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Trial of NanoPac® Focal Therapy in Subjects With Prostate Cancer

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ClinicalTrials.gov Identifier: NCT03077659
Recruitment Status : Completed
First Posted : March 13, 2017
Results First Posted : August 20, 2019
Last Update Posted : August 20, 2019
Sponsor:
Collaborator:
US Biotest, Inc.
Information provided by (Responsible Party):
NanOlogy, LLC

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Sequential Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Adenocarcinoma of the Prostate
Intervention Drug: NanoPac®
Enrollment 16
Recruitment Details  
Pre-assignment Details  
Arm/Group Title NanoPac® 6 mg/mL NanoPac® 10 mg/mL NanoPac® 15 mg/mL
Hide Arm/Group Description NanoPac® 6 mg/mL injected into the prostate lobe containing the dominant lesion at a volume of 20% prostate lobe volume 4 weeks prior to prostatectomy. NanoPac® 10 mg/mL injected into the prostate lobe containing the dominant lesion at a volume of 20% prostate lobe volume 4 weeks prior to prostatectomy. NanoPac® 15 mg/mL injected into the prostate lobe containing the dominant lesion at a volume of 20% prostate lobe volume 4 weeks prior to prostatectomy.
Period Title: Overall Study
Started 3 3 10
Completed 3 3 9
Not Completed 0 0 1
Reason Not Completed
Withdrawal by Subject             0             0             1
Arm/Group Title NanoPac® 6 mg/mL NanoPac® 10 mg/mL NanoPac® 15 mg/mL Total
Hide Arm/Group Description NanoPac® 6 mg/mL injected into the prostate lobe containing the dominant lesion at a volume of 20% prostate lobe volume 4 weeks prior to prostatectomy. NanoPac® 10 mg/mL injected into the prostate lobe containing the dominant lesion at a volume of 20% prostate lobe volume 4 weeks prior to prostatectomy. NanoPac® 15 mg/mL injected into the prostate lobe containing the dominant lesion at a volume of 20% prostate lobe volume 4 weeks prior to prostatectomy. Total of all reporting groups
Overall Number of Baseline Participants 3 3 10 16
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 3 participants 3 participants 10 participants 16 participants
63.0  (12.3) 73.3  (7.8) 63.8  (7.9) 65.4  (9.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 10 participants 16 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Male
3
 100.0%
3
 100.0%
10
 100.0%
16
 100.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 10 participants 16 participants
Hispanic or Latino
1
  33.3%
2
  66.7%
2
  20.0%
5
  31.3%
Not Hispanic or Latino
2
  66.7%
1
  33.3%
7
  70.0%
10
  62.5%
Unknown or Not Reported
0
   0.0%
0
   0.0%
1
  10.0%
1
   6.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 10 participants 16 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
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
   0.0%
Black or African American
0
   0.0%
0
   0.0%
1
  10.0%
1
   6.3%
White
3
 100.0%
2
  66.7%
8
  80.0%
13
  81.3%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
1
  33.3%
1
  10.0%
2
  12.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 3 participants 3 participants 10 participants 16 participants
3 3 10 16
1.Primary Outcome
Title Number of Participants With Treatment Emergent Adverse Events (Safety and Tolerability)
Hide Description Treatment Emergent Adverse Events included laboratory assessments, physical examination findings, and vital signs.
Time Frame Day 1 to Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title NanoPac® 6 mg/mL NanoPac® 10 mg/mL NanoPac® 15 mg/mL
Hide Arm/Group Description:

NanoPac® 6 mg/mL injected into the prostate lobe containing the dominant lesion at a volume of 20% prostate lobe volume

NanoPac®: Subjects with prostate cancer scheduled for prostatectomy will have NanoPac® injected intratumorally under image guidance directly into the lobe of the prostate with the dominant lesion 4 weeks prior to prostatectomy.

NanoPac® 10 mg/mL injected into the prostate lobe containing the dominant lesion at a volume of 20% prostate lobe volume

NanoPac®: Subjects with prostate cancer scheduled for prostatectomy will have NanoPac® injected intratumorally under image guidance directly into the lobe of the prostate with the dominant lesion 4 weeks prior to prostatectomy.

