A Randomized Study of Safety and Efficacy of Pazopanib and Gemcitabine in Persistent or Relapsed Ovarian Cancer

Ovarian cancer is the leading cause of gynecologic cancer deaths, and the fifth most common
cause of cancer deaths in women. While approximately 75% of patients with epithelial ovarian
cancer will respond to first-line chemotherapy with platinum and paclitaxel, most patients
with advanced stage epithelial ovarian cancer will experience disease recurrence. Pazopanib
is a novel agent has recently been approved for the treatment of subjects with advanced renal
cell carcinoma (RCC), and preclinical studies suggest it may be effective in other cancers
such as ovarian cancer. Therefore, the purpose of this study is to test the efficacy and
safety of a novel agent, pazopanib, as an adjunct to a standard treatment, gemcitabine, for
recurrent or persistent ovarian cancer. This is an open label study in which subjects will be
randomized 1:1 to receive 4 cycles of either gemcitabine, or gemcitabine with pazopanib.
Gemcitabine will be administered as an IV infusion weekly on days 1 and 8 of a 21 day cycle.
Subjects randomized to receive pazopanib will take 800 mg daily during the 21 day cycle. All
subjects will be monitored for toxicity and other indicators of safety (labs, physical exams,
vitals) at intervals throughout the treatment cycles. Subjects will be followed for up to 5
years following the conclusion of treatment to evaluate efficacy. The primary endpoints of
the study are progression free survival and overall survival, which will be assessed at three
years.