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Trial record 2 of 4 for:    sor007
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Study of Topical SOR007 Ointment for Cutaneous Metastases

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03101358
Recruitment Status : Completed
First Posted : April 5, 2017
Results First Posted : November 4, 2021
Last Update Posted : November 5, 2021
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 Cutaneous Metastasis
Intervention Drug: SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment
Enrollment 23
Recruitment Details  
Pre-assignment Details  
Arm/Group Title SOR007 0.15% SOR007 1.0% SOR007 2.0% Group A SOR007 2.0% Group B
Hide Arm/Group Description

0.15% SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment applied topically twice daily for 28 days

SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment: One (1) Finger Tip Unit (FTU), or approximately 0.5 g, of SOR007 ointment will be applied topically to a 50 cm2 treatment area.

1.0% SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment applied topically twice daily for 28 days

SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment: One (1) Finger Tip Unit (FTU), or approximately 0.5 g, of SOR007 ointment will be applied topically to a 50 cm2 treatment area.

2.0% SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment applied topically twice daily for 28 days

SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment: One (1) Finger Tip Unit (FTU), or approximately 0.5 g, of SOR007 ointment will be applied topically to a 50 cm2 treatment area.

2.0% SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment applied topically twice daily for 56 days

SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment: One (1) Finger Tip Unit (FTU), or approximately 0.5 g, of SOR007 ointment will be applied topically to a 50 cm2 treatment area.
Period Title: Overall Study
Started 4 3 5 11
Completed All Dosing 3 3 3 10
Completed 1 3 3 5
Not Completed 3 0 2 6
Reason Not Completed
Non-compliance with study schedule             1             0             0             1
Decision to start another clinical trial. Not related to AE.             0             0             1             0
Physician Decision             1             0             0             3
Adverse Event             0             0             1             0
Oncologist decision to start subject on IV chemotherapy prohibited under protocol.             0             0             0             1
Lost to Follow-up             1             0             0             1
Arm/Group Title SOR007 0.15% SOR007 1.0% SOR007 2.0% Group A SOR007 2.0% Group B Total
Hide Arm/Group Description

0.15% SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment applied topically twice daily for 28 days

SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment: One (1) Finger Tip Unit (FTU), or approximately 0.5 g, of SOR007 ointment will be applied topically to a 50 cm2 treatment area.

1.0% SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment applied topically twice daily for 28 days

SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment: One (1) Finger Tip Unit (FTU), or approximately 0.5 g, of SOR007 ointment will be applied topically to a 50 cm2 treatment area.

2.0% SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment applied topically twice daily for 28 days

SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment: One (1) Finger Tip Unit (FTU), or approximately 0.5 g, of SOR007 ointment will be applied topically to a 50 cm2 treatment area.

2.0% SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment applied topically twice daily for 56 days

SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment: One (1) Finger Tip Unit (FTU), or approximately 0.5 g, of SOR007 ointment will be applied topically to a 50 cm2 treatment area.

 Total of all reporting groups
Overall Number of Baseline Participants 4 3 5 11 23
Hide Baseline Analysis Population Description
All enrolled subjects are included in the baseline analysis population.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 4 participants 3 participants 5 participants 11 participants 23 participants
62.8  (12.7) 66.3  (8.3) 63.2  (11.3) 63.0  (10.8) 63.4  (10.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 3 participants 5 participants 11 participants 23 participants
Female
4
 100.0%
2
  66.7%
5
 100.0%
10
  90.9%
21
  91.3%
Male
0
   0.0%
1
  33.3%
0
   0.0%
1
   9.1%
2
   8.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 3 participants 5 participants 11 participants 23 participants
Hispanic or Latino
1
  25.0%
1
  33.3%
2
  40.0%
1
   9.1%
5
  21.7%
Not Hispanic or Latino
3
  75.0%
2
  66.7%
3
  60.0%
9
  81.8%
17
  73.9%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1
   9.1%
1
   4.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 3 participants 5 participants 11 participants 23 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
3
  27.3%
3
  13.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
2
  40.0%
1
   9.1%
3
  13.0%
White
4
 100.0%
3
 100.0%
1
  20.0%
6
  54.5%
14
  60.9%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
2
  40.0%
1
   9.1%
3
  13.0%
Body Mass Index  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 4 participants 3 participants 5 participants 11 participants 23 participants
23.23  (4.51) 26.13  (3.96) 29.54  (4.94) 25.05  (5.21) 25.85  (5.07)
ECOG Performance Status   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 4 participants 3 participants 5 participants 11 participants 23 participants
1.0  (0.8) 0.7  (0.6) 0.6  (0.9) 0.7  (0.5) 0.7  (0.6)
[1]
Measure Description: The ECOG performance status scale is a measurement that describes a patient's level of functioning in terms of their ability to care for themselves, daily activity, and physical ability. The scale ranges from 0 to 5, with a lower score indicating a more functional patient and a higher score indicating a patient with more negative impacts to their daily functions.
1.Primary Outcome
Title Incidence of Treatment Emergent Adverse Events
Hide Description Treatment emergent adverse events will include all reported adverse events, laboratory assessments, physical examination findings, and vital signs.
Time Frame Baseline through Day 59 (for 28 days of treatment) or Day 86 (for 56 days of treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who received SOR007 were included in the analysis population.
Arm/Group Title SOR007 0.15% SOR007 1.0% SOR007 2.0% Group A SOR007 2.0% Group B
Hide Arm/Group Description:

