Trial Outcomes & Findings for Safety & Efficacy of NV1020 in Colorectal Cancer Metastatic to the Liver (NCT NCT00149396)
NCT ID: NCT00149396
Last Updated: 2018-04-24
Results Overview
Incidence of adverse events for all patients (N=32); Overall incidence ≥20%; Adverse events listed by Medical Dictionary for Regulatory Activities (MedDRA) Preferred Term
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
32 participants
Primary outcome timeframe
From start of treatment through 12 months after completion of treatment
Results posted on
2018-04-24
Participant Flow
Participant milestones
| Measure |
NV1020
Escalating doses of NV1020: 3x10\^6, 1x10\^7, 3x10\^7, 1x10\^8
|
|---|---|
|
Overall Study
STARTED
|
32
|
|
Overall Study
Completed NV1020 Therapy
|
29
|
|
Overall Study
Completed NV1020 and Chemotherapy
|
9
|
|
Overall Study
COMPLETED
|
9
|
|
Overall Study
NOT COMPLETED
|
23
|
Reasons for withdrawal
| Measure |
NV1020
Escalating doses of NV1020: 3x10\^6, 1x10\^7, 3x10\^7, 1x10\^8
|
|---|---|
|
Overall Study
Death
|
15
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Subject noncompliance
|
2
|
|
Overall Study
other treatment
|
5
|
Baseline Characteristics
Safety & Efficacy of NV1020 in Colorectal Cancer Metastatic to the Liver
Baseline characteristics by cohort
| Measure |
NV1020
n=32 Participants
Escalating doses of NV1020: 3x10\^6, 1x10\^7, 3x10\^7, 1x10\^8
|
|---|---|
|
Age, Continuous
|
57.7 years
STANDARD_DEVIATION 11.9 • n=99 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
29 participants
n=99 Participants
|
|
Race/Ethnicity, Customized
African American
|
1 participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
1 participants
n=99 Participants
|
|
Carcinoembryonic Antigen (CEA) Level at Screening
|
175.5 ng/mL
STANDARD_DEVIATION 517.4 • n=99 Participants
|
|
Prior Chemotherapy
|
32 participants
n=99 Participants
|
|
Karnofsky Performance Status (KPS)
KPS 100
|
14 participants
n=99 Participants
|
|
Karnofsky Performance Status (KPS)
KPS 90
|
17 participants
n=99 Participants
|
|
Karnofsky Performance Status (KPS)
KPS 80
|
1 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: From start of treatment through 12 months after completion of treatmentIncidence of adverse events for all patients (N=32); Overall incidence ≥20%; Adverse events listed by Medical Dictionary for Regulatory Activities (MedDRA) Preferred Term
Outcome measures
| Measure |
All Patients
n=32 Participants
All patients in study
|
Dose Cohort 2
NV1020 Dose 1x10\^7 pfu (Stage 1)
|
Dose Cohort 3
NV1020 Dose 3x10\^7 pfu (Stage 1)
|
Dose Cohort 4
NV1020 Dose 1x10\^8 pfu (Stages 1 and 2)
|
|---|---|---|---|---|
|
Incidence of Adverse Events and Dose Limiting Adverse Events
Dose limiting adverse events
|
0 percentage of participants
|
—
|
—
|
—
|
|
Incidence of Adverse Events and Dose Limiting Adverse Events
Nausea
|
69 percentage of participants
|
—
|
—
|
—
|
|
Incidence of Adverse Events and Dose Limiting Adverse Events
Abdominal pain
|
47 percentage of participants
|
—
|
—
|
—
|
|
Incidence of Adverse Events and Dose Limiting Adverse Events
Diarrhea
|
44 percentage of participants
|
—
|
—
|
—
|
|
Incidence of Adverse Events and Dose Limiting Adverse Events
Vomiting
|
41 percentage of participants
|
—
|
—
|
—
|
|
Incidence of Adverse Events and Dose Limiting Adverse Events
Abdominal pain upper
|
25 percentage of participants
|
—
|
—
|
—
|
|
Incidence of Adverse Events and Dose Limiting Adverse Events
Constipation
|
22 percentage of participants
|
—
|
—
|
—
|
|
Incidence of Adverse Events and Dose Limiting Adverse Events
Pyrexia
|
94 percentage of participants
|
—
|
—
|
—
|
|
Incidence of Adverse Events and Dose Limiting Adverse Events
Chills
|
56 percentage of participants
|
—
|
—
|
—
|
|
Incidence of Adverse Events and Dose Limiting Adverse Events
Fatigue
|
56 percentage of participants
|
—
|
—
|
—
|
|
Incidence of Adverse Events and Dose Limiting Adverse Events
Edema peripheral
|
22 percentage of participants
|
—
|
—
|
—
|
|
Incidence of Adverse Events and Dose Limiting Adverse Events
Back pain
|
34 percentage of participants
|
—
|
—
|
—
|
|
Incidence of Adverse Events and Dose Limiting Adverse Events
Headache
|
41 percentage of participants
|
—
|
—
|
—
|
|
Incidence of Adverse Events and Dose Limiting Adverse Events
Anemia
|
41 percentage of participants
|
—
|
—
|
—
|
|
Incidence of Adverse Events and Dose Limiting Adverse Events
Neutropenia
|
22 percentage of participants
|
—
|
—
|
—
|
|
Incidence of Adverse Events and Dose Limiting Adverse Events
Rash
|
28 percentage of participants
|
—
|
—
|
—
|
|
Incidence of Adverse Events and Dose Limiting Adverse Events
Hypokalemia
|
22 percentage of participants
|
—
|
—
|
—
|
|
Incidence of Adverse Events and Dose Limiting Adverse Events
Insomnia
|
22 percentage of participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Daily for 2 weeks after the first and last NV1020 infusionsNumber of patients with NV1020 detected in saliva, skin, and/or mucosal surfaces; Analysis by polymerase chain reaction (PCR)
Outcome measures
| Measure |
All Patients
n=32 Participants
All patients in study
|
Dose Cohort 2
NV1020 Dose 1x10\^7 pfu (Stage 1)
|
Dose Cohort 3
NV1020 Dose 3x10\^7 pfu (Stage 1)
|
Dose Cohort 4
NV1020 Dose 1x10\^8 pfu (Stages 1 and 2)
|
|---|---|---|---|---|
|
NV1020 Pharmacokinetics - Presence of NV1020 in Body Fluids/Skin
|
0 participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Screening; after each NV1020 infusion; +7h, +24h, and +72h after NV1020 infusion; each chemotherapy visit; +3d, +7d, +14d after each chemo visit; 1 week after end of treatmentNumber of patients with clinically significant hematology laboratory abnormalities by NV1020 dose cohort (Post baseline)
Outcome measures
| Measure |
All Patients
