Phase II Study of Intraperitoneal NanoPac® in Patients With Ovarian Cancer

Exclusion Criteria

• •Epithelial ovarian cancer outside of the peritoneal cavity, with the exception of pleural effusions
• •Anticipated use of concomitant chemotherapy (other than the protocol-specified agents), immunotherapy, or radiation therapy
• •Treatment with a prior investigational agent within 30 days of planned instillation of NanoPac®, with the exception of subjects participating in poly (ADP-ribose) polymerase (PARP) inhibitor trials. These subjects must discontinue the investigational agent prior to surgery
• •Known sensitivity to any of the study medication components or the chemotherapy regimen
• •History of prior malignancy other than ovarian that has not been in remission for \>5 years, with the exception of basal cell or squamous cell carcinoma or cervical carcinoma in situ on biopsy
• •Ileostomy or hepatic resection during current cytoreductive surgery
• •Women of childbearing potential not practicing adequate forms of birth control