A Phase II Study of Tivozanib in Recurrent Glioblastoma
If you are willing to participate in this study, you will be asked to undergo some screening
tests and procedures that confirm you are eligible. Many of these tests and procedures are
likely to be part of regular cancer care and may be done even if it turns out taht you do
not take part in the research study. If you have had some of these tests or procedures
recently, they may or may not have to be repeated. The screening process may include the
following: a medical history, mini-mental status exam, physical exam, performance status,
electrocardiogram, blood tests, urine test. If these tests show that you are eligible to
participate in the research study, you will begin the study treatment. If you do not meet
the eligibility criteria, you will not be able to participate in this research study.
If you take part in this research study, you will be given a study drug-dosing calendar for
each treatment cycle. Each treatment cycle lasts 28 days (4 weeks) during which time you
will be taking the study drug once daily for 3 weeks and then no study drug for the last
week of each cycle. The diary will also include special instructions for taking the study
During all cycles you will have a physical exam and you will be asked questions about your
general health and specific questions about any problems that you might be having and any
medications you may be taking.
Standard contrast-enhanced (CE) MRI scans will be done prior to all odd-numbered study
cycles. Vascular MRI scans will be done prior to start of treatment, Day 1 of treatment and
prior to all even-numbered cycles. These studies will be done in the Charlestown Navy Yard.
We would like to keep track of your medical condition for up to 24 months after your last
dose of study treatment. We would like to do this by calling you on the telephone once a
year to see how you are doing. Keeping in touch with you and checking your condition every
year helps us look at the long-term effects of the research study.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Determine proportion of patients alive and progression free after 6 months
To determine the proportion of patients with recurrent glioblastoma (GBM) alive and progression free 6 months (PFR6) after start of tivozanib therapy
Elizabeth Gerstner, MD
Massachusetts General Hospital
United States: Food and Drug Administration
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|