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


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 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


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

Value
https://center6.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