NanoPac® 15 mg/mL injected into the prostate lobe containing the dominant lesion at a volume of 20% prostate lobe volume

NanoPac®: Subjects with prostate cancer scheduled for prostatectomy will have NanoPac® injected intratumorally under image guidance directly into the lobe of the prostate with the dominant lesion 4 weeks prior to prostatectomy.

Overall Number of Participants Analyzed 3 3 10
Measure Type: Count of Participants
Unit of Measure: Participants
All TEAEs
3
 100.0%
2
  66.7%
6
  60.0%
Possibly Related TEAEs
3
 100.0%
0
   0.0%
1
  10.0%
2.Secondary Outcome
Title Tumor Response Based on Change in Image Volume on mpMRI
Hide Description Tumor response to treatment with NanoPac was determined by evaluating the change in image volume with multiparametric MRI (mpMRI) within three months prior to consent and again within 48 hours of the prostatectomy procedure (Day 29). In those cases where two dimensions/axes were available, width was imputed to height for the purposes of calculation, i.e. the lesion was assumed to be an oblate spheroid. In those cases where only one dimension/axis was available, that dimension/axis was imputed for all three dimensions i.e. the lesion was assumed to be a sphere. For this reason, analyses were performed for all subjects with two dimensions available, as well as those for which at least one dimension was available. The data presented for this outcome measure is the one dimension lesion volume calculation: Lesion Volume (cc) = (3.14/6)*(length)³, where length is the longer or only measured dimension.
Time Frame Up to three months prior to consent and Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title NanoPac® 6 mg/mL NanoPac® 10 mg/mL NanoPac® 15 mg/mL
Hide Arm/Group Description:

NanoPac® 6 mg/mL injected into the prostate lobe containing the dominant lesion at a volume of 20% prostate lobe volume

NanoPac®: Subjects with prostate cancer scheduled for prostatectomy will have NanoPac® injected intratumorally under image guidance directly into the lobe of the prostate with the dominant lesion 4 weeks prior to prostatectomy.

NanoPac® 10 mg/mL injected into the prostate lobe containing the dominant lesion at a volume of 20% prostate lobe volume

NanoPac®: Subjects with prostate cancer scheduled for prostatectomy will have NanoPac® injected intratumorally under image guidance directly into the lobe of the prostate with the dominant lesion 4 weeks prior to prostatectomy.

NanoPac® 15 mg/mL injected into the prostate lobe containing the dominant lesion at a volume of 20% prostate lobe volume

NanoPac®: Subjects with prostate cancer scheduled for prostatectomy will have NanoPac® injected intratumorally under image guidance directly into the lobe of the prostate with the dominant lesion 4 weeks prior to prostatectomy.

Overall Number of Participants Analyzed 3 3 9
Mean (Standard Deviation)
Unit of Measure: cc
Lesion Volume at Screening 3.19  (1.46) 0.89  (0.44) 4.89  (5.12)
Lesion Volume at Day 29 1.80  (0.98) 1.91  (1.50) 5.10  (7.79)
3.Secondary Outcome
Title Tumor Response Based on Histologic Evaluation of Biopsied Prostate Samples (Gleason Score)
Hide Description Prostate tissue samples were obtained via biopsy at baseline and immediately prior to prostatectomy (Day 29). Histologic evaluation of these samples was used to determine the Gleason score, and the results at baseline and Day 29 were used to evaluate the tumor response to treatment with NanoPac®. The Gleason score is calculated by adding together the two grades of cancer cells that make up the largest areas of the biopsied tissue sample. The Gleason score usually ranges from 6 to 10. The lower the Gleason score, the more the cancer cells look like normal cells and are likely to grow and spread slowly; a higher Gleason score is likely to indicate a worse outcome. The Gleason score is used to help plan treatment and determine prognosis.
Time Frame Screening and Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis set
Arm/Group Title NanoPac® 6 mg/mL NanoPac® 10 mg/mL NanoPac® 15 mg/mL
Hide Arm/Group Description:

NanoPac® 6 mg/mL injected into the prostate lobe containing the dominant lesion at a volume of 20% prostate lobe volume

NanoPac®: Subjects with prostate cancer scheduled for prostatectomy will have NanoPac® injected intratumorally under image guidance directly into the lobe of the prostate with the dominant lesion 4 weeks prior to prostatectomy.

