Study NCT03077685
Trial of NanoPac® in Subjects With Locally Advanced Pancreatic Adenocarcinoma
Submitted Date:  March 19, 2024 (v22)
Quality Control Review Has Not Concluded

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Open or close this module Study Identification
Unique Protocol ID: NANOPAC-2016-05
Brief Title: Trial of NanoPac® in Subjects With Locally Advanced Pancreatic Adenocarcinoma
Official Title: Phase IIa Trial Evaluating the Safety of Intratumoral Injection of NanoPac® in Subjects With Locally Advanced Pancreatic Adenocarcinoma
Secondary IDs:
Open or close this module Study Status
Record Verification: March 2024
Overall Status: Completed
Study Start: December 1, 2017
Primary Completion: March 15, 2023 [Actual]
Study Completion: March 15, 2023 [Actual]
First Submitted: February 28, 2017
First Submitted that
Met QC Criteria:		 March 7, 2017
First Posted: March 13, 2017 [Actual]
Results First Submitted: March 19, 2024
Results First Submitted that
Met QC Criteria:
Results First Posted: April 17, 2024 [Actual]
Last Update Submitted that
Met QC Criteria:
Last Update Posted: April 17, 2024 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: NanOlogy, LLC
Responsible Party: Sponsor
Collaborators: US Biotest, Inc.
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: Open-label, dose-escalating, Phase IIa trial of NanoPac® to treat subjects with locally advanced pancreatic adenocarcinoma via direct intratumoral injection.
Detailed Description:

In this open-label, dose-escalating, Phase IIa trial, subjects with locally advanced pancreatic adenocarcinoma will receive intratumoral (ITU) NanoPac® (Sterile Nanoparticulate Paclitaxel) via endoscopic ultrasound-guided direct injection.

Subjects will be enrolled in sequential cohorts of NanoPac® at escalating doses, at a volume based on up to 20% of calculated tumor volume (with a maximum injection volume of 5 mL per subject). During the first phase of the trial (dose escalation), 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 most suitable for further evaluation, defined as the highest dose with an acceptable safety and tolerability profile as determined by the Data Safety Monitoring Board (DSMB), will be the dose used in the second phase of the study which will enroll 22 additional subjects who will receive two injections of NanoPac® at the same dose one month apart. In the third phase of the study, up to 30 subjects will receive up to four injections of NanoPac at the same dose, one month apart.

Plasma samples will be taken at various time points on the day of NanoPac® injection as well as once at each of the study visits, to characterize the pharmacokinetics (PK) of ITU NanoPac®.

Subjects will be followed for 12 months after NanoPac® injection for safety, overall survival (OS), progression-free survival (PFS), CA-19-9 levels, carcinoembryonic antigen (CEA) levels, reduction in pain, and tumor response to therapy (as shown by imaging).
Open or close this module Conditions
Conditions: Locally Advanced Pancreatic Adenocarcinoma
Keywords: pancreatic neoplasms
digestive system neoplasms
pancreatic diseases
digestive system diseases
pancreatic adenocarcinoma
pancreatic cancer
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2
Interventional Study Model: Sequential Assignment
Open-label, dose-escalating, Phase IIa trial.
Number of Arms: 5
Masking: None (Open Label)
Allocation: Non-Randomized
Enrollment: 54 [Actual]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Dose Escalation: NanoPac® 6 mg/mL
Intratumorally injected NanoPac® at a volume of up to 20% tumor volume
 Drug: NanoPac®
Subjects with locally advanced pancreatic adenocarcinoma will receive intratumoral (ITU) NanoPac® (Sterile Nanoparticulate Paclitaxel) via endoscopic ultrasound-guided direct injection.
Other Names:
  • Paclitaxel
Experimental: Dose Escalation: NanoPac® 10 mg/mL
Intratumorally injected NanoPac® at a volume of up to 20% tumor volume
 Drug: NanoPac®
Subjects with locally advanced pancreatic adenocarcinoma will receive intratumoral (ITU) NanoPac® (Sterile Nanoparticulate Paclitaxel) via endoscopic ultrasound-guided direct injection.
Other Names:
  • Paclitaxel
Experimental: Dose Escalation: NanoPac® 15 mg/mL
Intratumorally injected NanoPac® at a volume of up to 20% tumor volume
 Drug: NanoPac®
Subjects with locally advanced pancreatic adenocarcinoma will receive intratumoral (ITU) NanoPac® (Sterile Nanoparticulate Paclitaxel) via endoscopic ultrasound-guided direct injection.
Other Names:
  • Paclitaxel
Experimental: Second Phase: NanoPac® at Best Dose
Intratumorally injected NanoPac® at a volume of up to 20% tumor volume. The dose administered in the second phase will be determined during the dose escalation phase. Subjects will receive two NanoPac® administrations, with the second injection administered one month after the first injection.
 Drug: NanoPac®
Subjects with locally advanced pancreatic adenocarcinoma will receive intratumoral (ITU) NanoPac® (Sterile Nanoparticulate Paclitaxel) via endoscopic ultrasound-guided direct injection.
Other Names:
  • Paclitaxel
Experimental: Third Phase: NanoPac® at Best Dose
Intratumorally injected NanoPac® at a volume of up to 20% tumor volume. The dose administered in the third phase will be determined during the dose escalation phase. Subjects will receive four NanoPac® administrations, with the injections administered one month apart.
 Drug: NanoPac®
Subjects with locally advanced pancreatic adenocarcinoma will receive intratumoral (ITU) NanoPac® (Sterile Nanoparticulate Paclitaxel) via endoscopic ultrasound-guided direct injection.
Other Names:
  • Paclitaxel
Open or close this module Outcome Measures
[See Results Section.]
Primary Outcome Measures:
1. Incidence of Treatment Emergent Adverse Events (Safety and Tolerability)
[ Time Frame: Up to Week 24 for Dose Escalation subjects; up to Week 28 for Second Phase subjects; up to 9 Months for Third Phase subjects. ]

Treatment Emergent Adverse Events will include laboratory assessments, physical examination findings, and vital signs.
Secondary Outcome Measures:
1. Target Tumor Assessment
[ Time Frame: Week 24 ]

Response was determined using RECIST 1.1 parameters (complete response, partial response, stable disease, progressive disease, unevaluable) for the treated lesion in all groups.
2. Plasma Paclitaxel Concentration (pg/mL)
[ Time Frame: Day 1 and Week 24 ]

Plasma paclitaxel concentrations were analyzed in the dose escalation phase on Day 1 prior to injection and at 1, 2, 4, 6, and 24 hours after NanoPac injection, as well as at all other study visits. In the second and third phases, plasma paclitaxel concentrations were analyzed on Day 1 prior to NanoPac injection, and at 1 and 2 hours post NanoPac injection on all injection occasions, and at all study visits.
3. Pain (Visual Analog Scale) Score
[ Time Frame: Day 1 (pre-injection) and Week 24 ]

The visual analog scale (VAS) ranks pain from numbers 0 (no pain) to 10 (most pain). Lower scores mean a better outcome.
4. Serum CA19-9 Level
[ Time Frame: Day 1 (Pre-Injection) and Week 24 ]

CA19-9 is a tumor marker for pancreatic cancer. Serum CA19-9 levels were assessed at all study visits.
5. Serum CEA Levels
[ Time Frame: Day 1 (Pre-Injection) and Week 24 ]

Carcinoembryonic antigen (CEA) is a tumor marker for pancreatic cancer.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • Signed informed consent;
  • Age ≥18 years;
  • Histologically/cytologically confirmed locally advanced pancreatic adenocarcinoma; at least one lesion with a diameter of at least 1.5 cm but no more than 6 cm as documented via imaging (within 6 weeks of Screening);
  • Subject not a candidate for surgery;
  • Completion of at least one standard of care IV chemotherapy course for subjects in the dose escalation phase of the study. IV chemotherapy will be initiated prior to first NanoPac injection for subjects in the second and third phases. Hematologic recovery must be confirmed prior to study entry;
  • Performance Status (ECOG) 0-1 at study entry;
  • Life expectancy of at least 3 months;
  • Adequate marrow, liver, and renal function at study entry:
    • ANC ≥ 1.5 x 109/L
    • Hemoglobin ≥ 9.5 grams/dL
    • Platelets ≥ 75 x 109/L
    • Total bilirubin ≤ 1.5x institutional ULN
    • AST/ ALT ≤ 2.5x institutional ULN
    • Creatinine ≤ 1.5x institutional ULN
  • Effective contraception if the risk of conception exists.

