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Intravesical Administration of rAd-IFN/Syn3 in Patients With BCG-Refractory or Relapsed Bladder Cancer

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: NCT01687244
Recruitment Status : Completed
First Posted : September 18, 2012
Results First Posted : May 30, 2017
Last Update Posted : July 24, 2017
Sponsor:
Information provided by (Responsible Party):
FKD Therapies Oy

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition Superficial Bladder Cancer
Intervention Drug: INSTILADRIN
Enrollment 40
Recruitment Details  
Pre-assignment Details  
Arm/Group Title rAd-IFN Dose 1x10^11vps/ml rAd-IFN Dose 3x10^11 Vps/ml
Hide Arm/Group Description

Patients were randomized to the 1x10^11vps/ml rAd-IFN/Syn3 arm.

A 75 mL dose of rAd-IFN/Syn3 was given as a single, one-hour intravesical administration and, depending on clinical response, was repeated every 90 Days up to a maximum of 4 instilations.

Patients were randomized to the 3x10^11vps/ml rAd-IFN/Syn3 arm.

A 75 mL dose of rAd-IFN/Syn3 was given as a single, one-hour intravesical administration and, depending on clinical response, was repeated every 90 Days up to a maximum of 4 instilations.

Period Title: Overall Study
Started 21 19
Completed 21 19
Not Completed 0 0
Arm/Group Title rAd-IFN Dose 1x10^11vps/ml rAd-IFN Dose 3x10^11 Vps/ml Total
Hide Arm/Group Description Patients were randomly assigned to the 1x10^11vps/ml of rAd-IFN/Syn3 arm. Patients were randomly assigned to the 3x10^11vps/ml of rAd-IFN/Syn3 arm. Total of all reporting groups
Overall Number of Baseline Participants 21 19 40
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 19 participants 40 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
2
   9.5%
7
  36.8%
9
  22.5%
>=65 years
19
  90.5%
12
  63.2%
31
  77.5%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 21 participants 19 participants 40 participants
71.6  (8.07) 71.1  (9.42) 71.1  (9.42)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 19 participants 40 participants
Female
2
   9.5%
5
  26.3%
7
  17.5%
Male
19
  90.5%
14
  73.7%
33
  82.5%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 21 participants 19 participants 40 participants
21
 100.0%
19
 100.0%
40
 100.0%
1.Primary Outcome
Title Incidence of High Grade-Recurrence Free Survival at 360 Days
Hide Description Following the initial treatment, patients were clinically evaluated and re-treated at the Days 90, 180, and 270 time points, as outlined below. The decision to repeat treatment was determined by the clinical response observed following the previous treatment(s). Patients were assessed for High-Grade disease recurrence by cytology, cystoscopy and, if clinically indicated, biopsies were performed to obtain accurate staging. If no evidence of recurrence of High-Grade disease was detected, then a further dose of rAd-IFN/Syn3 was administered as maintenance therapy. Patients who had recurrence of High-Grade disease were withdrawn from treatment but were followed for survival and time to cystectomy. At 360 Days, a final efficacy evaluation was performed for patients receiving 4 doses of drug. This included cystoscopy, cytology, and biopsy.
Time Frame 360 Days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title rAd-IFN Dose 1x10^11 Vps/ml rAd-IFN Dose 3x10^11vps/ml
Hide Arm/Group Description:
Subjects were randomly assigned to the 1x10^11 vps/mI rAd-IFN/Syn3 arm.
Patients were randomly assigned to the 3x10^11vps/ml rAd-IFN/Syn3 arm.
Overall Number of Participants Analyzed 21 19
Measure Type: Count of Participants
Unit of Measure: Participants
7
  33.3%
7
  36.8%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection rAd-IFN Dose 3x10^11vps/ml
Comments The primary efficacy endpoint was the incidence of high-grade recurrence-free survival at 12 months. The proportion of patients achieving high-grade recurrence-free survival at 12 months was reported for each dose group, together with an exact 90% confidence interval for the proportion
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter HGRF survival at 12 months
Estimated Value 33.3
Confidence Interval (2-Sided) 90%
16.8 to 53.6
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection rAd-IFN Dose 1x10^11 Vps/ml
Comments The primary efficacy endpoint was the incidence of high-grade recurrence-free survival at 12 months. The proportion of patients achieving high-grade recurrence-free survival at 12 months was reported for each dose group, together with an exact 90% confidence interval for the proportion.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter HGRF survival at 12 months
Estimated Value 36.8
Confidence Interval (2-Sided) 90%
18.8 to 58.2
Estimation Comments The proportion of subjects achieving high-grade recurrence-free survival at 12 months
2.Secondary Outcome
Title Safety of rAd-IFN/Syn3
Hide Description Treatment Emergent Adverse Events (AEs) for patients receiving study drug were described by NCI-CTCAE V4.03 terminology according to System Organ Class.
