JAPIC ID: JapicCTI-090841
Registered date:
Basic Information
Recruitment status | |
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Health condition(s) or Problem(s) studied | Malignant glioma |
Date of first enrollment | 01/8/2009 |
Target sample size | 31 |
Countries of recruitment | |
Study type | INTERVENTIONAL |
Intervention(s) | Intervention name : R435(Bevacizumab) Dosage And administration of the intervention : 10mg/kg, every 2 weeks Control intervention name : - Dosage And administration of the control intervention : - |
Outcome(s)
Primary Outcome | 6-month progression free survival |
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Secondary Outcome | 1-year survival rate, Progression free survival, Overall response rate, Overall survival, Disease control rate |
Key inclusion & exclusion criteria
Age minimum | 20 |
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Age maximum | |
Gender | BOTH |
Include criteria | -Age >= 20 years -Histologically confirmed malignant glioma -All patients must have received prior temozolomide and prior radiation therapy for malignant glioma. -No evidence of recent hemorrhage on baseline MRI of the brain. -Karnofsky Performance Status >= 70% |
Exclude criteria | -The patient has received more than two regimens for malignant glioma. -History of hemoptysis(>=Grade2) within 1 month before randomization. -Serious non-healing wound or untreated bone fracture. |
Related Information
Primary Sponsor | Chugai Pharmaceutical Co., Ltd. |
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Secondary Sponsor | |
Source(s) of Monetary Support | Refer to the information of contact(s) |
Contact
public contact | |
Name | Chugai Pharmaceutical Co., Ltd. Clinical trials information |
Address | clinical-trials@chugai-pharm.co.jp |
Telephone | |
Affiliation | |
scientific contact | |
Name | Chugai Pharmaceutical Co., Ltd. Clinical trials information |
Address | clinical-trials@chugai-pharm.co.jp |
Telephone | |
Affiliation |