Ovarian CarcinomaPhase 2NCT03029585
Phase II Study of Intraperitoneal NanoPac® in Patients With Ovarian Cancer
A Phase 2 study testing NanoPac® 100 mg/m2, NanoPac® 200 mg/m2 and NanoPac® 300 mg/m2 in people with Ovarian Carcinoma, run by NanOlogy, LLC at 7 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Carcinoma
- What is being tested?
- NanoPac® 100 mg/m2, NanoPac® 200 mg/m2 and NanoPac® 300 mg/m2
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 7 sitesUnited States
- Study dates
- 19 Apr 2017to 4 Nov 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Greater Baltimore Medical Center
Baltimore, Maryland, 21204
SUNY Downstate
Brooklyn, New York, 11203
University of Chicago
Chicago, Illinois, 60637
University of Texas Southwestern
Dallas, Texas, 75390
University of Minnesota
Minneapolis, Minnesota, 55455
Magee-Womens Hospital of UPMC
Pittsburgh, Pennsylvania, 15213
Women & Infants Hospital of Rhode Island
Providence, Rhode Island, 02905
About this study
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
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.
Read the 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.
- Conditions
- Ovarian Carcinoma
- Being tested
- NanoPac® 100 mg/m2, NanoPac® 200 mg/m2, NanoPac® 300 mg/m2, NanoPac® 400 mg/m2, Standard of Care Intravenous Chemotherapy
- Keywords
- ovarian carcinoma, ovarian cancer, ovarian neoplasms, ovarian diseases
- Medical subject headings
- Ovarian Neoplasms, Ovarian Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NanoPac® 100 mg/m2Drug
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/m2Drug
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/m2Drug
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/m2Drug
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 ChemotherapyDrug
Cytoreductive surgery followed by standard-of-care IV carboplatin and IV paclitaxel treatment
| Study group | Role | What they receive |
|---|---|---|
| NanoPac® 100 mg/m2 | Experimental | Intraperitoneal NanoPac® 100 mg/m2 applied immediately post-cytoreductive surgery, followed by standard of care intravenous chemotherapy. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: Standard of Care Intravenous Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 12 months
Secondary outcomes (2)
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.
Measured: 12 months
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.
Measured: 12 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2017 (estimated)
- Study start19 Apr 2017
- Primary completion4 Nov 2019
- Study completion4 Nov 2019
Why it stopped: Business reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Ovarian CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- NanOlogy, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- US Biotest, Inc.
- Responsible party
- Sponsor
- Investigators
- Joan Walker, MD, Principal investigator, University of OklahomaGere diZerega, MD, Study chair, US Biotest, Inc./NanOlogy, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03029585
- Sponsor's protocol ID
- NANOPAC-2016-01
- Status last verified
- Mar 2021
- First submitted
- 20 Jan 2017
- Last updated
- 27 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03029585
- Acronym / sponsor ID
- NANOPAC-2016-01
- Conditions
- Ovarian Carcinoma
- Keywords
- ovarian carcinoma, ovarian cancer, ovarian neoplasms, ovarian diseases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business reasons
- Enrolment
- 10 participants (actual)
- Lead sponsor
- NanOlogy, LLCIndustry (pharma, biotech, devices)
- Collaborators
- US Biotest, Inc.
- Study start
- 19 Apr 2017 (actual)
- Primary completion
- 4 Nov 2019 (actual)
- Study completion
- 4 Nov 2019 (actual)
- First posted
- 24 Jan 2017 (estimated)
- Results
- Posted 27 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| NanoPac® 100 mg/m2 | Experimental | Drug: NanoPac® 100 mg/m2, Drug: Standard of Care Intravenous ChemotherapyIntraperitoneal NanoPac® 100 mg/m2 applied immediately post-cytoreductive surgery, followed by standard of care intravenous chemotherapy. |
| NanoPac® 200 mg/m2 | Experimental | Drug: NanoPac® 200 mg/m2, Drug: Standard of Care Intravenous ChemotherapyIntraperitoneal NanoPac® 200 mg/m2 applied immediately post-cytoreductive surgery, followed by standard of care intravenous chemotherapy. |
| NanoPac® 300 mg/m2 | Experimental | Drug: NanoPac® 300 mg/m2, Drug: Standard of Care Intravenous ChemotherapyIntraperitoneal NanoPac® 300 mg/m2 applied immediately post-cytoreductive surgery, followed by standard of care intravenous chemotherapy. |
| NanoPac® 400 mg/m2 | Experimental | Drug: NanoPac® 400 mg/m2, Drug: Standard of Care Intravenous ChemotherapyIntraperitoneal NanoPac® 400 mg/m2 applied immediately post-cytoreductive surgery, followed by standard of care intravenous chemotherapy. |
| Standard of Care Intravenous Chemotherapy | Active comparator | Drug: Standard of Care Intravenous ChemotherapyStandard of care intravenous chemotherapy (with platinum and taxane agents) administered per institutional standards. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NanoPac® 100 mg/m2Single intraperitoneal injection of 100 mg/m2 NanoPac® during cytoreductive surgery, followed by standard-of-care IV carboplatin and IV paclitaxel treatment | Drug | NanoPac® 100 mg/m2 |
| NanoPac® 200 mg/m2Single intraperitoneal injection of 200 mg/m2 NanoPac® during cytoreductive surgery, followed by standard-of-care IV carboplatin and IV paclitaxel treatment | Drug | NanoPac® 200 mg/m2 |
| NanoPac® 300 mg/m2Single intraperitoneal injection of 300 mg/m2 NanoPac® during cytoreductive surgery, followed by standard-of-care IV carboplatin and IV paclitaxel treatment | Drug | NanoPac® 300 mg/m2 |
| NanoPac® 400 mg/m2Single intraperitoneal injection of 400 mg/m2 NanoPac® during cytoreductive surgery, followed by standard-of-care IV carboplatin and IV paclitaxel treatment | Drug | NanoPac® 400 mg/m2 |
| Standard of Care Intravenous ChemotherapyCytoreductive surgery followed by standard-of-care IV carboplatin and IV paclitaxel treatment | Drug | NanoPac® 100 mg/m2, NanoPac® 200 mg/m2, NanoPac® 300 mg/m2, NanoPac® 400 mg/m2, Standard of Care Intravenous Chemotherapy |
Primary outcome
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).
2 secondary outcomes
Maximum Plasma Concentration of Paclitaxel (Cmax)
Time frame: 12 months
Progression Free Survival (PFS) at 12 Months
Time frame: 12 months post-treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joan Walker, MD principal investigator
University of Oklahoma
Gere diZerega, MD study chair
US Biotest, Inc./NanOlogy, LLC
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NanoPac® 100 mg/m2, NanoPac® 200 mg/m2 and NanoPac® 300 mg/m2 in people with Ovarian Carcinoma, run by NanOlogy, LLC at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment-emergent Adverse Events (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2021; AzTrials last refreshed its copy on 7 Nov 2026.