n=3 Participants
All patients in study
|
Dose Cohort 2
n=3 Participants
NV1020 Dose 1x10\^7 pfu (Stage 1)
|
Dose Cohort 3
n=4 Participants
NV1020 Dose 3x10\^7 pfu (Stage 1)
|
Dose Cohort 4
n=22 Participants
NV1020 Dose 1x10\^8 pfu (Stages 1 and 2)
|
|---|---|---|---|---|
|
Clinical Laboratory Safety - Hematology
Hemoglobin (g/dL)
|
0 participants
|
1 participants
|
0 participants
|
3 participants
|
|
Clinical Laboratory Safety - Hematology
Lymphocytes (%)
|
1 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Clinical Laboratory Safety - Hematology
Monocytes (%)
|
1 participants
|
1 participants
|
0 participants
|
1 participants
|
|
Clinical Laboratory Safety - Hematology
Neutrophils (bands) (%)
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Clinical Laboratory Safety - Hematology
Neutrophils (segs) (%)
|
1 participants
|
0 participants
|
0 participants
|
2 participants
|
|
Clinical Laboratory Safety - Hematology
Platelets (x10^3/uL)
|
0 participants
|
0 participants
|
0 participants
|
3 participants
|
|
Clinical Laboratory Safety - Hematology
Red blood cells (x10^6/uL)
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Clinical Laboratory Safety - Hematology
White blood cells (x10^3/uL)
|
1 participants
|
0 participants
|
0 participants
|
7 participants
|
|
Clinical Laboratory Safety - Hematology
Absolute neutrophil count (x10^3/uL)
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Clinical Laboratory Safety - Hematology
Basophils (%)
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Clinical Laboratory Safety - Hematology
Eosinophils (%)
|
0 participants
|
0 participants
|
0 participants
|
2 participants
|
|
Clinical Laboratory Safety - Hematology
Hematocrit (%)
|
0 participants
|
1 participants
|
0 participants
|
3 participants
|
PRIMARY outcome
Timeframe: Screening; after each NV1020 infusion; +7h, +24h, and +72h after NV1020 infusion; each chemotherapy visit; +3d, +7d, +14d after each chemo visit; 1 week after end of treatmentNumber of patients with post-baseline clinically significant laboratory chemistry abnormalities by NV1020 dose cohort
Outcome measures
| Measure |
All Patients
n=3 Participants
All patients in study
|
Dose Cohort 2
n=3 Participants
NV1020 Dose 1x10\^7 pfu (Stage 1)
|
Dose Cohort 3
n=4 Participants
NV1020 Dose 3x10\^7 pfu (Stage 1)
|
Dose Cohort 4
n=22 Participants
NV1020 Dose 1x10\^8 pfu (Stages 1 and 2)
|
|---|---|---|---|---|
|
Clinical Laboratory Safety - Chemistry
Alkaline Phosphatase (U/L)
|
2 participants
|
2 participants
|
0 participants
|
8 participants
|
|
Clinical Laboratory Safety - Chemistry
ALT (SGPT) (U/L)
|
0 participants
|
0 participants
|
0 participants
|
6 participants
|
|
Clinical Laboratory Safety - Chemistry
AST (SGOT) (U/L)
|
1 participants
|
0 participants
|
0 participants
|
6 participants
|
|
Clinical Laboratory Safety - Chemistry
Bicarbonate (mmol/L)
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Clinical Laboratory Safety - Chemistry
BUN (mg/dL)
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Clinical Laboratory Safety - Chemistry
Calcium (mg/dL)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Clinical Laboratory Safety - Chemistry
Chloride (mmol/L)
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Clinical Laboratory Safety - Chemistry
Creatinine (mg/dL)
|
1 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Clinical Laboratory Safety - Chemistry
Glucose (mg/dL)
|
1 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Clinical Laboratory Safety - Chemistry
Potassium (mmol/L)
|
0 participants
|
1 participants
|
0 participants
|
4 participants
|
|
Clinical Laboratory Safety - Chemistry
Sodium (mmol/L)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Clinical Laboratory Safety - Chemistry
Total Bilirubin (mg/dL)
|
1 participants
|
0 participants
|
0 participants
|
5 participants
|
|
Clinical Laboratory Safety - Chemistry
YGT/GGT (U/L)
|
2 participants
|
2 participants
|
0 participants
|
5 participants
|
PRIMARY outcome
Timeframe: Screening; after each NV1020 infusion; +7h, +24h, and +72h after NV1020 infusion; each chemotherapy visit; +3d, +7d, +14d after each chemo visit; 1 week after end of treatmentNumber of patients with post-baseline clinically significant laboratory coagulation abnormalities by NV1020 dose cohort
Outcome measures
| Measure |
All Patients
n=3 Participants
All patients in study
|
Dose Cohort 2
n=3 Participants
NV1020 Dose 1x10\^7 pfu (Stage 1)
|
Dose Cohort 3
n=4 Participants
NV1020 Dose 3x10\^7 pfu (Stage 1)
|
Dose Cohort 4
n=22 Participants
NV1020 Dose 1x10\^8 pfu (Stages 1 and 2)
|
|---|---|---|---|---|
|
Clinical Laboratory Safety - Coagulation
C-reactive Protein (mg/dL)
|
1 participants
|
1 participants
|
0 participants
|
6 participants
|
|
Clinical Laboratory Safety - Coagulation
D-dimer (ug/mL)
|
2 participants
|
1 participants
|
0 participants
|
6 participants
|
|
Clinical Laboratory Safety - Coagulation
Fibrinogen (ug/mL)
|
2 participants
|
0 participants
|
0 participants
|
4 participants
|
|
Clinical Laboratory Safety - Coagulation
INR
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Clinical Laboratory Safety - Coagulation
Prothrombin Time (PT) (sec)
|
0 participants
|
0 participants
|
0 participants
|
3 participants
|
|
Clinical Laboratory Safety - Coagulation
Partial Thromboplastin Time (PTT) (sec)
|
1 participants
|
0 participants
|
0 participants
|
3 participants
|
SECONDARY outcome
Timeframe: Screening (baseline), Chemo visit 1, Chemo visit 2, Follow-up Visit 1 (1 week after end of treatment), Follow-up Visit 2 (+6M), Follow-up Visit 3 (+9M), Follow-up Visit 4 (+12M)Population: Number of participants analyzed decreases through the follow-up visits. Thus the "Number of Participants Analyzed" indicated here refer to the number at baseline.
