Intracystic Injection of NanoPac® in Subjects With Mucinous Cystic Pancreatic Neoplasms

Sponsor
NanOlogy, LLC (Industry)
Overall Status
Completed
CT.gov ID
NCT03188991
Collaborator
US Biotest, Inc. (Industry)
20
4
4
33
5
0.2

Study Details

Study Description

Brief Summary

This study will evaluate intracystic NanoPac® (Sterile Nanoparticulate Paclitaxel) administered via endoscopic ultrasound-guided fine needle injection (EUS-FNI) in subjects with mucinous cystic pancreatic neoplasms.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

In this open-label, dose rising trial, subjects with mucinous cystic pancreatic neoplasms will receive intracystic NanoPac® via endoscopic ultrasound-guided fine needle injection (EUS-FNI).

In the dose escalation phase, subjects will be enrolled in sequential cohorts of NanoPac® at 6, 10, and 15 mg/mL at volumes sufficient to fill the cyst, at least equal to the amount of cyst fluid aspirated. Each cohort will have three subjects, with cohorts enrolled sequentially starting at the lowest concentration. Following Data Safety Monitoring Board (DSMB) review of the cohort data, the next cohort may begin enrolling, an additional three at the current dose may be enrolled, or if the first dose does not provide adequate safety and tolerability the study may be halted. The dose determined to be the most suitable for further evaluation, defined as the highest dose with an acceptable safety and tolerability profile (as determined by the DSMB), will be the dose used in the second phase of the study which will enroll 9 additional subjects. Subjects enrolled in the second phase of the study will also receive a second injection of NanoPac at the same dose 12 weeks after the first NanoPac injection..

Plasma samples will be taken on the day(s) of NanoPac® injection at 1 and 2 hours after injection, as well as at each of the subsequent study visits, to characterize the pharmacokinetics (PK) of intracystic NanoPac®.

Subjects will be followed for 6 months after the first NanoPac® injection for safety, tolerability and cyst response to therapy (as shown by imaging).

Study Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
Non-Randomized
Intervention Model:
Sequential Assignment
Intervention Model Description:
Open-label, dose rising trial. During the dose escalation phase, subjects will be enrolled in sequential cohorts of NanoPac®. Each cohort will have three subjects, with cohorts enrolled sequentially starting at the lowest concentration. Following DSMB review of the cohort data, the next cohort may begin enrolling, an additional three subjects at the current dose may be enrolled, or, if the first dose does not provide adequate safety and tolerability, the study may be halted. The dose determined to be the most suitable for further evaluation, defined as the highest dose with an acceptable safety and tolerability profile (as determined by the DSMB), will be the dose used in the second phase of the study which will enroll 9 additional subjects. Subjects enrolled in the second phase of the study will also receive a second injection of NanoPac at the same dose 12 weeks after the first NanoPac injection.Open-label, dose rising trial. During the dose escalation phase, subjects will be enrolled in sequential cohorts of NanoPac®. Each cohort will have three subjects, with cohorts enrolled sequentially starting at the lowest concentration. Following DSMB review of the cohort data, the next cohort may begin enrolling, an additional three subjects at the current dose may be enrolled, or, if the first dose does not provide adequate safety and tolerability, the study may be halted. The dose determined to be the most suitable for further evaluation, defined as the highest dose with an acceptable safety and tolerability profile (as determined by the DSMB), will be the dose used in the second phase of the study which will enroll 9 additional subjects. Subjects enrolled in the second phase of the study will also receive a second injection of NanoPac at the same dose 12 weeks after the first NanoPac injection.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Trial Evaluating Escalating Doses and the Safety of Intracystic Injection of NanoPac® in Subjects With Mucinous Cystic Pancreatic Neoplasms
Actual Study Start Date :
Sep 29, 2017
Actual Primary Completion Date :
Jun 29, 2020
Actual Study Completion Date :
Jun 29, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Dose Escalation: NanoPac® 6 mg/mL