0.15% SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment applied topically twice daily for 28 days

SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment: One (1) Finger Tip Unit (FTU), or approximately 0.5 g, of SOR007 ointment will be applied topically to a 50 cm2 treatment area.

1.0% SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment applied topically twice daily for 28 days

SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment: One (1) Finger Tip Unit (FTU), or approximately 0.5 g, of SOR007 ointment will be applied topically to a 50 cm2 treatment area.

2.0% SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment applied topically twice daily for 28 days

SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment: One (1) Finger Tip Unit (FTU), or approximately 0.5 g, of SOR007 ointment will be applied topically to a 50 cm2 treatment area.

2.0% SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment applied topically twice daily for 56 days

SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment: One (1) Finger Tip Unit (FTU), or approximately 0.5 g, of SOR007 ointment will be applied topically to a 50 cm2 treatment area.
Overall Number of Participants Analyzed 4 3 5 11
Measure Type: Count of Participants
Unit of Measure: Participants
4
 100.0%
3
 100.0%
5
 100.0%
10
  90.9%
2.Secondary Outcome
Title Objective Clinical Response
Hide Description

Objective Clinical Response (Complete Clinical Response (CR) + Partial Response (PR)) is defined as the percentage of study subjects who achieve complete clinical response or partial response 14 days after last treatment (Day 43 or Day 70).

Complete clinical response (CR) is defined as absence of any detectable residual disease in the treatment area; partial response (PR) as at least a 30% decrease in the sum of the diameters of eligible lesion(s) within the treatment area compared to baseline; progressive disease (PD) as at least a 20% increase in the sum of diameters of eligible lesion(s) within the treatment area, taking as reference the smallest sum on study (the sum must also demonstrate an absolute increase of at least 5 mm); and stable disease (SD) as between that defined as PR or PD. Eligible lesions will be determined at baseline by the RECIST definition of measurable tumors (≥ 10mm in its longest diameter).
Time Frame Baseline and Day 43 (for 28 days of treatment) or Day 70 (for 56 days of treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 23 Subjects enrolled, evaluable photography 14 days after the last dose of SOR007 was provided in 14 (60.9%) Subjects; two in the 0.15% treatment group, three in the 1.0% treatment group, four in 2.0% A treatment group, and five in 2.0% B treatment group.
Arm/Group Title SOR007 0.15% SOR007 1.0% SOR007 2.0% Group A SOR007 2.0% Group B
Hide Arm/Group Description:

0.15% SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment applied topically twice daily for 28 days

SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment: One (1) Finger Tip Unit (FTU), or approximately 0.5 g, of SOR007 ointment will be applied topically to a 50 cm2 treatment area.

1.0% SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment applied topically twice daily for 28 days

SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment: One (1) Finger Tip Unit (FTU), or approximately 0.5 g, of SOR007 ointment will be applied topically to a 50 cm2 treatment area.

2.0% SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment applied topically twice daily for 28 days

SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment: One (1) Finger Tip Unit (FTU), or approximately 0.5 g, of SOR007 ointment will be applied topically to a 50 cm2 treatment area.