Exclusion Criteria:

  • Thrombotic or embolic events;
  • Acute or subacute intestinal occlusion;
  • History of inflammatory bowel disease;
  • Known hypersensitivity to study drugs;
  • Known drug or alcohol abuse;
  • Pregnant or breastfeeding women;
  • Previous or concurrent history of non-pancreatic malignancy except for non-melanoma skin cancer.
Open or close this module Contacts/Locations
Study Officials: Shelagh Verco, PhD
Study Director
Vice President, Clinical Development, NanOlogy, LLC
Locations: United States, California
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
United States, Indiana
Parkview Cancer Institute
Fort Wayne, Indiana, United States, 46845
United States, Texas
Texas Tech University Health Sciences Center
El Paso, Texas, United States, 79905
Baylor College of Medicine
Houston, Texas, United States, 77030
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations: Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, Dancey J, Arbuck S, Gwyther S, Mooney M, Rubinstein L, Shankar L, Dodd L, Kaplan R, Lacombe D, Verweij J. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009 Jan;45(2):228-47. doi: 10.1016/j.ejca.2008.10.026. PubMed 19097774
Taxol® (paclitaxel) Injection Package Insert. Bristol-Myers Squibb Company. Rev July 2011.
ABRAXANE Package Insert. Celgene Company. Rev July 2015.
Von Hoff DD, Ervin T, Arena FP, Chiorean EG, Infante J, Moore M, Seay T, Tjulandin SA, Ma WW, Saleh MN, Harris M, Reni M, Dowden S, Laheru D, Bahary N, Ramanathan RK, Tabernero J, Hidalgo M, Goldstein D, Van Cutsem E, Wei X, Iglesias J, Renschler MF. Increased survival in pancreatic cancer with nab-paclitaxel plus gemcitabine. N Engl J Med. 2013 Oct 31;369(18):1691-703. doi: 10.1056/NEJMoa1304369. Epub 2013 Oct 16. PubMed 24131140
Links:
Available IPD/Information:
Open or close this module Document Section
Study Protocol
Document Date: March 25, 2020
Uploaded: 01/22/2024 13:56
File Name: Prot_000.pdf
Statistical Analysis Plan
Document Date: April 3, 2023
Uploaded: 01/22/2024 13:51
File Name: SAP_001.pdf
Study Results
Open or close this module Participant Flow
Recruitment Details
Pre-assignment Details
 
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 Third Phase: NanoPac® 15 mg/mL
Arm/Group Description Intratumorally injected NanoPac® 6 mg/mL at a volume of up to 20% tumor volume via endoscopic ultrasound-guided direct injection. Intratumorally injected NanoPac® 10 mg/mL at a volume of up to 20% tumor volume via endoscopic ultrasound-guided direct injection. Intratumorally injected NanoPac® 15 mg/mL at a volume of up to 20% tumor volume via endoscopic ultrasound-guided direct injection. Intratumorally injected NanoPac® 15 mg/mL at a volume of up to 20% tumor volume via endoscopic ultrasound-guided direct injection. Subjects receive two NanoPac® administrations, with the second injection administered one month after the first injection. Intratumorally injected NanoPac® 15 mg/mL at a volume of up to 20% tumor volume via endoscopic ultrasound-guided direct injection. Subjects receive up to four NanoPac® administrations, with injections administered one month apart.
Period Title: Overall Study
Started 3 3 4 25 19
Completed 2 3 2 19 8
Not Completed 1 0 2 6 11
Reason Not Completed
Lost to Follow-up 0 0 0 0 1
Death 0 0 1 1 3
Withdrawal by Subject 0 0 0 2 1
Physician Decision 0 0 1 0 3
Disease Progression 1 0 0 2 1
Withdrawn to proceed to surgery 0 0 0 1 1
Subject entered hospice care 0 0 0 0 1
Open or close this module Baseline Characteristics
Arm/Group TitleDose Escalation: NanoPac® 6 mg/mLDose Escalation: NanoPac® 10 mg/mLDose Escalation: NanoPac® 15 mg/mLSecond Phase: NanoPac® 15 mg/mLThird Phase: NanoPac® 15 mg/mLTotal
Arm/Group DescriptionIntratumorally injected NanoPac® 6 mg/mL at a volume of up to 20% tumor volume via endoscopic ultrasound-guided direct injection.Intratumorally injected NanoPac® 10 mg/mL at a volume of up to 20% tumor volume via endoscopic ultrasound-guided direct injection.Intratumorally injected NanoPac® 15 mg/mL at a volume of up to 20% tumor volume via endoscopic ultrasound-guided direct injection.Intratumorally injected NanoPac® 15 mg/mL at a volume of up to 20% tumor volume via endoscopic ultrasound-guided direct injection. Subjects receive two NanoPac® administrations, with the second injection administered one month after the first injection.Intratumorally injected NanoPac® 15 mg/mL at a volume of up to 20% tumor volume via endoscopic ultrasound-guided direct injection. Subjects receive up to four NanoPac® administrations, with injections administered one month apart.Total of all reporting groups
Overall Number of Baseline Participants 3 3 4 25 19 54
Baseline Analysis Population Description [Not Specified]
Age, Continuous
Mean (Standard Deviation)
Unit of measure: years
Number Analyzed3 Participants3 Participants4 Participants25 Participants19 Participants54 Participants
64.0(9.00)71.3(8.08)72.0(9.56)65.6(10.08)71.3(11.19)68.3(10.74)
Sex: Female, Male
Measure Type: Count of Participants
Unit of measure: Participants
Number Analyzed3 Participants3 Participants4 Participants25 Participants19 Participants54 Participants
Female
1
33.33%
0
0%
0
0%
11
44%
10
52.63%
22
40.74%
Male
2
66.67%
3
100%
4
100%
14
56%
9
47.37%
32
59.26%
Ethnicity (NIH/OMB)
Measure Type: Count of Participants
Unit of measure: Participants
Number Analyzed3 Participants3 Participants4 Participants25 Participants19 Participants54 Participants
Hispanic or Latino
1
33.33%
1
33.33%
1
25%
0
0%
4
21.05%
7
12.96%
Not Hispanic or Latino
2
66.67%
2
66.67%
3
75%
25
100%
15
78.95%
47
87.04%
Unknown or Not Reported
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
Race (NIH/OMB)
Measure Type: Count of Participants
Unit of measure: Participants
Number Analyzed3 Participants3 Participants4 Participants25 Participants19 Participants54 Participants
American Indian or Alaska Native
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
Asian
0
0%
1
33.33%
1
25%
4
16%
0
0%
6
11.11%
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
4%
1
5.26%
2
3.7%
White
3
100%
2
66.67%
3
75%
20
80%
18
94.74%
46
85.19%
More than one race
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
Unknown or Not Reported
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
Region of Enrollment
Measure Type: Number
Unit of measure: participants
Number Analyzed3 Participants3 Participants4 Participants25 Participants19 Participants54 Participants
United States
334251954
Open or close this module Outcome Measures
1. Primary Outcome:
Title Incidence of 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 Week 24 for Dose Escalation subjects; up to Week 28 for Second Phase subjects; up to 9 Months for Third Phase subjects.
Outcome Measure Data
Analysis Population Description
[Not Specified]
   
