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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014181
Receipt No. R000016515
Scientific Title Prediction of adverse events in patients with EGFR-mutant non-small cell lung cancer using population pharmacokinetics of afatinib
Date of disclosure of the study information 2014/06/06
Last modified on 2020/04/30

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Basic information
Public title Prediction of adverse events in patients with EGFR-mutant non-small cell lung cancer using population pharmacokinetics of afatinib
Acronym Population pharmacokinetics of afatinib
Scientific Title Prediction of adverse events in patients with EGFR-mutant non-small cell lung cancer using population pharmacokinetics of afatinib
Scientific Title:Acronym Population pharmacokinetics of afatinib
Region
Japan

Condition
Condition EGFR-mutant non-small cell lung cancer
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 prediction of adverse event and efficacy using poplulation pharmacokinetics of afatinib
Basic objectives2 Pharmacokinetics
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes correlation of adverse event and efficacy with plasma concentration of afatinib
Key secondary outcomes correlation of response rate and progression-free survival with plasma concentration of afatinib,
correlation of adverse event and efficacy with T790M mutation

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 Other
Interventions/Control_1 Patients are treated with afatinib and serial blood samples are collected (drug concentrations and T790M mutation are investigated)
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Eligibility criteria are as follows: (1) patients with EGFR-mutant non-small cell lung cancer adaptable to afatinib; (2)with written informed consent.; (3) without infection of HIV, HTLV, HBV, HCV, and TP.
Key exclusion criteria Unsuitable cases are whom doctors jugde unable to be carried out this research safely.
Target sample size 80

Research contact person
Name of lead principal investigator
1st name Shinji
Middle name
Last name Atagi
Organization National Hospital Organization Kinki-chuo Chest Medical Center
Division name Department of Clinical Research Center
Zip code 591-8555
Address 1180 Nagasone, Kita-ku, Sakai, Japan
TEL 072-252-3021
Email s-atagi@kch.hosp.go.jp

Public contact
Name of contact person
1st name Keiko
Middle name
Last name Nakao
Organization National Hospital Organization Kinki-chuo Chest Medical Center
Division name Department of Internal Medicine
Zip code 591-8555
Address 1180 Nagasone, Kita-ku, Sakai, Japan
TEL 072-252-3021
Homepage URL
Email keinakao@kch.hosp.go.jp

Sponsor
Institute National Hospital Organization Kinki-chuo Chest Medical Center
Institute
Department

Funding Source
Organization nothing
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 National Hospital Organization Kinki-chuo Chest Medical Center
Address 1180 Nagasone, Kita-ku, Sakai, Japan
Tel 072-252-3021
Email keinakao@kch.hosp.go.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

Other administrative information
Date of disclosure of the study information
2014 Year 06 Month 06 Day

Related information
URL releasing protocol https://www.nature.com/articles/s41598-019-54804-9
Publication of results Published

Result
URL related to results and publications https://www.nature.com/articles/s41598-019-54804-9
Number of participants that the trial has enrolled 34
Results
Afatinib trough plasma concentrations on day 8 were higher in patients with adverse events of grade 3 or higher.
The population PK analysis showed that hepatic impairment affected afatinib PK parameters and contributed to the high inter-patient variability and high plasma concentrations of afatinib following multiple treatments.
Results date posted
2020 Year 04 Month 28 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The population PK analysis was performed using plasma afatinib samples obtained from 34 patients with NSCLC, who started afatinib therapy at the National Hospital Organization Kinki-Chuo Chest Medical Center and the Osaka Habikino Medical Center between August 2014 and May 2016. All patients met the following criteria: cytologically or histologically confirmed as EGFR mutation-positive NSCLC, with no history of treatment with afatinib in previous chemotherapy. Patients who had undergone gefitinib or erlotinib treatments in the past were included. 
Participant flow
Afatinib was orally administered at a dose of 40mg once daily until disease progression or intolerable toxicity. Physicians were able to increase the afatinib dose up to 50mg daily when they judged it was appropriate to increase the dose.
Adverse events
As expected, anorexia, diarrhea, skin complications, and stomatitis were the most frequently reported AEs. Grade 3 to 4 hematological toxicities (number; % of patients) included leukopenia (1; 2.9%) and neutropenia (1; 2.9%), whereas grade 3 to 4 nonhematological toxicities included anorexia (4; 11.8%), stomatitis (2; 5.9%), diarrhea (8; 23.5%), skin complications (3; 8.8%), pneumonitis (3; 8.8%), and infection (7; 20.6%).
Outcome measures
Patients who experienced grade 3 anorexia, grade 3 stomatitis, grade 3 or 4 diarrhea, and grade 3 skin complications showed higher trough plasma concentrations of afatinib on day 8 than patients who experienced  under grade 2 AEs. In patients required dose reduction or interruption of afatinib, the trough plasma concentration of afatinib were significantly higher than that in those who did not require dose reduction or interruption.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2014 Year 06 Month 05 Day
Date of IRB
2014 Year 07 Month 25 Day
Anticipated trial start date
2014 Year 07 Month 25 Day
Last follow-up date
2016 Year 11 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information correlation of adverse event and efficacy (response rate and progression-free survival) with plasma concentration of afatinib,
correlation of adverse event and efficacy with T790M mutation

Management information
Registered date
2014 Year 06 Month 05 Day
Last modified on
2020 Year 04 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016515

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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