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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000033549
Receipt No. R000038257
Scientific Title Observational research to decide optimal dose of Afatinib in patients with primary lung adenocarcinoma harbouring the sensitive mutation of epidermal growth factor receptor (EGFR) by pharmacokinetic analyses
Date of disclosure of the study information 2018/08/01
Last modified on 2018/10/30

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Basic information
Public title Observational research to decide optimal dose of Afatinib in patients with primary lung adenocarcinoma harbouring the sensitive mutation of epidermal growth factor receptor (EGFR) by pharmacokinetic analyses
Acronym Observational research to decide optimal dose of Afatinib by pharmacokinetic analyses
Scientific Title Observational research to decide optimal dose of Afatinib in patients with primary lung adenocarcinoma harbouring the sensitive mutation of epidermal growth factor receptor (EGFR) by pharmacokinetic analyses
Scientific Title:Acronym Observational research to decide optimal dose of Afatinib by pharmacokinetic analyses
Region
Japan

Condition
Condition Patients have primary lung adenocarcinoma harbouring the sensitive mutation of epidermal growth factor receptor (EGFR)
Classification by specialty
Medicine in general Pneumology Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To seek optimal dose of Afatinib in patients with primary lung adenocarcinoma harbouring the sensitive mutation of EGFR by pharmacokinetic analyses
Basic objectives2 Others
Basic objectives -Others To examine the relationship between the efficacy of Afatinib and the copy number of EGFR mutation
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes To seek the pharmacological optimal dose of Afatinib in patients with primary lung adenocarcinoma harbouring the sensitive mutation of EGFR by pharmacokinetic analyses
Key secondary outcomes To seek the clinical optimal dose of Afatinib: Progression free survival (PFS),Time to Treatment failure (TTF), Health states evaluation; time with toxicity more than Grade 2 (TOX-G2), 20% duration of TOX-G2 among PFS (20% TOX-G2; TOX20).
To examine the relationship between the efficacy of Afatinib and the copy number of EGFR mutation

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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)Histologically or cytologically proven lung adenocarcinoma
2)Stage IIIB/IV(UICC ver.8) or recurrence after surgical treatment
3)Tumor has sensitive mutation for EGFR-TKI
4)Naive treatment of EGFR-TKI
5)Tumor has the evaluable lesion
6)Eastern Cooperative Oncology Group performance status of 0-2
7)Age; > or = 20 years and < 80 years
8) No history of thoracic irradiation
9)Adequate organ function, Adequate organ function
Neutrocyte count; > or = 1,500/mm3
Hemoglobin concentration; > or = 10.0g/dl
Platelet count; > or = 100,000/mm3
Total bilirubin level; < or = 2.0 mg/dl
Aspartate aminotransferse and alanine aminotransferase levels; < or = 100 IU/L
Creatinine clearance; > or = 30mL/min
Or serum creatinine; < or = 1.5 mg/dl
SpO2 at room air; > or = 70 torr at room air
10)Neither overt interstitial pneumonia nor overt lung fibrosis
11)Written informed consent
Key exclusion criteria Exclusion criteria included:
1)Uncontrollable comorbid disease.
2)Symptomatic brain metastases
3)Active concomitant malignancy
4)Active infectious disease
5)Pregnant status or lactation
6)Acute or chronic diarrhea
7)Clinically active interstitial pneumonia
8)Acute myocardial ischemia within 3 months or unstable angina pectoris
9)Other ineligible status judged by medical oncologist
Target sample size 34

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuichiro Takeda
Organization Center Hospital of the National Center for Global health and Medicine
Division name Department of Respiratory Medicine
Zip code
Address 1-21-1 Toyama, Shinjuku-ku, Tokyo, 162-8655, Japan
TEL 03-3202-7181
Email ytakeda@hosp.ncgm.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yuichiro Takeda
Organization Center Hospital of the National Center for Global health and Medicine
Division name Department of Respiratory Medicine
Zip code
Address 1-21-1 Toyama, Shinjuku-ku, Tokyo, 162-8655, Japan
TEL 03-3202-7181
Homepage URL
Email ytakeda@hosp.ncgm.go.jp

Sponsor
Institute Department of Respiratory Medicine
in the Center Hospital of the National Center for Global health and Medicine
Institute
Department

Funding Source
Organization Research funding of the Department of Respiratory Medicine in the Center Hospital of the National Center for Global health and Medicine
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization not applicable

Other related organizations
Co-sponsor Department of drug metabolism and disposition
Meiji pharmaceutical university
Name of secondary funder(s) None

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 国立国際医療研究センター病院(東京都)

Other administrative information
Date of disclosure of the study information
2018 Year 08 Month 01 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 Enrolling by invitation
Date of protocol fixation
2018 Year 06 Month 17 Day
Date of IRB
Anticipated trial start date
2018 Year 10 Month 30 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information According to the post hoc analyses from two phase III trial on afatinib, dose reduction led to decreases in the incidence of drug-related toxicities, and was more likely in patients with higher afatinib plasma concentrations. Patients who dose reduced to 30 mg had geometric mean afatinib plasma concentrations of 23.3 ng/ml, versus 22.8 ng/ml in patients who remained on 40 mg. The median PFS was similar in patients who dose reduced versus those who did not. Therefore, 20 mg to 40 mg daily dose of afatinib is clinically used according to weight, performance status, or comorbidity of patients.

Management information
Registered date
2018 Year 07 Month 28 Day
Last modified on
2018 Year 10 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038257

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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