Single intracystic injection of NanoPac® at a dose of 6 mg/mL in a volume sufficient to fill the cyst, at least equal to the amount of cyst fluid aspirated

Drug: NanoPac®
NanoPac® (Sterile Nanoparticulate Paclitaxel) for intracystic injection via endoscopic ultrasound-guided injection (EUS-FNI)

Experimental: Dose Escalation: NanoPac® 10 mg/mL

Single intracystic injection of NanoPac® at a dose of 10 mg/mL in a volume sufficient to fill the cyst, at least equal to the amount of cyst fluid aspirated

Drug: NanoPac®
NanoPac® (Sterile Nanoparticulate Paclitaxel) for intracystic injection via endoscopic ultrasound-guided injection (EUS-FNI)

Experimental: Dose Escalation: NanoPac® 15 mg/mL

Single intracystic injection of NanoPac® at a dose of 15 mg/mL in a volume sufficient to fill the cyst, at least equal to the amount of cyst fluid aspirated

Drug: NanoPac®
NanoPac® (Sterile Nanoparticulate Paclitaxel) for intracystic injection via endoscopic ultrasound-guided injection (EUS-FNI)

Experimental: Second Phase: NanoPac® at Best Dose

Intracystic injection of NanoPac®. The dose administered in the second phase will be determined during the dose escalation phase. Subjects will receive two NanoPac® injections, with the second injection administered 12 weeks after the first injection.

Drug: NanoPac®
NanoPac® (Sterile Nanoparticulate Paclitaxel) for intracystic injection via endoscopic ultrasound-guided injection (EUS-FNI)

Outcome Measures

Primary Outcome Measures

  1. Number of Participants With Treatment Emergent Adverse Events (Safety and Tolerability) [Up to 6 (six) months after first NanoPac® injection]

    Treatment Emergent Adverse Events will include laboratory assessments, physical examination findings, and vital signs.

Secondary Outcome Measures

  1. Cyst Volume Response [Screening and 6 (six) months after first NanoPac® injection]

    Cyst volume at screening will be compared with the volume at Weeks 12 and 24 (or early termination).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Signed informed consent;

  • Patients over the age of 18;

  • Recently confirmed mucinous cystic pancreatic neoplasm; may be confirmed by presence of mucin, cyst fluid carcinoembryonic antigen (CEA) above 192 U/L, or other reliable diagnostic means such as endomicroscopy; KRAS analysis may also be performed at the discretion of the Investigator;

  • Unilocular cyst with diameter of at least 1.5 cm but no more than 4 cm;

  • Normal hematologic, hepatic, and renal function at study entry;

  • Appropriate steps taken to minimize or avoid the potential for pregnancy for subjects of child-bearing potential.*

  • Note: A female patient is considered to be of childbearing potential unless she has had a hysterectomy, is at least one year postmenopausal or has undergone tubal ligation. For the purposes of this study, adequate birth control includes at least one medically approved and highly effective method of birth control, defined as those which result in a low failure rate (i.e., < 1% per year) when used consistently and correctly, such as implants, injectables and oral contraceptives combined with the use of condoms. Only male patients whose vasectomy has been confirmed by semen analysis at least 3 months after the vasectomy are allowed not to use acceptable contraceptive methods.

Exclusion Criteria:
  • Positive cytology indicating malignancy;

  • Thrombotic or embolic events;

  • Known hypersensitivity to study agent;

  • Known drug or alcohol abuse;

  • Pregnant or breastfeeding women.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Parkview Cancer Institute Fort Wayne Indiana United States 46845
2 The Ohio State University, Wexner Medical Center Columbus Ohio United States 43210
3 Texas Tech University Health Sciences Center El Paso Texas United States 79905
4 Baylor College of Medicine Houston Texas United States 77030

Sponsors and Collaborators

  • NanOlogy, LLC
  • US Biotest, Inc.

Investigators

None specified.

