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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017050
Receipt No. R000019762
Scientific Title First-Line Afatinib in Patients Aged 75 or Older With Advanced Non-Small Cell Lung Cancer Harboring EGFR Mutation -Multicenter study on the Pharmacokinetics and pharmacogenetics of Afatinib-
Date of disclosure of the study information 2015/04/10
Last modified on 2019/04/08

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Basic information
Public title First-Line Afatinib in Patients Aged 75 or Older With Advanced Non-Small Cell Lung Cancer Harboring EGFR Mutation -Multicenter study on the Pharmacokinetics and pharmacogenetics of Afatinib-
Acronym First-Line Afatinib in Patients Aged 75 or Older
Scientific Title First-Line Afatinib in Patients Aged 75 or Older With Advanced Non-Small Cell Lung Cancer Harboring EGFR Mutation -Multicenter study on the Pharmacokinetics and pharmacogenetics of Afatinib-
Scientific Title:Acronym First-Line Afatinib in Patients Aged 75 or Older
Region
Japan

Condition
Condition patients aged 75 or older
with advanced non small cell lung cancer harboring EGFR mutation
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To evaluate the efficacy and safty of afatinib in patients aged 75 or older
with advanced non small cell lung cancer harboring EGFR mutation
Basic objectives2 PK,PD
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes response rate
Key secondary outcomes disease control rate
progression free survival
overall survival
Adverse events
Quality of life
PK/PGx

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)Histlogically or cytologically confirmed EGFR mutation positive non small cell lung cancer(NSCLC)
2)Unresectable and metastatic NSCLC
3)Harboring sensitive EGFR mutation
4)Patients who have never treated with EGFR-TKI and cytotoxic chemotherapy.
5)More than 75 years old
6)Performance Status (ECOG) 0-1
7)Measurable lesion for RECIST(version 1.1)
8)Adequate organ functions
9)Life expectancy over 3 months
10)Written informed consent
Key exclusion criteria 1)Concomitant treatment with other anticancer agent, radiotherapy, or immunotherapy.
2)Preexisting interstitial lung disease of chest CT
3)HBs antigen positive
4)HBs or HBc antibody positive, and HBV-DNA positive
5)EGFR minor mutation or exon 20 T790M
6)Active double cancer
7)Digestive disease influencing absorption of afatinib
8)Oral feeding difficulty
9)Patients whose attending doctor consider as inappropriate for this study
Target sample size 35

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Oizumi Satoshi
Organization Hokkaido Cancer Center
Division name Respiratory Medicine
Zip code
Address Kikusui4, West 2, Shiroishi-ku, Sapporo
TEL 011-811-9111
Email soizumi@sap-cc.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hidenori Mizugaki
Organization Hokkaido University Hospital
Division name First department of medicine
Zip code
Address North 14, West 5, Kita-ku, Sapporo
TEL 011-706-5911
Homepage URL
Email mhide@med.hokudai.ac.jp

Sponsor
Institute Hokkaido University Hospital, First department of medicine
Institute
Department

Funding Source
Organization Cancer Fundation
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor National Cancer Center
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 04 Month 10 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 03 Month 04 Day
Date of IRB
2015 Year 07 Month 14 Day
Anticipated trial start date
2015 Year 07 Month 15 Day
Last follow-up date
2019 Year 02 Month 28 Day
Date of closure to data entry
Date trial data considered complete
2019 Year 07 Month 31 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 04 Month 05 Day
Last modified on
2019 Year 04 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019762

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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