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Safety & Efficacy of NV1020 in Colorectal Cancer Metastatic to the Liver

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00149396
Recruitment Status : Completed
First Posted : September 8, 2005
Results First Posted : April 24, 2018
Last Update Posted : April 24, 2018
Sponsor:
Information provided by (Responsible Party):
MediGene

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Colorectal Cancer
Liver Neoplasms
Intervention Drug: NV1020
Enrollment 32

Recruitment Details  
Pre-assignment Details  
Arm/Group Title NV1020
Hide Arm/Group Description Escalating doses of NV1020: 3x10^6, 1x10^7, 3x10^7, 1x10^8
Period Title: Overall Study
Started 32
Completed NV1020 Therapy 29
Completed NV1020 and Chemotherapy 9
Completed 9
Not Completed 23
Reason Not Completed
Death             15
Withdrawal by Subject             1
Subject noncompliance             2
other treatment             5
Arm/Group Title NV1020
Hide Arm/Group Description Escalating doses of NV1020: 3x10^6, 1x10^7, 3x10^7, 1x10^8
Overall Number of Baseline Participants 32
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 32 participants
57.7  (11.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants
Female
11
  34.4%
Male
21
  65.6%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 32 participants
Caucasian 29
African American 1
Asian 1
Hispanic 1
Carcinoembryonic Antigen (CEA) Level at Screening  
Mean (Standard Deviation)
Unit of measure:  ng/mL
Number Analyzed 32 participants
175.5  (517.4)
Prior Chemotherapy  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 32 participants
32
Karnofsky Performance Status (KPS)   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 32 participants
KPS 100 14
KPS 90 17
KPS 80 1
[1]
Measure Description:

The KPS was rated as follows:

100 - Normal, no complaints, no evidence of disease; 90 - Able to carry on normal activity; minor signs or symptoms of disease; 80 - Normal activity with effort; some signs or symptoms of disease

1.Primary Outcome
Title Incidence of Adverse Events and Dose Limiting Adverse Events
Hide Description Incidence of adverse events for all patients (N=32); Overall incidence ≥20%; Adverse events listed by Medical Dictionary for Regulatory Activities (MedDRA) Preferred Term
Time Frame From start of treatment through 12 months after completion of treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Patients
Hide Arm/Group Description:
All patients in study
Overall Number of Participants Analyzed 32
Measure Type: Number
Unit of Measure: percentage of participants
Dose limiting adverse events 0
Nausea 69
Abdominal pain 47
Diarrhea 44
Vomiting 41
Abdominal pain upper 25
Constipation 22
Pyrexia 94
Chills 56
Fatigue 56
Edema peripheral 22
Back pain 34
Headache 41
Anemia 41
Neutropenia 22
Rash 28
Hypokalemia 22
Insomnia 22
2.Primary Outcome
Title NV1020 Pharmacokinetics - Presence of NV1020 in Body Fluids/Skin
Hide Description Number of patients with NV1020 detected in saliva, skin, and/or mucosal surfaces; Analysis by polymerase chain reaction (PCR)
Time Frame Daily for 2 weeks after the first and last NV1020 infusions
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Patients
Hide Arm/Group Description:
All patients in study
Overall Number of Participants Analyzed 32
Measure Type: Number