Arm/Group TitleDose Escalation: NanoPac® 6 mg/mLDose Escalation: NanoPac® 10 mg/mLDose Escalation: NanoPac® 15 mg/mLSecond Phase: NanoPac® 15 mg/mLThird Phase: NanoPac® 15 mg/mL
Arm/Group DescriptionIntratumorally injected NanoPac® 6 mg/mL at a volume of up to 20% tumor volume via endoscopic ultrasound-guided direct injection.Intratumorally injected NanoPac® 10 mg/mL at a volume of up to 20% tumor volume via endoscopic ultrasound-guided direct injection.Intratumorally injected NanoPac® 15 mg/mL at a volume of up to 20% tumor volume via endoscopic ultrasound-guided direct injection.Intratumorally injected NanoPac® 15 mg/mL at a volume of up to 20% tumor volume via endoscopic ultrasound-guided direct injection. Subjects receive two NanoPac® administrations, with the second injection administered one month after the first injection.Intratumorally injected NanoPac® 15 mg/mL at a volume of up to 20% tumor volume via endoscopic ultrasound-guided direct injection. Subjects receive up to four NanoPac® administrations, with injections administered one month apart.
Overall Number of Participants Analyzed3 3 4 25 19
Measure Type: Count of Participants
Unit of Measure: Participants
Number of subjects with at least one TEAE
3
100%
3
100%
4
100%
23
92%
19
100%
Number of subjects without any TEAE
0
0%
0
0%
0
0%
2
8%
0
0%
2. Secondary Outcome:
Title Target Tumor Assessment
Description Response was determined using RECIST 1.1 parameters (complete response, partial response, stable disease, progressive disease, unevaluable) for the treated lesion in all groups.
Time Frame Week 24
Outcome Measure Data
Analysis Population Description
[Not Specified]
   
Arm/Group TitleDose Escalation: NanoPac® 6 mg/mLDose Escalation: NanoPac® 10 mg/mLDose Escalation: NanoPac® 15 mg/mLSecond Phase: NanoPac® 15 mg/mLThird Phase: NanoPac® 15 mg/mL
Arm/Group DescriptionIntratumorally injected NanoPac® 6 mg/mL at a volume of up to 20% tumor volume via endoscopic ultrasound-guided direct injection.Intratumorally injected NanoPac® 10 mg/mL at a volume of up to 20% tumor volume via endoscopic ultrasound-guided direct injection.Intratumorally injected NanoPac® 15 mg/mL at a volume of up to 20% tumor volume via endoscopic ultrasound-guided direct injection.Intratumorally injected NanoPac® 15 mg/mL at a volume of up to 20% tumor volume via endoscopic ultrasound-guided direct injection. Subjects received two NanoPac® administrations, with the second injection administered one month after the first injection.Intratumorally injected NanoPac® 15 mg/mL at a volume of up to 20% tumor volume via endoscopic ultrasound-guided direct injection. Subjects received up to four NanoPac® administrations, with injections administered one month apart.
Overall Number of Participants Analyzed3 3 4 25 19
Measure Type: Count of Participants
Unit of Measure: Participants
Complete Response
0
0%
0
0%
0
0%
0
0%
0
0%
Partial Response
0
0%
1
33.3%
0
0%
2
8%
3
15.8%
Stable Disease
1
33.3%
0
0%
1
25%
12
48%
2
10.5%
Progressive Disease
1
33.3%
2
66.7%
0
0%
1
4%
5
26.3%
Not evaluable
1
33.3%
0
0%
3
75%
10
40%
9
47.4%
3. Secondary Outcome:
Title Plasma Paclitaxel Concentration (pg/mL)
Description Plasma paclitaxel concentrations were analyzed in the dose escalation phase on Day 1 prior to injection and at 1, 2, 4, 6, and 24 hours after NanoPac injection, as well as at all other study visits. In the second and third phases, plasma paclitaxel concentrations were analyzed on Day 1 prior to NanoPac injection, and at 1 and 2 hours post NanoPac injection on all injection occasions, and at all study visits.
Time Frame Day 1 and Week 24
Outcome Measure Data
Analysis Population Description
On Day 1, in dose escalation, data available for one subject in 6 mg/mL, none in 10 mg/mL, and one in 15 mg/mL; in second phase, six subjects and third phase three subjects. At Week 24, in dose escalation, data available for one subject in 6 mg/mL, none in 10 mg/mL, and none in 15 mg/mL; in second phase, eight subjects and third phase five subjects. Forty subjects received concomitant IV chemotherapy while on study; of these, 14 received concomitant taxane therapy.
 
Arm/Group TitleDose Escalation: NanoPac® 6 mg/mLDose Escalation: NanoPac® 10 mg/mLDose Escalation: NanoPac® 15 mg/mLSecond Phase: NanoPac® 15 mg/mLThird Phase: NanoPac® 15 mg/mL
Arm/Group DescriptionIntratumorally injected NanoPac® 6 mg/mL at a volume of up to 20% tumor volume via endoscopic ultrasound-guided direct injection.Intratumorally injected NanoPac® 10 mg/mL at a volume of up to 20% tumor volume via endoscopic ultrasound-guided direct injection.Intratumorally injected NanoPac® 15 mg/mL at a volume of up to 20% tumor volume via endoscopic ultrasound-guided direct injection.Intratumorally injected NanoPac® 15 mg/mL at a volume of up to 20% tumor volume via endoscopic ultrasound-guided direct injection. Subjects received two NanoPac® administrations, with the second injection administered one month after the first injection.Intratumorally injected NanoPac® 15 mg/mL at a volume of up to 20% tumor volume via endoscopic ultrasound-guided direct injection. Subjects received up to four NanoPac® administrations, with injections administered one month apart.
Overall Number of Participants Analyzed3 3 4 25 19
Mean (Standard Deviation)
Unit of Measure: pg/mL
Day 1 Pre-Injection
62.1(NA) [1] NA(NA) [2] 304(NA) [1] 5497.0(11887.04) 17347.7(27686.44)
Week 24
30(NA) [1] NA(NA) [2] NA(NA) [2] 5017.8(12139.23) 63.2(60.16)
[1]NA Explanation: Only 1 subject analyzed.
[2]NA Explanation: Data not available for any subjects in group.

Quality Control Review Comment provided by the National Library of Medicine:

  1. The number of participants analyzed appears inconsistent with data here or in other parts of the record.
4. Secondary Outcome:
Title Pain (Visual Analog Scale) Score
Description The visual analog scale (VAS) ranks pain from numbers 0 (no pain) to 10 (most pain). Lower scores mean a better outcome.
Time Frame Day 1 (pre-injection) and Week 24
Outcome Measure Data
Analysis Population Description
Pain measured with VAS was not available for all subjects at all timepoints. For the Day 1 Pre-Injection timepoint, there was one subject in the 6 mg/mL dose escalation group for whom VAS was not available. For the Week 24 timepoint, there was one subject in the 6 mg/mL dose escalation group, three in the 15 mg/mL dose escalation group, 12 in the second phase, and 9 in the third phase for whom VAS data was not available.
 
