UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013806 |
|---|---|
| Receipt number | R000016105 |
| Scientific Title | A biomarker analysis of plasma and tumor DNA in afatinib-treatedpatients with EGFR mutation-positive advanced adenocarcinoma of the lung. |
| Date of disclosure of the study information | 2014/05/07 |
| Last modified on | 2018/04/27 10:05:16 |
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Basic information
Public title
A biomarker analysis of plasma and
tumor DNA in afatinib-treatedpatients with EGFR mutation-positive advanced adenocarcinoma of the lung.
Acronym
Afatinib I I S
Scientific Title
A biomarker analysis of plasma and
tumor DNA in afatinib-treatedpatients with EGFR mutation-positive advanced adenocarcinoma of the lung.
Scientific Title:Acronym
Afatinib I I S
Region
| Japan |
Condition
Condition
adenocarcinoma of the lung
Classification by specialty
| Pneumology | Laboratory medicine |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
1.To investigate gene mutation and expression level as a biomarker related with the resistance to afatinib in EGFR gene mutation-positive pulmonary adenocarcinoma using a tumor tissue and a peripheral circulatory free DNA.
2.To investigate clinical benefit of peripheral circulatory free DNA.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
A detection of a biomarker about afatinib tolerance
Key secondary outcomes
1.Progression Free Survival
2.Time to Systemic PD
3.Response rate
4.Safety
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
Afatinib40mg/day:oral daily
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) Patients with pulmonary adenocarcinoma with a histological diagnosis and cytodiagnosis.
2) Patients with EGFR gene mutation(exon 19 deletion mutation or L858R mutation in exon 21)within 1 year before enrollment.
3)Patients whose tumor specimen can be submitted.
4)Patients with pathologically confirmed diagnosis of stage IIIB(not amenable for curative intent local radiotherapy)/IV (recurrent or metastatic)adenocarcinoma of the lung.
5) Patients with no treatment of EGFR-TKI.
6) Patients that 2 wks pass from the last dosage of the anticancer drug in the case of systemic chemotherapy.
7) Patients with more than 20 years old on the enrollment day.
8) Patients with ECOG PS 0 or 1.
9) Patients harboring a more than one measurable lesion.
10) Patient whose latest level of laboratory test within 14 days before enrollment meets all following categories (the examination of the same date two weeks before the registration day is permitted).
(1) Neutrophil >= 1,500/mm3
(2) Hemoglobin >= 9.0 g/dL(A blood transfusion is not enforced within 14 days of the examination before enrollment)
(3) Platelet >= 10X104/ mm3
(4) Total bilirubin <= 1.5 mg/dl
(5) AST(GOT)<= 100
(6) ALT(GPT)<= 100
(7) Serum creatinine <= 2.0 mg/dl
(8) SpO2 >= 92%. In case of SpO2 < 92%, PaO2 >= 60 torr is eligible.
11) Patients providing written informed consent.
Key exclusion criteria
1) Patients with active double cancer
2)Patients with interstitial pneumonia confirmed by chest CT.
3)Patient with neurologic symptom caused by non-treated brain metastasis
4) Patients with either superior vena cava syndrome, pericardial effusion, pleural effusion or ascites >= Grade 3.
5) Patients with an operation with the systemic anesthesia within 28 days before enrollment.
6)Patient with a palliative radiotherapy for the metastatic focus except the chest (including gamma knife treatment for the brain metastatic focus) within 7 days before enrollment (the irradiation of the same day 2 weeks ago is permitted as enrollment day as day0).
7) Patient with a radiation exposure to the chest or mediastinum within 14 days before enrollment (the irradiation of the same day 2 weeks ago is permitted as enrollment day as day0).
8)Patients with complication with mental disease or a mind symptom, and are judged to have difficulty in participation in the study.
9) Patient with positive HBs antigen.
10) Patient having a serious infection to need systemic treatment.
11)Any other patients who are regarded as unsuitable for this study by the investigators.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Isamu Okamoto |
Organization
Kyushu University Hospital
Division name
Research Institute for Disease of the Chest / Center for Clinical and Translational Research
Zip code
Address
3-1-1 Maidashi ,Higashi-ku,Fukuoka,
TEL
092-642-5378
okamotoi@kokyu.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Eiji Iwama |
Organization
Graduate School of Medical Sciences, Kyushu University
Division name
Faculty of Medical Sciences, Department of Comprehensive Clinical Oncology
Zip code
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka, Japan, 812-8582
TEL
092-642-5378
Homepage URL
iwama@kokyu.med.kyushu-u.ac.jp
Sponsor or person
Institute
Clinical Research Support Center Kyushu
Institute
Department
Personal name
Funding Source
Organization
Nippon Boehringer Ingelheim Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
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 | 05 | Month | 07 | 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
| 2014 | Year | 04 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 05 | Month | 07 | Day |
Last follow-up date
| 2017 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 04 | Month | 25 | Day |
Last modified on
| 2018 | Year | 04 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016105
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