A Phase II, Multicenter, Clinical Trial to Evaluate The Efficacy and Safety of Bevacizumab in Recurrent Malignant Glioma
Phase 2
- Conditions
- Malignant glioma
- Registration Number
- JPRN-jRCT2080220811
- Lead Sponsor
- Chugai Pharmaceutical Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 31
Inclusion 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%
Exclusion 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 6-month progression free survival
- Secondary Outcome Measures
Name Time Method 1-year survival rate, Progression free survival, Overall response rate, Overall survival, Disease control rate