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

NCT03029585 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: NANOPAC-2016-01
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 7

Brief 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.

Conditions

Ovarian Carcinoma

Keywords

ovarian carcinoma; ovarian cancer; ovarian neoplasms; ovarian diseases

Outcome Measures

Primary Outcomes (1)

• Treatment-emergent Adverse Events

  Adverse events will include any clinically relevant changes in laboratory values, vital signs, and physical examination. Treatment-emergent adverse events occur when the date and time of the adverse event onset is on or after the first application of the investigational agent and any time up to when the intravenous chemotherapy commences. Treatment-emergent adverse events will be summarized for each treatment group. The summaries will include an overall summary of the number of subjects reporting and the number of events reported, summaries of adverse events leading to termination or death, and summaries by severity and relatedness (separately and combined). Of greatest interest will be post-surgery signs of toxicity (e.g., severe abdominal pain after 5-7 days, neutropenia, thrombocytopenia, bowel dehiscence, prolonged ileus).

  12 months

Secondary Outcomes (2)

• Maximum Plasma Concentration of Paclitaxel (Cmax)

  12 months

• Progression Free Survival (PFS) at 12 Months

  12 months post-treatment

Study Arms (5)

NanoPac® 100 mg/m2

EXPERIMENTAL

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

Drug: NanoPac® 100 mg/m2; Drug: Standard of Care Intravenous Chemotherapy

NanoPac® 200 mg/m2

EXPERIMENTAL

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

Drug: NanoPac® 200 mg/m2; Drug: Standard of Care Intravenous Chemotherapy

NanoPac® 300 mg/m2

EXPERIMENTAL

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

Drug: NanoPac® 300 mg/m2; Drug: Standard of Care Intravenous Chemotherapy

NanoPac® 400 mg/m2

EXPERIMENTAL

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

Drug: NanoPac® 400 mg/m2; Drug: Standard of Care Intravenous Chemotherapy

Standard of Care Intravenous Chemotherapy

ACTIVE COMPARATOR

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

Drug: Standard of Care Intravenous Chemotherapy

Interventions

NanoPac® 100 mg/m2 DRUG

Single intraperitoneal injection of 100 mg/m2 NanoPac® during cytoreductive surgery, followed by standard-of-care IV carboplatin and IV paclitaxel treatment

NanoPac® 100 mg/m2

NanoPac® 200 mg/m2 DRUG

Single intraperitoneal injection of 200 mg/m2 NanoPac® during cytoreductive surgery, followed by standard-of-care IV carboplatin and IV paclitaxel treatment

NanoPac® 200 mg/m2

NanoPac® 300 mg/m2 DRUG

Single intraperitoneal injection of 300 mg/m2 NanoPac® during cytoreductive surgery, followed by standard-of-care IV carboplatin and IV paclitaxel treatment

NanoPac® 300 mg/m2

NanoPac® 400 mg/m2 DRUG

Single intraperitoneal injection of 400 mg/m2 NanoPac® during cytoreductive surgery, followed by standard-of-care IV carboplatin and IV paclitaxel treatment

NanoPac® 400 mg/m2

Standard of Care Intravenous Chemotherapy DRUG

Cytoreductive surgery followed by standard-of-care IV carboplatin and IV paclitaxel treatment

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

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NanOlogy, LLC: lead
• US Biotest, Inc.: collaborator

Study Sites (7)

University of Chicago

Chicago, Illinois, 60637, United States

Location

Greater Baltimore Medical Center

Baltimore, Maryland, 21204, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

SUNY Downstate

Brooklyn, New York, 11203, United States

Location

Magee-Womens Hospital of UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

Women & Infants Hospital of Rhode Island

Providence, Rhode Island, 02905, United States

Location

University of Texas Southwestern

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Ovarian Neoplasms; Ovarian Diseases

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Limitations and Caveats

Early termination leading to small numbers of subjects analyzed.

Results Point of Contact

• Title: Gere S. diZerega, MD, Responsible Medical Officer
• Organization: US Biotest, Inc.

gere.dizerega@usbiotest.com

1-805-595-1300

Study Officials

• Joan Walker, MD

  University of Oklahoma

  PRINCIPAL INVESTIGATOR

• Gere diZerega, MD

  US Biotest, Inc./NanOlogy, LLC

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2017
• First Posted: January 24, 2017
• Study Start: April 19, 2017
• Primary Completion: November 4, 2019
• Study Completion: November 4, 2019
• Last Updated: April 27, 2021
• Results First Posted: April 27, 2021

Record last verified: 2021-03

Locations

US (7)