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

NanOlogy

Status and phase: Terminated; Phase 2

Conditions: Ovarian Carcinoma

Treatments: Drug: Standard of Care Intravenous Chemotherapy; Drug: NanoPac® 200 mg/m2; Drug: NanoPac® 300 mg/m2; Drug: NanoPac® 100 mg/m2; Drug: NanoPac® 400 mg/m2

Study type: Interventional

Funder types: Industry

Identifiers

NCT03029585

NANOPAC-2016-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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10 participants in 5 patient groups

NanoPac® 100 mg/m2

Experimental group

Description:

Intraperitoneal NanoPac® 100 mg/m2 applied immediately post-cytoreductive surgery, followed by standard of care intravenous chemotherapy.

Treatment:

Drug: NanoPac® 100 mg/m2

Drug: Standard of Care Intravenous Chemotherapy

NanoPac® 200 mg/m2

Experimental group

Description:

Intraperitoneal NanoPac® 200 mg/m2 applied immediately post-cytoreductive surgery, followed by standard of care intravenous chemotherapy.

Treatment:

Drug: NanoPac® 200 mg/m2

Drug: Standard of Care Intravenous Chemotherapy

NanoPac® 300 mg/m2

Experimental group

Description:

Intraperitoneal NanoPac® 300 mg/m2 applied immediately post-cytoreductive surgery, followed by standard of care intravenous chemotherapy.

Treatment:

Drug: NanoPac® 300 mg/m2

Drug: Standard of Care Intravenous Chemotherapy

NanoPac® 400 mg/m2

Experimental group

Description:

Intraperitoneal NanoPac® 400 mg/m2 applied immediately post-cytoreductive surgery, followed by standard of care intravenous chemotherapy.

Treatment:

Drug: Standard of Care Intravenous Chemotherapy

Drug: NanoPac® 400 mg/m2

Standard of Care Intravenous Chemotherapy

Active Comparator group

Description:

Standard of care intravenous chemotherapy (with platinum and taxane agents) administered per institutional standards.

Treatment:

Drug: Standard of Care Intravenous Chemotherapy