Arm/Group TitleDose Escalation: NanoPac® 6 mg/mLDose Escalation: NanoPac® 10 mg/mLDose Escalation: NanoPac® 15 mg/mLSecond Phase: NanoPac® 15 mg/mLThird Phase: NanoPac® 15 mg/mL
Arm/Group DescriptionIntratumorally injected NanoPac® 6 mg/mL at a volume of up to 20% tumor volume via endoscopic ultrasound-guided direct injection.Intratumorally injected NanoPac® 10 mg/mL at a volume of up to 20% tumor volume via endoscopic ultrasound-guided direct injection.Intratumorally injected NanoPac® 15 mg/mL at a volume of up to 20% tumor volume via endoscopic ultrasound-guided direct injection.Intratumorally injected NanoPac® 15 mg/mL at a volume of up to 20% tumor volume via endoscopic ultrasound-guided direct injection. Subjects received two NanoPac® administrations, with the second injection administered one month after the first injection.Intratumorally injected NanoPac® 15 mg/mL at a volume of up to 20% tumor volume via endoscopic ultrasound-guided direct injection. Subjects received up to four NanoPac® administrations, with injections administered one month apart.
Overall Number of Participants Analyzed3 3 4 25 19
Mean (Standard Deviation)
Unit of Measure: units on a scale
Day 1 (Pre-Injection)
0(0) 0(0) 5.5(4.12) 1.2(2.41) 0.8(1.42)
Week 24
5.3(3.18) 0.8(1.44) 5.0(NA) [1] 1.7(2.53) 1.1(2.23)
[1]NA Explanation: Data only available from one subject

Quality Control Review Comment provided by the National Library of Medicine:

  1. The number of participants analyzed appears inconsistent with data here or in other parts of the record.
5. Secondary Outcome:
Title Serum CA19-9 Level
Description CA19-9 is a tumor marker for pancreatic cancer. Serum CA19-9 levels were assessed at all study visits.
Time Frame Day 1 (Pre-Injection) and Week 24
Outcome Measure Data
Analysis Population Description
Missing CA19-9 data for Day 1: dose escalation 6 mg/mL two subjects; second phase two subjects; third phase three subjects. Missing CA19-9 data for Week 24: dose escalation 6 mg/mL one subject; dose escalation 15 mg/mL two subjects; second phase 10 subjects; third phase nine subjects.
 
Arm/Group TitleDose Escalation: NanoPac® 6 mg/mLDose Escalation: NanoPac® 10 mg/mLDose Escalation: NanoPac® 15 mg/mLSecond Phase: NanoPac® 15 mg/mLThird Phase: NanoPac® 15 mg/mL
Arm/Group DescriptionIntratumorally injected NanoPac® 6 mg/mL at a volume of up to 20% tumor volume via endoscopic ultrasound-guided direct injection.Intratumorally injected NanoPac® 10 mg/mL at a volume of up to 20% tumor volume via endoscopic ultrasound-guided direct injection.Intratumorally injected NanoPac® 15 mg/mL at a volume of up to 20% tumor volume via endoscopic ultrasound-guided direct injection.Intratumorally injected NanoPac® 15 mg/mL at a volume of up to 20% tumor volume via endoscopic ultrasound-guided direct injection. Subjects received two NanoPac® administrations, with the second injection administered one month after the first injection.Intratumorally injected NanoPac® 15 mg/mL at a volume of up to 20% tumor volume via endoscopic ultrasound-guided direct injection. Subjects received up to four NanoPac® administrations, with injections administered one month apart.
Overall Number of Participants Analyzed3 3 4 25 19
Mean (Standard Deviation)
Unit of Measure: U/mL
Day 1 - Pre-Injection
248(NA) [1] 24(24) 2958(4749) 952(2171) 198(362)
Week 24
5476(6396.49) 49.3(60.3) 6179(5402.3) 141.6(184.03) 1222.6(3126)
[1]NA Explanation: Data available for only one subject

Quality Control Review Comment provided by the National Library of Medicine:

  1. The number of participants analyzed appears inconsistent with data here or in other parts of the record.
6. Secondary Outcome:
Title Serum CEA Levels
Description Carcinoembryonic antigen (CEA) is a tumor marker for pancreatic cancer.
Time Frame Day 1 (Pre-Injection) and Week 24
Outcome Measure Data
Analysis Population Description
Missing CEA data for Day 1: dose escalation 6 mg/mL one subject; second phase two subjects; third phase two subjects. Missing CEA data for Week 24: dose escalation 6 mg/mL one subject; dose escalation 15 mg/mL three subjects; second phase 11 subjects; third phase nine subjects.
 
Arm/Group TitleDose Escalation: NanoPac® 6 mg/mLDose Escalation: NanoPac® 10 mg/mLDose Escalation: NanoPac® 15 mg/mLSecond Phase: NanoPac® 15 mg/mLThird Phase: NanoPac® 15 mg/mL
Arm/Group DescriptionIntratumorally injected NanoPac® 6 mg/mL at a volume of up to 20% tumor volume via endoscopic ultrasound-guided direct injection.Intratumorally injected NanoPac® 10 mg/mL at a volume of up to 20% tumor volume via endoscopic ultrasound-guided direct injection.Intratumorally injected NanoPac® 15 mg/mL at a volume of up to 20% tumor volume via endoscopic ultrasound-guided direct injection.Intratumorally injected NanoPac® 15 mg/mL at a volume of up to 20% tumor volume via endoscopic ultrasound-guided direct injection. Subjects received two NanoPac® administrations, with the second injection administered one month after the first injection.Intratumorally injected NanoPac® 15 mg/mL at a volume of up to 20% tumor volume via endoscopic ultrasound-guided direct injection. Subjects received up to four NanoPac® administrations, with injections administered one month apart.
Overall Number of Participants Analyzed3 3 4 25 19
Mean (Standard Deviation)
Unit of Measure: ug/L
Day 1 - Pre-Injection
1.65(0.778) 27.1(41.57) 4.58(1.68) 5.17(3.163) 6.69(5.976)
Week 24
4.55(2.758) 53.33(84.577) 10.3(NA) [1] 5.49(3.291) 13.04(16.718)
[1]NA Explanation: Data available only for one subject

Quality Control Review Comment provided by the National Library of Medicine:

  1. The number of participants analyzed appears inconsistent with data here or in other parts of the record.
Open or close this module Adverse Events
 
Time Frame Up to 9 months
Adverse Event Reporting Description 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. Total AEs are reported in this record regardless of relationship to study treatment.
 
