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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03029585
Other study ID # NANOPAC-2016-01
Secondary ID
Status Terminated
Phase Phase 2
First received
Last updated
Start date April 19, 2017
Est. completion date November 4, 2019

Study information

Verified date March 2021
Source NanOlogy, LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 10
Est. completion date November 4, 2019
Est. primary completion date November 4, 2019
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

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
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
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
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
Standard of Care Intravenous Chemotherapy
Cytoreductive surgery followed by standard-of-care IV carboplatin and IV paclitaxel treatment

Locations

Country Name City State
United States Greater Baltimore Medical Center Baltimore Maryland
United States SUNY Downstate Brooklyn New York
United States University of Chicago Chicago Illinois
United States University of Texas Southwestern Dallas Texas
United States University of Minnesota Minneapolis Minnesota
United States Magee-Womens Hospital of UPMC Pittsburgh Pennsylvania
United States Women & Infants Hospital of Rhode Island Providence Rhode Island

Sponsors (2)

Lead Sponsor Collaborator
NanOlogy, LLC US Biotest, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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. 12 months
Secondary 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. 12 months post-treatment
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