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

NCT03029585 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2021-04-27

Study results available
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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

Interventions

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

Sponsors & Collaborators

  • US Biotest, Inc.

    collaborator INDUSTRY

  • NanOlogy, LLC

    lead INDUSTRY

Principal Investigators

  • Joan Walker, MD · University of Oklahoma

  • Gere diZerega, MD · US Biotest, Inc./NanOlogy, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-19
Primary Completion
2019-11-04
Completion
2019-11-04
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03029585 on ClinicalTrials.gov