Time Frame 360 Days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title rAd-IFN Dose 1x10^11vps/ml rAd-IFN Dose 3x10^11 Vps/ml
Hide Arm/Group Description:
Patients were randomly assigned to the 1x10^11vps/ml rAd-IFN/Syn3 arm.
Patients were randomly assigned to the 3x10^11 vps/ml rAd-IFN/Syn3 arm.
Overall Number of Participants Analyzed 21 19
Measure Type: Count of Participants
Unit of Measure: Participants
20
  95.2%
19
 100.0%
3.Secondary Outcome
Title Incidence of High Grade Recurrence-Free Survival at 3 Months (90 Days).
Hide Description All patients were evaluated 3 Months (90 Days) after the start of treatment for recurrence of high grade disease by cytology, cystoscopy, and biopsy if clinically indicated. Patients that we free of High-Grade disease recurrence received another dose. Data are presented as the number and percent of patients with High-Grade disease recurrence.
Time Frame 90 Days
Hide Outcome Measure Data
Hide Analysis Population Description
All patients at 90 Days were assessed for High-Grade disease by cytology, cystoscopy, and biopsy if clinically indicated.
Arm/Group Title rAd-IFN Dose 1x10^11 Vps/ml rAd-IFN Dose 3x10^11vps/ml
Hide Arm/Group Description:
Patients were randomly assigned to the 1x10^11 vps/ml rAd-IFN/Syn3 arm.
Patients were randomly assigned to the 3x10^11vps/ml rAd-IFN/Syn3 arm.
Overall Number of Participants Analyzed 21 19
Measure Type: Count of Participants
Unit of Measure: Participants
10
  47.6%
13
  68.4%
4.Secondary Outcome
Title Incidence of High Grade-Recurrence-Free Survival at 6 Months (180 Days).
Hide Description All patients were evaluated 6 Months (180 Days) after the start of treatment for recurrence of high grade disease by cytology, cystoscopy, and biopsy if clinically indicated. Patients that we free of High-Grade disease recurrence received another dose. Data are presented as the number and percent of patients with High-Grade disease recurrence.
Time Frame 180 Days
Hide Outcome Measure Data
Hide Analysis Population Description
All patients receiving a dose at 90 Days were assessed at 180 Days for High-Grade disease by cytology, cystoscopy, and biopsy if clinically indicated.
Arm/Group Title rAd-IFN Dose 1x10^11 Vps/ml rAd-IFN Dose 3x10^11vps/ml
Hide Arm/Group Description:

Patients were randomly assigned to the 1x10^11 vps/ml rAd-IFN/Syn3 arm.

Patients were randomly assigned to the 3x10^11vps/ml rAd-IFN/Syn3 arm.
Overall Number of Participants Analyzed 21 19
Measure Type: Count of Participants
Unit of Measure: Participants
8
  38.1%
9
  47.4%
5.Secondary Outcome
Title Incidence of High Grade-Recurrence-Free Survival at 9 Months (270 Days).
Hide Description All patients were evaluated 9 Months (270 Days) after the start of treatment for recurrence of high grade disease by cytology, cystoscopy, and biopsy if clinically indicated. Patients that we free of High-Grade disease recurrence received a final dose. Data are presented as the number and percent of patients with High-Grade disease recurrence.
Time Frame 270 Days
Hide Outcome Measure Data
Hide Analysis Population Description
All patients that received a dose at Day 180 were assessed for High-Grade disease by cytology, cystoscopy, and biopsy if clinically indicated.
Arm/Group Title rAd-IFN Dose 1x10^11 Vps/ml rAd-IFN Dose 3x10^11vps/ml
Hide Arm/Group Description:
Patients were randomly assigned to the 1x10^11 vps/ml rAd-IFN/Syn3 arm.