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
NanOlogy, LLC
ClinicalTrials.gov Identifier:
NCT03188991
Other Study ID Numbers:
  • NANOPAC-2017-01
First Posted:
Jun 16, 2017
Last Update Posted:
Jun 14, 2021
Last Verified:
Jun 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by NanOlogy, LLC
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group Title Dose Escalation: NanoPac® 6 mg/mL Dose Escalation: NanoPac® 10 mg/mL Dose Escalation: NanoPac® 15 mg/mL Second Phase: NanoPac® 15 mg/mL (Up to Two Injections)
Arm/Group Description Single intracystic injection of NanoPac® at a dose of 6 mg/mL in a volume sufficient to fill the cyst, at least equal to the amount of cyst fluid aspirated NanoPac®: NanoPac® (Sterile Nanoparticulate Paclitaxel) for intracystic injection via endoscopic ultrasound-guided injection (EUS-FNI) Single intracystic injection of NanoPac® at a dose of 10 mg/mL in a volume sufficient to fill the cyst, at least equal to the amount of cyst fluid aspirated NanoPac®: NanoPac® (Sterile Nanoparticulate Paclitaxel) for intracystic injection via endoscopic ultrasound-guided injection (EUS-FNI) Single intracystic injection of NanoPac® at a dose of 15 mg/mL in a volume sufficient to fill the cyst, at least equal to the amount of cyst fluid aspirated NanoPac®: NanoPac® (Sterile Nanoparticulate Paclitaxel) for intracystic injection via endoscopic ultrasound-guided injection (EUS-FNI) Intracystic injection of NanoPac®. The dose administered in the second phase will be determined during the dose escalation phase. Subjects will receive up to two NanoPac® injections, with the second injection administered 12 weeks after the first injection. NanoPac®: NanoPac® (Sterile Nanoparticulate Paclitaxel) for intracystic injection via endoscopic ultrasound-guided injection (EUS-FNI)
Period Title: Overall Study
STARTED 3 3 3 11
COMPLETED 3 3 3 10
NOT COMPLETED 0 0 0 1

Baseline Characteristics

Arm/Group Title Dose Escalation: NanoPac® 6 mg/mL Dose Escalation: NanoPac® 10 mg/mL Dose Escalation: NanoPac® 15 mg/mL Second Phase: NanoPac® 15 mg/mL (Up to Two Injections) Total
Arm/Group Description Single intracystic injection of NanoPac® at a dose of 6 mg/mL in a volume sufficient to fill the cyst, at least equal to the amount of cyst fluid aspirated NanoPac®: NanoPac® (Sterile Nanoparticulate Paclitaxel) for intracystic injection via endoscopic ultrasound-guided injection (EUS-FNI) Single intracystic injection of NanoPac® at a dose of 10 mg/mL in a volume sufficient to fill the cyst, at least equal to the amount of cyst fluid aspirated NanoPac®: NanoPac® (Sterile Nanoparticulate Paclitaxel) for intracystic injection via endoscopic ultrasound-guided injection (EUS-FNI) Single intracystic injection of NanoPac® at a dose of 15 mg/mL in a volume sufficient to fill the cyst, at least equal to the amount of cyst fluid aspirated NanoPac®: NanoPac® (Sterile Nanoparticulate Paclitaxel) for intracystic injection via endoscopic ultrasound-guided injection (EUS-FNI) Intracystic injection of NanoPac®. The dose administered in the second phase will be determined during the dose escalation phase. Subjects will receive up to two NanoPac® injections, with the second injection administered 12 weeks after the first injection. NanoPac®: NanoPac® (Sterile Nanoparticulate Paclitaxel) for intracystic injection via endoscopic ultrasound-guided injection (EUS-FNI) Total of all reporting groups
Overall Participants 3 3 3 10 19
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
66.3
(8.3)
73.7
(11.5)
59.7
(9.1)
67.8
(6.6)
67.2
(8.4)
Sex: Female, Male (Count of Participants)
Female
3
100%
2
66.7%
2
66.7%
6
60%
13
68.4%
Male
0
0%
1
33.3%
1
33.3%
4
40%
6
31.6%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino
0
0%
0
0%
0
0%
3
30%
3
15.8%
Not Hispanic or Latino
3
100%
3
100%
3
100%
7
70%
16
84.2%
Unknown or Not Reported
0
0%
0
0%
0
0%
0
0%
0
0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native
0
0%
0
0%
0
0%
0
0%
0
0%
Asian
0
0%
0
0%
0
0%
0
0%
0
0%
Native Hawaiian or Other Pacific Islander
0
0%
0
0%
0
0%
0
0%
0
0%
Black or African American
2
66.7%
0
0%
0
0%
1
10%
3
15.8%
White
1
33.3%
3
100%
3
100%
8
80%
15
78.9%
More than one race
0
0%
0
0%
0
0%
0
0%
0
0%
Unknown or Not Reported
0
0%
0
0%
0
0%
1
10%
1
5.3%
Body Mass Index (BMI) (kg/m2) (kg/m2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m2]
34.83
(11.71)
27.93
(10.20)
26.67
(3.43)
32.82
(7.17)
31.39
(7.91)