Unit of Measure: participants
0
3.Primary Outcome
Title Clinical Laboratory Safety - Hematology
Hide Description Number of patients with clinically significant hematology laboratory abnormalities by NV1020 dose cohort (Post baseline)
Time Frame 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 treatment
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dose Cohort 1 Dose Cohort 2 Dose Cohort 3 Dose Cohort 4
Hide Arm/Group Description:
NV1020 Dose 3x10^6 pfu (Stage 1)
NV1020 Dose: 1x10^7 pfu (Stage 1)
NV1020 Dose 3x10^7 pfu (Stage 1)
NV1020 Dose 1x10^8 pfu (Stages 1 and 2)
Overall Number of Participants Analyzed 3 3 4 22
Measure Type: Number
Unit of Measure: participants
Absolute neutrophil count (x10^3/uL) 1 0 0 0
Basophils (%) 0 0 0 1
Eosinophils (%) 0 0 0 2
Hematocrit (%) 0 1 0 3
Hemoglobin (g/dL) 0 1 0 3
Lymphocytes (%) 1 0 0 1
Monocytes (%) 1 1 0 1
Neutrophils (bands) (%) 1 0 0 0
Neutrophils (segs) (%) 1 0 0 2
Platelets (x10^3/uL) 0 0 0 3
Red blood cells (x10^6/uL) 0 0 0 1
White blood cells (x10^3/uL) 1 0 0 7
4.Primary Outcome
Title Clinical Laboratory Safety - Chemistry
Hide Description Number of patients with post-baseline clinically significant laboratory chemistry abnormalities by NV1020 dose cohort
Time Frame 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 treatment
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dose Cohort 1 Dose Cohort 2 Dose Cohort 3 Dose Cohort 4
Hide Arm/Group Description:
NV1020 Dose 3x10^6 pfu (Stage 1)
NV1020 Dose 1x10^7 pfu (Stage 1)
NV1020 Dose 3x10^7 pfu (Stage 1)
NV1020 Dose 1x10^8 pfu (Stages 1 and 2)
Overall Number of Participants Analyzed 3 3 4 22
Measure Type: Number
Unit of Measure: participants
Alkaline Phosphatase (U/L) 2 2 0 8
ALT (SGPT) (U/L) 0 0 0 6
AST (SGOT) (U/L) 1 0 0 6
Bicarbonate (mmol/L) 0 0 0 1
BUN (mg/dL) 0 1 0 0
Calcium (mg/dL) 0 0 0 0
Chloride (mmol/L) 0 0 0 1
Creatinine (mg/dL) 1 1 0 0
Glucose (mg/dL) 1 1 0 0
Potassium (mmol/L) 0 1 0 4
Sodium (mmol/L) 0 0 0 0
Total Bilirubin (mg/dL) 1 0 0 5
YGT/GGT (U/L) 2 2 0 5
5.Primary Outcome
Title Clinical Laboratory Safety - Coagulation
Hide Description Number of patients with post-baseline clinically significant laboratory coagulation abnormalities by NV1020 dose cohort
Time Frame 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 treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dose Cohort 1 Dose Cohort 2 Dose Cohort 3 Dose Cohort 4
Hide Arm/Group Description:
NV1020 Dose 3x10^6 pfu (Stage 1)
NV1020 Dose 1x10^7 pfu (Stage 1)
NV1020 Dose 3x10^7 pfu (Stage 1)
NV1020 Dose 1x10^8 pfu (Stages 1 and 2)
Overall Number of Participants Analyzed 3 3 4 22
Measure Type: Number
Unit of Measure: participants
C-reactive Protein (mg/dL) 1 1 0 6
D-dimer (ug/mL) 2 1 0 6
Fibrinogen (ug/mL) 2 0 0 4
INR 0 0 0 0
Prothrombin Time (PT) (sec) 0 0 0 3
Partial Thromboplastin Time (PTT) (sec) 1 0 0 3
6.Secondary Outcome
Title Mean Change From Baseline in Serum Carcinoembryonic Antigen (CEA) After Administration of NV1020 and 2 Cycles of Chemotherapy
Hide Description [Not Specified]
Time Frame 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)
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Hide Analysis Population Description
Number of participants analyzed decreases through the follow-up visits. Thus the "Number of Participants Analyzed" indicated here refer to the number at baseline.