Patients were randomly assigned to the 3x10^11vps/ml rAd-IFN/Syn3 arm.
Overall Number of Participants Analyzed 21 19
Measure Type: Count of Participants
Unit of Measure: Participants
8
  38.1%
9
  47.4%
6.Secondary Outcome
Title Incidence of Cystectomy in All Patients
Hide Description This secondary objective measures the incidence of cystectomy at 360 Days for the Efficacy Analysis Set.
Time Frame 360 Days
Hide Outcome Measure Data
Hide Analysis Population Description
The data are presented as the number of patients per dose group having a cystectomy during the 360 days of the study.
Arm/Group Title rAd-IFN Dose 1x10^11vps/ml rAd-IFN Dose 3x10^11vps/ml
Hide Arm/Group Description:
Patients were randomly assigned to the 1x10^11 vps/ml rAd-IFN/Syn3 arm.
Patients were randomly assigned to the 3x10^11vps/ml rAd-IFN/Syn3 arm.
Overall Number of Participants Analyzed 21 19
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
7.Secondary Outcome
Title Overall Survival in All Patients.
Hide Description Overall survival was defined as the number who survived from the first dose of rAd-IFN/Syn3 to the end of the primary assessment (360 Days) or Withdrawal.
Time Frame 360 Days
Hide Outcome Measure Data
Hide Analysis Population Description
The data are presented as the number of patients who survived the study (360 Days). All patients were monitored for this endpoint.
Arm/Group Title rAd-IFN Dose 1x10^11 Vps/ml rAd-IFN Dose 3x10^11vps/ml
Hide Arm/Group Description:
Patients were randomly assigned to the 1x10^11 vps/mI rAd-IFN/Syn3 arm.
Subjects were randomly assigned to the 3x10^11vps/ml rAd-IFN/Syn3 arm.
Overall Number of Participants Analyzed 21 19
Measure Type: Count of Participants
Unit of Measure: Participants
21
 100.0%
19
 100.0%
8.Secondary Outcome
Title Number of Patients With Elevated Levels of Viral Vector in Blood
Hide Description The level of viral vector as measured by qPCR in blood was determined in all patients on the initial day of dosing Day 1 (pre-dose) and at Day 2, Day 4, Day 12, and for patients that were free of High-Grade disease recurrence and received a second dose at Day 91 (pre-dose), Day 92, Day 94, and Day 103.
Time Frame 103 Days
Hide Outcome Measure Data
Hide Analysis Population Description
Data are reported as number of patients demonstrating viral vector by qPCR in blood.
Arm/Group Title rAd-IFN Dose 1x10^11vps/ml rAd-IFN Dose 3x10^11vps/ml
Hide Arm/Group Description:
Patients were randomly assigned to the 1x10^11 vps/ml rAd-IFN/Syn3 arm.
Patients were randomly assigned to the 3x10^11vps/ml rAd-IFN/Syn3 arm.
Overall Number of Participants Analyzed 21 19
Measure Type: Count of Participants
Unit of Measure: Participants
Pre-Dose Day 1 Number Analyzed 21 participants 19 participants
0
   0.0%
0
   0.0%
Day 2 Number Analyzed 21 participants 19 participants
0
   0.0%
0
   0.0%
Day 4 Number Analyzed 21 participants 19 participants
0
   0.0%
0
   0.0%
Day 12 Number Analyzed 21 participants 19 participants
0
   0.0%
0
   0.0%
Pre-Dose Day 91 Number Analyzed 10 participants 13 participants
0
   0.0%
0
   0.0%
Day 92 Number Analyzed 10 participants 13 participants
0
   0.0%
0
   0.0%
Day 94 Number Analyzed 10 participants 13 participants
0
   0.0%
0
   0.0%
Day 103 Number Analyzed 9 participants 12 participants
0
   0.0%
0
   0.0%
9.Secondary Outcome
Title Number of Patients With Elevated Levels of Viral Vector in Urine
Hide Description The level of viral vector as measured by qPCR in urine was determined in all patients on the initial day of dosing Day 1 (pre-dose) and at Day 2, Day 4, Day 12, and for patients that were free of High-Grade disease recurrence and received a second dose at Day 91 (pre-dose), Day 92, Day 94, and Day 103.
Time Frame 103 Days
Hide Outcome Measure Data
Hide Analysis Population Description
Data are reported as number of patients demonstrating increased levels of viral vector by qPCR in urine.