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 Third Phase: NanoPac® 15 mg/mL
Arm/Group Description Intratumorally injected NanoPac® 6 mg/mL at a volume of up to 20% tumor volume via endoscopic ultrasound-guided direct injection. Intratumorally injected NanoPac® 10 mg/mL at a volume of up to 20% tumor volume via endoscopic ultrasound-guided direct injection. Intratumorally injected NanoPac® 15 mg/mL at a volume of up to 20% tumor volume via endoscopic ultrasound-guided direct injection. Intratumorally injected NanoPac® 15 mg/mL at a volume of up to 20% tumor volume via endoscopic ultrasound-guided direct injection. Subjects received two NanoPac® administrations, with the second injection administered one month after the first injection. Intratumorally injected NanoPac® 15 mg/mL at a volume of up to 20% tumor volume via endoscopic ultrasound-guided direct injection. Subjects received up to four NanoPac® administrations, with injections administered one month apart.
All-Cause Mortality
  Dose Escalation: NanoPac® 6 mg/mLDose Escalation: NanoPac® 10 mg/mLDose Escalation: NanoPac® 15 mg/mLSecond Phase: NanoPac® 15 mg/mLThird Phase: NanoPac® 15 mg/mL
 Affected / At Risk (%)# Events Affected / At Risk (%)# Events Affected / At Risk (%)# Events Affected / At Risk (%)# Events Affected / At Risk (%)# Events
Total 0 / 3 (0%)0 / 3 (0%)1 / 4 (25%)1 / 25 (4%)3 / 19 (15.79%)
Serious Adverse Events
  Dose Escalation: NanoPac® 6 mg/mLDose Escalation: NanoPac® 10 mg/mLDose Escalation: NanoPac® 15 mg/mLSecond Phase: NanoPac® 15 mg/mLThird Phase: NanoPac® 15 mg/mL
 Affected / At Risk (%)# Events Affected / At Risk (%)# Events Affected / At Risk (%)# Events Affected / At Risk (%)# Events Affected / At Risk (%)# Events
Total 1 / 3 (33.33%)2 / 3 (66.67%)3 / 4 (75%)13 / 25 (52%)8 / 19 (42.11%)
Cardiac disorders
Arrhythmia † A 0 / 3 (0%)00 / 3 (0%)00 / 4 (0%)00 / 25 (0%)01 / 19 (5.26%)1
Gastrointestinal disorders
Abdominal Pain † A 0 / 3 (0%)01 / 3 (33.33%)12 / 4 (50%)42 / 25 (8%)21 / 19 (5.26%)3
Colitis † A 0 / 3 (0%)00 / 3 (0%)00 / 4 (0%)00 / 25 (0%)01 / 19 (5.26%)1
Diarrhoea haemorrhagic † A 0 / 3 (0%)00 / 3 (0%)00 / 4 (0%)01 / 25 (4%)10 / 19 (0%)0
Duodenal obstruction † A 0 / 3 (0%)00 / 3 (0%)00 / 4 (0%)01 / 25 (4%)11 / 19 (5.26%)1
Intestinal obstruction † A 0 / 3 (0%)00 / 3 (0%)00 / 4 (0%)01 / 25 (4%)10 / 19 (0%)0
Nausea † A 1 / 3 (33.33%)10 / 3 (0%)00 / 4 (0%)00 / 25 (0%)00 / 19 (0%)0
Obstruction gastric † A 0 / 3 (0%)00 / 3 (0%)00 / 4 (0%)00 / 25 (0%)01 / 19 (5.26%)1
Small intestinal haemorrhage † A 0 / 3 (0%)00 / 3 (0%)00 / 4 (0%)01 / 25 (4%)11 / 19 (5.26%)1
Upper gastrointestinal haemorrhage † A 0 / 3 (0%)00 / 3 (0%)00 / 4 (0%)00 / 25 (0%)01 / 19 (5.26%)1
Vomiting † A 1 / 3 (33.33%)10 / 3 (0%)00 / 4 (0%)00 / 25 (0%)00 / 19 (0%)0
General disorders
Disease progression † A 0 / 3 (0%)00 / 3 (0%)00 / 4 (0%)00 / 25 (0%)01 / 19 (5.26%)1
Pyrexia † A 0 / 3 (0%)00 / 3 (0%)00 / 4 (0%)01 / 25 (4%)10 / 19 (0%)0
Hepatobiliary disorders
Bile duct obstruction † A 1 / 3 (33.33%)10 / 3 (0%)00 / 4 (0%)00 / 25 (0%)00 / 19 (0%)0
Bile duct stenosis † A 0 / 3 (0%)00 / 3 (0%)00 / 4 (0%)00 / 25 (0%)01 / 19 (5.26%)1
Cholangitis † A 0 / 3 (0%)00 / 3 (0%)00 / 4 (0%)01 / 25 (4%)11 / 19 (5.26%)1
Cholangitis acute † A 0 / 3 (0%)00 / 3 (0%)00 / 4 (0%)00 / 25 (0%)01 / 19 (5.26%)1
Jaundice cholestatic † A 0 / 3 (0%)00 / 3 (0%)00 / 4 (0%)01 / 25 (4%)11 / 19 (5.26%)1
Infections and infestations
Abdominal abscess † A 0 / 3 (0%)00 / 3 (0%)00 / 4 (0%)00 / 25 (0%)01 / 19 (5.26%)1
Biliary tract infection † A 0 / 3 (0%)00 / 3 (0%)00 / 4 (0%)02 / 25 (8%)30 / 19 (0%)0
Sepsis † A 0 / 3 (0%)01 / 3 (33.33%)11 / 4 (25%)23 / 25 (12%)40 / 19 (0%)0
Urinary tract infection † A 0 / 3 (0%)00 / 3 (0%)00 / 4 (0%)01 / 25 (4%)10 / 19 (0%)0
Metabolism and nutrition disorders
Acidosis † A 0 / 3 (0%)00 / 3 (0%)00 / 4 (0%)01 / 25 (4%)10 / 19 (0%)0
Dehydration † A 0 / 3 (0%)00 / 3 (0%)00 / 4 (0%)00 / 25 (0%)01 / 19 (5.26%)1
Musculoskeletal and connective tissue disorders
Back pain † A 0 / 3 (0%)00 / 3 (0%)00 / 4 (0%)01 / 25 (4%)10 / 19 (0%)0
Product Issues
Device occlusion † A 0 / 3 (0%)00 / 3 (0%)00 / 4 (0%)00 / 25 (0%)01 / 19 (5.26%)1
Renal and urinary disorders
Haematuria † A 0 / 3 (0%)00 / 3 (0%)00 / 4 (0%)01 / 25 (4%)10 / 19 (0%)0
Urinary retention † A 1 / 3 (33.33%)10 / 3 (0%)00 / 4 (0%)00 / 25 (0%)00 / 19 (0%)0
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure † A 0 / 3 (0%)00 / 3 (0%)00 / 4 (0%)01 / 25 (4%)10 / 19 (0%)0
Pulmonary embolism † A 0 / 3 (0%)00 / 3 (0%)01 / 4 (25%)11 / 25 (4%)10 / 19 (0%)0
Respiratory failure † A 0 / 3 (0%)00 / 3 (0%)00 / 4 (0%)00 / 25 (0%)01 / 19 (5.26%)1
