A Phase I/II Trial of Multiple Dose VB-111 and Weekly Paclitaxel for the Treatment of Recurrent Platinum-Resistant Mullerian Cancer
We are looking for the highest dose of the study drug that can be administered safely
without severe or unmanageable side effects in participants who have ovarian cancer. For
this reason not everyone who participates in the research study will receive the same dose
of the study drug. The dose you get will depend on the number of participants who have been
enrolled in the study before you and how well they have tolerated their doses.
This study will be performed in cycles. Each cycle will be 28 days long. If you take part in
this research study, you will receive VB-111 as a 15-minute intravenous infusion on Day 1 of
odd cycles (e.g. every 2 cycles, or 2 months). VB-111 will be infused immediately following
You will receive paclitaxel as a 60-minute intravenous infusion weekly (days 1, 8, 15 and 22
of each 4 week cycle).
On Day 1 of each cycle you will undergo a medical history, physical exam, performance
status, vital signs check, urine sample, routine blood tests, biomarker blood tests and
biodistribution blood and urine tests. On Day 1 of each odd cycle you will undergo a CT scan
or MRI to assess your tumor.
After the final dose of VB-111 you will be required to return to the clinic for a follow up
visit. This visit will consist of a medical history, vital signs, physical examination,
performance status, blood samples, urine samples, EKG and measurement of your tumor by CT or
MRI. In the case of unexplained death, we will ask your family's permission for an autopsy.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Define toxicities of a limited number of doses of combination VB-111 and weekly paclitaxel spanning anticipated effective doses.
Richard T Penson, MD
Massachusetts General Hospital
United States: Food and Drug Administration
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Brigham and Women's Hospital||Boston, Massachusetts 02115|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|