Outcome measures
| Measure |
All Patients
n=3 Participants
All patients in study
|
Dose Cohort 2
n=3 Participants
NV1020 Dose 1x10\^7 pfu (Stage 1)
|
Dose Cohort 3
n=4 Participants
NV1020 Dose 3x10\^7 pfu (Stage 1)
|
Dose Cohort 4
n=22 Participants
NV1020 Dose 1x10\^8 pfu (Stages 1 and 2)
|
|---|---|---|---|---|
|
Mean Change From Baseline in Serum Carcinoembryonic Antigen (CEA) After Administration of NV1020 and 2 Cycles of Chemotherapy
Mean Change - Follow-up 2
|
6995.9 ng/mL
Standard Deviation 12110.6
|
134.7 ng/mL
Standard Deviation NA
N=1 for this timepoint
|
1.8 ng/mL
Standard Deviation 3.5
|
97.3 ng/mL
Standard Deviation 311.9
|
|
Mean Change From Baseline in Serum Carcinoembryonic Antigen (CEA) After Administration of NV1020 and 2 Cycles of Chemotherapy
Mean Baseline CEA
|
1814.4 ng/mL
Standard Deviation 3105.2
|
161.0 ng/mL
Standard Deviation 235.1
|
121.6 ng/mL
Standard Deviation 230.3
|
181.7 ng/mL
Standard Deviation 373.3
|
|
Mean Change From Baseline in Serum Carcinoembryonic Antigen (CEA) After Administration of NV1020 and 2 Cycles of Chemotherapy
Mean Change - Chemo visit 1
|
869.6 ng/mL
Standard Deviation 1489.9
|
96.0 ng/mL
Standard Deviation 106.1
|
8.6 ng/mL
Standard Deviation 17.0
|
165.6 ng/mL
Standard Deviation 410.5
|
|
Mean Change From Baseline in Serum Carcinoembryonic Antigen (CEA) After Administration of NV1020 and 2 Cycles of Chemotherapy
Mean Change - Chemo visit 2
|
17.9 ng/mL
Standard Deviation 13.2
|
194.4 ng/mL
Standard Deviation 212.8
|
-0.6 ng/mL
Standard Deviation NA
N=1 for this timepoint
|
98.2 ng/mL
Standard Deviation 254.1
|
|
Mean Change From Baseline in Serum Carcinoembryonic Antigen (CEA) After Administration of NV1020 and 2 Cycles of Chemotherapy
Mean Change - Follow-up 1
|
-353.9 ng/mL
Standard Deviation 628.8
|
615.6 ng/mL
Standard Deviation 867.5
|
5.4 ng/mL
Standard Deviation 5.8
|
97.0 ng/mL
Standard Deviation 334.1
|
|
Mean Change From Baseline in Serum Carcinoembryonic Antigen (CEA) After Administration of NV1020 and 2 Cycles of Chemotherapy
Mean Change - Follow-up 3
|
NA ng/mL
Standard Deviation NA
N=0 for this timepoint
|
NA ng/mL
Standard Deviation NA
N=0 for this timepoint
|
16.5 ng/mL
Standard Deviation NA
N=1 for this timepoint
|
-52.3 ng/mL
Standard Deviation 94.9
|
|
Mean Change From Baseline in Serum Carcinoembryonic Antigen (CEA) After Administration of NV1020 and 2 Cycles of Chemotherapy
Mean Change - Follow-up 4
|
NA ng/mL
Standard Deviation NA
N=0 for this timepoint
|
NA ng/mL
Standard Deviation NA
N=0 for this timepoint
|
-1.7 ng/mL
Standard Deviation NA
N=1 for this timepoint
|
290.9 ng/mL
Standard Deviation 447.8
|
SECONDARY outcome
Timeframe: Screening (baseline), Chemo visit 1, Follow-up visits 1 (1 week post end of treatment), 2 (+6M), 3 (+9M), 4 (+12M)Maximum percentage changes in tumor diameter after administration of NV1020 followed by chemotherapy as measured by CT scan and Modified Response Evaluation Criteria in Solid Tumors (RECIST) assessment
Outcome measures
| Measure |
All Patients
n=13 Participants
All patients in study
|
Dose Cohort 2
n=19 Participants
NV1020 Dose 1x10\^7 pfu (Stage 1)
|
Dose Cohort 3
NV1020 Dose 3x10\^7 pfu (Stage 1)
|
Dose Cohort 4
NV1020 Dose 1x10\^8 pfu (Stages 1 and 2)
|
|---|---|---|---|---|
|
Liver Tumor Response After Administration of NV1020 Followed by Chemotherapy, Determined by Radiological (Computed Tomography [CT] Scan) Assessment
Patient 203
|
25.00 percentage
|
NA percentage
This patient not in Stage 2 of study
|
—
|
—
|
|
Liver Tumor Response After Administration of NV1020 Followed by Chemotherapy, Determined by Radiological (Computed Tomography [CT] Scan) Assessment
Patient 101
|
22.70 percentage
|
NA percentage
This patient not in Stage 2 of study
|
—
|
—
|
|
Liver Tumor Response After Administration of NV1020 Followed by Chemotherapy, Determined by Radiological (Computed Tomography [CT] Scan) Assessment
Patient 102
|
41.76 percentage
|
NA percentage
This patient not in Stage 2 of study
|
—
|
—
|
|
Liver Tumor Response After Administration of NV1020 Followed by Chemotherapy, Determined by Radiological (Computed Tomography [CT] Scan) Assessment
Patient 103
|
18.85 percentage
|
NA percentage
This patient not in Stage 2 of study
|
—
|
—
|
|
Liver Tumor Response After Administration of NV1020 Followed by Chemotherapy, Determined by Radiological (Computed Tomography [CT] Scan) Assessment
Patient 201
|
36.91 percentage
|
NA percentage
This patient not in Stage 2 of study
|
—
|
—
|
|
Liver Tumor Response After Administration of NV1020 Followed by Chemotherapy, Determined by Radiological (Computed Tomography [CT] Scan) Assessment
Patient 202
|
21.55 percentage
|
NA percentage
This patient not in Stage 2 of study
|
—
|
—
|
|
Liver Tumor Response After Administration of NV1020 Followed by Chemotherapy, Determined by Radiological (Computed Tomography [CT] Scan) Assessment
Patient 301
|
4.92 percentage
|
NA percentage
This patient not in Stage 2 of study
|
—
|
—
|
|
Liver Tumor Response After Administration of NV1020 Followed by Chemotherapy, Determined by Radiological (Computed Tomography [CT] Scan) Assessment
Patient 302
|
24.55 percentage
|
NA percentage
This patient not in Stage 2 of study
|
—
|
—
|
|
Liver Tumor Response After Administration of NV1020 Followed by Chemotherapy, Determined by Radiological (Computed Tomography [CT] Scan) Assessment
Patient 303
|
10.74 percentage
|
NA percentage
This patient not in Stage 2 of study
|
—
|
—
|
|
Liver Tumor Response After Administration of NV1020 Followed by Chemotherapy, Determined by Radiological (Computed Tomography [CT] Scan) Assessment
Patient 304
|
2.68 percentage
|
NA percentage
This patient not in Stage 2 of study
|
—
|
—
|
|
Liver Tumor Response After Administration of NV1020 Followed by Chemotherapy, Determined by Radiological (Computed Tomography [CT] Scan) Assessment
Patient 401
|
-24.51 percentage
|
NA percentage
This patient not in Stage 2 of study
|
—
|
—
|
|
Liver Tumor Response After Administration of NV1020 Followed by Chemotherapy, Determined by Radiological (Computed Tomography [CT] Scan) Assessment
Patient 402
|
-5.36 percentage
|
NA percentage
This patient not in Stage 2 of study
|
—
|
—
|
|
Liver Tumor Response After Administration of NV1020 Followed by Chemotherapy, Determined by Radiological (Computed Tomography [CT] Scan) Assessment
Patient 403
|
-7.98 percentage
|
NA percentage
This patient not in Stage 2 of study
|
—
|
—
|
|
Liver Tumor Response After Administration of NV1020 Followed by Chemotherapy, Determined by Radiological (Computed Tomography [CT] Scan) Assessment
Patient 801
|
NA percentage
This patient not in Stage 1 of study
|
5.45 percentage
|
—
|
—
|
|
Liver Tumor Response After Administration of NV1020 Followed by Chemotherapy, Determined by Radiological (Computed Tomography [CT] Scan) Assessment
Patient 802
|
NA percentage
This patient not in Stage 1 of study
|
35.89 percentage
|
—
|
—
|
|
