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

Primary Purpose

Ovarian Carcinoma

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
NanoPac® 100 mg/m2
NanoPac® 200 mg/m2
NanoPac® 300 mg/m2
NanoPac® 400 mg/m2
Standard of Care Intravenous Chemotherapy
Sponsored by
NanOlogy, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Carcinoma focused on measuring ovarian carcinoma, ovarian cancer, ovarian neoplasms, ovarian diseases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • University of Chicago
  • Greater Baltimore Medical Center
  • University of Minnesota
  • SUNY Downstate
  • Magee-Womens Hospital of UPMC
  • Women & Infants Hospital of Rhode Island
  • University of Texas Southwestern

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Active Comparator

Arm Label

NanoPac® 100 mg/m2

NanoPac® 200 mg/m2

NanoPac® 300 mg/m2

NanoPac® 400 mg/m2

Standard of Care Intravenous Chemotherapy

Arm Description

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

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

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

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

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Maximum Plasma Concentration of Paclitaxel (Cmax)
Plasma samples will be taken on Day 1 at 1, 2, 4, 8, and 24 hours post-intraperitoneal administration of NanoPac® and weekly thereafter until IV chemotherapy begins. Additionally, a pharmacokinetics (PK) sample will be collected from every subject prior to each cycle of IV chemotherapy for determination of paclitaxel concentrations to assess potential NanoPac® persistence. PK levels of paclitaxel in the plasma will be summarized descriptively.
Progression Free Survival (PFS) at 12 Months
Progression free survival (PFS) was assessed every 3 months until the end of the 12-month follow-up period, and every 6 months thereafter until progression or the last subject in the trial has completed 12 months of follow-up. Factors taken into account to determine time-to-progression included CA-125 levels, tumor burden as assessed by imaging and utilizing RECIST version 1.1 for assessment of response, and cancer-related symptoms such as bowel obstruction and ascites.

Full Information

First Posted
January 20, 2017
Last Updated
March 31, 2021
Sponsor
NanOlogy, LLC
Collaborators
US Biotest, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03029585
Brief Title
Phase II Study of Intraperitoneal NanoPac® in Patients With Ovarian Cancer
Official Title
Phase II Study of Four Dose Levels of Intraperitoneal NanoPac® Plus IV Carboplatin and Paclitaxel in Patients With Epithelial Ovarian Cancer Undergoing Cytoreductive Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Terminated
Why Stopped
Business reasons
Study Start Date
April 19, 2017 (Actual)
Primary Completion Date
November 4, 2019 (Actual)
Study Completion Date
November 4, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NanOlogy, LLC
Collaborators
US Biotest, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Carcinoma
Keywords
ovarian carcinoma, ovarian cancer, ovarian neoplasms, ovarian diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NanoPac® 100 mg/m2
Arm Type
Experimental
Arm Description
Intraperitoneal NanoPac® 100 mg/m2 applied immediately post-cytoreductive surgery, followed by standard of care intravenous chemotherapy.
Arm Title
NanoPac® 200 mg/m2
Arm Type
Experimental
Arm Description
Intraperitoneal NanoPac® 200 mg/m2 applied immediately post-cytoreductive surgery, followed by standard of care intravenous chemotherapy.
Arm Title
NanoPac® 300 mg/m2
Arm Type
Experimental
Arm Description
Intraperitoneal NanoPac® 300 mg/m2 applied immediately post-cytoreductive surgery, followed by standard of care intravenous chemotherapy.
Arm Title
NanoPac® 400 mg/m2
Arm Type
Experimental
Arm Description
Intraperitoneal NanoPac® 400 mg/m2 applied immediately post-cytoreductive surgery, followed by standard of care intravenous chemotherapy.
Arm Title
Standard of Care Intravenous Chemotherapy
Arm Type
Active Comparator
Arm Description
Standard of care intravenous chemotherapy (with platinum and taxane agents) administered per institutional standards.
Intervention Type
Drug
Intervention Name(s)
NanoPac® 100 mg/m2
Intervention Description
Single intraperitoneal injection of 100 mg/m2 NanoPac® during cytoreductive surgery, followed by standard-of-care IV carboplatin and IV paclitaxel treatment
Intervention Type
Drug
Intervention Name(s)
NanoPac® 200 mg/m2
Intervention Description
Single intraperitoneal injection of 200 mg/m2 NanoPac® during cytoreductive surgery, followed by standard-of-care IV carboplatin and IV paclitaxel treatment
Intervention Type
Drug
Intervention Name(s)
NanoPac® 300 mg/m2
Intervention Description
Single intraperitoneal injection of 300 mg/m2 NanoPac® during cytoreductive surgery, followed by standard-of-care IV carboplatin and IV paclitaxel treatment
Intervention Type
Drug
Intervention Name(s)
NanoPac® 400 mg/m2
Intervention Description
Single intraperitoneal injection of 400 mg/m2 NanoPac® during cytoreductive surgery, followed by standard-of-care IV carboplatin and IV paclitaxel treatment
Intervention Type
Drug
Intervention Name(s)
Standard of Care Intravenous Chemotherapy
Intervention Description
Cytoreductive surgery followed by standard-of-care IV carboplatin and IV paclitaxel treatment
Primary Outcome Measure Information:
Title
Treatment-emergent Adverse Events
Description
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).
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Maximum Plasma Concentration of Paclitaxel (Cmax)
Description
Plasma samples will be taken on Day 1 at 1, 2, 4, 8, and 24 hours post-intraperitoneal administration of NanoPac® and weekly thereafter until IV chemotherapy begins. Additionally, a pharmacokinetics (PK) sample will be collected from every subject prior to each cycle of IV chemotherapy for determination of paclitaxel concentrations to assess potential NanoPac® persistence. PK levels of paclitaxel in the plasma will be summarized descriptively.
Time Frame
12 months
Title
Progression Free Survival (PFS) at 12 Months
Description
Progression free survival (PFS) was assessed every 3 months until the end of the 12-month follow-up period, and every 6 months thereafter until progression or the last subject in the trial has completed 12 months of follow-up. Factors taken into account to determine time-to-progression included CA-125 levels, tumor burden as assessed by imaging and utilizing RECIST version 1.1 for assessment of response, and cancer-related symptoms such as bowel obstruction and ascites.
Time Frame
12 months post-treatment

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joan Walker, MD
Organizational Affiliation
University of Oklahoma
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gere diZerega, MD
Organizational Affiliation
US Biotest, Inc./NanOlogy, LLC
Official's Role
Study Chair
Facility Information:
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Greater Baltimore Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
SUNY Downstate
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Facility Name
Magee-Womens Hospital of UPMC
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Women & Infants Hospital of Rhode Island
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02905
Country
United States
Facility Name
University of Texas Southwestern
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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