UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014065 |
|---|---|
| Receipt number | R000016375 |
| Scientific Title | A study to examine cerebrospinal fluid transitivity and efficacy of afatinib in carcinomatous meningitis patients with non-small cell lung cancer patients harboring EGFR mutation. |
| Date of disclosure of the study information | 2014/05/26 |
| Last modified on | 2017/08/13 08:57:11 |
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Basic information
Public title
A study to examine cerebrospinal fluid transitivity and efficacy of afatinib in carcinomatous meningitis patients with non-small cell lung cancer patients harboring EGFR mutation.
Acronym
A cerebrospinal fluid transitivity identification test of afatinib
Scientific Title
A study to examine cerebrospinal fluid transitivity and efficacy of afatinib in carcinomatous meningitis patients with non-small cell lung cancer patients harboring EGFR mutation.
Scientific Title:Acronym
A cerebrospinal fluid transitivity identification test of afatinib
Region
| Japan |
Condition
Condition
carcinomatous meningitis patients with NSCLC harboring EGFR mutation
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Cerebrospinal fluid transitivity confirmation of afatinib in carcinomtous meningitis patients
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Cerebrospinal fluid transitivity of afatinib
Key secondary outcomes
efficacy and safety of afatinib
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. NSCLC, EGFR mutation positive, carcinomatous meningitis patients
2. no treatment of afatinib
3. over 20 years old at the registration
4. ECOG PS 0-3
5. good status of main organ
6. written informed concent
Key exclusion criteria
1. over Grade 2 of diarrhea, a severe gastrointestinal disorder
2. Interstitial lung disease
3. diagnose of malignancy in 5 years
4. Angina and myocardial infarction within six months, heart disorder, severe arrhythmia
5. pleural effusion or ascites which need treatment
6. uncontrolled complications
7. Serious drug allergy history
8. Cannot promise contraception
9. No pregnancy, during nursing
10. A chief physician decide not eligible
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinji Atagi |
Organization
Kinki-Chuo Chest Medical Center
Division name
Clinical Research Center
Zip code
Address
1180, Nagasone-cho, Kita-ku, Sakai City, Osaka, JAPAN
TEL
072-252-3-21
s-atagi@kch.hosp.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akihiro Tamiya |
Organization
Kinki-Chuo Chest Medical Center
Division name
Internal Medicine
Zip code
Address
1180, Nagasone-cho, Kita-ku, Sakai City, Osaka, JAPAN
TEL
072-252-3021
Homepage URL
atamiya@kch.hiosp.go.jp
Sponsor or person
Institute
Kinki-Chuo Chest Medical Center
Institute
Department
Personal name
Funding Source
Organization
Kinki-Chuo Chest Medical Center
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
大阪府立呼吸器アレルギー医療センター
摂南大学 薬学部
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 05 | Month | 26 | 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
| 2014 | Year | 05 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 05 | Month | 26 | 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 | 05 | Month | 25 | Day |
Last modified on
| 2017 | Year | 08 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016375
