Talimogene Laherparepvec in Patients With Unresectable Pancreatic Cancer

• ClinicalTrials.gov Identifier: NCT00402025
• Recruitment Status: Completed
• First Posted: November 22, 2006
• Results First Posted: April 15, 2016
• Last Update Posted: April 15, 2016
• Sponsor: BioVex Limited
• Information provided by (Responsible Party): BioVex Limited

• Study Type: Interventional
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Pancreatic Cancer
• Intervention: Biological: Talimogene Laherparepvec
• Enrollment: 17

Participant Flow

Recruitment Details	Participants were enrolled sequentially into each dose cohort.
Pre-assignment Details

Arm/Group Title	Talimogene Laherparepvec 10⁴/ 10⁵ PFU/mL	Talimogene Laherparepvec 10⁵ / 10⁶ PFU/mL	Talimogene Laherparepvec 10⁶ / 10⁷ PFU/mL
Arm/Group Description	Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁴plaque-forming units (PFU)/mL followed by 2 doses of 10⁵ PFU/mL, each 3 weeks apart. At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses.	Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁵ PFU/mL followed by 2 doses of 10⁶ PFU/mL, each 3 weeks apart. At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses.	Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁶ PFU/mL followed by 2 doses of 10⁷ PFU/mL, each 3 weeks apart. At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses.
Period Title: Overall Study
Started	3	4	10
Completed	1	1	0
Not Completed	2	3	10
Reason Not Completed
Adverse Event	0	0	2
Death	0	1	5
Disease Progression	1	1	2
Physician Decision	1	1	0
Participant Decision	0	0	1

Baseline Characteristics

Arm/Group Title		Talimogene Laherparepvec 10⁴/ 10⁵ PFU/mL	Talimogene Laherparepvec 10⁵ / 10⁶ PFU/mL	Talimogene Laherparepvec 10⁶ / 10⁷ PFU/mL	Total
Arm/Group Description		Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁴PFU/mL followed by 2 doses of 10⁵ PFU/mL, each 3 weeks apart. At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses.	Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁵ PFU/mL followed by 2 doses of 10⁶ PFU/mL, each 3 weeks apart. At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses.	Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁶ PFU/mL followed by 2 doses of 10⁷ PFU/mL, each 3 weeks apart. At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses.	Total of all reporting groups
Overall Number of Baseline Participants		3	4	10	17
Baseline Analysis Population Description		The Intention-to-Treat (ITT) population included all participants who received at least 1 dose of talimogene laherparepvec.
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	3 participants	4 participants	10 participants	17 participants
		54.7 (10.97)	63.8 (10.21)	50.8 (6.68)	54.5 (9.47)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	3 participants	4 participants	10 participants	17 participants
	Female	0 0.0%	3 75.0%	3 30.0%	6 35.3%
	Male	3 100.0%	1 25.0%	7 70.0%	11 64.7%
Race/Ethnicity, Customized; Measure Type: Number; Unit of measure: Participants	Number Analyzed	3 participants	4 participants	10 participants	17 participants
White		2	3	8	13
Black		1	1	0	2
Other		0	0	2	2
Eastern Cooperative Oncology Group (ECOG) Performance Status [1]; Measure Type: Number; Unit of measure: Participants	Number Analyzed	3 participants	4 participants	10 participants	17 participants
0 (Fully active)		1	0	2	3
1 (Restrictive but ambulatory)		1	3	7	11
2 (Ambulatory but unable to work)		1	1	1	3
		[1] Measure Description: Scale used to assess how a patient's disease is progressing, how the disease affects the daily living abilities of the patient: 0 = Fully active, able to carry on all pre-disease performance without restriction; 1 = Restricted in physically strenuous activity, ambulatory, able to carry out work of a light nature; 2 = Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about > 50% of waking hours; 3 = Capable of only limited self care, confined to a bed or chair > 50% of waking hours; 4 = Completely disabled, confined to bed or chair; 5 = Dead.