Arm/Group Title Dose Cohort 1 Dose Cohort 2 Dose Cohort 3 Dose Cohort 4
Hide Arm/Group Description:
NV1020 Dose 3x10^6 pfu (Stage 1)
NV1020 Dose 1x10^7 pfu (Stage 1)
NV1020 Dose 3x10^7 pfu (Stage 1)
NV1020 Dose 1x10^8 pfu (Stages 1 and 2)
Overall Number of Participants Analyzed 3 3 4 22
Mean (Standard Deviation)
Unit of Measure: ng/mL
Mean Baseline CEA 1814.4  (3105.2) 161.0  (235.1) 121.6  (230.3) 181.7  (373.3)
Mean Change - Chemo visit 1 869.6  (1489.9) 96.0  (106.1) 8.6  (17.0) 165.6  (410.5)
Mean Change - Chemo visit 2 17.9  (13.2) 194.4  (212.8) -0.6 [1]   (NA) 98.2  (254.1)
Mean Change - Follow-up 1 -353.9  (628.8) 615.6  (867.5) 5.4  (5.8) 97.0  (334.1)
Mean Change - Follow-up 2 6995.9  (12110.6) 134.7 [1]   (NA) 1.8  (3.5) 97.3  (311.9)
Mean Change - Follow-up 3 NA [2]   (NA) NA [2]   (NA) 16.5 [1]   (NA) -52.3  (94.9)
Mean Change - Follow-up 4 NA [2]   (NA) NA [2]   (NA) -1.7 [1]   (NA) 290.9  (447.8)
[1]
N=1 for this timepoint
[2]
N=0 for this timepoint
7.Secondary Outcome
Title Liver Tumor Response After Administration of NV1020 Followed by Chemotherapy, Determined by Radiological (Computed Tomography [CT] Scan) Assessment
Hide Description 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
Time Frame Screening (baseline), Chemo visit 1, Follow-up visits 1 (1 week post end of treatment), 2 (+6M), 3 (+9M), 4 (+12M)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Stage 1 Stage 2
Hide Arm/Group Description:
Escalating doses of NV1020: 3x10^6 pfu, 1x10^7 pfu, 3x10^7 pfu, 1x10^8 pfu
Optimal dose from Stage 1: 1x10^8 pfu
Overall Number of Participants Analyzed 13 19
Measure Type: Number
Unit of Measure: percentage
Patient 101 22.70 NA [1] 
Patient 102 41.76 NA [1] 
Patient 103 18.85 NA [1] 
Patient 201 36.91 NA [1] 
Patient 202 21.55 NA [1] 
Patient 203 25.00 NA [1] 
Patient 301 4.92 NA [1] 
Patient 302 24.55 NA [1] 
Patient 303 10.74 NA [1] 
Patient 304 2.68 NA [1] 
Patient 401 -24.51 NA [1] 
Patient 402 -5.36 NA [1] 
Patient 403 -7.98 NA [1] 
Patient 801 NA [2]  5.45
Patient 802 NA [2]  35.89
Patient 803 NA [2]  -35.56
Patient 804 NA [2]  21.43
Patient 805 NA [2]  11.41
Patient 806 NA [2]  18.90
Patient 807 NA [2]  29.98
Patient 808 NA [2]  16.77
Patient 809 NA [2]  30.00
Patient 810 NA [2]  57.67
Patient 811 NA [2]  -1.93
Patient 812 NA [2]  -19.05
Patient 813 NA [2]  25.29
Patient 814 NA [2]  114.29
Patient 815 NA [2]  9.38
Patient 816 NA [2]  12.20
Patient 817 NA [2]  3.30
Patient 818 NA [2]  -11.19
Patient 819 NA [2]  -24.18
[1]
This patient not in Stage 2 of study
[2]
This patient not in Stage 1 of study
8.Secondary Outcome
Title Pharmacodynamic Effects of NV1020: NV1020 Neutralizing Antibody Titer Assay
Hide Description Mean change from baseline in NV1020 neutralizing antibody titer by dose cohort
Time Frame Screening, Chemo Visit 1, Follow-up Visits 1 (1 week post end of treatment), 2 (+6M), 3 (+9M), 4 (+12M)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dose Cohort 1 Dose Cohort 2 Dose Cohort 3 Dose Cohort 4
Hide Arm/Group Description:
NV1020 Dose 3x10^6 pfu (Stage 1)
NV1020 Dose 1x10^7 pfu (Stage 1)
NV1020 Dose 3x10^7 pfu (Stage 1)
NV1020 Dose 1x10^8 pfu (Stages 1 and 2)
Overall Number of Participants Analyzed 3 3 4 22
Mean (Standard Deviation)
Unit of Measure: antibody titer
Mean Baseline Neutralizing Antibody 282.7  (96.4) 1242.7  (1585.2) 1006.6  (844.6) 334.2  (309.1)
Mean Change - Chemotherapy Visit 1 1341  (914) 1061  (1430) 4926  (1444) 3481  (2251)
Mean Change - Follow-up Visit 1 1231  (1382) 950  (1344) 2154  (473) 2389  (1736)
Mean Change - Follow-up Visit 2 824  (622) 1152 [1]   (NA) 1887  (1133) 1292  (1245)
Mean Change - Follow-up Visit 3 NA [2]   (NA) NA [2]   (NA) 450 [1]   (NA) 1029  (863)
Mean Change - Follow-up Visit 4 NA [2]   (NA) NA [2]   (NA) -543.1 [1]   (NA) 403  (374)
[1]
N=1 for this timepoint
[2]
N=0 for this timepoint
9.Secondary Outcome
Title Time to Disease Progression; Survival Time
Hide Description Progression 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.
