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

• Status: Terminated
• Trial end date: 2019-11-04
• Target enrollment: 0
• Participant gender: Female

Summary

This study will evaluate NanoPac® administered intraperitoneally (IP) immediately post-cytoreductive surgery, followed by standard of care (SOC) intravenous (IV) chemotherapy, in women with ovarian cancer. The study will compare IP NanoPac® (plus IV chemotherapy) with SOC IV chemotherapy alone.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NanOlogy, LLC
• Collaborator: US Biotest, Inc.
• Treatments: Carboplatin; Paclitaxel

Criteria

Inclusion Criteria:

• Epithelial ovarian cancer which is contained within the abdomen, but may include pleural effusion if that is the limit of non-peritoneal cavity disease. If subject has recurrent epithelial ovarian cancer, the disease must be platinum sensitive (recurrence >6 months from prior chemotherapy regimen that included a platinum agent and cytoreductive surgery)

• Subject appropriate for cytoreductive surgery and treatment with IV platinum and paclitaxel

• Minimal or non-symptomatic ascites

• ≥18 years old

• Signed informed consent

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