka |
Organization
Hirosaki University Graduate School of Medicine
Division name
Cardiology, Respiratory medicine and Nephrology
Zip code
Address
5 Zaifu-cho Hirosaki city, Aomori Prefecture, JAPAN
TEL
0172-39-5057
Homepage URL
xyghx335@gmail.com
Sponsor or person
Institute
Hirosaki University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Hirosaki University Graduate 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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 02 | Month | 04 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Completed
Date of protocol fixation
| 2015 | Year | 01 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 02 | Month | 04 | 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
| 2015 | Year | 02 | Month | 04 | Day |
Last modified on
| 2018 | Year | 09 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019088
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