Liver Tumor Response After Administration of NV1020 Followed by Chemotherapy, Determined by Radiological (Computed Tomography [CT] Scan) Assessment
Patient 803
|
NA percentage
This patient not in Stage 1 of study
|
-35.56 percentage
|
—
|
—
|
|
Liver Tumor Response After Administration of NV1020 Followed by Chemotherapy, Determined by Radiological (Computed Tomography [CT] Scan) Assessment
Patient 804
|
NA percentage
This patient not in Stage 1 of study
|
21.43 percentage
|
—
|
—
|
|
Liver Tumor Response After Administration of NV1020 Followed by Chemotherapy, Determined by Radiological (Computed Tomography [CT] Scan) Assessment
Patient 805
|
NA percentage
This patient not in Stage 1 of study
|
11.41 percentage
|
—
|
—
|
|
Liver Tumor Response After Administration of NV1020 Followed by Chemotherapy, Determined by Radiological (Computed Tomography [CT] Scan) Assessment
Patient 806
|
NA percentage
This patient not in Stage 1 of study
|
18.90 percentage
|
—
|
—
|
|
Liver Tumor Response After Administration of NV1020 Followed by Chemotherapy, Determined by Radiological (Computed Tomography [CT] Scan) Assessment
Patient 807
|
NA percentage
This patient not in Stage 1 of study
|
29.98 percentage
|
—
|
—
|
|
Liver Tumor Response After Administration of NV1020 Followed by Chemotherapy, Determined by Radiological (Computed Tomography [CT] Scan) Assessment
Patient 808
|
NA percentage
This patient not in Stage 1 of study
|
16.77 percentage
|
—
|
—
|
|
Liver Tumor Response After Administration of NV1020 Followed by Chemotherapy, Determined by Radiological (Computed Tomography [CT] Scan) Assessment
Patient 809
|
NA percentage
This patient not in Stage 1 of study
|
30.00 percentage
|
—
|
—
|
|
Liver Tumor Response After Administration of NV1020 Followed by Chemotherapy, Determined by Radiological (Computed Tomography [CT] Scan) Assessment
Patient 810
|
NA percentage
This patient not in Stage 1 of study
|
57.67 percentage
|
—
|
—
|
|
Liver Tumor Response After Administration of NV1020 Followed by Chemotherapy, Determined by Radiological (Computed Tomography [CT] Scan) Assessment
Patient 811
|
NA percentage
This patient not in Stage 1 of study
|
-1.93 percentage
|
—
|
—
|
|
Liver Tumor Response After Administration of NV1020 Followed by Chemotherapy, Determined by Radiological (Computed Tomography [CT] Scan) Assessment
Patient 812
|
NA percentage
This patient not in Stage 1 of study
|
-19.05 percentage
|
—
|
—
|
|
Liver Tumor Response After Administration of NV1020 Followed by Chemotherapy, Determined by Radiological (Computed Tomography [CT] Scan) Assessment
Patient 813
|
NA percentage
This patient not in Stage 1 of study
|
25.29 percentage
|
—
|
—
|
|
Liver Tumor Response After Administration of NV1020 Followed by Chemotherapy, Determined by Radiological (Computed Tomography [CT] Scan) Assessment
Patient 814
|
NA percentage
This patient not in Stage 1 of study
|
114.29 percentage
|
—
|
—
|
|
Liver Tumor Response After Administration of NV1020 Followed by Chemotherapy, Determined by Radiological (Computed Tomography [CT] Scan) Assessment
Patient 815
|
NA percentage
This patient not in Stage 1 of study
|
9.38 percentage
|
—
|
—
|
|
Liver Tumor Response After Administration of NV1020 Followed by Chemotherapy, Determined by Radiological (Computed Tomography [CT] Scan) Assessment
Patient 816
|
NA percentage
This patient not in Stage 1 of study
|
12.20 percentage
|
—
|
—
|
|
Liver Tumor Response After Administration of NV1020 Followed by Chemotherapy, Determined by Radiological (Computed Tomography [CT] Scan) Assessment
Patient 817
|
NA percentage
This patient not in Stage 1 of study
|
3.30 percentage
|
—
|
—
|
|
Liver Tumor Response After Administration of NV1020 Followed by Chemotherapy, Determined by Radiological (Computed Tomography [CT] Scan) Assessment
Patient 818
|
NA percentage
This patient not in Stage 1 of study
|
-11.19 percentage
|
—
|
—
|
|
Liver Tumor Response After Administration of NV1020 Followed by Chemotherapy, Determined by Radiological (Computed Tomography [CT] Scan) Assessment
Patient 819
|
NA percentage
This patient not in Stage 1 of study
|
-24.18 percentage
|
—
|
—
|
SECONDARY outcome
Timeframe: Screening, Chemo Visit 1, Follow-up Visits 1 (1 week post end of treatment), 2 (+6M), 3 (+9M), 4 (+12M)Mean change from baseline in NV1020 neutralizing antibody titer by dose cohort
Outcome measures
| Measure |
All Patients
n=3 Participants
All patients in study
|
Dose Cohort 2
n=3 Participants
NV1020 Dose 1x10\^7 pfu (Stage 1)
|
Dose Cohort 3
n=4 Participants
NV1020 Dose 3x10\^7 pfu (Stage 1)
|
Dose Cohort 4
n=22 Participants
NV1020 Dose 1x10\^8 pfu (Stages 1 and 2)
|
|---|---|---|---|---|
|
Pharmacodynamic Effects of NV1020: NV1020 Neutralizing Antibody Titer Assay
Mean Baseline Neutralizing Antibody
|
282.7 antibody titer
Standard Deviation 96.4
|
1242.7 antibody titer
Standard Deviation 1585.2
|
1006.6 antibody titer
Standard Deviation 844.6
|
334.2 antibody titer
Standard Deviation 309.1
|
|
Pharmacodynamic Effects of NV1020: NV1020 Neutralizing Antibody Titer Assay
Mean Change - Chemotherapy Visit 1
|
1341 antibody titer
Standard Deviation 914
|
1061 antibody titer
Standard Deviation 1430
|
4926 antibody titer
Standard Deviation 1444
|
3481 antibody titer
Standard Deviation 2251
|
|
Pharmacodynamic Effects of NV1020: NV1020 Neutralizing Antibody Titer Assay
Mean Change - Follow-up Visit 1
|
1231 antibody titer
Standard Deviation 1382
|
950 antibody titer
Standard Deviation 1344
|
2154 antibody titer
Standard Deviation 473
|
2389 antibody titer
Standard Deviation 1736
|
|
Pharmacodynamic Effects of NV1020: NV1020 Neutralizing Antibody Titer Assay
Mean Change - Follow-up Visit 2
|
824 antibody titer
Standard Deviation 622
|
1152 antibody titer
Standard Deviation NA
N=1 for this timepoint
|
1887 antibody titer
Standard Deviation 1133
|
1292 antibody titer
Standard Deviation 1245
|
|
Pharmacodynamic Effects of NV1020: NV1020 Neutralizing Antibody Titer Assay
Mean Change - Follow-up Visit 3
|
NA antibody titer
Standard Deviation NA
N=0 for this timepoint
|
NA antibody titer
Standard Deviation NA
N=0 for this timepoint
|
450 antibody titer
Standard Deviation NA
N=1 for this timepoint
|
1029 antibody titer
Standard Deviation 863
|
|
Pharmacodynamic Effects of NV1020: NV1020 Neutralizing Antibody Titer Assay
Mean Change - Follow-up Visit 4
|
NA antibody titer
Standard Deviation NA
N=0 for this timepoint
|
NA antibody titer
Standard Deviation NA
N=0 for this timepoint
|
-543.1 antibody titer
Standard Deviation NA
N=1 for this timepoint
|
403 antibody titer
Standard Deviation 374
|
SECONDARY outcome
Timeframe: Progression: Chemo visit 1, FU1 (1 week post treatment), FU2 (+6M), FU3 (+9M), FU4 (+12M); Survival: death of patientProgression assessed from CT and PET measurements and is determined as an increase of greater than or equal to 25% in the sum of the products of perpendicular diameters of all tumors, or the appearance of any new lesion.