Time Frame Progression: Chemo visit 1, FU1 (1 week post treatment), FU2 (+6M), FU3 (+9M), FU4 (+12M); Survival: death of patient
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Stage 1 Stage 2
Hide Arm/Group Description:
Escalating doses of NV1020: 3x10^6 pfu, 1x10^7 pfu, 3x10^7 pfu, 1x10^8 pfu
Optimal dose from Stage 1: 1x10^8 pfu
Overall Number of Participants Analyzed 13 19
Median (95% Confidence Interval)
Unit of Measure: months
Median time to progression
3.5
(2.8 to 6.9)
6.4
(2 to 8.9)
Median survival time
12.4
(9.6 to 15.0)
11.6
(8.3 to 20.7)
10.Secondary Outcome
Title Pharmacodynamic Effects of NV1020: Serum Cytokines (INF Gamma)
Hide Description Median change from baseline of Interferon (INF) gamma 8 hours post NV1020 infusion (Visits 1, 3, 5, 7)
Time Frame Baseline, after each NV1020 infusion (Visit 1, Visit 3, Visit 5, Visit 7)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dose Cohort 1 Dose Cohort 2 Dose Cohort 3 Dose Cohort 4
Hide Arm/Group Description:
NV1020 Dose 3x10^6 pfu (Stage 1)
NV1020 Dose 1x10^7 pfu (Stage 1)
NV1020 Dose 3x10^7 pfu (Stage 1)
NV1020 Dose 1x10^8 pfu (Stages 1 and 2)
Overall Number of Participants Analyzed 3 3 4 22
Median (Full Range)
Unit of Measure: pg/mL
Median Baseline INF gamma
1.1
(0.6 to 1.9)
0.9
(0.6 to 1.7)
0.7
(0.6 to 1.3)
0.6
(0.6 to 15.0)
Median Change - Visit 1 (post 8 hr)
5.8
(0.1 to 6.0)
0.5
(-1.1 to 0.5)
4.7
(3.0 to 6.0)
22.9
(0.0 to 169.4)
Median Change - Visit 3 (post 8 hr)
7.7
(2.9 to 42.1)
0.8
(-1.1 to 6.3)
36.0
(15.9 to 111.4)
51.8
(0.2 to 433.4)
Median Change - Visit 5 (post 8 hr)
2.5
(1.5 to 3.5)
0.2
(-0.8 to 4.0)
10.3
(9.7 to 64.4)
18.8
(1.3 to 281.4)
Median Change - Visit 7 (post 8 hr)
1.3
(0.3 to 3.3)
-0.3
(-1.1 to 3.9)
7.6
(4.3 to 13.0)
18.1
(1.4 to 327.8)
11.Secondary Outcome
Title Pharmacodynamic Effects of NV1020: Serum Cytokines (IL-6)
Hide Description Median change from baseline of Interleukin-6 (IL-6) 8 hours post NV1020 infusion (Visits 1, 3, 5, 7)
Time Frame Baseline, after each NV1020 infusion (Visit 1, Visit 3, Visit 5, Visit 7)
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dose Cohort 1 Dose Cohort 2 Dose Cohort 3 Dose Cohort 4
Hide Arm/Group Description:
NV1020 Dose 3x10^6 pfu (Stage 1)
NV1020 Dose 1x10^7 pfu (Stage 1)
NV1020 Dose 3x10^7 pfu (Stage 1)
NV1020 Dose 1x10^8 pfu (Stages 1 and 2)
Overall Number of Participants Analyzed 3 3 4 22
Median (Full Range)
Unit of Measure: pg/mL
Median Baseline IL-6
6.9
(4.2 to 8.3)
11.0
(6.5 to 12.0)
15.5
(3.7 to 31.0)
6.2
(1.6 to 169.0)
Median change - Visit 1 (post 8 hr)
1.7
(-4.8 to 27.8)
6.0
(0.0 to 19.0)
16.5
(3.8 to 57.0)
32.1
(-0.4 to 497.2)
Median change - Visit 3 (post 8 hr)
29.8
(16.1 to 194.7)
3.0
(2.0 to 13.5)
50.2
(34.0 to 475.0)
60.6
(1.7 to 989.0)
Median change - Visit 5 (post 8 hr)
12.1
(8.8 to 26.7)
14.5
(8.0 to 49.0)
63.0
(17.3 to 102.0)
32.2
(2.4 to 371.0)
Median change - Visit 7 (post 8 hr)
34.7
(19.1 to 44.8)
8.5
(8.0 to 49.0)
11.3
(10.0 to 62.0)
43.0
(8.0 to 433.0)