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Adverse Events
Description	A serious adverse event is defined as any untoward medical occurrence that at any dose results in death, is life threatening, requires hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, is an important and significant medical event that, based upon appropriate medical judgment, may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed above.
Time Frame	From first dose of talimogene laherparepvec until 30 days after the last dose; the median duration of treatment was 44.0 days, 22.0 days, and 11.5 days in each group respectively.

Outcome Measure Data

Analysis Population Description

ITT population

Arm/Group Title	Talimogene Laherparepvec 10⁴/ 10⁵ PFU/mL	Talimogene Laherparepvec 10⁵ / 10⁶ PFU/mL	Talimogene Laherparepvec 10⁶ / 10⁷ PFU/mL
Arm/Group Description:	Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁴PFU/mL followed by 2 doses of 10⁵ PFU/mL, each 3 weeks apart. At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses.	Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁵ PFU/mL followed by 2 doses of 10⁶ PFU/mL, each 3 weeks apart. At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses.	Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁶ PFU/mL followed by 2 doses of 10⁷ PFU/mL, each 3 weeks apart. At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses.
Overall Number of Participants Analyzed	3	4	10
Measure Type: Number; Unit of Measure: participants
Any adverse event	3	4	10
Serious adverse events	2	3	9
Deaths	1	1	6
Discontinued study treatment due to adverse event	0	0	2

2. Primary Outcome

Title	Number of Participants With Talimogene Laherparepvec Detected in Blood and Urine
Description	Samples of blood and urine collected before and up to 24 hours after dosing were tested for the presence of talimogene laherparepvec deoxyribonucleic acid (DNA) using a validated quantitative polymerase chain reaction (qPCR) assay.
Time Frame	Treatment Day 1 predose and 2, 6, 12 and 24 hours postdose, and Week 3 and 6 at (predose and 2 hours postdose.

Outcome Measure Data

Analysis Population Description

ITT population

Arm/Group Title	Talimogene Laherparepvec 10⁴/ 10⁵ PFU/mL	Talimogene Laherparepvec 10⁵ / 10⁶ PFU/mL	Talimogene Laherparepvec 10⁶ / 10⁷ PFU/mL
Arm/Group Description:	Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁴PFU/mL followed by 2 doses of 10⁵ PFU/mL, each 3 weeks apart. At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses.	Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁵ PFU/mL followed by 2 doses of 10⁶ PFU/mL, each 3 weeks apart. At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses.	Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁶ PFU/mL followed by 2 doses of 10⁷ PFU/mL, each 3 weeks apart. At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses.
Overall Number of Participants Analyzed	3	4	10
Measure Type: Number; Unit of Measure: participants
Blood	0	4	1
Urine	1	2	4

3. Primary Outcome

Title	Number of Participants Positive for Anti-herpes Simplex Virus-1 (HSV-1) Antibodies
Description	Anti-HSV-1 antibodies were detected using an enzyme-linked immunosorbent assay (ELISA).
Time Frame	Week 0 (Day 1, predose) and Week 3

Outcome Measure Data

Analysis Population Description

ITT population with available antibody results (indicated by N)

Arm/Group Title	Talimogene Laherparepvec 10⁴/ 10⁵ PFU/mL	Talimogene Laherparepvec 10⁵ / 10⁶ PFU/mL	Talimogene Laherparepvec 10⁶ / 10⁷ PFU/mL
Arm/Group Description:	Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁴PFU/mL followed by 2 doses of 10⁵ PFU/mL, each 3 weeks apart. At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses.	Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁵ PFU/mL followed by 2 doses of 10⁶ PFU/mL, each 3 weeks apart. At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses.	Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁶ PFU/mL followed by 2 doses of 10⁷ PFU/mL, each 3 weeks apart. At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses.
Overall Number of Participants Analyzed	3	4	10
Measure Type: Number; Unit of Measure: participants
Baseline (predose) (N= 3, 3, 8)	2	3	6
Week 3 (N=3, 3, 6)	3	3	6

4. Secondary Outcome

Title	Change From Baseline in Sum of Longest Diameters of Injected Tumors
Description	Spiral computed tomography (CT) scans were performed to assess tumors at screening and at Weeks 6, 12 and 18 after the initial dose.
Time Frame	Baseline and Week 6, 12 and 18

Outcome Measure Data

Analysis Population Description

ITT population with available data at each time point (indicated by "N").