Arm/Group Title rAd-IFN Dose 1x10^11 Vps/ml rAd-IFN Dose 3x10^11vps/ml
Hide Arm/Group Description:
Patients were randomly assigned to the 1x10^11 vps/mI rAd-IFN/Syn3 arm.
Patients were randomly assigned to the 3x10^11vps/ml rAd-IFN/Syn3 arm.
Overall Number of Participants Analyzed 21 19
Measure Type: Count of Participants
Unit of Measure: Participants
Pre-Dose Day 1 Number Analyzed 21 participants 19 participants
1
   4.8%
0
   0.0%
Day 2 Number Analyzed 21 participants 18 participants
21
 100.0%
18
 100.0%
Day 4 Number Analyzed 21 participants 19 participants
20
  95.2%
19
 100.0%
Day 12 Number Analyzed 20 participants 19 participants
17
  85.0%
16
  84.2%
Pre-Dose Day 91 Number Analyzed 10 participants 13 participants
1
  10.0%
2
  15.4%
Day 92 Number Analyzed 10 participants 11 participants
10
 100.0%
11
 100.0%
Day 94 Number Analyzed 9 participants 12 participants
8
  88.9%
11
  91.7%
Day 103 Number Analyzed 8 participants 13 participants
2
  25.0%
4
  30.8%
10.Secondary Outcome
Title Number of Patients With Elevated IFN alpha2b Protein Levels in Serum
Hide Description The levels of serum IFN alpha2b protein as measured by ELISA were determined in all patients on the initial day of dosing (Pre-Dose Day 1), at Day 2, Day 4, Day 12, and for patients that were free of High-Grade disease recurrence and received subsequent doses at Day 91 (pre-dose), Day 92, Day 94, Day 103, Day 180 (pre-dose), Day 270 (pre-dose), and Day 360 or Withdrawal.
Time Frame 360 Days
Hide Outcome Measure Data
Hide Analysis Population Description
Data are reported as the number of patients with increased levels of IFN alpha2b protein in serum.
Arm/Group Title rAd-IFN Dose 1x10^11 Vps/ml rAd-IFN Dose 3x10^11vps/ml
Hide Arm/Group Description:
Patients were randomly assigned to the 1x10^11 vps/mI rAd-IFN/Syn3 arm.
Patients were randomly assigned to the 3x10^11vps/ml rAd-IFN/Syn3 arm.
Overall Number of Participants Analyzed 21 19
Measure Type: Count of Participants
Unit of Measure: Participants
Pre-Dose Day 1 Number Analyzed 21 participants 19 participants
1
   4.8%
1
   5.3%
Day 2 Number Analyzed 21 participants 18 participants
2
   9.5%
10
  55.6%
Day 4 Number Analyzed 21 participants 19 participants
1
   4.8%
6
  31.6%
Day 12 Number Analyzed 20 participants 19 participants
1
   5.0%
1
   5.3%
Day 91 Number Analyzed 10 participants 13 participants
1
  10.0%
1
   7.7%
Day 92 Number Analyzed 10 participants 12 participants
1
  10.0%
1
   8.3%
Day 94 Number Analyzed 10 participants 11 participants
1
  10.0%
1
   9.1%
Day 103 Number Analyzed 9 participants 13 participants
1
  11.1%
1
   7.7%
Pre-Dose Day 180 Number Analyzed 7 participants 9 participants
0
   0.0%
0
   0.0%
Pre-Dose Day 270 Number Analyzed 7 participants 9 participants
0
   0.0%
0
   0.0%
Day 360 or Withdrawal Number Analyzed 14 participants 13 participants
0
   0.0%
0
   0.0%
11.Secondary Outcome
Title Number of Patients With Elevated IFN alpha2b Protein Levels in Urine
Hide Description The levels of urine IFN alpha2b protein as measured by ELISA were measured in all patients on the initial day of dosing Day 1 (pre-dose) and at Day 2, Day 4, Day 12, and for patients that did not have recurrence of HGD and received a second dose at Day 91 (pre-dose), Day 92, Day 94, and Day 103.
Time Frame 103 Days
Hide Outcome Measure Data
Hide Analysis Population Description
Data are reported as the number of patients with elevated levels of IFN alpha2b levels in urine.