2.0% SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment applied topically twice daily for 56 days

SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment: One (1) Finger Tip Unit (FTU), or approximately 0.5 g, of SOR007 ointment will be applied topically to a 50 cm2 treatment area.
Overall Number of Participants Analyzed 2 3 4 5
Measure Type: Count of Participants
Unit of Measure: Participants
Complete Response
0
   0.0%
0
   0.0%
0
   0.0%
1
  20.0%
Partial Response
0
   0.0%
2
  66.7%
0
   0.0%
0
   0.0%
Progressive Disease
1
  50.0%
0
   0.0%
3
  75.0%
0
   0.0%
Stable Disease
1
  50.0%
1
  33.3%
1
  25.0%
4
  80.0%
3.Secondary Outcome
Title Change in Pain at the Treatment Area
Hide Description Change in pain at the treatment area will be measured by the Numeric Rating Scale (NRS-11). The numerical scale ranges from 0 to 10, with 0 being "no pain" and 10 being "the worst pain imaginable." A lower score equates to less severe pain (better outcome) and a higher score equates to more severe pain (worse outcome).
Time Frame Baseline and Day 43 (for 28 days of treatment) or Day 70 (for 56 days of treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who received SOR007 were included in the analysis population.
Arm/Group Title SOR007 0.15% SOR007 1.0% SOR007 2.0% Group A SOR007 2.0% Group B
Hide Arm/Group Description:

0.15% SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment applied topically twice daily for 28 days

SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment: One (1) Finger Tip Unit (FTU), or approximately 0.5 g, of SOR007 ointment will be applied topically to a 50 cm2 treatment area.

1.0% SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment applied topically twice daily for 28 days

SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment: One (1) Finger Tip Unit (FTU), or approximately 0.5 g, of SOR007 ointment will be applied topically to a 50 cm2 treatment area.

2.0% SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment applied topically twice daily for 28 days

SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment: One (1) Finger Tip Unit (FTU), or approximately 0.5 g, of SOR007 ointment will be applied topically to a 50 cm2 treatment area.

2.0% SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment applied topically twice daily for 56 days

SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment: One (1) Finger Tip Unit (FTU), or approximately 0.5 g, of SOR007 ointment will be applied topically to a 50 cm2 treatment area.
Overall Number of Participants Analyzed 4 3 5 11
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline (Day 1) 0.0  (0.0) 0.3  (0.6) 1.4  (1.3) 1.1  (2.0)
2 Weeks after Last Dose (Day 43 for 28-day treatment groups or Day 70 for 56-day treatment groups) 0.0  (0.0) 1.0  (1.7) 3.8  (2.6) 0.3  (0.7)
4.Secondary Outcome
Title Objective Tumor Response (OTR)
Hide Description Objective Tumor Response (OTR), defined as the difference in the lesion size within the treatment area between baseline and 14 days after the last dose in the dose group i.e. Day 43 for dose escalation Subjects, and dose expansion Group A Subjects; Day 70 for dose expansion Group B Subjects; or between baseline and last tumor assessment for early terminators. Four OTRs are calculated based on different definitions of "lesion size": 1) Area of the primary eligible lesion, 2) Sum of area of all eligible lesions, 3) Longest diameter of the primary eligible lesion, and 4) Sum of longest diameter of all eligible lesions.
Time Frame Baseline and Day 43 (for 28 days of treatment) or Day 70 (for 56 days of treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
One subject in SOR007 2.0% Group A was not included in the analysis.
Arm/Group Title SOR007 0.15% SOR007 1.0% SOR007 2.0%
Hide Arm/Group Description:

0.15% SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment applied topically twice daily for 28 days

SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment: One (1) Finger Tip Unit (FTU), or approximately 0.5 g, of SOR007 ointment will be applied topically to a 50 cm2 treatment area.

1.0% SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment applied topically twice daily for 28 days

SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment: One (1) Finger Tip Unit (FTU), or approximately 0.5 g, of SOR007 ointment will be applied topically to a 50 cm2 treatment area.