Outcome Measures

1. Primary Outcome
Title Number of Participants With Treatment Emergent Adverse Events (Safety and Tolerability)
Description Treatment Emergent Adverse Events will include laboratory assessments, physical examination findings, and vital signs.
Time Frame Up to 6 (six) months after first NanoPac® injection

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Dose Escalation: NanoPac® 6 mg/mL Dose Escalation: NanoPac® 10 mg/mL Dose Escalation: NanoPac® 15 mg/mL Second Phase: NanoPac® 15 mg/mL (Up to Two Injections)
Arm/Group Description Single intracystic injection of NanoPac® at a dose of 6 mg/mL in a volume sufficient to fill the cyst, at least equal to the amount of cyst fluid aspirated NanoPac®: NanoPac® (Sterile Nanoparticulate Paclitaxel) for intracystic injection via endoscopic ultrasound-guided injection (EUS-FNI) Single intracystic injection of NanoPac® at a dose of 10 mg/mL in a volume sufficient to fill the cyst, at least equal to the amount of cyst fluid aspirated NanoPac®: NanoPac® (Sterile Nanoparticulate Paclitaxel) for intracystic injection via endoscopic ultrasound-guided injection (EUS-FNI) Single intracystic injection of NanoPac® at a dose of 15 mg/mL in a volume sufficient to fill the cyst, at least equal to the amount of cyst fluid aspirated NanoPac®: NanoPac® (Sterile Nanoparticulate Paclitaxel) for intracystic injection via endoscopic ultrasound-guided injection (EUS-FNI) Intracystic injection of NanoPac®. The dose administered in the second phase will be determined during the dose escalation phase. Subjects will receive up to two NanoPac® injections, with the second injection administered 12 weeks after the first injection. NanoPac®: NanoPac® (Sterile Nanoparticulate Paclitaxel) for intracystic injection via endoscopic ultrasound-guided injection (EUS-FNI)
Measure Participants 3 3 3 10
Count of Participants [Participants]
3
100%
3
100%
3
100%
9
90%
2. Secondary Outcome
Title Cyst Volume Response
Description Cyst volume at screening will be compared with the volume at Weeks 12 and 24 (or early termination).
Time Frame Screening and 6 (six) months after first NanoPac® injection

