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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000004199
Receipt No. R000005046
Scientific Title Phase II study of OK-432 intrapleural administration followed by systemic carboplatin, pemetrexed and bevasizumab for non-squamous non-small cell lung cancer with pleuritis carcinomatosa
Date of disclosure of the study information 2010/09/14
Last modified on 2010/09/13

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Basic information
Public title Phase II study of OK-432 intrapleural administration followed by systemic carboplatin, pemetrexed and bevasizumab for non-squamous non-small cell lung cancer with pleuritis carcinomatosa
Acronym Phase II study of OK-432 intrapleural administration followed by systemic carboplatin, pemetrexed and bevasizumab for non-squamous non-small cell lung cancer with pleuritis carcinomatosa
Scientific Title Phase II study of OK-432 intrapleural administration followed by systemic carboplatin, pemetrexed and bevasizumab for non-squamous non-small cell lung cancer with pleuritis carcinomatosa
Scientific Title:Acronym Phase II study of OK-432 intrapleural administration followed by systemic carboplatin, pemetrexed and bevasizumab for non-squamous non-small cell lung cancer with pleuritis carcinomatosa
Region
Japan

Condition
Condition non-squamous non-small cell lung cancer with pleuritis carcinomatosa
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of OK-432 intrapleural administration followed by systemic carboplatin, pemetrexed and bevasizumab for non-squamous non-small cell lung cancer with pleuritis carcinomatosa(phaseII).
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes progression free survival two months after OK-432 intrapleural administration.
Key secondary outcomes response rate
overall survival
progression free survival
adverse events


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 1.administration of OK432 5-10KE
2.Cb(AUC5)day1+Pem 500mg/m2 day1+Bev 15mg/kg day1:q3-4w
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 non-squamous cell lung cancer
2)untreated or previous 1 or 2 regimens chemotherapy without pemetrexed and bevasizumab or relapse after surgery
3)pleuritis carcinomatosa
4)Age: over 20 years old
5)ECOG Perfomance status 0-2
6)preserved organ's function
WBC>=3,000/mm3
Hemoglobin>= 9.0g/dl
Platelet count>=100,000/mm3
Total serum bilirubin <=1.5 mg/dl
AST/ALT <100 IU/l
Serum creatinine <=1.5mg/dl
7)Acquisition of written informed consent
Key exclusion criteria 1)Massive pericardial effusion
2)Severe complications; myocardial infarction, unstable angina, heart failure, uncontrolled hypertension, and unconrolled diabetis mellitus, uncontrolled infection.
3)Severe bone marrow suppression
4)Previous carboplatin allergy
5)Brain metastsis
6)Hemoptysis(more than 2.5ml), continuous or treatment-required bloody sputum
7)Lung fibrosis
8)Pregnancy
9)Other inappropriate cases
Target sample size 11

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Fumihiro Oshita
Organization Kanagawa Cancaer Center
Division name Thoracic oncology
Zip code
Address Nakao1-1-2,Asahi-ku,Yokohama
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Kanagawa Cancaer Center
Division name Thoracic oncology
Zip code
Address Nakao1-1-2,Asahi-ku,Yokohama
TEL
Homepage URL
Email

Sponsor
Institute Kanagawa Cancaer Center
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
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
2010 Year 09 Month 14 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 Enrolling by invitation
Date of protocol fixation
2010 Year 08 Month 17 Day
Date of IRB
Anticipated trial start date
2010 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 09 Month 13 Day
Last modified on
2010 Year 09 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005046

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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