Arm/Group Title rAd-IFN Dose 1x10^11vps/ml rAd-IFN Dose 3x10^11vps/ml
Hide Arm/Group Description:
Patients were randomly assigned to the 1x10^11 vps/ml rAd-IFN/Syn3 arm.
Patients were randomly assigned to the 3x10^11vps/ml rAd-IFN/Syn3 arm.
Overall Number of Participants Analyzed 21 19
Measure Type: Count of Participants
Unit of Measure: Participants
Pre-Dose Day 1 Number Analyzed 21 participants 18 participants
0
   0.0%
0
   0.0%
Day 2 Number Analyzed 21 participants 18 participants
21
 100.0%
18
 100.0%
Day 4 Number Analyzed 21 participants 19 participants
17
  81.0%
18
  94.7%
Day 12 Number Analyzed 20 participants 19 participants
1
   5.0%
6
  31.6%
Pre-Dose Day 91 Number Analyzed 10 participants 13 participants
0
   0.0%
0
   0.0%
Day 92 Number Analyzed 10 participants 11 participants
8
  80.0%
9
  81.8%
Day 94 Number Analyzed 10 participants 12 participants
5
  50.0%
3
  25.0%
Day 103 Number Analyzed 8 participants 13 participants
0
   0.0%
0
   0.0%
12.Secondary Outcome
Title Number of Patients With Elevated Levels of Anti-IFN alpha2b Antibodies in Serum
Hide Description The levels of serum anti-IFN alpha2b antibodies as measured by ELISA were determined in all patients on the initial day of dosing (Pre-Dose Day 1), at Day 12, and for patients that were free of High-Grade disease recurrence and received subsequent doses at Day 180 (pre-dose), Day 270 (pre-dose), and Day 360 or Withdrawal.
Time Frame 360 Days
Hide Outcome Measure Data
Hide Analysis Population Description
Data are reported at Number of Patients with a Positive Titre.
Arm/Group Title rAd-IFN Dose 1x10^11 Vps/ml rAd-IFN Dose 3x10^11vps/ml
Hide Arm/Group Description:
Patients were randomly assigned to the 1x10^11 vps/ml rAd-IFN/Syn3 arm.
Patients were randomly assigned to the 3x10^11vps/ml rAd-IFN/Syn3 arm.
Overall Number of Participants Analyzed 21 19
Measure Type: Count of Participants
Unit of Measure: Participants
Pre-Dose Day 1 Number Analyzed 21 participants 19 participants
0
   0.0%
0
   0.0%
Day 12 Number Analyzed 20 participants 17 participants
0
   0.0%
1
   5.9%
Pre-Dose Day 180 Number Analyzed 8 participants 9 participants
0
   0.0%
0
   0.0%
Pre-Dose Day 270 Number Analyzed 8 participants 9 participants
0
   0.0%
0
   0.0%
Day 360 or Withdrawal Number Analyzed 21 participants 15 participants
0
   0.0%
0
   0.0%
13.Secondary Outcome
Title Number of Patients With Elevated Levels of Anti-Adenovirus Type 5 Antibodies in Serum.
Hide Description The levels of serum anti-adenovirus type 5 antibodies as measured by ELISA were determined in all patients on the initial day of dosing (Pre-Dose Day 1), at Day 12, and for patients that were free of High-Grade disease recurrence and received subsequent subsequent doses at Day 180 (pre-dose), Day 270 (pre-dose), and Day 360 or Withdrawal.
Time Frame 360 Days
Hide Outcome Measure Data
Hide Analysis Population Description
Data are reported at Number of Patients with a Positive Titer.
Arm/Group Title rAd-IFN Dose 1x10^11vps/ml rAd-IFN Dose 3x10^11vps/mL
Hide Arm/Group Description:
Patients were randomly assigned to the 1x10^11 vps/ml rAd-IFN/Syn3 arm.
Patients were randomly assigned to the 3x10^11 vps/ml rAd-IFN/Syn3 arm.