NanoPac® 10 mg/mL injected into the prostate lobe containing the dominant lesion at a volume of 20% prostate lobe volume

NanoPac®: Subjects with prostate cancer scheduled for prostatectomy will have NanoPac® injected intratumorally under image guidance directly into the lobe of the prostate with the dominant lesion 4 weeks prior to prostatectomy.

NanoPac® 15 mg/mL injected into the prostate lobe containing the dominant lesion at a volume of 20% prostate lobe volume

NanoPac®: Subjects with prostate cancer scheduled for prostatectomy will have NanoPac® injected intratumorally under image guidance directly into the lobe of the prostate with the dominant lesion 4 weeks prior to prostatectomy.

Overall Number of Participants Analyzed 3 3 10
Mean (Standard Deviation)
Unit of Measure: score on a scale
Gleason Score at Screening 7.7  (1.2) 7.0  (0.0) 7.4  (0.7)
Gleason Score at Day 29 7.7  (1.2) 7.0  (0.0) 7.1  (0.9)
4.Secondary Outcome
Title Percentage of Sample Considered Adenocarcinoma
Hide Description Tissues excised from the primary tumor during prostatectomy (Day 29) were evaluated for the percentage considered adenocarcinoma
Time Frame Day 29 (prostatectomy)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title NanoPac® 6 mg/mL NanoPac® 10 mg/mL NanoPac® 15 mg/mL
Hide Arm/Group Description:

NanoPac® 6 mg/mL injected into the prostate lobe containing the dominant lesion at a volume of 20% prostate lobe volume

NanoPac®: Subjects with prostate cancer scheduled for prostatectomy will have NanoPac® injected intratumorally under image guidance directly into the lobe of the prostate with the dominant lesion 4 weeks prior to prostatectomy.

NanoPac® 10 mg/mL injected into the prostate lobe containing the dominant lesion at a volume of 20% prostate lobe volume

NanoPac®: Subjects with prostate cancer scheduled for prostatectomy will have NanoPac® injected intratumorally under image guidance directly into the lobe of the prostate with the dominant lesion 4 weeks prior to prostatectomy.

NanoPac® 15 mg/mL injected into the prostate lobe containing the dominant lesion at a volume of 20% prostate lobe volume

NanoPac®: Subjects with prostate cancer scheduled for prostatectomy will have NanoPac® injected intratumorally under image guidance directly into the lobe of the prostate with the dominant lesion 4 weeks prior to prostatectomy.

Overall Number of Participants Analyzed 3 3 10
Mean (Standard Deviation)
Unit of Measure: percentage of sample adenocarcinoma
Primary Tumor at Screening 53.3  (5.8) 33.3  (24.7) 47.5  (22.0)
Primary Tumor at Day 29 25.0  (15.0) 56.7  (25.2) 42.5  (28.0)
5.Secondary Outcome
Title Concentration of Paclitaxel in the Systemic Circulation
Hide Description Pharmacokinetic samples were taken on Day 1 at 1, 2, 4, and 6 hours post-injection, and weekly until prostatectomy. All numeric paclitaxel concentration data above the Lower Limit of Quantitation (25 pg/mL) was tabulated by cohort.
Time Frame Day 1, Day 8, Day 15, Day 22, and Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title NanoPac® 6 mg/mL NanoPac® 10 mg/mL NanoPac® 15 mg/mL
Hide Arm/Group Description:
NanoPac® 6 mg/mL injected into the prostate lobe containing the dominant lesion at a volume of 20% prostate lobe volume.
NanoPac® 10 mg/mL injected into the prostate lobe containing the dominant lesion at a volume of 20% prostate lobe volume.
NanoPac® 15 mg/mL injected into the prostate lobe containing the dominant lesion at a volume of 20% prostate lobe volume.
Overall Number of Participants Analyzed 3 3 10
Mean (Standard Deviation)
Unit of Measure: Plasma paclitaxel concentration (pg/mL)
Day 1 - 1 hr Post-Injection 5590.00  (2312.336) 19673.33  (20736.445) 19010.50  (15105.857)
Day 1 - 2 hr Post-Injection 3483.33  (1851.657) 9103.33  (7881.982) 12948.70  (10230.061)
Day 1 - 4 hr Post-Injection 2240.00  (756.241) 4740.00  (3889.884) 6830.80  (5219.617)
Day 1 - 6 hr Post-Injection 1926.67  (823.549) 5006.67  (4938.181) 5109.00  (3544.025)
Day 8 177.10  (102.777) 234.33  (73.446) 404.25  (221.326)
Day 15 65.10  (24.974) 82.85  (7.283) 106.11  (62.626)
Day 22 55.70  (15.556) 43.05  (16.051) 86.63  (52.358)
Day 29 35.45  (14.496) 54.75  (36.275) 57.64  (29.269)
6.Post-Hoc Outcome
Title Change in PSA Density
Hide Description PSA density was measured with mpMRI
Time Frame Screening and Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title NanoPac® 6 mg/mL NanoPac® 10 mg/mL NanoPac® 15 mg/mL
Hide Arm/Group Description:

