NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JAPIC ID: JapicCTI-090841

Registered date:

Basic Information

Recruitment status
Health condition(s) or Problem(s) studiedMalignant glioma
Date of first enrollment01/8/2009
Target sample size31
Countries of recruitment
Study typeINTERVENTIONAL
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 Outcome6-month progression free survival
Secondary Outcome1-year survival rate, Progression free survival, Overall response rate, Overall survival, Disease control rate

Key inclusion & exclusion criteria

Age minimum20
Age maximum
GenderBOTH
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

Contact

public contact
Name Chugai Pharmaceutical Co., Ltd. Clinical trials information
Address clinical-trials@chugai-pharm.co.jp
Telephone
E-mail
Affiliation
scientific contact
Name Chugai Pharmaceutical Co., Ltd. Clinical trials information
Address clinical-trials@chugai-pharm.co.jp
Telephone
E-mail
Affiliation