The purpose of this study is to find out the effect of bevacizumab with or without a new investigational drug, AMG 386, on you and your tumor. Bevacizumab is a protein that works by preventing new cancer-related blood vessel formation. The U.S. Food and Drug Administration (FDA) has approved bevacizumab for the treatment of recurrent glioblastoma. However, treatment with bevacizumab alone has only modestly improved overall survival in patients with this type of brain tumor. For this reason, other drugs, such as AMG 386, are being evaluated.
You may or may not receive the investigational drug AMG 386 depending on which treatment group you are placed in. The word “investigational” means that the drug is being tested and is not approved by the FDA. This study will look at whether or not adding AMG 386 to bevacizumab is more effective in fighting your brain tumor by slowing its growth, stopping growth, or shrinking the tumor as compared to bevacizumab alone. This study will also look at the side effects of AMG 386 plus bevacizumab in you and other participants with glioblastoma. It is hoped that AMG 386 will kill tumor cells and that it may also block blood vessels that supply the tumor in your brain with nutrients and oxygen. AMG 386 has been used and is currently being used in other clinical trials treating recurrent glioblastoma and other cancers.
The first part of this study (Cohort 1) will test the safety of a combination of AMG 386 weekly and bevacizumab every 2 weeks in participants who have never received any treatments that block blood vessel formation. When the safety of this treatment is determined, the second part of this study (Cohort 2) will begin.
In Cohort 2 you will be randomized (randomly assigned) to receive either bevacizumab plus placebo (inactive substance) or bevacizumab plus AMG 386. You will receive bevacizumab every 2 weeks and placebo or AMG 386 once per week.
After you are finished taking bevacizumab plus AMG 386/placebo, you will have follow-up assessments 30 days after the end of treatment, then every 2 months for 1 year after the end of treatment, then every 6 months for the next year, and then annually.
About 141 people will take part in this study with about 6 of those being local.
Eligible patients must be at least 18 years old and have a brain tumor, called a glioblastoma or gliosarcoma, which has become worse after other treatment.
Alison Kastl 513-584-0436 or firstname.lastname@example.org