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Trial record 4 of 4 for:    nanopac

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

This study is currently recruiting participants.
Verified October 2017 by NanOlogy, LLC
Sponsor:
ClinicalTrials.gov Identifier:
NCT03029585
First Posted: January 24, 2017
Last Update Posted: October 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
US Biotest, Inc.
Information provided by (Responsible Party):
NanOlogy, LLC
  Purpose
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.

Condition Intervention Phase
Ovarian Carcinoma Drug: NanoPac® 100 mg/m2 Drug: NanoPac® 200 mg/m2 Drug: NanoPac® 300 mg/m2 Drug: NanoPac® 400 mg/m2 Drug: Standard of Care Intravenous Chemotherapy Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by NanOlogy, LLC:

Primary Outcome Measures:
  • Treatment-emergent adverse events [ Time Frame: 12 months ]
    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).

  • Progression-free survival at 12 months [ Time Frame: 12 months ]
    In the efficacy phase of the study, subjects will be randomized 1:1:1 to one of two best doses from the dose-finding phase (plus standard of care intravenous chemotherapy) or standard of care intravenous chemotherapy alone. Subjects in this phase will be monitored every three months for the first 12 months and then every six months thereafter until disease progression or until the last subject in the trial has been monitored for 12 months. All monitoring information, including CA-125, imaging, and cancer-related symptoms (e.g., bowel obstruction and ascites), will be summarized in tables displaying the treatment group results across time. Progression will be presented as time to progression (Kaplan-Meier) as well as percent progressed up to and including 12 months post-intravenous chemotherapy.


Secondary Outcome Measures:
  • Maximum Plasma Concentration of Paclitaxel (Cmax) [ Time Frame: 12 months ]
    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.


Estimated Enrollment: 61
Actual Study Start Date: April 19, 2017
Estimated Study Completion Date: September 2019
Estimated Primary Completion Date: September 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NanoPac® 100 mg/m2
Intraperitoneal NanoPac® 100 mg/m2 applied immediately post-cytoreductive surgery, followed by standard of care intravenous chemotherapy.
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: Standard of Care Intravenous Chemotherapy
Cytoreductive surgery followed by standard-of-care IV carboplatin and IV paclitaxel treatment
Experimental: NanoPac® 200 mg/m2
Intraperitoneal NanoPac® 200 mg/m2 applied immediately post-cytoreductive surgery, followed by standard of care intravenous chemotherapy.
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: Standard of Care Intravenous Chemotherapy
Cytoreductive surgery followed by standard-of-care IV carboplatin and IV paclitaxel treatment
Experimental: NanoPac® 300 mg/m2
Intraperitoneal NanoPac® 300 mg/m2 applied immediately post-cytoreductive surgery, followed by standard of care intravenous chemotherapy.
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: Standard of Care Intravenous Chemotherapy
Cytoreductive surgery followed by standard-of-care IV carboplatin and IV paclitaxel treatment
Experimental: NanoPac® 400 mg/m2
Intraperitoneal NanoPac® 400 mg/m2 applied immediately post-cytoreductive surgery, followed by standard of care intravenous chemotherapy.
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
Active Comparator: Standard of Care Intravenous Chemotherapy
Standard of care intravenous chemotherapy (with platinum and taxane agents) administered per institutional standards.
Drug: Standard of Care Intravenous Chemotherapy
Cytoreductive surgery followed by standard-of-care IV carboplatin and IV paclitaxel treatment

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03029585


Contacts
Contact: Leanne Drummond 805-595-1300 NANOPAC201601@usbiotest.com

Locations
United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: US Biotest    805-595-1300    NANOPAC201601@usbiotest.com   
United States, Maryland
Greater Baltimore Medical Center Recruiting
Baltimore, Maryland, United States, 21204
Contact: US Biotest    805-595-1300    NANOPAC201601@usbiotest.com   
United States, New York
SUNY Downstate Recruiting
Brooklyn, New York, United States, 11203
Contact: US Biotest    805-595-1300    NANOPAC201601@usbiotest.com   
United States, Oklahoma
University of Oklahoma Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: US Biotest    805-595-1300    NANOPAC201601@usbiotest.com   
United States, Pennsylvania
Magee-Womens Hospital of UPMC Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: US Biotest    805-595-1300    NANOPAC201601@usbiotest.com   
United States, Rhode Island
Women & Infants Hospital of Rhode Island Recruiting
Providence, Rhode Island, United States, 02905
Contact: US Biotest    805-595-1300    NANOPAC201601@usbiotest.com   
United States, Texas
University of Texas Southwestern Recruiting
Dallas, Texas, United States, 75390
Contact: US Biotest    805-595-1300    NANOPAC201601@usbiotest.com   
Sponsors and Collaborators
NanOlogy, LLC
US Biotest, Inc.
Investigators
Principal Investigator: Joan Walker, MD University of Oklahoma
Study Chair: Gere diZerega, MD US Biotest, Inc./NanOlogy, LLC
  More Information

Responsible Party: NanOlogy, LLC
ClinicalTrials.gov Identifier: NCT03029585     History of Changes
Other Study ID Numbers: NANOPAC-2016-01
First Submitted: January 20, 2017
First Posted: January 24, 2017
Last Update Posted: October 23, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by NanOlogy, LLC:
ovarian carcinoma
ovarian cancer
ovarian neoplasms
ovarian diseases

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Paclitaxel
Carboplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action