Outcome measures
| Measure |
All Patients
n=13 Participants
All patients in study
|
Dose Cohort 2
n=19 Participants
NV1020 Dose 1x10\^7 pfu (Stage 1)
|
Dose Cohort 3
NV1020 Dose 3x10\^7 pfu (Stage 1)
|
Dose Cohort 4
NV1020 Dose 1x10\^8 pfu (Stages 1 and 2)
|
|---|---|---|---|---|
|
Time to Disease Progression; Survival Time
Median time to progression
|
3.5 months
Interval 2.8 to 6.9
|
6.4 months
Interval 2.0 to 8.9
|
—
|
—
|
|
Time to Disease Progression; Survival Time
Median survival time
|
12.4 months
Interval 9.6 to 15.0
|
11.6 months
Interval 8.3 to 20.7
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, after each NV1020 infusion (Visit 1, Visit 3, Visit 5, Visit 7)Median change from baseline of Interferon (INF) gamma 8 hours post NV1020 infusion (Visits 1, 3, 5, 7)
Outcome measures
| Measure |
All Patients
n=3 Participants
All patients in study
|
Dose Cohort 2
n=3 Participants
NV1020 Dose 1x10\^7 pfu (Stage 1)
|
Dose Cohort 3
n=4 Participants
NV1020 Dose 3x10\^7 pfu (Stage 1)
|
Dose Cohort 4
n=22 Participants
NV1020 Dose 1x10\^8 pfu (Stages 1 and 2)
|
|---|---|---|---|---|
|
Pharmacodynamic Effects of NV1020: Serum Cytokines (INF Gamma)
Median Baseline INF gamma
|
1.1 pg/mL
Interval 0.6 to 1.9
|
0.9 pg/mL
Interval 0.6 to 1.7
|
0.7 pg/mL
Interval 0.6 to 1.3
|
0.6 pg/mL
Interval 0.6 to 15.0
|
|
Pharmacodynamic Effects of NV1020: Serum Cytokines (INF Gamma)
Median Change - Visit 1 (post 8 hr)
|
5.8 pg/mL
Interval 0.1 to 6.0
|
0.5 pg/mL
Interval -1.1 to 0.5
|
4.7 pg/mL
Interval 3.0 to 6.0
|
22.9 pg/mL
Interval 0.0 to 169.4
|
|
Pharmacodynamic Effects of NV1020: Serum Cytokines (INF Gamma)
Median Change - Visit 3 (post 8 hr)
|
7.7 pg/mL
Interval 2.9 to 42.1
|
0.8 pg/mL
Interval -1.1 to 6.3
|
36.0 pg/mL
Interval 15.9 to 111.4
|
51.8 pg/mL
Interval 0.2 to 433.4
|
|
Pharmacodynamic Effects of NV1020: Serum Cytokines (INF Gamma)
Median Change - Visit 5 (post 8 hr)
|
2.5 pg/mL
Interval 1.5 to 3.5
|
0.2 pg/mL
Interval -0.8 to 4.0
|
10.3 pg/mL
Interval 9.7 to 64.4
|
18.8 pg/mL
Interval 1.3 to 281.4
|
|
Pharmacodynamic Effects of NV1020: Serum Cytokines (INF Gamma)
Median Change - Visit 7 (post 8 hr)
|
1.3 pg/mL
Interval 0.3 to 3.3
|
-0.3 pg/mL
Interval -1.1 to 3.9
|
7.6 pg/mL
Interval 4.3 to 13.0
|
18.1 pg/mL
Interval 1.4 to 327.8
|
SECONDARY outcome
Timeframe: Baseline, after each NV1020 infusion (Visit 1, Visit 3, Visit 5, Visit 7)Median change from baseline of Interleukin-6 (IL-6) 8 hours post NV1020 infusion (Visits 1, 3, 5, 7)
Outcome measures
| Measure |
All Patients
n=3 Participants
All patients in study
|
Dose Cohort 2
n=3 Participants
NV1020 Dose 1x10\^7 pfu (Stage 1)
|
Dose Cohort 3
n=4 Participants
NV1020 Dose 3x10\^7 pfu (Stage 1)
|
Dose Cohort 4
n=22 Participants
NV1020 Dose 1x10\^8 pfu (Stages 1 and 2)
|
|---|---|---|---|---|
|
Pharmacodynamic Effects of NV1020: Serum Cytokines (IL-6)
Median Baseline IL-6
|
6.9 pg/mL
Interval 4.2 to 8.3
|
11.0 pg/mL
Interval 6.5 to 12.0
|
15.5 pg/mL
Interval 3.7 to 31.0
|
6.2 pg/mL
Interval 1.6 to 169.0
|
|
Pharmacodynamic Effects of NV1020: Serum Cytokines (IL-6)
Median change - Visit 1 (post 8 hr)
|
1.7 pg/mL
Interval -4.8 to 27.8
|
6.0 pg/mL
Interval 0.0 to 19.0
|
16.5 pg/mL
Interval 3.8 to 57.0
|
32.1 pg/mL
Interval -0.4 to 497.2
|
|
Pharmacodynamic Effects of NV1020: Serum Cytokines (IL-6)
Median change - Visit 3 (post 8 hr)
|
29.8 pg/mL
Interval 16.1 to 194.7
|
3.0 pg/mL
Interval 2.0 to 13.5
|
50.2 pg/mL
Interval 34.0 to 475.0
|
60.6 pg/mL
Interval 1.7 to 989.0
|
|
Pharmacodynamic Effects of NV1020: Serum Cytokines (IL-6)
Median change - Visit 5 (post 8 hr)
|
12.1 pg/mL
Interval 8.8 to 26.7
|
14.5 pg/mL
Interval 8.0 to 49.0
|
63.0 pg/mL
Interval 17.3 to 102.0
|
32.2 pg/mL
Interval 2.4 to 371.0
|
|
Pharmacodynamic Effects of NV1020: Serum Cytokines (IL-6)
Median change - Visit 7 (post 8 hr)
|
34.7 pg/mL
Interval 19.1 to 44.8
|
8.5 pg/mL
Interval 8.0 to 49.0
|
11.3 pg/mL
Interval 10.0 to 62.0
|
43.0 pg/mL
Interval 8.0 to 433.0
|
SECONDARY outcome
Timeframe: Baseline, after each NV1020 infusion (Visit 1, Visit 3, Visit 5, Visit 7)Median change from baseline of tumor necrosis factor (TNF-alpha) 8 hours post NV1020 infusion (Visits 1, 3, 5, 7)
Outcome measures
| Measure |
All Patients
n=3 Participants
All patients in study
|
Dose Cohort 2
n=3 Participants
NV1020 Dose 1x10\^7 pfu (Stage 1)
|
Dose Cohort 3
n=4 Participants
NV1020 Dose 3x10\^7 pfu (Stage 1)
|
Dose Cohort 4
n=22 Participants
NV1020 Dose 1x10\^8 pfu (Stages 1 and 2)
|
|---|---|---|---|---|
|
Pharmacodynamic Effects of NV1020: Serum Cytokines (TNF-alpha)
Median Baseline TNF-alpha
|
1.8 pg/mL
Interval 0.6 to 2.9
|
2.0 pg/mL
Interval 1.6 to 2.2
|
2.5 pg/mL
Interval 1.8 to 4.9
|
1.3 pg/mL
Interval 0.6 to 3.6
|
|
Pharmacodynamic Effects of NV1020: Serum Cytokines (TNF-alpha)
Median change - Visit 1 (post 8 hr)
|
0.2 pg/mL
Interval -8.0 to 3.8
|
1.4 pg/mL
Interval 0.2 to 4.1
|
-0.2 pg/mL
Interval -2.5 to 0.6
|
2.4 pg/mL
Interval -0.9 to 6.6
|
|
Pharmacodynamic Effects of NV1020: Serum Cytokines (TNF-alpha)
Median change - Visit 3 (post 8 hr)
|
3.6 pg/mL
Interval 0.2 to 7.1
|
0.4 pg/mL
Interval 0.0 to 1.5
|
2.3 pg/mL
Interval 1.3 to 3.9
|
5.9 pg/mL
Interval 0.3 to 22.0
|
|
Pharmacodynamic Effects of NV1020: Serum Cytokines (TNF-alpha)
Median change - Visit 5 (post 8 hr)
|
2.3 pg/mL
Interval 1.0 to 3.3
|
1.3 pg/mL
Interval -0.7 to 1.4
|
1.8 pg/mL
Interval 1.1 to 2.2
|
5.5 pg/mL
Interval 0.9 to 14.0
|
|
Pharmacodynamic Effects of NV1020: Serum Cytokines (TNF-alpha)
Median change - Visit 7 (post 8 hr)
|
2.2 pg/mL
Interval 0.9 to 2.7
|
1.5 pg/mL
Interval -0.8 to 2.4
|
0.8 pg/mL
Interval 0.7 to 5.4
|
5.7 pg/mL
Interval 1.4 to 11.3
|
Adverse Events
NV1020
Serious events: 5 serious events
Other events: 32 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
NV1020
n=32 participants at risk
Escalating doses of NV1020: 3x10\^6, 1x10\^7, 3x10\^7, 1x10\^8
|
|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
3.1%
1/32 • Number of events 1 • 3 years, 11 months (First subject enrolled to last subject completed)
\*Serious adverse events exclude those which were deemed to be unrelated to NV1020
|
|
General disorders
Pyrexia
|
3.1%
1/32 • Number of events 1 • 3 years, 11 months (First subject enrolled to last subject completed)
\*Serious adverse events exclude those which were deemed to be unrelated to NV1020
|
|
Gastrointestinal disorders
Vomiting
|
6.2%
2/32 • Number of events 3 • 3 years, 11 months (First subject enrolled to last subject completed)
\*Serious adverse events exclude those which were deemed to be unrelated to NV1020
|
|
Gastrointestinal disorders
Diarrhoea
|
3.1%
1/32 • Number of events 2 • 3 years, 11 months (First subject enrolled to last subject completed)
\*Serious adverse events exclude those which were deemed to be unrelated to NV1020
|
|
