UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031845 |
|---|---|
| Receipt number | R000036359 |
| Scientific Title | Prospective study to investigate the resistant mechanism to afatinib treatment in EGFR mutation-positive non-small cell lung cancer |
| Date of disclosure of the study information | 2018/03/22 |
| Last modified on | 2020/09/25 09:55:16 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Prospective study to investigate the resistant mechanism to afatinib treatment in EGFR mutation-positive non-small cell lung cancer
Acronym
Prospective study to investigate the resistant mechanism to afatinib treatment in EGFR mutation-positive non-small cell lung cancer
Scientific Title
Prospective study to investigate the resistant mechanism to afatinib treatment in EGFR mutation-positive non-small cell lung cancer
Scientific Title:Acronym
Prospective study to investigate the resistant mechanism to afatinib treatment in EGFR mutation-positive non-small cell lung cancer
Region
| Japan |
Condition
Condition
Lung Cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the factor of resistance to afatinib in EGFR gene mutation positive NSCLC. To investigate the frequency of T790M mutation and concordance rate between blood and tumor tissue at PD
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The frequency of T790M mutation and concordance rate between blood and tumor tissue at PD
Key secondary outcomes
1) PFS
2) ORR
3) TTF
4) OS
5) Safety
6) The correlation between blood concentration of afatinib and 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
Afatinib 40mg/day
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 NSCLC with a histological diagnosis or cytodiagnosis
2) Patients with EGFR gene mutation
3) Patients with unresectable advanced case
4) Patients that 14 days pass from the last dosage of systemic chemotherapy
5) Patients with more than 20 years old
6) Patients with ECOG PS 0,1,2
7) Patients harboring a more than one measurable lesion
8) Patients that expected survival time is more than 2 months
9) Patients with adequate organ function
Neutrophil >= 1500/mm3
Platelet >= 100,000/mm3
Hemoglobin >= 8.0g/dl
AST,ALT <=2.5 x ULN
Total bilirubin <= 2mg/dl
10) Patients providing written informed consent
Key exclusion criteria
1) Patients with interstitial pneumonitis or pulmonary fibrosis
2) Patients with serious infection
3) Patients with unsteady angina or cardiac infarction
4) Patients with severe complication
5) Patients with active double cancer
6) Patients requiring medication influenced P glycoprotein
7) Patients with history of dosage afatinib
8) Patients with contraindication against afatinib
9) Patients with history of serious hypersensitivity or allergy
10) Pregnant, pregnancy suspect, nursing women, patients who plan to have a baby
11) Patients with complication with mental disease or a mind symptom, and are judged to have difficulty in participation in the study
12) 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 | Keiko |
| Middle name | |
| Last name | Mizuno |
Organization
Kagoshima University Hospital
Division name
Department of Pulmonary medicine
Zip code
890-8520
Address
8-35-1, Sakuragaoka, Kagoshima-city
TEL
99-275-5111
keim@m.kufm.kagoshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Keiko |
| Middle name | |
| Last name | Mizuno |
Organization
Kagoshima University Hospital
Division name
Department of Pulmonary medicine
Zip code
890-8520
Address
8-35-1, Sakuragaoka, Kagoshima-city
TEL
099-275-5111
Homepage URL
keim@m.kufm.kagoshima-u.ac.jp
Sponsor or person
Institute
Kagoshima University Hospital
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
Ethics Committee on Clinical Research, Kagoshima University Hospital
Address
8-35-1, Sakuragaoka, Kagoshima-city
Tel
099-275-5111
kufsyomu@kuas.kagoshima-u.ac.jp
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
鹿児島大学病院(鹿児島県）
川内市医師会立市民病院(鹿児島県）
南九州病院(鹿児島県）
鹿児島市立病院(鹿児島県）
鹿児島厚生連病院(鹿児島県）
今給黎総合病院(鹿児島県）
南風病院(鹿児島県）
鹿児島県立北薩病院(鹿児島県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 03 | Month | 22 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
26
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
| 2017 | Year | 02 | Month | 24 | Day |
Date of IRB
| 2017 | Year | 09 | Month | 15 | Day |
Anticipated trial start date
| 2017 | Year | 09 | Month | 15 | Day |
Last follow-up date
| 2020 | Year | 08 | 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
| 2018 | Year | 03 | Month | 22 | Day |
Last modified on
| 2020 | Year | 09 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036359