2.0% SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment applied topically twice daily for 28 days or up to 56 days

SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment: One (1) Finger Tip Unit (FTU), or approximately 0.5 g, of SOR007 ointment will be applied topically to a 50 cm2 treatment area.
Overall Number of Participants Analyzed 4 3 15
Mean (Standard Deviation)
Unit of Measure: mm^2
Based on Area of the Primary Eligible Lesion -31.03  (22.00) 302.63  (330.55) -165.05  (679.24)
Based on Total Area of all Eligible Lesions -40.57  (25.56) 407.33  (499.66) -176.61  (883.76)
Based on Longest Diameter of the Primary Eligible Lesion -5.50  (9.75) 5.11  (6.55) -0.96  (16.57)
Based on Total Longest Diameter of all Eligible Lesions -5.75  (9.58) 4.88  (6.17) 1.26  (37.34)
Time Frame The Investigator recorded all reportable events with start dates occurring any time after first study drug dose application until 30 days after the last study drug application, or in the case of an TESAE, at least 30 days after onset, whichever was later.
Adverse Event Reporting Description AEs were collected at all study visits from the time of first study drug application. Study personnel were required to review the Subject's diary at each visit to confirm it was adequately completed and to address and document discrepancies, missing entries and errors. Study personnel also asked open-ended questions to obtain information about AEs at every visit.
 
Arm/Group Title SOR007 0.15% SOR007 1.0% SOR007 2.0% Group A SOR007 2.0% Group B
Hide Arm/Group Description

0.15% SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment applied topically twice daily for 28 days

SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment: One (1) Finger Tip Unit (FTU), or approximately 0.5 g, of SOR007 ointment will be applied topically to a 50 cm2 treatment area.

1.0% SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment applied topically twice daily for 28 days

SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment: One (1) Finger Tip Unit (FTU), or approximately 0.5 g, of SOR007 ointment will be applied topically to a 50 cm2 treatment area.

2.0% SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment applied topically twice daily for 28 days

SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment: One (1) Finger Tip Unit (FTU), or approximately 0.5 g, of SOR007 ointment will be applied topically to a 50 cm2 treatment area.

2.0% SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment applied topically twice daily for 56 days

SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment: One (1) Finger Tip Unit (FTU), or approximately 0.5 g, of SOR007 ointment will be applied topically to a 50 cm2 treatment area.
All-Cause Mortality
SOR007 0.15% SOR007 1.0% SOR007 2.0% Group A SOR007 2.0% Group B
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/4 (25.00%)      0/3 (0.00%)      0/5 (0.00%)      0/11 (0.00%)    
Hide Serious Adverse Events
SOR007 0.15% SOR007 1.0% SOR007 2.0% Group A SOR007 2.0% Group B
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/4 (25.00%)      0/3 (0.00%)      2/5 (40.00%)      4/11 (36.36%)    
General disorders         
Chest pain † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/5 (20.00%)  1 0/11 (0.00%)  0
Infections and infestations         
Medical device site infection † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/5 (0.00%)  0 1/11 (9.09%)  1
Metabolism and nutrition disorders         
Hypercalcaemia † 1  1/4 (25.00%)  1 0/3 (0.00%)  0 0/5 (0.00%)  0 0/11 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Arthralgia † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/5 (0.00%)  0 1/11 (9.09%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Breast cancer † 1  1/4 (25.00%)  1 0/3 (0.00%)  0 0/5 (0.00%)  0 0/11 (0.00%)  0
Lung neoplasm malignant † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/5 (0.00%)  0 1/11 (9.09%)  1
Respiratory, thoracic and mediastinal disorders         
Pleural effusion † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/5 (20.00%)  1 0/11 (0.00%)  0
Pulmonary embolism † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/5 (0.00%)  0 1/11 (9.09%)  1
1
Term from vocabulary, MedDRA 20.1
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
SOR007 0.15% SOR007 1.0% SOR007 2.0% Group A SOR007 2.0% Group B
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/4 (100.00%)      3/3 (100.00%)      5/5 (100.00%)      10/11 (90.91%)    
Blood and lymphatic system disorders         
Anaemia † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/5 (0.00%)  0 2/11 (18.18%)  2
Anaemia macrocytic † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/5 (0.00%)  0 1/11 (9.09%)  1
Leukopenia † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/5 (0.00%)  0 2/11 (18.18%)  2
Lymphopenia † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/5 (20.00%)  1 1/11 (9.09%)  1
Neutropenia † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/5 (0.00%)  0 2/11 (18.18%)  3
Thrombocytopenia † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/5 (0.00%)  0 1/11 (9.09%)  2
Cardiac disorders         
Left atrial enlargement † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/5 (0.00%)  0 1/11 (9.09%)  1
Tachycardia † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/5 (0.00%)  0 2/11 (18.18%)  2
Eye disorders         
Blepharitis † 1  0/4 (0.00%)  0 1/3 (33.33%)  1 0/5 (0.00%)  0 0/11 (0.00%)  0
Gastrointestinal disorders         
Abdominal pain upper † 1  1/4 (25.00%)  1 1/3 (33.33%)  1 0/5 (0.00%)  0 0/11 (0.00%)  0
Constipation † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/5 (0.00%)  0 2/11 (18.18%)  2
Gingival bleeding † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/5 (0.00%)  0 1/11 (9.09%)  1
Loose tooth † 1  0/4 (0.00%)  0 1/3 (33.33%)  1 0/5 (0.00%)  0 0/11 (0.00%)  0
Nausea † 1  1/4 (25.00%)  1 0/3 (0.00%)  0 0/5 (0.00%)  0 2/11 (18.18%)  2
Rectal haemorrhage † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/5 (20.00%)  1 0/11 (0.00%)  0
Vomiting † 1  1/4 (25.00%)  1 0/3 (0.00%)  0 0/5 (0.00%)  0 1/11 (9.09%)  1
General disorders         
Application site discomfort † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/5 (0.00%)  0 1/11 (9.09%)  1
Application site irritation † 1  1/4 (25.00%)  1 0/3 (0.00%)  0 0/5 (0.00%)  0 0/11 (0.00%)  0
Application site pain † 1  1/4 (25.00%)  1 1/3 (33.33%)  1 2/5 (40.00%)  7 3/11 (27.27%)  4
Application site pruritus † 1  1/4 (25.00%)  1 1/3 (33.33%)  1 0/5 (0.00%)  0 0/11 (0.00%)  0
Application site reaction † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/5 (0.00%)  0 1/11 (9.09%)  2
Application site wound † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/5 (0.00%)  0 1/11 (9.09%)  1
Application site haemorrhage † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 3/5 (60.00%)  4 3/11 (27.27%)  3
Chest pain † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/5 (20.00%)  1 1/11 (9.09%)  2
Crepitations † 1  1/4 (25.00%)  1 0/3 (0.00%)  0 0/5 (0.00%)  0 0/11 (0.00%)  0
Discomfort † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/5 (20.00%)  1 0/11 (0.00%)  0
Fatigue † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/5 (0.00%)  0 3/11 (27.27%)  3
Gait disturbance † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/5 (0.00%)  0 2/11 (18.18%)  2
Nodule † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/5 (0.00%)  0 1/11 (9.09%)  1
Oedema peripheral † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/5 (0.00%)  0 2/11 (18.18%)  2
Puncture site pain † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/5 (0.00%)  0 1/11 (9.09%)  1
