UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033549 |
|---|---|
| Receipt number | 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 | 2022/05/28 13:36:14 |
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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 | Yuichiro |
| Middle name | |
| Last name | Takeda |
Organization
Center Hospital of the National Center for Global health and Medicine
Division name
Department of Respiratory Medicine / Laboratory Testing Department
Zip code
1628655
Address
National Center for Global Health and Medicine
TEL
+81332027181
ytakeda@hosp.ncgm.go.jp
Public contact
Name of contact person
| 1st name | Yuichiro |
| Middle name | |
| Last name | Takeda |
Organization
National Center for Global Health and Medicine
Division name
Department of Respiratory Medicine / Laboratory Testing Department
Zip code
1628655
Address
National Center for Global Health and Medicine
TEL
+81332027181
Homepage URL
ytakeda@hosp.ncgm.go.jp
Sponsor or person
Institute
Department of Respiratory Medicine
in the Center Hospital of the National Center for Global health and Medicine
Institute
Department
Personal name
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
The institutional review board for clinical research
Address
1-21-1 Toyama, Shinjuku-ku, Tokyo, 162-8655, Japan
Tel
+81332027181
rinrijm@hosp.ncgm.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
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
1
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
Terminated
Date of protocol fixation
| 2018 | Year | 06 | Month | 17 | Day |
Date of IRB
| 2018 | Year | 07 | Month | 06 | Day |
Anticipated trial start date
| 2018 | Year | 10 | Month | 30 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
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.
Due to significant delays in enrollment, the study was terminated as of March 31, 2022.
Management information
Registered date
| 2018 | Year | 07 | Month | 28 | Day |
Last modified on
| 2022 | Year | 05 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038257
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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