Vascular disorders
Embolism † A 0 / 3 (0%)00 / 3 (0%)00 / 4 (0%)01 / 25 (4%)10 / 19 (0%)0
†Indicates events were collected by systematic assessment.
ATerm from vocabulary, MedDRA (20.0)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
  Dose Escalation: NanoPac® 6 mg/mLDose Escalation: NanoPac® 10 mg/mLDose Escalation: NanoPac® 15 mg/mLSecond Phase: NanoPac® 15 mg/mLThird Phase: NanoPac® 15 mg/mL
 Affected / At Risk (%)# Events Affected / At Risk (%)# Events Affected / At Risk (%)# Events Affected / At Risk (%)# Events Affected / At Risk (%)# Events
Total 3 / 3 (100%)3 / 3 (100%)4 / 4 (100%)23 / 25 (92%)19 / 19 (100%)
Blood and lymphatic system disorders
Anaemia † A 0 / 3 (0%)00 / 3 (0%)00 / 4 (0%)01 / 25 (4%)13 / 19 (15.79%)4
Leukocytosis † A 0 / 3 (0%)00 / 3 (0%)00 / 4 (0%)00 / 25 (0%)01 / 19 (5.26%)1
Leukopenia † A 0 / 3 (0%)00 / 3 (0%)00 / 4 (0%)00 / 25 (0%)01 / 19 (5.26%)1
Neutropenia † A 0 / 3 (0%)00 / 3 (0%)01 / 4 (25%)10 / 25 (0%)01 / 19 (5.26%)1
Pancytopenia † A 0 / 3 (0%)00 / 3 (0%)01 / 4 (25%)11 / 25 (4%)10 / 19 (0%)0
Retroperitoneal lymphadenopathy † A 1 / 3 (33.33%)10 / 3 (0%)00 / 4 (0%)00 / 25 (0%)00 / 19 (0%)0
Thrombocytopenia † A 0 / 3 (0%)00 / 3 (0%)00 / 4 (0%)01 / 25 (4%)10 / 19 (0%)0
Cardiac disorders
Bradycardia † A 0 / 3 (0%)01 / 3 (33.33%)10 / 4 (0%)00 / 25 (0%)00 / 19 (0%)0
Pericardial effusion † A 0 / 3 (0%)00 / 3 (0%)00 / 4 (0%)00 / 25 (0%)01 / 19 (5.26%)1
Tachycardia † A 0 / 3 (0%)00 / 3 (0%)00 / 4 (0%)01 / 25 (4%)10 / 19 (0%)0
Ear and labyrinth disorders
Vertigo † A 0 / 3 (0%)00 / 3 (0%)00 / 4 (0%)01 / 25 (4%)10 / 19 (0%)0
Eye disorders
Dry eye † A 0 / 3 (0%)00 / 3 (0%)00 / 4 (0%)00 / 25 (0%)01 / 19 (5.26%)1
Gastrointestinal disorders
Abdominal discomfort † A 0 / 3 (0%)00 / 3 (0%)00 / 4 (0%)00 / 25 (0%)01 / 19 (5.26%)1
Abdominal distension † A 1 / 3 (33.33%)10 / 3 (0%)00 / 4 (0%)04 / 25 (16%)52 / 19 (10.53%)3
Abdominal pain † A 2 / 3 (66.67%)21 / 3 (33.33%)13 / 4 (75%)310 / 25 (40%)166 / 19 (31.58%)7
Abdominal pain upper † A 1 / 3 (33.33%)10 / 3 (0%)00 / 4 (0%)04 / 25 (16%)40 / 19 (0%)0
Abdominal tenderness † A 0 / 3 (0%)00 / 3 (0%)01 / 4 (25%)11 / 25 (4%)10 / 19 (0%)0
Ascites † A 0 / 3 (0%)00 / 3 (0%)00 / 4 (0%)03 / 25 (12%)30 / 19 (0%)0
Colitis † A 0 / 3 (0%)00 / 3 (0%)01 / 4 (25%)10 / 25 (0%)00 / 19 (0%)0
Constipation † A 0 / 3 (0%)00 / 3 (0%)01 / 4 (25%)15 / 25 (20%)53 / 19 (15.79%)3
Diarrhoea † A 0 / 3 (0%)01 / 3 (33.33%)10 / 4 (0%)05 / 25 (20%)62 / 19 (10.53%)2
Dry mouth † A 0 / 3 (0%)00 / 3 (0%)00 / 4 (0%)00 / 25 (0%)01 / 19 (5.26%)1
Duodenal stenosis † A 0 / 3 (0%)00 / 3 (0%)00 / 4 (0%)00 / 25 (0%)01 / 19 (5.26%)1
Duodenal ulcer † A 0 / 3 (0%)00 / 3 (0%)00 / 4 (0%)02 / 25 (8%)22 / 19 (10.53%)2
Dyspepsia † A 0 / 3 (0%)01 / 3 (33.33%)10 / 4 (0%)00 / 25 (0%)01 / 19 (5.26%)1
Dysphagia † A 0 / 3 (0%)00 / 3 (0%)00 / 4 (0%)01 / 25 (4%)10 / 19 (0%)0
Flatulence † A 0 / 3 (0%)00 / 3 (0%)00 / 4 (0%)02 / 25 (8%)32 / 19 (10.53%)2
Gastritis † A 0 / 3 (0%)00 / 3 (0%)00 / 4 (0%)01 / 25 (4%)10 / 19 (0%)0
Gastrointestinal motility disorder † A 0 / 3 (0%)00 / 3 (0%)00 / 4 (0%)01 / 25 (4%)10 / 19 (0%)0
Gastrooesophageal reflux disease † A 0 / 3 (0%)00 / 3 (0%)00 / 4 (0%)00 / 25 (0%)02 / 19 (10.53%)2
Haematochezia † A 0 / 3 (0%)00 / 3 (0%)00 / 4 (0%)03 / 25 (12%)30 / 19 (0%)0
Haemorrhoids † A 0 / 3 (0%)00 / 3 (0%)00 / 4 (0%)00 / 25 (0%)01 / 19 (5.26%)1
Large intestine polyp † A 0 / 3 (0%)00 / 3 (0%)00 / 4 (0%)01 / 25 (4%)10 / 19 (0%)0
Melaena † A 0 / 3 (0%)00 / 3 (0%)00 / 4 (0%)01 / 25 (4%)11 / 19 (5.26%)1
Nausea † A 2 / 3 (66.67%)22 / 3 (66.67%)21 / 4 (25%)17 / 25 (28%)83 / 19 (15.79%)4
Stomatitis † A 0 / 3 (0%)00 / 3 (0%)00 / 4 (0%)01 / 25 (4%)10 / 19 (0%)0
Vomiting † A 0 / 3 (0%)00 / 3 (0%)01 / 4 (25%)15 / 25 (20%)82 / 19 (10.53%)4
General disorders
Asthenia † A 1 / 3 (33.33%)10 / 3 (0%)00 / 4 (0%)00 / 25 (0%)01 / 19 (5.26%)1
Chills † A 0 / 3 (0%)00 / 3 (0%)00 / 4 (0%)00 / 25 (0%)02 / 19 (10.53%)2
Discomfort † A 1 / 3 (33.33%)10 / 3 (0%)00 / 4 (0%)00 / 25 (0%)00 / 19 (0%)0
Face oedema † A 0 / 3 (0%)00 / 3 (0%)00 / 4 (0%)01 / 25 (4%)10 / 19 (0%)0
Fatigue † A 0 / 3 (0%)00 / 3 (0%)00 / 4 (0%)09 / 25 (36%)96 / 19 (31.58%)11
Malaise † A 0 / 3 (0%)00 / 3 (0%)00 / 4 (0%)00 / 25 (0%)01 / 19 (5.26%)1
Mucosal inflammation † A 0 / 3 (0%)00 / 3 (0%)00 / 4 (0%)01 / 25 (4%)10 / 19 (0%)0
Oedema † A 0 / 3 (0%)00 / 3 (0%)00 / 4 (0%)01 / 25 (4%)12 / 19 (10.53%)2
Oedema peripheral † A 0 / 3 (0%)00 / 3 (0%)01 / 4 (25%)12 / 25 (8%)21 / 19 (5.26%)1
Pain † A 0 / 3 (0%)01 / 3 (33.33%)10 / 4 (0%)00 / 25 (0%)00 / 19 (0%)0
Pyrexia † A 0 / 3 (0%)00 / 3 (0%)01 / 4 (25%)30 / 25 (0%)02 / 19 (10.53%)2
