UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002953 |
|---|---|
| Receipt number | 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 18:17:40 |
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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
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
Sponsor or person
Institute
National Hospital Organization Kinki-Chuo Chest Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003591