NanoPac® 6 mg/mL injected into the prostate lobe containing the dominant lesion at a volume of 20% prostate lobe volume

NanoPac®: Subjects with prostate cancer scheduled for prostatectomy will have NanoPac® injected intratumorally under image guidance directly into the lobe of the prostate with the dominant lesion 4 weeks prior to prostatectomy.

NanoPac® 10 mg/mL injected into the prostate lobe containing the dominant lesion at a volume of 20% prostate lobe volume

NanoPac®: Subjects with prostate cancer scheduled for prostatectomy will have NanoPac® injected intratumorally under image guidance directly into the lobe of the prostate with the dominant lesion 4 weeks prior to prostatectomy.

NanoPac® 15 mg/mL injected into the prostate lobe containing the dominant lesion at a volume of 20% prostate lobe volume

NanoPac®: Subjects with prostate cancer scheduled for prostatectomy will have NanoPac® injected intratumorally under image guidance directly into the lobe of the prostate with the dominant lesion 4 weeks prior to prostatectomy.

Overall Number of Participants Analyzed 3 3 10
Mean (Standard Deviation)
Unit of Measure: ng/mL/cc
PSA Density at Screening 3.64  (5.75) 0.23  (0.02) 0.31  (0.31)
PSA Density at Day 29 1.95  (2.84) 0.20  (0.01) 0.20  (0.11)
7.Post-Hoc Outcome
Title Change in PI-RADS Score
Hide Description The Prostate Imaging Reporting and Data System (PI-RADS) assessment uses a five-point scale based on the probability that a combination of mpMRI findings on T2 weighting (T2W), Diffusion Weighted Imaging (DWI), and Dynamic Contrast Enhancement (DCE) correlates with the presence of a clinically significant cancer in the prostate gland. A PI-RADS score of 1 is considered to be most probably benign and a score of 5 is considered to be highly suspicious of a prostate malignancy. PI-RADS 1: very low (clinically significant cancer is highly unlikely to be present); PI-RADS 2: low (clinically significant cancer is unlikely to be present); PI-RADS 3: intermediate (presence of clinically significant cancer is equivocal); PI-RADS 4: high (clinically significant cancer is likely to be present); PI-RADS 5: very high (clinically significant cancer is highly likely to be present).
Time Frame Screening and Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title NanoPac® 6 mg/mL NanoPac® 10 mg/mL NanoPac® 15 mg/mL
Hide Arm/Group Description:

NanoPac® 6 mg/mL injected into the prostate lobe containing the dominant lesion at a volume of 20% prostate lobe volume

NanoPac®: Subjects with prostate cancer scheduled for prostatectomy will have NanoPac® injected intratumorally under image guidance directly into the lobe of the prostate with the dominant lesion 4 weeks prior to prostatectomy.

NanoPac® 10 mg/mL injected into the prostate lobe containing the dominant lesion at a volume of 20% prostate lobe volume

NanoPac®: Subjects with prostate cancer scheduled for prostatectomy will have NanoPac® injected intratumorally under image guidance directly into the lobe of the prostate with the dominant lesion 4 weeks prior to prostatectomy.

NanoPac® 15 mg/mL injected into the prostate lobe containing the dominant lesion at a volume of 20% prostate lobe volume

NanoPac®: Subjects with prostate cancer scheduled for prostatectomy will have NanoPac® injected intratumorally under image guidance directly into the lobe of the prostate with the dominant lesion 4 weeks prior to prostatectomy.