12.Secondary Outcome
Title Pharmacodynamic Effects of NV1020: Serum Cytokines (TNF-alpha)
Hide Description Median change from baseline of tumor necrosis factor (TNF-alpha) 8 hours post NV1020 infusion (Visits 1, 3, 5, 7)
Time Frame Baseline, after each NV1020 infusion (Visit 1, Visit 3, Visit 5, Visit 7)
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dose Cohort 1 Dose Cohort 2 Dose Cohort 3 Dose Cohort 4
Hide Arm/Group Description:
NV1020 Dose 3x10^6 pfu (Stage 1)
NV1020 Dose 1x10^7 pfu (Stage 1)
NV1020 Dose 3x10^7 pfu (Stage 1)
NV1020 Dose 1x10^8 pfu (Stages 1 and 2)
Overall Number of Participants Analyzed 3 3 4 22
Median (Full Range)
Unit of Measure: pg/mL
Median Baseline TNF-alpha
1.8
(0.6 to 2.9)
2.0
(1.6 to 2.2)
2.5
(1.8 to 4.9)
1.3
(0.6 to 3.6)
Median change - Visit 1 (post 8 hr)
0.2
(-8.0 to 3.8)
1.4
(0.2 to 4.1)
-0.2
(-2.5 to 0.6)
2.4
(-0.9 to 6.6)
Median change - Visit 3 (post 8 hr)
3.6
(0.2 to 7.1)
0.4
(0.0 to 1.5)
2.3
(1.3 to 3.9)
5.9
(0.3 to 22.0)
Median change - Visit 5 (post 8 hr)
2.3
(1.0 to 3.3)
1.3
(-0.7 to 1.4)
1.8
(1.1 to 2.2)
5.5
(0.9 to 14.0)
Median change - Visit 7 (post 8 hr)
2.2
(0.9 to 2.7)
1.5
(-0.8 to 2.4)
0.8
(0.7 to 5.4)
5.7
(1.4 to 11.3)
Time Frame 3 years, 11 months (First subject enrolled to last subject completed)
Adverse Event Reporting Description *Serious adverse events exclude those which were deemed to be unrelated to NV1020
 
Arm/Group Title NV1020
Hide Arm/Group Description Escalating doses of NV1020: 3x10^6, 1x10^7, 3x10^7, 1x10^8
All-Cause Mortality
NV1020
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
NV1020
Affected / at Risk (%) # Events
Total   5/32 (15.63%)    
Blood and lymphatic system disorders   
Febrile neutropenia *  1/32 (3.13%)  1
Gastrointestinal disorders   
Vomiting *  2/32 (6.25%)  3
Diarrhoea *  1/32 (3.13%)  2
Nausea *  2/32 (6.25%)  2
Abdominal pain *  2/32 (6.25%)  2
General disorders   
Pyrexia *  1/32 (3.13%)  1
Chest pain *  1/32 (3.13%)  1
Hepatobiliary disorders   
Bile duct obstruction *  1/32 (3.13%)  1
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
NV1020
Affected / at Risk (%) # Events
Total   32/32 (100.00%)    
Blood and lymphatic system disorders   
Anaemia *  13/32 (40.63%)  24
Neurtopenia *  7/32 (21.88%)  9
Leukopenia *  2/32 (6.25%)  4
Lymphopenia *  2/32 (6.25%)  15
Thrombocytopenia *  2/32 (6.25%)  2
Cardiac disorders   
Tachycardia *  4/32 (12.50%)  4
Gastrointestinal disorders   
Nausea *  22/32 (68.75%)  50
Abdominal pain *  15/32 (46.88%)  27
Diarrhoea *  14/32 (43.75%)  29
Vomiting *  13/32 (40.63%)  30
Abdominal pain upper *  8/32 (25.00%)  10
Constipation *  7/32 (21.88%)  7
Abdominal distension *  6/32 (18.75%)  6
Abdonimal tenderness *  4/32 (12.50%)  4
Dyspepsia *  4/32 (12.50%)  4
Gastroesophageal reflux disease *  4/32 (12.50%)  4
Flatulence *  3/32 (9.38%)  3
Stomatitis *  3/32 (9.38%)  3
Abdominal discomfort *  2/32 (6.25%)  2
Ascites *  2/32 (6.25%)  2
Dry mouth *  2/32 (6.25%)  2
General disorders   
