Phase 2 Combination Trial of Tivozanib and Enzalutamide in Men With Advanced Prostate Cancer
Patients will be treated in treatment cycles of 28 days (4 weeks), during which time they
will take tivozanib once a day for 21 days (3 weeks) followed by a one week break from
treatment. The other medication, enzalutamide, will be taken every day throughout each
Patients will be given a Study Drug Administration Diary to keep a brief record of
medication administration, and to record any side effects or symptoms.
Patients will be seen in the clinic at the beginning of each cycle (every 4 weeks). During
each visit they will have the following procedures: medical history, vital sign
measurements, complete physical examination, performance status, routine blood tests, urine
sample, prostate specific antigen (PSA) test, assessment of tumor, review of study drug
administration diary, and review of current medications.
About four weeks after stopping the study drug patients will be asked to return to the
research clinic for a final study visit. The following procedures will be done: medical
history, vital sign measurements, brief physical examination, electrocardiogram, review of
other medications used since the last visit, routine blood tests, urine sample and a review
of any changes in health.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression Free Survival
The primary objective of this study will be to demonstrate an improvement in progression free survival in men with metastatic castration resistant prostate cancer (mCRPC) treated with tivozanib and enzalutamide.
M. Dror Michaelson, MD, PhD
Massachusetts General Hospital
United States: Food and Drug Administration
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|