Overall Number of Participants Analyzed 3 3 10
Measure Type: Count of Participants
Unit of Measure: Participants
PI-RADS 3 : Screening
1
  33.3%
1
  33.3%
1
  10.0%
PI-RADS 3 : Day 29
0
   0.0%
0
   0.0%
2
  20.0%
PI-RADS 4 : Screening
0
   0.0%
1
  33.3%
5
  50.0%
PI-RADS 4 : Day 29
1
  33.3%
2
  66.7%
2
  20.0%
PI-RADS 5 : Screening
2
  66.7%
1
  33.3%
4
  40.0%
PI-RADS 5 : Day 29
2
  66.7%
1
  33.3%
6
  60.0%
8.Post-Hoc Outcome
Title Tumor Invasion Into Surrounding Tissues
Hide Description Assessed histologically after TRUS biopsy at Screening and on Day 29 prior to prostatectomy.
Time Frame Screening and Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title NanoPac® 6 mg/mL NanoPac® 10 mg/mL NanoPac® 15 mg/mL
Hide Arm/Group Description:

NanoPac® 6 mg/mL injected into the prostate lobe containing the dominant lesion at a volume of 20% prostate lobe volume

NanoPac®: Subjects with prostate cancer scheduled for prostatectomy will have NanoPac® injected intratumorally under image guidance directly into the lobe of the prostate with the dominant lesion 4 weeks prior to prostatectomy.

NanoPac® 10 mg/mL injected into the prostate lobe containing the dominant lesion at a volume of 20% prostate lobe volume

NanoPac®: Subjects with prostate cancer scheduled for prostatectomy will have NanoPac® injected intratumorally under image guidance directly into the lobe of the prostate with the dominant lesion 4 weeks prior to prostatectomy.

NanoPac® 15 mg/mL injected into the prostate lobe containing the dominant lesion at a volume of 20% prostate lobe volume

NanoPac®: Subjects with prostate cancer scheduled for prostatectomy will have NanoPac® injected intratumorally under image guidance directly into the lobe of the prostate with the dominant lesion 4 weeks prior to prostatectomy.

Overall Number of Participants Analyzed 3 3 10
Measure Type: Count of Participants
Unit of Measure: Participants
Any invasion at Screening? Yes
2
  66.7%
0
   0.0%
4
  40.0%
Any invasion at Screening? No
1
  33.3%
3
 100.0%
6
  60.0%
Any invasion at Day 29? Yes
2
  66.7%
2
  66.7%
2
  20.0%
Any invasion at Day 29? No
1
  33.3%
1
  33.3%
8
  80.0%
Time Frame 28 days, from Day 1 (the day of NanoPac injection) to Day 29 (the day of prostatectomy)
Adverse Event Reporting Description Adverse events (AEs) were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
 
