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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002953
Receipt No. R000003591
Scientific Title Pharmacokinetic, pharmacodynamic and phase II study of gefitinib in patients with malignant pleural effusion from non-small cell lung cancer
Date of disclosure of the study information 2009/12/28
Last modified on 2009/12/28

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Basic information
Public title Pharmacokinetic, pharmacodynamic and phase II study of gefitinib in patients with malignant pleural effusion from non-small cell lung cancer
Acronym Pharmacokinetic, pharmacodynamic and phase II study of gefitinib in patients with malignant pleural effusion from non-small cell lung cancer
Scientific Title Pharmacokinetic, pharmacodynamic and phase II study of gefitinib in patients with malignant pleural effusion from non-small cell lung cancer
Scientific Title:Acronym Pharmacokinetic, pharmacodynamic and phase II study of gefitinib in patients with malignant pleural effusion from 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 efficacy, safety, pharmacokinetics and pharmacodynamics of gefitinib in patients with malignant pleural effusion from non-small cell lung cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Efficacy and safety
Pharmacokinetics
Pharmacodynamics
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 Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine Maneuver
Interventions/Control_1 Oral gefitinib treatment
Chest tube drainage and sampling pleural effusion
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) Pathologically confirmed non-small cell lung cancer
2) Requirement of chest tube drainage for symptomatic relief from pathologically confirmed malignant pleural effusion.
3) Measurable or evaluable disease
4) Performance status (ECOG): 0-3.
5) Adequate major organ functions
6) Written informed consent
Key exclusion criteria 1) Comorbidity of interstitial lung disease, severe pneumoconiosis, or severe chronic obstructive lung diseases.
2) Other uncontrolled comorbid diseases.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akihito Kubo
Organization Aichi Medical University School of Medicine
Division name Division of Respiratory Medicine and Allergology
Zip code
Address 21 Karimata, Yazako, Nagakute, Aichi, Aichi, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Aichi Medical University School of Medicine
Division name Division of Respiratory Medicine and Allergology
Zip code
Address 21 Karimata, Yazako, Nagakute, Aichi, Aichi, Japan
TEL
Homepage URL
Email

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

Funding Source
Organization Grant-in-Aid for Cancer Research
Organization
Division
Category of Funding Organization
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 国立病院機構 近畿中央胸部疾患センター(大阪府)

Other administrative information
Date of disclosure of the study information
2009 Year 12 Month 28 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 Completed
Date of protocol fixation
2006 Year 06 Month 13 Day
Date of IRB
Anticipated trial start date
2006 Year 09 Month 01 Day
Last follow-up date
2009 Year 02 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 12 Month 28 Day
Last modified on
2009 Year 12 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003591

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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