Arm/Group Title	Talimogene Laherparepvec 10⁴/ 10⁵ PFU/mL	Talimogene Laherparepvec 10⁵ / 10⁶ PFU/mL	Talimogene Laherparepvec 10⁶ / 10⁷ PFU/mL
Arm/Group Description:	Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁴PFU/mL followed by 2 doses of 10⁵ PFU/mL, each 3 weeks apart. At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses.	Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁵ PFU/mL followed by 2 doses of 10⁶ PFU/mL, each 3 weeks apart. At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses.	Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁶ PFU/mL followed by 2 doses of 10⁷ PFU/mL, each 3 weeks apart. At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses.
Overall Number of Participants Analyzed	3	4	10
Mean (Standard Deviation); Unit of Measure: mm
Week 6 (N=2, 1, 4)	2.5 (3.54)	18.0 [1] (NA)	-3.3 (12.42)
Week 12 (N=1, 1, 0)	0.0 [1] (NA)	18.0 [1] (NA)	NA [2] (NA)
Week 18 (N=2, 2, 1)	11.5 (9.19)	25.5 (10.61)	37.0 [1] (NA)

[1]

Could not be calculated due to a sample size = 1

[2]

Could not be calculated due to a sample size = 0

5. Secondary Outcome

Title	Number of Participants With Overall Objective Response
Description	Tumor response was assessed via CT scan by the investigator using Response Evaluation Criteria In Solid Tumors (RECIST) v1.0 guidelines. Objective response is defined as a complete response (CR) or partial response (PR). CR: Disappearance of all target and non-target lesions, normalization of tumor marker level and no new lesions and with confirmation no less than 4 weeks after the criteria for CR is first met. PR: At least a 30% decrease in the sum of longest diameters of target lesions taking as reference the baseline sum of the longest diameters, absence of non-target lesion progression, and no new lesions. These criteria must be confirmed no less than 4 weeks after they are first met.
Time Frame	Every 6 weeks until 12 weeks after the last dose; the median duration of treatment was 44.0 days, 22.0 days, and 11.5 days in each group respectively.

Outcome Measure Data

Analysis Population Description

ITT population

Arm/Group Title	Talimogene Laherparepvec 10⁴/ 10⁵ PFU/mL	Talimogene Laherparepvec 10⁵ / 10⁶ PFU/mL	Talimogene Laherparepvec 10⁶ / 10⁷ PFU/mL
Arm/Group Description:	Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁴PFU/mL followed by 2 doses of 10⁵ PFU/mL, each 3 weeks apart. At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses.	Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁵ PFU/mL followed by 2 doses of 10⁶ PFU/mL, each 3 weeks apart. At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses.	Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁶ PFU/mL followed by 2 doses of 10⁷ PFU/mL, each 3 weeks apart. At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses.
Overall Number of Participants Analyzed	3	4	10
Measure Type: Number; Unit of Measure: participants
	0	0	0

6. Secondary Outcome

Title	Change From Baseline in Pain Intensity
Description	Pain was assessed by the participant using a validated Visual Analog Scale (VAS) pain assessment instrument. A single 10-cm line was used with the leftmost end (0 cm) representing "no pain" and the rightmost end (10 cm) representing "worst pain". The distance was measured from the leftmost part of the scale to the mark made by the participant indicating pain level.
Time Frame	Baseline and Weeks 3 and 6

Outcome Measure Data

Analysis Population Description

ITT population with available VAS data; this assessment was added in the third protocol amendment and change from baseline could only be assessed for participants in cohort 3.

