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Note: This record shows only 21 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: JPRN
Last refreshed on: 29 January 2018
Main ID:  JPRN-JapicCTI-163294
Date of registration: 10/06/2016
Prospective Registration: Yes
Primary sponsor: CHUGAI PHARMACEUTICAL CO., LTD.
Public title: A Phase II Trial of R435(Bevacizumab) in chemotherapy naive and inoperable malignant pleural mesothelioma patients
Scientific title: A Phase II Trial of R435(Bevacizumab) in chemotherapy naive and inoperable malignant pleural mesothelioma patients
Date of first enrolment: 06/2016
Target sample size: 6
Recruitment status: Complete
URL:  http://www.clinicaltrials.jp/user/showCteDetailE.jsp?japicId=JapicCTI-163294
Study type:  INTERVENTIONAL
Study design:  Multicenter, Open-label, Single-arm study  
Phase:  2
Countries of recruitment
Japan
Contacts
Name: Chugai Pharmaceutical Co., Ltd. Clinical trials information   
Address: 
Telephone:
Email: clinical-trials@chugai-pharm.co.jp
Affiliation: 
Name: Chugai Pharmaceutical Co., Ltd. Clinical trials information   
Address: 
Telephone:
Email: clinical-trials@chugai-pharm.co.jp
Affiliation: 
Key inclusion & exclusion criteria
Inclusion criteria: - ECOG Performance status 0 ot 2
- Histologically confirmed malignant pleural mesothelioma which is inoperable
- chemotherapy naive (including pre or post operative adjuvant chemotherapy)
- Identifiable tumor image present

Exclusion criteria: - History of anti-tumor therapy(chemotherapy, Immunotherapy or biotherapy)
- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abcess in the last 6 months
- Clinical symptoms accompanying or treatment requiring metastasis to central nervous system
- History of cerebral vascular accident or transient ischemic attack in the last 6 months


Age minimum: 20
Age maximum:
Gender: BOTH
Health Condition(s) or Problem(s) studied
chemotherapy naive and inoperable malignant pleural mesothelioma
Intervention(s)
Intervention name : bevacizumab
INN of the intervention : bevacizumab
Dosage And administration of the intervention : 15mg/kg, every 3 weeks
Primary Outcome(s)
Tolerability
Secondary Outcome(s)
Safety, Efficacy
Secondary ID(s)
Source(s) of Monetary Support
Refer to the information of contact(s)
Secondary Sponsor(s)
Results
Results available:
Date Posted:
URL:
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