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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000026410
Receipt No. R000030343
Scientific Title The research of factor influencing erlotinib-induced toxicity in patients with non-small cell lung cancer
Date of disclosure of the study information 2017/03/06
Last modified on 2018/10/06

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Basic information
Public title The research of factor influencing erlotinib-induced toxicity in patients with non-small cell lung cancer
Acronym The research of factor influencing erlotinib-induced toxicity in patients with non-small cell lung cancer
Scientific Title The research of factor influencing erlotinib-induced toxicity in patients with non-small cell lung cancer
Scientific Title:Acronym The research of factor influencing erlotinib-induced toxicity in patients with non-small cell lung cancer
Region
Japan

Condition
Condition Non-small cell lung cancer
Classification by specialty
Pneumology Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To evaluate the relationship between pharmacokinetics of erlotinib and genetic polymorphisms of metabolic enzymes and transporters
Basic objectives2 Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To elucidate the pharmacokinetic factors relating erlotinib-induced toxicity
Key secondary outcomes

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 Erlotinib
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 confirmed non-small cell lung cancer
2) Unresectable advanced or recurrent disease
3) Age is over 20 years.
4) Performance status (ECOG) is 0 to 2
5) Adequate organ function, evidenced by following laboratory results within 14 days prior to starting chemotherapy
Absolute neutrophil count>1,500/mm3
Platelet count>100,000/mm3
Hemoglobin>8.0g/dL
AST and ALT<2.5 times the upper limit of normal(ULN)
Total bilirubin<2.0mg/dL
6) Signed, written informed concent is obtained
Key exclusion criteria 1) Interstitial pneumonia, pulmonary fibrosis
2) Severe active infection
3) Serological positive for HBs-antigen or HCV-antibody
4) Previous therapy with pazopanib
5) Unstable angina or myocardial infarction within 3 months
6) Severe complication (e.g., uncontrollable diabetis mellitus, liver disease)
7) Active synchronous cancer
8) Severe psychiatric disorder
9) Pregnant or lactating women, or men and women without wanting pregnancy
10) Severe hypersensitivity to medicine
11) Taking medicines affecting CYP3A4 within one week before starting gefitinib therapy (e.g., phenytoin, carbamazepine, rifampicin, phenobarbital, ketokonazole, macrolide)
12) Taking proton pump inhibitor or H2 blocker within one week before starting gefitinib therapy
13) Patients who were judged inappropriate for the study
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroo Ishida
Organization Showa University School of Medicine
Division name Division of Medical Oncology, Department of Medicine
Zip code
Address 1-5-8 Hatanodai, Shinagawa-ku, Tokyo
TEL 03-3784-8000
Email hishida@med.showa-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroo Ishida
Organization Showa University School of Medicine
Division name Division of Medical Oncology, Department of Medicine
Zip code
Address 1-5-8 Hatanodai, Shinagawa-ku, Tokyo
TEL 03-3784-8000
Homepage URL
Email hishida@med.showa-u.ac.jp

Sponsor
Institute Showa University School of Medicine
Institute
Department

Funding Source
Organization Showa University School of Medicine
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
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
2017 Year 03 Month 06 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 Terminated
Date of protocol fixation
2013 Year 11 Month 08 Day
Date of IRB
Anticipated trial start date
2013 Year 12 Month 01 Day
Last follow-up date
2018 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 03 Month 06 Day
Last modified on
2018 Year 10 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030343

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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