Arm/Group Title	Talimogene Laherparepvec 10⁴/ 10⁵ PFU/mL	Talimogene Laherparepvec 10⁵ / 10⁶ PFU/mL	Talimogene Laherparepvec 10⁶ / 10⁷ PFU/mL
Arm/Group Description:	Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁴PFU/mL followed by 2 doses of 10⁵ PFU/mL, each 3 weeks apart. At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses.	Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁵ PFU/mL followed by 2 doses of 10⁶ PFU/mL, each 3 weeks apart. At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses.	Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁶ PFU/mL followed by 2 doses of 10⁷ PFU/mL, each 3 weeks apart. At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses.
Overall Number of Participants Analyzed	0	0	6
Mean (Standard Deviation); Unit of Measure: cm
Week 3 (N=0, 0, 6)			1.250 (2.456)
Week 6 (N=0, 0, 4)			2.575 (3.305)

Adverse Events

Time Frame	From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Adverse Event Reporting Description	Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Arm/Group Title	Talimogene Laherparepvec 10⁴/ 10⁵ PFU/mL	Talimogene Laherparepvec 10⁵ / 10⁶ PFU/mL	Talimogene Laherparepvec 10⁶ / 10⁷ PFU/mL
Arm/Group Description	Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁴PFU/mL followed by 2 doses of 10⁵ PFU/mL, each 3 weeks apart. At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses.	Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁵ PFU/mL followed by 2 doses of 10⁶ PFU/mL, each 3 weeks apart. At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses.	Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁶ PFU/mL followed by 2 doses of 10⁷ PFU/mL, each 3 weeks apart. At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses.
All-Cause Mortality
	Talimogene Laherparepvec 10⁴/ 10⁵ PFU/mL	Talimogene Laherparepvec 10⁵ / 10⁶ PFU/mL	Talimogene Laherparepvec 10⁶ / 10⁷ PFU/mL
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	--/--	--/--	--/--
Serious Adverse Events
	Talimogene Laherparepvec 10⁴/ 10⁵ PFU/mL	Talimogene Laherparepvec 10⁵ / 10⁶ PFU/mL	Talimogene Laherparepvec 10⁶ / 10⁷ PFU/mL
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	2/3 (66.67%)	3/4 (75.00%)	9/10 (90.00%)
Blood and lymphatic system disorders
ANAEMIA † 1	0/3 (0.00%)	0/4 (0.00%)	1/10 (10.00%)
LEUKOCYTOSIS † 1	0/3 (0.00%)	0/4 (0.00%)	1/10 (10.00%)
Cardiac disorders
ACUTE MYOCARDIAL INFARCTION † 1	0/3 (0.00%)	0/4 (0.00%)	1/10 (10.00%)
BRADYCARDIA † 1	0/3 (0.00%)	0/4 (0.00%)	1/10 (10.00%)
CARDIAC ARREST † 1	0/3 (0.00%)	0/4 (0.00%)	1/10 (10.00%)
TACHYCARDIA † 1	0/3 (0.00%)	0/4 (0.00%)	1/10 (10.00%)