Pyrexia † 1  1/4 (25.00%)  3 0/3 (0.00%)  0 0/5 (0.00%)  0 1/11 (9.09%)  1
Tenderness † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/5 (0.00%)  0 1/11 (9.09%)  1
Immune system disorders         
Drug hypersensitivity † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/5 (0.00%)  0 1/11 (9.09%)  1
Infections and infestations         
Corynebacterium infection † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/5 (0.00%)  0 1/11 (9.09%)  1
Herpes zoster † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/5 (0.00%)  0 1/11 (9.09%)  1
Medical device site infection † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/5 (0.00%)  0 1/11 (9.09%)  1
Pseudomonas infection † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/5 (20.00%)  1 0/11 (0.00%)  0
Upper respiratory tract infection † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/5 (0.00%)  0 1/11 (9.09%)  1
Urinary tract infection † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/5 (0.00%)  0 1/11 (9.09%)  1
Urinary tract infection fungal † 1  0/4 (0.00%)  0 1/3 (33.33%)  1 0/5 (0.00%)  0 0/11 (0.00%)  0
Wound infection bacterial † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/5 (20.00%)  1 0/11 (0.00%)  0
Injury, poisoning and procedural complications         
Fall † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/5 (0.00%)  0 1/11 (9.09%)  1
Wound complication † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/5 (20.00%)  1 0/11 (0.00%)  0
Investigations         
Alanine aminotransferase increased † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/5 (0.00%)  0 1/11 (9.09%)  1
Aspartate aminotransferase increased † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/5 (0.00%)  0 4/11 (36.36%)  4
Blood alkaline phosphatase increased † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/5 (0.00%)  0 3/11 (27.27%)  3
Gamma-glutamyltransferase increased † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/5 (20.00%)  1 1/11 (9.09%)  1
Lymphocyte count decreased † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 2/5 (40.00%)  2 0/11 (0.00%)  0
Neutrophil count decreased † 1  1/4 (25.00%)  1 0/3 (0.00%)  0 0/5 (0.00%)  0 0/11 (0.00%)  0
Metabolism and nutrition disorders         
Decreased appetite † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/5 (0.00%)  0 1/11 (9.09%)  1
Hypercalcaemia † 1  1/4 (25.00%)  1 0/3 (0.00%)  0 0/5 (0.00%)  0 1/11 (9.09%)  1
Hyperglycaemia † 1  1/4 (25.00%)  1 0/3 (0.00%)  0 2/5 (40.00%)  2 2/11 (18.18%)  3
Hypoalbuminaemia † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/5 (0.00%)  0 1/11 (9.09%)  1
Hypokalaemia † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/5 (20.00%)  1 0/11 (0.00%)  0
Hypomagnesaemia † 1  1/4 (25.00%)  1 0/3 (0.00%)  0 1/5 (20.00%)  1 1/11 (9.09%)  1
Hypophosphataemia † 1  1/4 (25.00%)  1 0/3 (0.00%)  0 0/5 (0.00%)  0 0/11 (0.00%)  0
Oedema † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/5 (0.00%)  0 1/11 (9.09%)  1
Vitamin B12 deficiency † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/5 (0.00%)  0 1/11 (9.09%)  1
Musculoskeletal and connective tissue disorders         
Arthralgia † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/5 (0.00%)  0 2/11 (18.18%)  2
Back pain † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/5 (0.00%)  0 2/11 (18.18%)  2
Flank pain † 1  1/4 (25.00%)  1 0/3 (0.00%)  0 0/5 (0.00%)  0 0/11 (0.00%)  0
Joint range of motion decreased † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/5 (0.00%)  0 1/11 (9.09%)  1
Joint swelling † 1  1/4 (25.00%)  1 0/3 (0.00%)  0 0/5 (0.00%)  0 0/11 (0.00%)  0
Muscle spasms † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/5 (0.00%)  0 2/11 (18.18%)  2
Muscle twitching † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/5 (20.00%)  1 0/11 (0.00%)  0
Muscular weakness † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/5 (0.00%)  0 2/11 (18.18%)  2
Musculoskeletal chest pain † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/5 (0.00%)  0 1/11 (9.09%)  2
Musculoskeletal pain † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/5 (0.00%)  0 2/11 (18.18%)  2
Myalgia † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/5 (0.00%)  0 1/11 (9.09%)  1
Pain in extremity † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/5 (0.00%)  0 2/11 (18.18%)  2
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Breast cancer † 1  1/4 (25.00%)  1 0/3 (0.00%)  0 0/5 (0.00%)  0 0/11 (0.00%)  0
Cancer pain † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 2/5 (40.00%)  4 0/11 (0.00%)  0
Lung neoplasm malignant † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/5 (0.00%)  0 1/11 (9.09%)  1
Metastases to skin † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/5 (20.00%)  1 0/11 (0.00%)  0
Nervous system disorders         
Dementia † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/5 (0.00%)  0 1/11 (9.09%)  1
Dizziness † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/5 (0.00%)  0 2/11 (18.18%)  3
Dysgeusia † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/5 (0.00%)  0 1/11 (9.09%)  1
