NCT03029585

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

Phase II Study of Four Dose Levels of Intraperitoneal NanoPac® Plus IV Carboplatin and Paclitaxel in Patients With Epithelial Ovarian Cancer Undergoing Cytoreductive Surgery

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: NanOlogy, LLC · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Research has shown that the administration of chemotherapy directly into the peritoneal cavity (intraperitoneal \[IP\] chemotherapy) may provide a significant survival benefit to women with ovarian cancer when combined with cytoreductive surgery and IV chemotherapy. This study will include a dose-finding phase and an efficacy phase to evaluate IP NanoPac® administered immediately post-cytoreductive surgery in women with ovarian cancer. In the dose-finding phase, subjects will be enrolled in dose-escalated cohorts of three subjects and receive IP NanoPac® at 100, 200, 300, or 400 mg/m2 plus standard of care (SOC) IV chemotherapy. Subjects will be followed for disease status for 12 months. The two best doses from the dose-finding phase will be determined. In the efficacy phase, subjects will be randomized 1:1:1 to one of the two best doses plus SOC IV chemotherapy or SOC alone.

Conditions

• Ovarian Carcinoma

Interventions

Type	Name	Description
DRUG	NanoPac® 100 mg/m2	Single intraperitoneal injection of 100 mg/m2 NanoPac® during cytoreductive surgery, followed by standard-of-care IV carboplatin and IV paclitaxel treatment
DRUG	NanoPac® 200 mg/m2	Single intraperitoneal injection of 200 mg/m2 NanoPac® during cytoreductive surgery, followed by standard-of-care IV carboplatin and IV paclitaxel treatment
DRUG	NanoPac® 300 mg/m2	Single intraperitoneal injection of 300 mg/m2 NanoPac® during cytoreductive surgery, followed by standard-of-care IV carboplatin and IV paclitaxel treatment
DRUG	NanoPac® 400 mg/m2	Single intraperitoneal injection of 400 mg/m2 NanoPac® during cytoreductive surgery, followed by standard-of-care IV carboplatin and IV paclitaxel treatment
DRUG	Standard of Care Intravenous Chemotherapy	Cytoreductive surgery followed by standard-of-care IV carboplatin and IV paclitaxel treatment

Timeline

• Start date: 2017-04-19
• Primary completion: 2019-11-04
• Completion: 2019-11-04
• First posted: 2017-01-24
• Last updated: 2021-04-27
• Results posted: 2021-04-27

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study