Gastrointestinal disorders
ABDOMINAL PAIN † 1	0/3 (0.00%)	0/4 (0.00%)	2/10 (20.00%)
ASCITES † 1	1/3 (33.33%)	0/4 (0.00%)	3/10 (30.00%)
GASTROINTESTINAL HAEMORRHAGE † 1	0/3 (0.00%)	0/4 (0.00%)	1/10 (10.00%)
General disorders
CHEST PAIN † 1	0/3 (0.00%)	0/4 (0.00%)	1/10 (10.00%)
DISEASE PROGRESSION † 1	0/3 (0.00%)	1/4 (25.00%)	0/10 (0.00%)
GENERAL PHYSICAL HEALTH DETERIORATION † 1	0/3 (0.00%)	0/4 (0.00%)	3/10 (30.00%)
Infections and infestations
BACTERAEMIA † 1	1/3 (33.33%)	0/4 (0.00%)	0/10 (0.00%)
Metabolism and nutrition disorders
ACIDOSIS † 1	0/3 (0.00%)	0/4 (0.00%)	1/10 (10.00%)
DEHYDRATION † 1	1/3 (33.33%)	0/4 (0.00%)	1/10 (10.00%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTATIC PAIN † 1	0/3 (0.00%)	1/4 (25.00%)	0/10 (0.00%)
Psychiatric disorders
MENTAL STATUS CHANGES † 1	0/3 (0.00%)	1/4 (25.00%)	1/10 (10.00%)
Respiratory, thoracic and mediastinal disorders
ACUTE RESPIRATORY FAILURE † 1	0/3 (0.00%)	0/4 (0.00%)	1/10 (10.00%)
PULMONARY EMBOLISM † 1	0/3 (0.00%)	1/4 (25.00%)	2/10 (20.00%)
RESPIRATORY ARREST † 1	0/3 (0.00%)	0/4 (0.00%)	1/10 (10.00%)
RESPIRATORY FAILURE † 1	0/3 (0.00%)	0/4 (0.00%)	1/10 (10.00%)
Vascular disorders
HYPOTENSION † 1	0/3 (0.00%)	0/4 (0.00%)	1/10 (10.00%)
SUPERIOR MESENTERIC ARTERY SYNDROME † 1	0/3 (0.00%)	0/4 (0.00%)	1/10 (10.00%)
† Indicates events were collected by systematic assessment; 1 Term from vocabulary, MedDRA 11.1
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Talimogene Laherparepvec 10⁴/ 10⁵ PFU/mL	Talimogene Laherparepvec 10⁵ / 10⁶ PFU/mL	Talimogene Laherparepvec 10⁶ / 10⁷ PFU/mL
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	3/3 (100.00%)	4/4 (100.00%)	10/10 (100.00%)
Blood and lymphatic system disorders
ANAEMIA † 1	0/3 (0.00%)	2/4 (50.00%)	3/10 (30.00%)
SPLENOMEGALY † 1	0/3 (0.00%)	0/4 (0.00%)	1/10 (10.00%)
Cardiac disorders
SINUS TACHYCARDIA † 1	0/3 (0.00%)	1/4 (25.00%)	0/10 (0.00%)
TACHYCARDIA † 1	0/3 (0.00%)	0/4 (0.00%)	1/10 (10.00%)
Endocrine disorders
HYPOTHYROIDISM † 1	0/3 (0.00%)	0/4 (0.00%)	1/10 (10.00%)
Eye disorders
DRY EYE † 1	0/3 (0.00%)	0/4 (0.00%)	1/10 (10.00%)
Gastrointestinal disorders
ABDOMINAL DISTENSION † 1	0/3 (0.00%)	0/4 (0.00%)	3/10 (30.00%)
ABDOMINAL HERNIA † 1	0/3 (0.00%)	0/4 (0.00%)	1/10 (10.00%)
ABDOMINAL PAIN † 1	0/3 (0.00%)	0/4 (0.00%)	6/10 (60.00%)
ABDOMINAL PAIN UPPER † 1	1/3 (33.33%)	0/4 (0.00%)	0/10 (0.00%)
ANORECTAL DISORDER † 1	0/3 (0.00%)	0/4 (0.00%)	1/10 (10.00%)
ASCITES † 1	1/3 (33.33%)	0/4 (0.00%)	5/10 (50.00%)
COLITIS † 1	0/3 (0.00%)	0/4 (0.00%)	1/10 (10.00%)
CONSTIPATION † 1	0/3 (0.00%)	1/4 (25.00%)	5/10 (50.00%)