Hepatobiliary disorders
Bile duct stenosis † A 0 / 3 (0%)00 / 3 (0%)00 / 4 (0%)00 / 25 (0%)01 / 19 (5.26%)1
Bile duct stone † A 0 / 3 (0%)00 / 3 (0%)00 / 4 (0%)00 / 25 (0%)01 / 19 (5.26%)1
Cholecystitis chronic † A 0 / 3 (0%)00 / 3 (0%)00 / 4 (0%)00 / 25 (0%)01 / 19 (5.26%)1
Hepatic lesion † A 0 / 3 (0%)00 / 3 (0%)01 / 4 (25%)10 / 25 (0%)00 / 19 (0%)0
Hepatomegaly † A 1 / 3 (33.33%)10 / 3 (0%)00 / 4 (0%)00 / 25 (0%)00 / 19 (0%)0
Jaundice † A 0 / 3 (0%)00 / 3 (0%)00 / 4 (0%)00 / 25 (0%)01 / 19 (5.26%)2
Portal vein thrombosis † A 0 / 3 (0%)00 / 3 (0%)00 / 4 (0%)01 / 25 (4%)10 / 19 (0%)0
Infections and infestations
Candida infection † A 0 / 3 (0%)00 / 3 (0%)00 / 4 (0%)01 / 25 (4%)10 / 19 (0%)0
Clostridium difficile infection † A 0 / 3 (0%)00 / 3 (0%)00 / 4 (0%)00 / 25 (0%)01 / 19 (5.26%)1
Corona virus infection † A 0 / 3 (0%)00 / 3 (0%)00 / 4 (0%)00 / 25 (0%)01 / 19 (5.26%)1
Eye infection † A 0 / 3 (0%)00 / 3 (0%)00 / 4 (0%)01 / 25 (4%)10 / 19 (0%)0
Lung infection † A 0 / 3 (0%)00 / 3 (0%)00 / 4 (0%)01 / 25 (4%)10 / 19 (0%)0
Medical device site cellulitis † A 1 / 3 (33.33%)10 / 3 (0%)00 / 4 (0%)00 / 25 (0%)00 / 19 (0%)0
Sepsis † A 1 / 3 (33.33%)10 / 3 (0%)00 / 4 (0%)00 / 25 (0%)00 / 19 (0%)0
Upper respiratory tract infection † A 0 / 3 (0%)00 / 3 (0%)00 / 4 (0%)02 / 25 (8%)20 / 19 (0%)0
Urinary tract infection † A 0 / 3 (0%)00 / 3 (0%)00 / 4 (0%)01 / 25 (4%)42 / 19 (10.53%)2
Injury, poisoning and procedural complications
Animal bite † A 0 / 3 (0%)00 / 3 (0%)00 / 4 (0%)01 / 25 (4%)10 / 19 (0%)0
Chest injury † A 0 / 3 (0%)00 / 3 (0%)00 / 4 (0%)00 / 25 (0%)01 / 19 (5.26%)1
Contusion † A 0 / 3 (0%)00 / 3 (0%)00 / 4 (0%)00 / 25 (0%)02 / 19 (10.53%)2
Rib fracture † A 0 / 3 (0%)00 / 3 (0%)00 / 4 (0%)01 / 25 (4%)10 / 19 (0%)0
Vascular access complication † A 0 / 3 (0%)00 / 3 (0%)00 / 4 (0%)01 / 25 (4%)10 / 19 (0%)0
Investigations
Alanine aminotransferase increased † A 0 / 3 (0%)00 / 3 (0%)00 / 4 (0%)00 / 25 (0%)01 / 19 (5.26%)2
Aspartate aminotransferase increased † A 0 / 3 (0%)00 / 3 (0%)00 / 4 (0%)00 / 25 (0%)01 / 19 (5.26%)3
Blood alkaline phosphatase increased † A 0 / 3 (0%)00 / 3 (0%)00 / 4 (0%)00 / 25 (0%)01 / 19 (5.26%)2
Blood bilirubin increased † A 0 / 3 (0%)00 / 3 (0%)00 / 4 (0%)00 / 25 (0%)02 / 19 (10.53%)3
Full blood count abnormal † A 0 / 3 (0%)00 / 3 (0%)01 / 4 (25%)10 / 25 (0%)00 / 19 (0%)0
Liver function test increased † A 0 / 3 (0%)00 / 3 (0%)01 / 4 (25%)10 / 25 (0%)03 / 19 (15.79%)3
Neutrophil count decreased † A 0 / 3 (0%)00 / 3 (0%)00 / 4 (0%)01 / 25 (4%)10 / 19 (0%)0
Pancreatic enzymes decreased † A 0 / 3 (0%)00 / 3 (0%)00 / 4 (0%)02 / 25 (8%)20 / 19 (0%)0
Platelet count decreased † A 0 / 3 (0%)00 / 3 (0%)00 / 4 (0%)03 / 25 (12%)31 / 19 (5.26%)1
Urine analysis abnormal † A 0 / 3 (0%)00 / 3 (0%)00 / 4 (0%)00 / 25 (0%)02 / 19 (10.53%)4
Weight decreased † A 1 / 3 (33.33%)10 / 3 (0%)00 / 4 (0%)06 / 25 (24%)73 / 19 (15.79%)4
White blood cell count decreased † A 0 / 3 (0%)00 / 3 (0%)00 / 4 (0%)00 / 25 (0%)01 / 19 (5.26%)1
White blood cell count increased † A 0 / 3 (0%)00 / 3 (0%)00 / 4 (0%)00 / 25 (0%)02 / 19 (10.53%)3
Metabolism and nutrition disorders
Cachexia † A 0 / 3 (0%)00 / 3 (0%)01 / 4 (25%)10 / 25 (0%)00 / 19 (0%)0
Decreased appetite † A 1 / 3 (33.33%)11 / 3 (33.33%)11 / 4 (25%)12 / 25 (8%)22 / 19 (10.53%)2
Dehydration † A 0 / 3 (0%)00 / 3 (0%)00 / 4 (0%)03 / 25 (12%)33 / 19 (15.79%)4
Diabetes mellitus † A 1 / 3 (33.33%)10 / 3 (0%)00 / 4 (0%)00 / 25 (0%)00 / 19 (0%)0
Hyperglycaemia † A 0 / 3 (0%)00 / 3 (0%)00 / 4 (0%)00 / 25 (0%)01 / 19 (5.26%)1
Hypoglycaemia † A 0 / 3 (0%)00 / 3 (0%)00 / 4 (0%)00 / 25 (0%)01 / 19 (5.26%)1
Hypokalaemia † A 0 / 3 (0%)01 / 3 (33.33%)10 / 4 (0%)01 / 25 (4%)25 / 19 (26.32%)7
Hypomagnesaemia † A 0 / 3 (0%)00 / 3 (0%)00 / 4 (0%)01 / 25 (4%)11 / 19 (5.26%)2
Hyponatraemia † A 0 / 3 (0%)00 / 3 (0%)00 / 4 (0%)02 / 25 (8%)20 / 19 (0%)0
Malnutrition † A 0 / 3 (0%)00 / 3 (0%)00 / 4 (0%)01 / 25 (4%)10 / 19 (0%)0
Musculoskeletal and connective tissue disorders
Arthralgia † A 0 / 3 (0%)00 / 3 (0%)00 / 4 (0%)01 / 25 (4%)12 / 19 (10.53%)2
Back pain † A 1 / 3 (33.33%)11 / 3 (33.33%)10 / 4 (0%)01 / 25 (4%)11 / 19 (5.26%)1
Bone pain † A 0 / 3 (0%)00 / 3 (0%)00 / 4 (0%)00 / 25 (0%)02 / 19 (10.53%)2
Flank pain † A 0 / 3 (0%)00 / 3 (0%)00 / 4 (0%)00 / 25 (0%)01 / 19 (5.26%)1
Muscle twitching † A 0 / 3 (0%)00 / 3 (0%)01 / 4 (25%)10 / 25 (0%)00 / 19 (0%)0
Muscular weakness † A 0 / 3 (0%)00 / 3 (0%)00 / 4 (0%)00 / 25 (0%)02 / 19 (10.53%)2
Musculoskeletal pain † A 0 / 3 (0%)00 / 3 (0%)00 / 4 (0%)00 / 25 (0%)01 / 19 (5.26%)1
Myalgia † A 0 / 3 (0%)00 / 3 (0%)00 / 4 (0%)01 / 25 (4%)10 / 19 (0%)0