Outcome Measure Data

Analysis Population Description
In the dose escalation phase, baseline imaging data for the measurement of cyst diameters and calculation of cyst volume was available in all subjects. At Week 12, 18 of 19 subjects had three cyst diameters available for analyses. At Week 24, 17 of 19 subjects had three cyst diameters available for analyses.
Arm/Group Title Dose Escalation: NanoPac® 6 mg/mL Dose Escalation: NanoPac® 10 mg/mL Dose Escalation: NanoPac® 15 mg/mL Second Phase: NanoPac® 15 mg/mL (Up to Two Injections)
Arm/Group Description Single intracystic injection of NanoPac® at a dose of 6 mg/mL in a volume sufficient to fill the cyst, at least equal to the amount of cyst fluid aspirated NanoPac®: NanoPac® (Sterile Nanoparticulate Paclitaxel) for intracystic injection via endoscopic ultrasound-guided injection (EUS-FNI) Single intracystic injection of NanoPac® at a dose of 10 mg/mL in a volume sufficient to fill the cyst, at least equal to the amount of cyst fluid aspirated NanoPac®: NanoPac® (Sterile Nanoparticulate Paclitaxel) for intracystic injection via endoscopic ultrasound-guided injection (EUS-FNI) Single intracystic injection of NanoPac® at a dose of 15 mg/mL in a volume sufficient to fill the cyst, at least equal to the amount of cyst fluid aspirated NanoPac®: NanoPac® (Sterile Nanoparticulate Paclitaxel) for intracystic injection via endoscopic ultrasound-guided injection (EUS-FNI) Intracystic injection of NanoPac®. The dose administered in the second phase will be determined during the dose escalation phase. Subjects will receive up to two NanoPac® injections, with the second injection administered 12 weeks after the first injection. NanoPac®: NanoPac® (Sterile Nanoparticulate Paclitaxel) for intracystic injection via endoscopic ultrasound-guided injection (EUS-FNI)
Measure Participants 3 3 3 10
Screening
7.770
(3.283)
4.810
(5.109)
10.960
(8.484)
11.442
(8.132)
Week 12
5.710
(3.892)
3.453
(2.188)
9.633
(9.284)
12.293
(10.755)
Week 24/EOS
4.140
(3.920)
4.383
(0.521)
8.533
(7.183)
11.138
(11.931)

