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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005556
Receipt No. R000006584
Scientific Title Phase I / II study for appropriate dose of Erlotinib in patients with lung adenocarcinoma having the sensitive mutation to epidermal growth factor receptor (EGFR) - tyrosine kinase inhibitor (TKI)
Date of disclosure of the study information 2011/05/10
Last modified on 2019/03/30

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Basic information
Public title Phase I / II study for appropriate dose of Erlotinib in patients with lung adenocarcinoma having the sensitive mutation to epidermal growth factor receptor (EGFR) - tyrosine kinase inhibitor (TKI)
Acronym Phase I / II study for reduced dose of Erlotinib
Scientific Title Phase I / II study for appropriate dose of Erlotinib in patients with lung adenocarcinoma having the sensitive mutation to epidermal growth factor receptor (EGFR) - tyrosine kinase inhibitor (TKI)
Scientific Title:Acronym Phase I / II study for reduced dose of Erlotinib
Region
Japan

Condition
Condition Lung adenocarcinoma having the sensitive mutation to EGFR-TKI
Classification by specialty
Pneumology Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To find the minimum effective dose of Erlotinib which achieve the disease control (DC) without growth in patients with lung adenocarcinoma having sensitive EGFR-TKI mutation
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I,II

Assessment
Primary outcomes 1) Phase I; To find the minimum effective dose(MED) of Erlotinib

2) Phase II; The rates of DC(Disease Control) without growth on the MED after 6 to 8 weeks later.
Key secondary outcomes 1)Phase I; Adverse effects on the MED

2)Phase II; QOL questionnaires, pharmacokinetics, progression free survival (PFS), and the rates of adverse effects and response on the MED

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 Phase I; Dose reduction is guided following a Continual Reassessment Method (CRM) based on effect and toxicity. Starting dose of erlotinib is decided by the dose reduction plan. Evaluation of efficacy and toxicity is determined between 6 and 8 weeks. After evaluation of starting dose, efficacy and toxicity data are used to estimate the parameters that define the dose-efficacy / toxicity curve to determine the next dose. Repeating above process, minimum effective dose of erlotinib is determined. In day 1, Erlotinib is orally administered. Pharamacokinetics of erlotinib is performed from day 1 to 2. From day 3, erlotinib is orally administered once every day.

Phase II; Minimum effective dose determined by phase I study is given at day 1. Patients are not given erlotinib but carefully observed in day 2. Pharamacokinetics of erlotinib is performed from day 1 to 2. Erlotinib is orally administered once every day from day 3. Evaluation of efficacy and toxicity is determined between 6 and 8 weeks. Safety is assessed around every 4 weeks. Efficacy is evaluated around every 2 to 6 months. Treatment by minimum effective dose will be continued until severe toxicities or disease progression.
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.7) 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)Adequate organ function, Adequate organ function
Leukocyte count; > or = 3,000/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
PaO2; > or = 70 torr at room air
9)Neither overt interstitial pneumonia nor overt lung fibrosis
10)Written informed consent
Key exclusion criteria 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 20

Research contact person
Name of lead principal investigator
1st name Yuichiro
Middle name
Last name Takeda
Organization National Center for Global health and Medicine
Division name Department of Respiratory Medicine
Zip code 162-865
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 Yuichiro
Middle name
Last name Takeda
Organization National Center for Global health and Medicine
Division name Department of Respiratory Medicine
Zip code 162-8655
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
National Center for Global health and Medicine
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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 Center for Clinical sciences, National Center for Global health and Medicine
Address 1-21-1 Toyama, Shinjuku-ku, Tokyo, 162-8655, Japan
Tel 03-3202-7181
Email rinrijim@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
2011 Year 05 Month 10 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications http://www2.convention.co.jp/jca2017/
Number of participants that the trial has enrolled 38
Results
Safety and efficacy committee were held in October 25th 2013. According to their opinion, we collected additional information. They decided the recommended dose of expanded phase II portion in Dec 27th 2013 by these data.  The phase II portion began in Dec 25th 2013. As to Dec 31th 2016,20 patients have registered in phase II portion.  Allocation completed already. 
Results date posted
2019 Year 03 Month 30 Day
Results Delayed
Delay expected
Results Delay Reason preparing for publication
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
2010 Year 06 Month 25 Day
Date of IRB
2010 Year 06 Month 25 Day
Anticipated trial start date
2010 Year 12 Month 01 Day
Last follow-up date
2017 Year 09 Month 01 Day
Date of closure to data entry
2017 Year 09 Month 07 Day
Date trial data considered complete
2017 Year 09 Month 11 Day
Date analysis concluded
2018 Year 06 Month 30 Day

Other
Other related information

Management information
Registered date
2011 Year 05 Month 05 Day
Last modified on
2019 Year 03 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006584

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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