UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004199 |
|---|---|
| Receipt number | 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 15:07:39 |
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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
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
Sponsor or person
Institute
Kanagawa Cancaer Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005046