Gastrointestinal disorders
Nausea
|
6.2%
2/32 • Number of events 2 • 3 years, 11 months (First subject enrolled to last subject completed)
\*Serious adverse events exclude those which were deemed to be unrelated to NV1020
|
|
Gastrointestinal disorders
Abdominal pain
|
6.2%
2/32 • Number of events 2 • 3 years, 11 months (First subject enrolled to last subject completed)
\*Serious adverse events exclude those which were deemed to be unrelated to NV1020
|
|
Hepatobiliary disorders
Bile duct obstruction
|
3.1%
1/32 • Number of events 1 • 3 years, 11 months (First subject enrolled to last subject completed)
\*Serious adverse events exclude those which were deemed to be unrelated to NV1020
|
|
General disorders
Chest pain
|
3.1%
1/32 • Number of events 1 • 3 years, 11 months (First subject enrolled to last subject completed)
\*Serious adverse events exclude those which were deemed to be unrelated to NV1020
|
Other adverse events
| Measure |
NV1020
n=32 participants at risk
Escalating doses of NV1020: 3x10\^6, 1x10\^7, 3x10\^7, 1x10\^8
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
68.8%
22/32 • Number of events 50 • 3 years, 11 months (First subject enrolled to last subject completed)
\*Serious adverse events exclude those which were deemed to be unrelated to NV1020
|
|
Gastrointestinal disorders
Abdominal pain
|
46.9%
15/32 • Number of events 27 • 3 years, 11 months (First subject enrolled to last subject completed)
\*Serious adverse events exclude those which were deemed to be unrelated to NV1020
|
|
Gastrointestinal disorders
Diarrhoea
|
43.8%
14/32 • Number of events 29 • 3 years, 11 months (First subject enrolled to last subject completed)
\*Serious adverse events exclude those which were deemed to be unrelated to NV1020
|
|
Gastrointestinal disorders
Vomiting
|
40.6%
13/32 • Number of events 30 • 3 years, 11 months (First subject enrolled to last subject completed)
\*Serious adverse events exclude those which were deemed to be unrelated to NV1020
|
|
Gastrointestinal disorders
Abdominal pain upper
|
25.0%
8/32 • Number of events 10 • 3 years, 11 months (First subject enrolled to last subject completed)
\*Serious adverse events exclude those which were deemed to be unrelated to NV1020
|
|
Gastrointestinal disorders
Constipation
|
21.9%
7/32 • Number of events 7 • 3 years, 11 months (First subject enrolled to last subject completed)
\*Serious adverse events exclude those which were deemed to be unrelated to NV1020
|
|
Gastrointestinal disorders
Abdominal distension
|
18.8%
6/32 • Number of events 6 • 3 years, 11 months (First subject enrolled to last subject completed)
\*Serious adverse events exclude those which were deemed to be unrelated to NV1020
|
|
Gastrointestinal disorders
Abdonimal tenderness
|
12.5%
4/32 • Number of events 4 • 3 years, 11 months (First subject enrolled to last subject completed)
\*Serious adverse events exclude those which were deemed to be unrelated to NV1020
|
|
Gastrointestinal disorders
Dyspepsia
|
12.5%
4/32 • Number of events 4 • 3 years, 11 months (First subject enrolled to last subject completed)
\*Serious adverse events exclude those which were deemed to be unrelated to NV1020
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
12.5%
4/32 • Number of events 4 • 3 years, 11 months (First subject enrolled to last subject completed)
\*Serious adverse events exclude those which were deemed to be unrelated to NV1020
|
|
Gastrointestinal disorders
Flatulence
|
9.4%
3/32 • Number of events 3 • 3 years, 11 months (First subject enrolled to last subject completed)
\*Serious adverse events exclude those which were deemed to be unrelated to NV1020
|
|
Gastrointestinal disorders
Stomatitis
|
9.4%
3/32 • Number of events 3 • 3 years, 11 months (First subject enrolled to last subject completed)
\*Serious adverse events exclude those which were deemed to be unrelated to NV1020
|
|
Gastrointestinal disorders
Abdominal discomfort
|
6.2%
2/32 • Number of events 2 • 3 years, 11 months (First subject enrolled to last subject completed)
\*Serious adverse events exclude those which were deemed to be unrelated to NV1020
|
|
Gastrointestinal disorders
Ascites
|
6.2%
2/32 • Number of events 2 • 3 years, 11 months (First subject enrolled to last subject completed)
\*Serious adverse events exclude those which were deemed to be unrelated to NV1020
|
|
Gastrointestinal disorders
Dry mouth
|
6.2%
2/32 • Number of events 2 • 3 years, 11 months (First subject enrolled to last subject completed)
\*Serious adverse events exclude those which were deemed to be unrelated to NV1020
|
|
General disorders
Pyrexia
|
93.8%
30/32 • Number of events 111 • 3 years, 11 months (First subject enrolled to last subject completed)
\*Serious adverse events exclude those which were deemed to be unrelated to NV1020
|
|
General disorders
Chills
|
56.2%
18/32 • Number of events 41 • 3 years, 11 months (First subject enrolled to last subject completed)
\*Serious adverse events exclude those which were deemed to be unrelated to NV1020
|
|
General disorders
Fatigue
|
56.2%
18/32 • Number of events 36 • 3 years, 11 months (First subject enrolled to last subject completed)
\*Serious adverse events exclude those which were deemed to be unrelated to NV1020
|
|
General disorders
Edema peripheral
|
21.9%
7/32 • Number of events 9 • 3 years, 11 months (First subject enrolled to last subject completed)
\*Serious adverse events exclude those which were deemed to be unrelated to NV1020
|
|
General disorders
Asthenia
|
9.4%
3/32 • Number of events 4 • 3 years, 11 months (First subject enrolled to last subject completed)
\*Serious adverse events exclude those which were deemed to be unrelated to NV1020
|
|
General disorders
Chest pain
|
9.4%
3/32 • Number of events 3 • 3 years, 11 months (First subject enrolled to last subject completed)
\*Serious adverse events exclude those which were deemed to be unrelated to NV1020
|
|
General disorders
Pain
|
9.4%
3/32 • Number of events 3 • 3 years, 11 months (First subject enrolled to last subject completed)
\*Serious adverse events exclude those which were deemed to be unrelated to NV1020
|
|
General disorders
Disease progression
|
6.2%
2/32 • Number of events 2 • 3 years, 11 months (First subject enrolled to last subject completed)
\*Serious adverse events exclude those which were deemed to be unrelated to NV1020
|
|
General disorders
Edema
|
6.2%
2/32 • Number of events 2 • 3 years, 11 months (First subject enrolled to last subject completed)
\*Serious adverse events exclude those which were deemed to be unrelated to NV1020
|
|
General disorders
Temperature intolerance
|
6.2%
2/32 • Number of events 2 • 3 years, 11 months (First subject enrolled to last subject completed)
\*Serious adverse events exclude those which were deemed to be unrelated to NV1020