DIARRHOEA † 1	2/3 (66.67%)	0/4 (0.00%)	2/10 (20.00%)
FLATULENCE † 1	1/3 (33.33%)	0/4 (0.00%)	0/10 (0.00%)
GASTROINTESTINAL HAEMORRHAGE † 1	0/3 (0.00%)	0/4 (0.00%)	1/10 (10.00%)
GASTROINTESTINAL OEDEMA † 1	0/3 (0.00%)	0/4 (0.00%)	1/10 (10.00%)
GASTROOESOPHAGEAL REFLUX DISEASE † 1	0/3 (0.00%)	1/4 (25.00%)	1/10 (10.00%)
HIATUS HERNIA † 1	0/3 (0.00%)	0/4 (0.00%)	1/10 (10.00%)
ILEUS † 1	0/3 (0.00%)	0/4 (0.00%)	1/10 (10.00%)
INTESTINAL OBSTRUCTION † 1	0/3 (0.00%)	0/4 (0.00%)	1/10 (10.00%)
NAUSEA † 1	2/3 (66.67%)	0/4 (0.00%)	4/10 (40.00%)
PANCREATITIS † 1	0/3 (0.00%)	0/4 (0.00%)	1/10 (10.00%)
STEATORRHOEA † 1	1/3 (33.33%)	0/4 (0.00%)	0/10 (0.00%)
STOMACH DISCOMFORT † 1	1/3 (33.33%)	0/4 (0.00%)	0/10 (0.00%)
VOMITING † 1	1/3 (33.33%)	1/4 (25.00%)	3/10 (30.00%)
General disorders
ASTHENIA † 1	0/3 (0.00%)	0/4 (0.00%)	1/10 (10.00%)
CATHETER RELATED COMPLICATION † 1	0/3 (0.00%)	0/4 (0.00%)	1/10 (10.00%)
CHEST PAIN † 1	0/3 (0.00%)	0/4 (0.00%)	1/10 (10.00%)
CHILLS † 1	0/3 (0.00%)	0/4 (0.00%)	1/10 (10.00%)
FATIGUE † 1	0/3 (0.00%)	0/4 (0.00%)	1/10 (10.00%)
INFLUENZA LIKE ILLNESS † 1	0/3 (0.00%)	1/4 (25.00%)	1/10 (10.00%)
OEDEMA PERIPHERAL † 1	1/3 (33.33%)	0/4 (0.00%)	0/10 (0.00%)
PAIN † 1	1/3 (33.33%)	0/4 (0.00%)	2/10 (20.00%)
PYREXIA † 1	0/3 (0.00%)	1/4 (25.00%)	3/10 (30.00%)
Hepatobiliary disorders
BILE DUCT OBSTRUCTION † 1	0/3 (0.00%)	1/4 (25.00%)	0/10 (0.00%)
BILE DUCT STENOSIS † 1	1/3 (33.33%)	0/4 (0.00%)	0/10 (0.00%)
JAUNDICE † 1	1/3 (33.33%)	1/4 (25.00%)	0/10 (0.00%)
Immune system disorders
SEASONAL ALLERGY † 1	1/3 (33.33%)	0/4 (0.00%)	0/10 (0.00%)
Infections and infestations
ABDOMINAL INFECTION † 1	0/3 (0.00%)	1/4 (25.00%)	0/10 (0.00%)
CANDIDIASIS † 1	0/3 (0.00%)	1/4 (25.00%)	0/10 (0.00%)
INFECTION † 1	0/3 (0.00%)	1/4 (25.00%)	0/10 (0.00%)
UPPER RESPIRATORY TRACT INFECTION † 1	1/3 (33.33%)	0/4 (0.00%)	1/10 (10.00%)
URINARY TRACT INFECTION † 1	0/3 (0.00%)	0/4 (0.00%)	1/10 (10.00%)
Investigations
AMMONIA INCREASED † 1	0/3 (0.00%)	1/4 (25.00%)	0/10 (0.00%)
BLOOD ALKALINE PHOSPHATASE INCREASED † 1	1/3 (33.33%)	0/4 (0.00%)	1/10 (10.00%)
BLOOD AMYLASE INCREASED † 1	1/3 (33.33%)	0/4 (0.00%)	0/10 (0.00%)
BLOOD BILIRUBIN INCREASED † 1	0/3 (0.00%)	1/4 (25.00%)	0/10 (0.00%)
BLOOD CREATINE INCREASED † 1	1/3 (33.33%)	0/4 (0.00%)	0/10 (0.00%)
LIPASE INCREASED † 1	1/3 (33.33%)	0/4 (0.00%)	0/10 (0.00%)
LIVER FUNCTION TEST ABNORMAL † 1	0/3 (0.00%)	1/4 (25.00%)	0/10 (0.00%)
WEIGHT DECREASED † 1	0/3 (0.00%)	0/4 (0.00%)	1/10 (10.00%)
Metabolism and nutrition disorders
ANOREXIA † 1	0/3 (0.00%)	0/4 (0.00%)	2/10 (20.00%)