Adverse Events

Time Frame AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
Adverse Event Reporting Description
Arm/Group Title Dose Escalation: NanoPac® 6 mg/mL Dose Escalation: NanoPac® 10 mg/mL Dose Escalation: NanoPac® 15 mg/mL Second Phase: NanoPac® 15 mg/mL (Up to Two Injections)
Arm/Group Description Single intracystic injection of NanoPac® at a dose of 6 mg/mL in a volume sufficient to fill the cyst, at least equal to the amount of cyst fluid aspirated NanoPac®: NanoPac® (Sterile Nanoparticulate Paclitaxel) for intracystic injection via endoscopic ultrasound-guided injection (EUS-FNI) Single intracystic injection of NanoPac® at a dose of 10 mg/mL in a volume sufficient to fill the cyst, at least equal to the amount of cyst fluid aspirated NanoPac®: NanoPac® (Sterile Nanoparticulate Paclitaxel) for intracystic injection via endoscopic ultrasound-guided injection (EUS-FNI) Single intracystic injection of NanoPac® at a dose of 15 mg/mL in a volume sufficient to fill the cyst, at least equal to the amount of cyst fluid aspirated NanoPac®: NanoPac® (Sterile Nanoparticulate Paclitaxel) for intracystic injection via endoscopic ultrasound-guided injection (EUS-FNI) Intracystic injection of NanoPac®. The dose administered in the second phase will be determined during the dose escalation phase. Subjects will receive up to two NanoPac® injections, with the second injection administered 12 weeks after the first injection. NanoPac®: NanoPac® (Sterile Nanoparticulate Paclitaxel) for intracystic injection via endoscopic ultrasound-guided injection (EUS-FNI)
All Cause Mortality
Dose Escalation: NanoPac® 6 mg/mL Dose Escalation: NanoPac® 10 mg/mL Dose Escalation: NanoPac® 15 mg/mL Second Phase: NanoPac® 15 mg/mL (Up to Two Injections)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/10 (0%)
Serious Adverse Events
Dose Escalation: NanoPac® 6 mg/mL Dose Escalation: NanoPac® 10 mg/mL Dose Escalation: NanoPac® 15 mg/mL Second Phase: NanoPac® 15 mg/mL (Up to Two Injections)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 1/3 (33.3%) 0/3 (0%) 1/3 (33.3%) 3/10 (30%)
Gastrointestinal disorders
Abdominal Pain 0/3 (0%) 0 0/3 (0%) 0 1/3 (33.3%) 1 0/10 (0%) 0
Obstruction Gastric 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 1/10 (10%) 1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer 1/3 (33.3%) 1 0/3 (0%) 0 0/3 (0%) 0 0/10 (0%) 0
Nervous system disorders
Hepatic encephalopathy 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 1/10 (10%) 1
Respiratory, thoracic and mediastinal disorders
Organising pneumonia 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 1/10 (10%) 1
Other (Not Including Serious) Adverse Events
Dose Escalation: NanoPac® 6 mg/mL Dose Escalation: NanoPac® 10 mg/mL Dose Escalation: NanoPac® 15 mg/mL Second Phase: NanoPac® 15 mg/mL (Up to Two Injections)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 3/3 (100%) 3/3 (100%) 3/3 (100%) 9/10 (90%)
Cardiac disorders
Atrial Fibrillation 1/3 (33.3%) 1 0/3 (0%) 0 0/3 (0%) 0 0/10 (0%) 0
Gastrointestinal disorders
Abdominal discomfort 2/3 (66.7%) 2 2/3 (66.7%) 3 1/3 (33.3%) 1 0/10 (0%) 0
Abdominal distension 0/3 (0%) 0 1/3 (33.3%) 1 0/3 (0%) 0 0/10 (0%) 0
Abdominal pain 1/3 (33.3%) 1 0/3 (0%) 0 1/3 (33.3%) 1 1/10 (10%) 1
Abdominal pain lower 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 1/10 (10%) 1
Abdominal pain upper 0/3 (0%) 0 2/3 (66.7%) 3 0/3 (0%) 0 1/10 (10%) 1
Diarrhoea 1/3 (33.3%) 1 2/3 (66.7%) 2 0/3 (0%) 0 1/10 (10%) 1
Duodenal ulcer, obstructive 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 1/10 (10%) 1
GI Motility disorder 0/3 (0%) 0 0/3 (0%) 0 1/3 (33.3%) 1 0/10 (0%) 0
Glossodynia 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 1/10 (10%) 1
Ileal stenosis 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 1/10 (10%) 1