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
34.4%
11/32 • Number of events 19 • 3 years, 11 months (First subject enrolled to last subject completed)
\*Serious adverse events exclude those which were deemed to be unrelated to NV1020
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
12.5%
4/32 • Number of events 7 • 3 years, 11 months (First subject enrolled to last subject completed)
\*Serious adverse events exclude those which were deemed to be unrelated to NV1020
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
9.4%
3/32 • Number of events 6 • 3 years, 11 months (First subject enrolled to last subject completed)
\*Serious adverse events exclude those which were deemed to be unrelated to NV1020
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
6.2%
2/32 • Number of events 3 • 3 years, 11 months (First subject enrolled to last subject completed)
\*Serious adverse events exclude those which were deemed to be unrelated to NV1020
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
6.2%
2/32 • Number of events 2 • 3 years, 11 months (First subject enrolled to last subject completed)
\*Serious adverse events exclude those which were deemed to be unrelated to NV1020
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
6.2%
2/32 • Number of events 2 • 3 years, 11 months (First subject enrolled to last subject completed)
\*Serious adverse events exclude those which were deemed to be unrelated to NV1020
|
|
Nervous system disorders
Headache
|
40.6%
13/32 • Number of events 20 • 3 years, 11 months (First subject enrolled to last subject completed)
\*Serious adverse events exclude those which were deemed to be unrelated to NV1020
|
|
Nervous system disorders
Dizziness
|
12.5%
4/32 • Number of events 5 • 3 years, 11 months (First subject enrolled to last subject completed)
\*Serious adverse events exclude those which were deemed to be unrelated to NV1020
|
|
Nervous system disorders
Hypoaesthesia
|
9.4%
3/32 • Number of events 3 • 3 years, 11 months (First subject enrolled to last subject completed)
\*Serious adverse events exclude those which were deemed to be unrelated to NV1020
|
|
Nervous system disorders
Neuropathy peripheral
|
6.2%
2/32 • Number of events 2 • 3 years, 11 months (First subject enrolled to last subject completed)
\*Serious adverse events exclude those which were deemed to be unrelated to NV1020
|
|
Blood and lymphatic system disorders
Anaemia
|
40.6%
13/32 • Number of events 24 • 3 years, 11 months (First subject enrolled to last subject completed)
\*Serious adverse events exclude those which were deemed to be unrelated to NV1020
|
|
Blood and lymphatic system disorders
Neurtopenia
|
21.9%
7/32 • Number of events 9 • 3 years, 11 months (First subject enrolled to last subject completed)
\*Serious adverse events exclude those which were deemed to be unrelated to NV1020
|
|
Blood and lymphatic system disorders
Leukopenia
|
6.2%
2/32 • Number of events 4 • 3 years, 11 months (First subject enrolled to last subject completed)
\*Serious adverse events exclude those which were deemed to be unrelated to NV1020
|
|
Blood and lymphatic system disorders
Lymphopenia
|
6.2%
2/32 • Number of events 15 • 3 years, 11 months (First subject enrolled to last subject completed)
\*Serious adverse events exclude those which were deemed to be unrelated to NV1020
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
6.2%
2/32 • Number of events 2 • 3 years, 11 months (First subject enrolled to last subject completed)
\*Serious adverse events exclude those which were deemed to be unrelated to NV1020
|
|
Skin and subcutaneous tissue disorders
Rash
|
28.1%
9/32 • Number of events 10 • 3 years, 11 months (First subject enrolled to last subject completed)
\*Serious adverse events exclude those which were deemed to be unrelated to NV1020
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
9.4%
3/32 • Number of events 3 • 3 years, 11 months (First subject enrolled to last subject completed)
\*Serious adverse events exclude those which were deemed to be unrelated to NV1020
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
9.4%
3/32 • Number of events 3 • 3 years, 11 months (First subject enrolled to last subject completed)
\*Serious adverse events exclude those which were deemed to be unrelated to NV1020
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
6.2%
2/32 • Number of events 3 • 3 years, 11 months (First subject enrolled to last subject completed)
\*Serious adverse events exclude those which were deemed to be unrelated to NV1020
|
|
Skin and subcutaneous tissue disorders
Erythema
|
6.2%
2/32 • Number of events 2 • 3 years, 11 months (First subject enrolled to last subject completed)
\*Serious adverse events exclude those which were deemed to be unrelated to NV1020
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
6.2%
2/32 • Number of events 5 • 3 years, 11 months (First subject enrolled to last subject completed)
\*Serious adverse events exclude those which were deemed to be unrelated to NV1020
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.2%
2/32 • Number of events 3 • 3 years, 11 months (First subject enrolled to last subject completed)
\*Serious adverse events exclude those which were deemed to be unrelated to NV1020
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
6.2%
2/32 • Number of events 2 • 3 years, 11 months (First subject enrolled to last subject completed)
\*Serious adverse events exclude those which were deemed to be unrelated to NV1020
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
15.6%
5/32 • Number of events 9 • 3 years, 11 months (First subject enrolled to last subject completed)
\*Serious adverse events exclude those which were deemed to be unrelated to NV1020
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
9.4%
3/32 • Number of events 3 • 3 years, 11 months (First subject enrolled to last subject completed)
\*Serious adverse events exclude those which were deemed to be unrelated to NV1020
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
6.2%
2/32 • Number of events 2 • 3 years, 11 months (First subject enrolled to last subject completed)
\*Serious adverse events exclude those which were deemed to be unrelated to NV1020
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
6.2%
2/32 • Number of events 2 • 3 years, 11 months (First subject enrolled to last subject completed)
\*Serious adverse events exclude those which were deemed to be unrelated to NV1020
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
21.9%
7/32 • Number of events 14 • 3 years, 11 months (First subject enrolled to last subject completed)
\*Serious adverse events exclude those which were deemed to be unrelated to NV1020
|
|
Metabolism and nutrition disorders
Dehydration
|
12.5%