CACHEXIA † 1	0/3 (0.00%)	1/4 (25.00%)	0/10 (0.00%)
DECREASED APPETITE † 1	0/3 (0.00%)	0/4 (0.00%)	1/10 (10.00%)
DEHYDRATION † 1	2/3 (66.67%)	0/4 (0.00%)	4/10 (40.00%)
HYPOKALAEMIA † 1	1/3 (33.33%)	0/4 (0.00%)	1/10 (10.00%)
HYPOMAGNESAEMIA † 1	0/3 (0.00%)	0/4 (0.00%)	2/10 (20.00%)
Musculoskeletal and connective tissue disorders
BACK PAIN † 1	0/3 (0.00%)	0/4 (0.00%)	2/10 (20.00%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BASAL CELL CARCINOMA † 1	1/3 (33.33%)	0/4 (0.00%)	0/10 (0.00%)
Nervous system disorders
HEADACHE † 1	1/3 (33.33%)	0/4 (0.00%)	1/10 (10.00%)
HEPATIC ENCEPHALOPATHY † 1	0/3 (0.00%)	0/4 (0.00%)	1/10 (10.00%)
MEMORY IMPAIRMENT † 1	0/3 (0.00%)	0/4 (0.00%)	1/10 (10.00%)
SOMNOLENCE † 1	0/3 (0.00%)	1/4 (25.00%)	0/10 (0.00%)
SYNCOPE VASOVAGAL † 1	0/3 (0.00%)	0/4 (0.00%)	1/10 (10.00%)
Psychiatric disorders
AGITATION † 1	0/3 (0.00%)	0/4 (0.00%)	1/10 (10.00%)
ANXIETY † 1	0/3 (0.00%)	0/4 (0.00%)	1/10 (10.00%)
DELIRIUM † 1	0/3 (0.00%)	0/4 (0.00%)	1/10 (10.00%)
DEPRESSION † 1	0/3 (0.00%)	0/4 (0.00%)	1/10 (10.00%)
HALLUCINATION † 1	0/3 (0.00%)	0/4 (0.00%)	2/10 (20.00%)
INSOMNIA † 1	0/3 (0.00%)	0/4 (0.00%)	3/10 (30.00%)
Renal and urinary disorders
URINARY RETENTION † 1	0/3 (0.00%)	1/4 (25.00%)	0/10 (0.00%)
Respiratory, thoracic and mediastinal disorders
ATELECTASIS † 1	0/3 (0.00%)	1/4 (25.00%)	1/10 (10.00%)
COUGH † 1	0/3 (0.00%)	0/4 (0.00%)	1/10 (10.00%)
DYSPNOEA † 1	0/3 (0.00%)	0/4 (0.00%)	1/10 (10.00%)
HICCUPS † 1	0/3 (0.00%)	1/4 (25.00%)	0/10 (0.00%)
LUNG INFILTRATION † 1	0/3 (0.00%)	0/4 (0.00%)	1/10 (10.00%)
PLEURAL EFFUSION † 1	0/3 (0.00%)	0/4 (0.00%)	3/10 (30.00%)
THROAT IRRITATION † 1	0/3 (0.00%)	0/4 (0.00%)	1/10 (10.00%)
Surgical and medical procedures
HERNIA REPAIR † 1	0/3 (0.00%)	1/4 (25.00%)	0/10 (0.00%)
Vascular disorders
DEEP VEIN THROMBOSIS † 1	0/3 (0.00%)	0/4 (0.00%)	3/10 (30.00%)
HYPOTENSION † 1	0/3 (0.00%)	0/4 (0.00%)	1/10 (10.00%)
† Indicates events were collected by systematic assessment; 1 Term from vocabulary, MedDRA 11.1

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS 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.

The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.

Results Point of Contact

• Name/Title: Study Director
• Organization: Amgen, Inc.
• Phone: 866-572-6436

• Responsible Party: BioVex Limited
• ClinicalTrials.gov Identifier: NCT00402025
• Other Study ID Numbers: 005/04
• First Submitted: November 17, 2006
• First Posted: November 22, 2006
• Results First Submitted: November 19, 2015
• Results First Posted: April 15, 2016
• Last Update Posted: April 15, 2016