Headache † 1  0/4 (0.00%)  0 1/3 (33.33%)  1 1/5 (20.00%)  1 2/11 (18.18%)  2
Lumbar radiculopathy † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/5 (0.00%)  0 1/11 (9.09%)  1
Neuropathy peripheral † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/5 (20.00%)  1 1/11 (9.09%)  1
Paraesthesia † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/5 (0.00%)  0 1/11 (9.09%)  1
Restless legs syndrome † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/5 (0.00%)  0 1/11 (9.09%)  1
Psychiatric disorders         
Anxiety † 1  0/4 (0.00%)  0 1/3 (33.33%)  1 0/5 (0.00%)  0 0/11 (0.00%)  0
Depression † 1  0/4 (0.00%)  0 1/3 (33.33%)  1 0/5 (0.00%)  0 0/11 (0.00%)  0
Insomnia † 1  0/4 (0.00%)  0 1/3 (33.33%)  1 0/5 (0.00%)  0 0/11 (0.00%)  0
Renal and urinary disorders         
Glycosuria † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/5 (0.00%)  0 1/11 (9.09%)  1
Micturition urgency † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/5 (0.00%)  0 1/11 (9.09%)  1
Pollakiuria † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/5 (0.00%)  0 1/11 (9.09%)  1
Reproductive system and breast disorders         
Breast pain † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/5 (20.00%)  1 0/11 (0.00%)  0
Vulvovaginal pain † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/5 (0.00%)  0 1/11 (9.09%)  1
Respiratory, thoracic and mediastinal disorders         
Atelectasis † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/5 (20.00%)  1 0/11 (0.00%)  0
Cough † 1  1/4 (25.00%)  1 0/3 (0.00%)  0 0/5 (0.00%)  0 2/11 (18.18%)  2
Dyspnoea † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/5 (0.00%)  0 2/11 (18.18%)  2
Dyspnoea exertional † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/5 (20.00%)  1 0/11 (0.00%)  0
Pleural effusion † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/5 (20.00%)  1 0/11 (0.00%)  0
Pulmonary embolism † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/5 (0.00%)  0 1/11 (9.09%)  1
Pulmonary hypertension † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/5 (0.00%)  0 1/11 (9.09%)  1
Respiratory disorder † 1  1/4 (25.00%)  1 0/3 (0.00%)  0 0/5 (0.00%)  0 0/11 (0.00%)  0
Wheezing † 1  1/4 (25.00%)  1 0/3 (0.00%)  0 0/5 (0.00%)  0 0/11 (0.00%)  0
Skin and subcutaneous tissue disorders         
Acne † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/5 (0.00%)  0 1/11 (9.09%)  1
Blister † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/5 (0.00%)  0 1/11 (9.09%)  1
Dermatitis † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/5 (0.00%)  0 1/11 (9.09%)  1
Dry skin † 1  1/4 (25.00%)  1 0/3 (0.00%)  0 0/5 (0.00%)  0 0/11 (0.00%)  0
Erythema † 1  0/4 (0.00%)  0 1/3 (33.33%)  1 1/5 (20.00%)  1 0/11 (0.00%)  0
Facial wasting † 1  1/4 (25.00%)  1 0/3 (0.00%)  0 0/5 (0.00%)  0 0/11 (0.00%)  0
Pain of skin † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/5 (20.00%)  1 0/11 (0.00%)  0
Prurigo † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/5 (0.00%)  0 1/11 (9.09%)  1
Pruritus † 1  0/4 (0.00%)  0 1/3 (33.33%)  1 3/5 (60.00%)  3 3/11 (27.27%)  3
Pruritus allergic † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/5 (0.00%)  0 1/11 (9.09%)  1
Pruritus generalised † 1  0/4 (0.00%)  0 1/3 (33.33%)  1 0/5 (0.00%)  0 0/11 (0.00%)  0
Rash † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/5 (0.00%)  0 1/11 (9.09%)  1
Skin haemorrhage † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 2/5 (40.00%)  2 0/11 (0.00%)  0
Skin hyperpigmentation † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/5 (0.00%)  0 1/11 (9.09%)  1
Skin irritation † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/5 (0.00%)  0 1/11 (9.09%)  1
Skin lesion † 1  1/4 (25.00%)  1 1/3 (33.33%)  1 0/5 (0.00%)  0 5/11 (45.45%)  7
Urticaria † 1  0/4 (0.00%)  0 1/3 (33.33%)  1 0/5 (0.00%)  0 0/11 (0.00%)  0
Surgical and medical procedures         
Wound drainage † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/5 (20.00%)  1 0/11 (0.00%)  0
Vascular disorders         
Deep vein thrombosis † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/5 (0.00%)  0 1/11 (9.09%)  1
Flushing † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/5 (0.00%)  0 1/11 (9.09%)  1
Haemorrhage † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/5 (0.00%)  0 1/11 (9.09%)  1
Hypertension † 1  1/4 (25.00%)  1 0/3 (0.00%)  0 0/5 (0.00%)  0 0/11 (0.00%)  0
Lymphoedema † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/5 (0.00%)  0 1/11 (9.09%)  1
1
Term from vocabulary, MedDRA 20.1
†
Indicates events were collected by systematic assessment
[Not Specified]
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 diZerega, MD
Organization: US Biotest, Inc.
Phone: 805.595.1300
EMail: gere.dizerega@usbiotest.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: NanOlogy, LLC
ClinicalTrials.gov Identifier: NCT03101358    
Other Study ID Numbers: SOR007-2017-01
First Submitted: March 29, 2017
First Posted: April 5, 2017
Results First Submitted: October 6, 2021
Results First Posted: November 4, 2021
Last Update Posted: November 5, 2021