4/32 • Number of events 4 • 3 years, 11 months (First subject enrolled to last subject completed)
\*Serious adverse events exclude those which were deemed to be unrelated to NV1020
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
9.4%
3/32 • Number of events 6 • 3 years, 11 months (First subject enrolled to last subject completed)
\*Serious adverse events exclude those which were deemed to be unrelated to NV1020
|
|
Metabolism and nutrition disorders
Anorexia
|
6.2%
2/32 • Number of events 2 • 3 years, 11 months (First subject enrolled to last subject completed)
\*Serious adverse events exclude those which were deemed to be unrelated to NV1020
|
|
Metabolism and nutrition disorders
Decreased appetite
|
6.2%
2/32 • Number of events 2 • 3 years, 11 months (First subject enrolled to last subject completed)
\*Serious adverse events exclude those which were deemed to be unrelated to NV1020
|
|
Metabolism and nutrition disorders
Hypoalbuminaenemia
|
6.2%
2/32 • Number of events 2 • 3 years, 11 months (First subject enrolled to last subject completed)
\*Serious adverse events exclude those which were deemed to be unrelated to NV1020
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
6.2%
2/32 • Number of events 2 • 3 years, 11 months (First subject enrolled to last subject completed)
\*Serious adverse events exclude those which were deemed to be unrelated to NV1020
|
|
Infections and infestations
Herpes simplex
|
9.4%
3/32 • Number of events 3 • 3 years, 11 months (First subject enrolled to last subject completed)
\*Serious adverse events exclude those which were deemed to be unrelated to NV1020
|
|
Infections and infestations
Bronchitis
|
6.2%
2/32 • Number of events 2 • 3 years, 11 months (First subject enrolled to last subject completed)
\*Serious adverse events exclude those which were deemed to be unrelated to NV1020
|
|
Infections and infestations
Oral candidiasis
|
6.2%
2/32 • Number of events 2 • 3 years, 11 months (First subject enrolled to last subject completed)
\*Serious adverse events exclude those which were deemed to be unrelated to NV1020
|
|
Infections and infestations
Pneumonia
|
6.2%
2/32 • Number of events 2 • 3 years, 11 months (First subject enrolled to last subject completed)
\*Serious adverse events exclude those which were deemed to be unrelated to NV1020
|
|
Infections and infestations
Sinusitis
|
6.2%
2/32 • Number of events 2 • 3 years, 11 months (First subject enrolled to last subject completed)
\*Serious adverse events exclude those which were deemed to be unrelated to NV1020
|
|
Infections and infestations
Urinary tract infection
|
6.2%
2/32 • Number of events 2 • 3 years, 11 months (First subject enrolled to last subject completed)
\*Serious adverse events exclude those which were deemed to be unrelated to NV1020
|
|
Psychiatric disorders
Insomnia
|
21.9%
7/32 • Number of events 9 • 3 years, 11 months (First subject enrolled to last subject completed)
\*Serious adverse events exclude those which were deemed to be unrelated to NV1020
|
|
Psychiatric disorders
Depression
|
12.5%
4/32 • Number of events 4 • 3 years, 11 months (First subject enrolled to last subject completed)
\*Serious adverse events exclude those which were deemed to be unrelated to NV1020
|
|
Psychiatric disorders
Anxiety
|
9.4%
3/32 • Number of events 3 • 3 years, 11 months (First subject enrolled to last subject completed)
\*Serious adverse events exclude those which were deemed to be unrelated to NV1020
|
|
Psychiatric disorders
Confusional state
|
6.2%
2/32 • Number of events 2 • 3 years, 11 months (First subject enrolled to last subject completed)
\*Serious adverse events exclude those which were deemed to be unrelated to NV1020
|
|
Vascular disorders
Hypertension
|
15.6%
5/32 • Number of events 5 • 3 years, 11 months (First subject enrolled to last subject completed)
\*Serious adverse events exclude those which were deemed to be unrelated to NV1020
|
|
Vascular disorders
Hypotension
|
15.6%
5/32 • Number of events 9 • 3 years, 11 months (First subject enrolled to last subject completed)
\*Serious adverse events exclude those which were deemed to be unrelated to NV1020
|
|
Vascular disorders
Haematoma
|
12.5%
4/32 • Number of events 4 • 3 years, 11 months (First subject enrolled to last subject completed)
\*Serious adverse events exclude those which were deemed to be unrelated to NV1020
|
|
Investigations
Weight decreased
|
15.6%
5/32 • Number of events 7 • 3 years, 11 months (First subject enrolled to last subject completed)
\*Serious adverse events exclude those which were deemed to be unrelated to NV1020
|
|
Investigations
Aspartate aminotransferase increased
|
9.4%
3/32 • Number of events 6 • 3 years, 11 months (First subject enrolled to last subject completed)
\*Serious adverse events exclude those which were deemed to be unrelated to NV1020
|
|
Investigations
Gamma-glutamyltransferase increased
|
9.4%
3/32 • Number of events 6 • 3 years, 11 months (First subject enrolled to last subject completed)
\*Serious adverse events exclude those which were deemed to be unrelated to NV1020
|
|
Investigations
Fibrin D dimer increased
|
6.2%
2/32 • Number of events 2 • 3 years, 11 months (First subject enrolled to last subject completed)
\*Serious adverse events exclude those which were deemed to be unrelated to NV1020
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
9.4%
3/32 • Number of events 4 • 3 years, 11 months (First subject enrolled to last subject completed)
\*Serious adverse events exclude those which were deemed to be unrelated to NV1020
|
|
Hepatobiliary disorders
Jaundice
|
6.2%
2/32 • Number of events 2 • 3 years, 11 months (First subject enrolled to last subject completed)
\*Serious adverse events exclude those which were deemed to be unrelated to NV1020
|
|
Injury, poisoning and procedural complications
Incision site complication
|
6.2%
2/32 • Number of events 2 • 3 years, 11 months (First subject enrolled to last subject completed)
\*Serious adverse events exclude those which were deemed to be unrelated to NV1020
|
|
Injury, poisoning and procedural complications
Procedural pain
|
6.2%
2/32 • Number of events 4 • 3 years, 11 months (First subject enrolled to last subject completed)
\*Serious adverse events exclude those which were deemed to be unrelated to NV1020
|
|
Cardiac disorders
Tachycardia
|
12.5%
4/32 • Number of events 4 • 3 years, 11 months (First subject enrolled to last subject completed)
\*Serious adverse events exclude those which were deemed to be unrelated to NV1020
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm progression
|
6.2%
2/32 • Number of events 2 • 3 years, 11 months (First subject enrolled to last subject completed)
\*Serious adverse events exclude those which were deemed to be unrelated to NV1020
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place