Senile osteoporosis † A 0 / 3 (0%)00 / 3 (0%)00 / 4 (0%)00 / 25 (0%)01 / 19 (5.26%)1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma † A 1 / 3 (33.33%)10 / 3 (0%)00 / 4 (0%)00 / 25 (0%)00 / 19 (0%)0
Metastases to liver † A 1 / 3 (33.33%)10 / 3 (0%)00 / 4 (0%)00 / 25 (0%)02 / 19 (10.53%)2
Metastases to lung † A 0 / 3 (0%)00 / 3 (0%)00 / 4 (0%)00 / 25 (0%)01 / 19 (5.26%)1
Uterine leiomyoma † A 0 / 3 (0%)00 / 3 (0%)00 / 4 (0%)01 / 25 (4%)10 / 19 (0%)0
Nervous system disorders
Dizziness † A 0 / 3 (0%)00 / 3 (0%)01 / 4 (25%)11 / 25 (4%)13 / 19 (15.79%)4
Dysgeusia † A 0 / 3 (0%)00 / 3 (0%)00 / 4 (0%)00 / 25 (0%)01 / 19 (5.26%)1
Encephalopathy † A 0 / 3 (0%)00 / 3 (0%)00 / 4 (0%)01 / 25 (4%)10 / 19 (0%)0
Haemorrhage intracranial † A 0 / 3 (0%)00 / 3 (0%)00 / 4 (0%)01 / 25 (4%)10 / 19 (0%)0
Hypersomnia † A 0 / 3 (0%)00 / 3 (0%)00 / 4 (0%)00 / 25 (0%)01 / 19 (5.26%)1
Neuropathy peripheral † A 0 / 3 (0%)00 / 3 (0%)00 / 4 (0%)02 / 25 (8%)25 / 19 (26.32%)5
Paraesthesia † A 0 / 3 (0%)00 / 3 (0%)00 / 4 (0%)01 / 25 (4%)12 / 19 (10.53%)3
Peripheral sensory neuropathy † A 0 / 3 (0%)00 / 3 (0%)00 / 4 (0%)00 / 25 (0%)01 / 19 (5.26%)2
Syncope † A 0 / 3 (0%)00 / 3 (0%)00 / 4 (0%)00 / 25 (0%)01 / 19 (5.26%)1
Product Issues
Device occlusion † A 0 / 3 (0%)00 / 3 (0%)00 / 4 (0%)01 / 25 (4%)11 / 19 (5.26%)1
Psychiatric disorders
Anxiety † A 1 / 3 (33.33%)11 / 3 (33.33%)10 / 4 (0%)00 / 25 (0%)00 / 19 (0%)0
Insomnia † A 0 / 3 (0%)00 / 3 (0%)00 / 4 (0%)01 / 25 (4%)11 / 19 (5.26%)1
Renal and urinary disorders
Acute kidney injury † A 0 / 3 (0%)00 / 3 (0%)00 / 4 (0%)01 / 25 (4%)10 / 19 (0%)0
Bladder trabeculation † A 0 / 3 (0%)00 / 3 (0%)00 / 4 (0%)01 / 25 (4%)10 / 19 (0%)0
Choluria † A 0 / 3 (0%)00 / 3 (0%)00 / 4 (0%)00 / 25 (0%)01 / 19 (5.26%)2
Hydronephrosis † A 0 / 3 (0%)00 / 3 (0%)00 / 4 (0%)01 / 25 (4%)10 / 19 (0%)0
Urinary incontinence † A 0 / 3 (0%)00 / 3 (0%)00 / 4 (0%)01 / 25 (4%)10 / 19 (0%)0
Urinary retention † A 0 / 3 (0%)00 / 3 (0%)00 / 4 (0%)01 / 25 (4%)11 / 19 (5.26%)1
Reproductive system and breast disorders
Genital rash † A 0 / 3 (0%)00 / 3 (0%)00 / 4 (0%)01 / 25 (4%)10 / 19 (0%)0
Pelvic pain † A 0 / 3 (0%)00 / 3 (0%)00 / 4 (0%)01 / 25 (4%)10 / 19 (0%)0
Respiratory, thoracic and mediastinal disorders
Bronchostenosis † A 0 / 3 (0%)00 / 3 (0%)00 / 4 (0%)00 / 25 (0%)01 / 19 (5.26%)1
Cough † A 0 / 3 (0%)00 / 3 (0%)00 / 4 (0%)00 / 25 (0%)01 / 19 (5.26%)1
Dyspnoea † A 0 / 3 (0%)00 / 3 (0%)01 / 4 (25%)11 / 25 (4%)12 / 19 (10.53%)2
Epistaxis † A 0 / 3 (0%)00 / 3 (0%)00 / 4 (0%)01 / 25 (4%)10 / 19 (0%)0
Pleural effusion † A 0 / 3 (0%)00 / 3 (0%)00 / 4 (0%)01 / 25 (4%)10 / 19 (0%)0
Pulmonary mass † A 0 / 3 (0%)00 / 3 (0%)00 / 4 (0%)00 / 25 (0%)01 / 19 (5.26%)1
Wheezing † A 1 / 3 (33.33%)10 / 3 (0%)00 / 4 (0%)01 / 25 (4%)11 / 19 (5.26%)1
Skin and subcutaneous tissue disorders
Alopecia † A 0 / 3 (0%)00 / 3 (0%)00 / 4 (0%)01 / 25 (4%)11 / 19 (5.26%)1
Eczema † A 0 / 3 (0%)00 / 3 (0%)00 / 4 (0%)01 / 25 (4%)10 / 19 (0%)0
Nail disorder † A 0 / 3 (0%)00 / 3 (0%)00 / 4 (0%)00 / 25 (0%)01 / 19 (5.26%)1
Pruritus † A 0 / 3 (0%)00 / 3 (0%)00 / 4 (0%)00 / 25 (0%)01 / 19 (5.26%)1
Pruritus generalised † A 1 / 3 (33.33%)10 / 3 (0%)00 / 4 (0%)00 / 25 (0%)00 / 19 (0%)0
Rash † A 1 / 3 (33.33%)10 / 3 (0%)00 / 4 (0%)00 / 25 (0%)00 / 19 (0%)0
Rash generalised † A 0 / 3 (0%)00 / 3 (0%)00 / 4 (0%)00 / 25 (0%)01 / 19 (5.26%)1
Rash maculo-papular † A 0 / 3 (0%)00 / 3 (0%)00 / 4 (0%)01 / 25 (4%)10 / 19 (0%)0
Skin ulcer † A 0 / 3 (0%)00 / 3 (0%)00 / 4 (0%)00 / 25 (0%)01 / 19 (5.26%)1
Surgical and medical procedures
Antiviral prophylaxis † A 0 / 3 (0%)00 / 3 (0%)00 / 4 (0%)01 / 25 (4%)10 / 19 (0%)0
Vascular disorders
Deep vein thrombosis † A 0 / 3 (0%)00 / 3 (0%)00 / 4 (0%)01 / 25 (4%)10 / 19 (0%)0
Haematoma † A 1 / 3 (33.33%)10 / 3 (0%)00 / 4 (0%)00 / 25 (0%)00 / 19 (0%)0
Hypertension † A 0 / 3 (0%)00 / 3 (0%)00 / 4 (0%)01 / 25 (4%)10 / 19 (0%)0
Hypotension † A 0 / 3 (0%)00 / 3 (0%)00 / 4 (0%)02 / 25 (8%)22 / 19 (10.53%)2
Peripheral coldness † A 0 / 3 (0%)00 / 3 (0%)00 / 4 (0%)00 / 25 (0%)01 / 19 (5.26%)1
†Indicates events were collected by systematic assessment.
ATerm from vocabulary, MedDRA (20.0)
Open or close this module Limitations and Caveats
[Not specified]
Open or close this module More Information
Certain Agreements:
Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between the Principal Investigator 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/Official Title:
 Mark Mitchell
Organization:
 NanOlogy, LLC
Phone:
 8179004074
Email:
 Mark.Mitchell@dfb.com
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