Pyrexia *  30/32 (93.75%)  111
Chills *  18/32 (56.25%)  41
Fatigue *  18/32 (56.25%)  36
Edema peripheral *  7/32 (21.88%)  9
Asthenia *  3/32 (9.38%)  4
Chest pain *  3/32 (9.38%)  3
Pain *  3/32 (9.38%)  3
Disease progression *  2/32 (6.25%)  2
Edema *  2/32 (6.25%)  2
Temperature intolerance *  2/32 (6.25%)  2
Hepatobiliary disorders   
Hyperbilirubinaemia *  3/32 (9.38%)  4
Jaundice *  2/32 (6.25%)  2
Infections and infestations   
Herpes simplex *  3/32 (9.38%)  3
Bronchitis *  2/32 (6.25%)  2
Oral candidiasis *  2/32 (6.25%)  2
Pneumonia *  2/32 (6.25%)  2
Sinusitis *  2/32 (6.25%)  2
Urinary tract infection *  2/32 (6.25%)  2
Injury, poisoning and procedural complications   
Incision site complication *  2/32 (6.25%)  2
Procedural pain *  2/32 (6.25%)  4
Investigations   
Weight decreased *  5/32 (15.63%)  7
Aspartate aminotransferase increased *  3/32 (9.38%)  6
Gamma-glutamyltransferase increased *  3/32 (9.38%)  6
Fibrin D dimer increased *  2/32 (6.25%)  2
Metabolism and nutrition disorders   
Hypokalaemia *  7/32 (21.88%)  14
Dehydration *  4/32 (12.50%)  4
Hyponatraemia *  3/32 (9.38%)  6
Anorexia *  2/32 (6.25%)  2
Decreased appetite *  2/32 (6.25%)  2
Hypoalbuminaenemia *  2/32 (6.25%)  2
Hypomagnesaemia *  2/32 (6.25%)  2
Musculoskeletal and connective tissue disorders   
Back pain *  11/32 (34.38%)  19
Pain in extremity *  4/32 (12.50%)  7
Myalgia *  3/32 (9.38%)  6
Groin pain *  2/32 (6.25%)  3
Musculoskeletal discomfort *  2/32 (6.25%)  2
Neck pain *  2/32 (6.25%)  2
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Neoplasm progression *  2/32 (6.25%)  2
Nervous system disorders   
Headache *  13/32 (40.63%)  20
Dizziness *  4/32 (12.50%)  5
Hypoaesthesia *  3/32 (9.38%)  3
Neuropathy peripheral *  2/32 (6.25%)  2
Psychiatric disorders   
Insomnia *  7/32 (21.88%)  9
Depression *  4/32 (12.50%)  4
Anxiety *  3/32 (9.38%)  3
Confusional state *  2/32 (6.25%)  2
Respiratory, thoracic and mediastinal disorders   
Dyspnoea *  5/32 (15.63%)  9
Epistaxis *  3/32 (9.38%)  3
Pharyngolaryngeal pain *  2/32 (6.25%)  2
Pleural effusion *  2/32 (6.25%)  2
Skin and subcutaneous tissue disorders   
Rash *  9/32 (28.13%)  10
Ecchymosis *  3/32 (9.38%)  3
Palmar-plantar erythrodysaesthesia syndrome *  3/32 (9.38%)  3
Dermatitis acneiform *  2/32 (6.25%)  3
Erythema *  2/32 (6.25%)  2
Hyperhidrosis *  2/32 (6.25%)  5
Pruritus *  2/32 (6.25%)  3
Rash macular *  2/32 (6.25%)  2
Vascular disorders   
Hypertension *  5/32 (15.63%)  5
Hypotension *  5/32 (15.63%)  9
Haematoma *  4/32 (12.50%)  4
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Associate Director Regulatory Affairs
Organization: Medigene
Phone: 858-586-2252
Responsible Party: MediGene
ClinicalTrials.gov Identifier: NCT00149396     History of Changes
Other Study ID Numbers: CT1030
First Submitted: September 6, 2005
First Posted: September 8, 2005
Results First Submitted: December 29, 2015
Results First Posted: April 24, 2018
Last Update Posted: April 24, 2018