AMG 102 and Avastin for Recurrent Malignant Glioma
Status:
Completed
Trial end date:
2015-09-01
Target enrollment:
Participant gender:
Summary
The primary purpose of the study is to assess the response rate of AMG 102 and Avastin
treatment in subjects with advanced malignant glioma. Secondary objectives are to estimate
overall survival and 6-month progression-free survival rates in this population and to assess
the safety of this combination in this population.
Patients must have recurrent histologically confirmed diagnosis of World Health Organization
(WHO) grade IV malignant glioma (glioblastoma multiforme or gliosarcoma) with no more than 3
prior progressions. Subjects will receive Avastin and AMG 102 every two weeks. Avastin will
be administered prior to AMG 102. Up to 36 adult subjects will take part in this study at
Duke.
In initial Phase I and II clinical trials, four potential Avastin-associated safety issues
were identified: hypertension, proteinuria, thromboembolic events, and hemorrhage. The most
common side effect for AMG 102 have been nausea and fatigue.