Arm/Group Title NanoPac® 6 mg/mL NanoPac® 10 mg/mL NanoPac® 15 mg/mL
Hide Arm/Group Description NanoPac® 6 mg/mL injected into the prostate lobe containing the dominant lesion at a volume of 20% prostate lobe volume 4 weeks prior to prostatectomy. NanoPac® 10 mg/mL injected into the prostate lobe containing the dominant lesion at a volume of 20% prostate lobe volume 4 weeks prior to prostatectomy. NanoPac® 15 mg/mL injected into the prostate lobe containing the dominant lesion at a volume of 20% prostate lobe volume 4 weeks prior to prostatectomy.
All-Cause Mortality
NanoPac® 6 mg/mL NanoPac® 10 mg/mL NanoPac® 15 mg/mL
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/3 (0.00%)      0/3 (0.00%)      0/10 (0.00%)    
Hide Serious Adverse Events
NanoPac® 6 mg/mL NanoPac® 10 mg/mL NanoPac® 15 mg/mL
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/3 (0.00%)      0/3 (0.00%)      0/10 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
NanoPac® 6 mg/mL NanoPac® 10 mg/mL NanoPac® 15 mg/mL
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/3 (100.00%)      2/3 (66.67%)      6/10 (60.00%)    
Blood and lymphatic system disorders       
Anemia * 1  2/3 (66.67%)  2 0/3 (0.00%)  0 1/10 (10.00%)  1
Leucocystosis  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/10 (0.00%)  0
Eye disorders       
Vision Blurred  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/10 (0.00%)  0
Gastrointestinal disorders       
Abdominal distension  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/10 (0.00%)  0
Abdominal Pain  1  2/3 (66.67%)  2 0/3 (0.00%)  0 0/10 (0.00%)  0
Constipation  1  1/3 (33.33%)  1 1/3 (33.33%)  1 0/10 (0.00%)  0
Diarrhoea  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/10 (10.00%)  1
Dry mouth  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/10 (0.00%)  0
Gastroesophageal reflux disease  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/10 (0.00%)  0
Ileus  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/10 (0.00%)  0
Nausea  1  2/3 (66.67%)  2 0/3 (0.00%)  0 2/10 (20.00%)  2
Procalgia  1  2/3 (66.67%)  2 0/3 (0.00%)  0 1/10 (10.00%)  1
Vomiting  1  0/3 (0.00%)  0 0/3 (0.00%)  0 2/10 (20.00%)  2
General disorders       
Fatigue  1  3/3 (100.00%)  5 0/3 (0.00%)  0 0/10 (0.00%)  0
Local swelling  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/10 (10.00%)  1
Oedema peripheral  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/10 (0.00%)  0
Infections and infestations       
Viral URTI  1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/10 (0.00%)  0
Injury, poisoning and procedural complications       
Procedural pain  1  0/3 (0.00%)  0 0/3 (0.00%)  0 4/10 (40.00%)  4
Wound complication  1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/10 (0.00%)  0
Metabolism and nutrition disorders       
Decreased appetite  1  2/3 (66.67%)  2 0/3 (0.00%)  0 0/10 (0.00%)  0
Hperglycaemia  1  1/3 (33.33%)  1 0/3 (0.00%)  0 1/10 (10.00%)  1
Hypokalaemia  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/10 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Arthralgia  1  1/3 (33.33%)  2 0/3 (0.00%)  0 0/10 (0.00%)  0
Bone pain  1  1/3 (33.33%)  2 1/3 (33.33%)  1 0/10 (0.00%)  0
Myalgia  1  1/3 (33.33%)  2 0/3 (0.00%)  0 0/10 (0.00%)  0
Nervous system disorders       
Dizziness  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/10 (0.00%)  0
Headache  1  0/3 (0.00%)  0 0/3 (0.00%)  0 2/10 (20.00%)  2
Lethargy  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/10 (0.00%)  0
Memory impairment  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/10 (0.00%)  0
Somnolence  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/10 (10.00%)  1
Tremor  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/10 (0.00%)  0
Psychiatric disorders       
Anxiety  1  1/3 (33.33%)  1 1/3 (33.33%)  1 1/10 (10.00%)  1
Insomnia  1  1/3 (33.33%)  3 0/3 (0.00%)  0 0/10 (0.00%)  0
Renal and urinary disorders       
Dysuria  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/10 (0.00%)  0
Haematuria  1  0/3 (0.00%)  0 1/3 (33.33%)  1 1/10 (10.00%)  1
Micturition urgency  1  1/3 (33.33%)  1 1/3 (33.33%)  1 0/10 (0.00%)  0
Nocturia  1  1/3 (33.33%)  1 1/3 (33.33%)  1 0/10 (0.00%)  0
Pollakiuria  1  1/3 (33.33%)  2 0/3 (0.00%)  0 0/10 (0.00%)  0
Urine flow decreased  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/10 (10.00%)  1
Reproductive system and breast disorders       
Erectile dysfunction  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/10 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Cough * 1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/10 (0.00%)  0
Vascular disorders       
Hypertension  1  0/3 (0.00%)  0 1/3 (33.33%)  2 1/10 (10.00%)  1
1
Term from vocabulary, MedDRA 20.0
*
Indicates events were collected by non-systematic assessment
Indicates events were collected by systematic assessment
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
Layout table for Results Point of Contact information
Name/Title: Gere S. diZerega, MD
Organization: NanOlogy, LLC
Phone: 805-595-1300
EMail: gere.dizerega@usbiotest.com
Layout table for additonal information
Responsible Party: NanOlogy, LLC
ClinicalTrials.gov Identifier: NCT03077659    
Other Study ID Numbers: NANOPAC-2016-02
First Submitted: February 28, 2017
First Posted: March 13, 2017
Results First Submitted: July 2, 2019
Results First Posted: August 20, 2019
Last Update Posted: August 20, 2019