Nausea 1/3 (33.3%) 1 2/3 (66.7%) 3 1/3 (33.3%) 1 1/10 (10%) 1
Obstruction gastric 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 1/10 (10%) 1
Oesophagitis 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 1/10 (10%) 1
Vomiting 0/3 (0%) 0 1/3 (33.3%) 1 0/3 (0%) 0 0/10 (0%) 0
General disorders
Asthenia 0/3 (0%) 0 1/3 (33.3%) 1 1/3 (33.3%) 1 0/10 (0%) 0
Chills 1/3 (33.3%) 1 0/3 (0%) 0 0/3 (0%) 0 0/10 (0%) 0
Device complication 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 1/10 (10%) 1
Fatigue 0/3 (0%) 0 1/3 (33.3%) 1 2/3 (66.7%) 3 1/10 (10%) 1
Hernia pain 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 1/10 (10%) 1
Oedema peripheral 2/3 (66.7%) 2 0/3 (0%) 0 2/3 (66.7%) 2 1/10 (10%) 2
Pyrexia 0/3 (0%) 0 1/3 (33.3%) 1 0/3 (0%) 0 0/10 (0%) 0
Infections and infestations
Bacterial infection 0/3 (0%) 0 1/3 (33.3%) 1 0/3 (0%) 0 0/10 (0%) 0
Infected bite 1/3 (33.3%) 1 0/3 (0%) 0 0/3 (0%) 0 0/10 (0%) 0
Sinusitis 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 1/10 (10%) 2
URTI 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 1/10 (10%) 1
UTI 1/3 (33.3%) 1 1/3 (33.3%) 2 0/3 (0%) 0 0/10 (0%) 0
Vulvovaginal mycotic infec. 1/3 (33.3%) 1 0/3 (0%) 0 0/3 (0%) 0 0/10 (0%) 0
Injury, poisoning and procedural complications
Contusion 0/3 (0%) 0 0/3 (0%) 0 2/3 (66.7%) 2 0/10 (0%) 0
Post procedural complication 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 1/10 (10%) 1
Procedural pain 1/3 (33.3%) 1 0/3 (0%) 0 0/3 (0%) 0 2/10 (20%) 2
Investigations
Platelet count increased 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 1/10 (10%) 1
WBC count decreased 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 1/10 (10%) 1
Metabolism and nutrition disorders
Decreased appetite 1/3 (33.3%) 1 1/3 (33.3%) 1 0/3 (0%) 0 1/10 (10%) 1
Gout 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 1/10 (10%) 2
Hyperkalaemia 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 1/10 (10%) 1
Musculoskeletal and connective tissue disorders
Medial tibial stress syndrome 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 1/10 (10%) 1
Muscular weakness 0/3 (0%) 0 1/3 (33.3%) 1 0/3 (0%) 0 0/10 (0%) 0
Musculoskeletal discomfort 0/3 (0%) 0 1/3 (33.3%) 1 0/3 (0%) 0 0/10 (0%) 0
Myopathy 0/3 (0%) 0 1/3 (33.3%) 1 0/3 (0%) 0 0/10 (0%) 0
Pain in extremity 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 1/10 (10%) 1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer 1/3 (33.3%) 1 0/3 (0%) 0 0/3 (0%) 0 0/10 (0%) 0
Nervous system disorders
Dizziness 0/3 (0%) 0 1/3 (33.3%) 1 2/3 (66.7%) 2 0/10 (0%) 0
Headache 0/3 (0%) 0 2/3 (66.7%) 4 0/3 (0%) 0 1/10 (10%) 1
Hepatic encephalopathy 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 1/10 (10%) 1
Migraine 1/3 (33.3%) 1 0/3 (0%) 0 0/3 (0%) 0 0/10 (0%) 0
Neuropathy peripheral 1/3 (33.3%) 1 0/3 (0%) 0 0/3 (0%) 0 0/10 (0%) 0
Radiculopathy 1/3 (33.3%) 1 0/3 (0%) 0 0/3 (0%) 0 0/10 (0%) 0
Renal and urinary disorders
Nephrolithiasis 0/3 (0%) 0 1/3 (33.3%) 1 0/3 (0%) 0 0/10 (0%) 0
Respiratory, thoracic and mediastinal disorders
Bradypnoea 0/3 (0%) 0 0/3 (0%) 0 1/3 (33.3%) 1 0/10 (0%) 0
Organising pneumonia 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 1/10 (10%) 1
Wheezing 0/3 (0%) 0 0/3 (0%) 0 1/3 (33.3%) 1 0/10 (0%) 0
Skin and subcutaneous tissue disorders
Pruritus 2/3 (66.7%) 2 0/3 (0%) 0 0/3 (0%) 0 1/10 (10%) 1
Rash 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 1/10 (10%) 1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/Title Gere S. diZerega, MD
Organization US Biotest, Inc.
Phone 805.595.1300
Email gere.dizerega@usbiotest.com
Responsible Party:
NanOlogy, LLC
ClinicalTrials.gov Identifier:
NCT03188991
Other Study ID Numbers:
  • NANOPAC-2017-01
First Posted:
Jun 16, 2017
Last Update Posted:
Jun 14, 2021
Last Verified:
Jun 1, 2021