UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016167 |
|---|---|
| Receipt number | R000018765 |
| Scientific Title | Phase II study of the effectiveness of prophylaxis against side effects associated with Afatinib (NLCTG 1401) |
| Date of disclosure of the study information | 2015/01/09 |
| Last modified on | 2017/01/10 10:35:59 |
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Basic information
Public title
Phase II study of the effectiveness of prophylaxis against side effects associated with Afatinib (NLCTG 1401)
Acronym
Phase II study of the effectiveness of prophylaxis against side effects associated with Afatinib (NLCTG 1401)
Scientific Title
Phase II study of the effectiveness of prophylaxis against side effects associated with Afatinib (NLCTG 1401)
Scientific Title:Acronym
Phase II study of the effectiveness of prophylaxis against side effects associated with Afatinib (NLCTG 1401)
Region
| Japan |
Condition
Condition
non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness of prophylaxis against side effects associated with Afatinib
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
In 4 weeks time Severe diarrhea expression inhibition rate
(Severe diarrhea:Diarrhea that is deemed necessary dose reduction of Afatinib dose reduction criteria defined in the protocol
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
loperamide,minocyclin,minocycline hydrochloride,azulene sodium sulfonate
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-small cell lung cancer proven by histology and/or cytology
2.EGFR mutation status is positive
3.Performance Status(ECOG)0-2
4.Afatinib has not been administered in the past
5.Chest radiation therapy that has not been enforced within the registration before 4 weeks
6.Adequate organ function
7.20 years or older
8.Written Informed Consent
Key exclusion criteria
(1)History of active double cancer
(2)No intention to birth control
(3)Unstable psychic disorder
(4)Interstitial pneumonia or active radiation pneumonia or drug-induced pneumonia
(5)Ileus
(6)Patients who can not take oral drugs
(7)Severe complications
(8)Patients in drug and tetracycline drug used in the present study a history of hypersensitivity
(9)Decision of ineligibility by a physician.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Kagamu |
Organization
Niigata University Medical & Dental Hospital
Division name
Respiratory and infectious diseases internal medicine
Zip code
Address
1-754 Asahimachi-dori, Chuo-ku, Niigata 951-8510, Japan
TEL
025-227-2200
hkagamu@med.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masaaki Okajima |
Organization
Niigata University Medical & Dental Hospital
Division name
Respiratory and infectious diseases internal medicine
Zip code
Address
1-754 Asahimachi-dori, Chuo-ku, Niigata 951-8510, Japan
TEL
025-227-2200
Homepage URL
okajima-nii@umin.ac.jp
Sponsor or person
Institute
Niigata Lung Cancer Treatment Group
Institute
Department
Personal name
Funding Source
Organization
None
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 | 01 | Month | 09 | 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
Completed
Date of protocol fixation
| 2015 | Year | 01 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 01 | Month | 09 | 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 | 01 | Month | 09 | Day |
Last modified on
| 2017 | Year | 01 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018765