Overall Number of Participants Analyzed 21 19
Measure Type: Count of Participants
Unit of Measure: Participants
Pre-Dose Day 1 Number Analyzed 21 participants 18 participants
0
   0.0%
0
   0.0%
Day 12 Number Analyzed 20 participants 17 participants
2
  10.0%
1
   5.9%
Pre-Dose Day 180 Number Analyzed 8 participants 9 participants
6
  75.0%
6
  66.7%
Pre-Dose Day 270 Number Analyzed 8 participants 9 participants
6
  75.0%
5
  55.6%
Day 360 or Withdrawal Number Analyzed 21 participants 15 participants
12
  57.1%
7
  46.7%
Time Frame From dosing day 1 up to 12 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title rAd-IFN Dose 1x10^11 Vps/ml rAd-IFN Dose 3x10^11vps/ml
Hide Arm/Group Description Patients were randomized to the 1x10^11 vps/ml INSTILADRIN arm. Patients were randomized the 3x10^11 vps/ml INSTILADRIN arm.
All-Cause Mortality
rAd-IFN Dose 1x10^11 Vps/ml rAd-IFN Dose 3x10^11vps/ml
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
rAd-IFN Dose 1x10^11 Vps/ml rAd-IFN Dose 3x10^11vps/ml
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/21 (14.29%)      2/19 (10.53%)    
Cardiac disorders     
Coronary artery occlusion * 1 [1]  1/21 (4.76%)  1 0/19 (0.00%)  0
Gastrointestinal disorders     
Diarrhea * 1 [2]  1/21 (4.76%)  1 0/19 (0.00%)  0
Functional gastrointestinal disorder * 1 [3]  1/21 (4.76%)  1 0/19 (0.00%)  0
Infections and infestations     
Sepsis * 1 [4]  1/21 (4.76%)  1 0/19 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Back pain * 1 [5]  0/21 (0.00%)  0 1/19 (5.26%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Renal neoplasm * 1 [6]  1/21 (4.76%)  1 0/19 (0.00%)  0
Nervous system disorders     
Syncope  1 [7]  1/21 (4.76%)  1 0/19 (0.00%)  0
Carotid artery occlusion * 1 [8]  1/21 (4.76%)  1 0/19 (0.00%)  0
Renal and urinary disorders     
Renal failure acute * 1 [9]  0/21 (0.00%)  0 1/19 (5.26%)  1
Surgical and medical procedures     
Nephroureterectomy * 1 [4]  1/21 (4.76%)  1 0/19 (0.00%)  0
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 15.0
[1]
Coronary artery blockage; not related to drug; grade 3; resolved
[2]
related to drug; grade 3; resolved
[3]
delayed return of bowel function; not related to drug; grade 3; resolved
[4]
not related to drug; grade 3; resolved
[5]
worsening of back pain; related to disease; not related to drug; grade 3; resolved
[6]
Left renal pelvis tumor - not related to drug; grade 3; resolved
[7]
Secondary to carotid artery stenosis - not related to drug; grade 3; resolved
[8]
Right carotid blockade
[9]
acute renal failure, pre-renal (dehydration); related to drug; grade 3; resolved
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 4%
rAd-IFN Dose 1x10^11 Vps/ml rAd-IFN Dose 3x10^11vps/ml
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   20/21 (95.24%)      19/19 (100.00%)    
Blood and lymphatic system disorders     
Leukocytosis * 1  0/21 (0.00%)  0 1/19 (5.26%)  1
Cardiac disorders     
Tachycardia * 1  2/21 (9.52%)  2 0/19 (0.00%)  0
Bradycardia * 1  0/21 (0.00%)  0 1/19 (5.26%)  1
Coronary Artery Occlusion * 1  1/21 (4.76%)  1 0/19 (0.00%)  0
Ear and labyrinth disorders     
Vertigo * 1  0/21 (0.00%)  0 1/19 (5.26%)  1
Eye Pain * 1  0/21 (0.00%)  0 1/19 (5.26%)  1
Endocrine disorders     
Hypothyroidism * 1  1/21 (4.76%)  1 0/19 (0.00%)  0
Eye disorders     
Blurred Vision * 1  1/21 (4.76%)  1 0/19 (0.00%)  0
Gastrointestinal disorders     
Abdominal Discomfort * 1  0/21 (0.00%)  0 1/19 (5.26%)  1
Abdominal Distension * 1  0/21 (0.00%)  0 1/19 (5.26%)  1
Abdominal Pain * 1  1/21 (4.76%)  1 2/19 (10.53%)  2
Constipation * 1  0/21 (0.00%)  0 2/19 (10.53%)  2
Diarrhea * 1  3/21 (14.29%)  3 2/19 (10.53%)  2
Frequent Bowel Movements * 1  0/21 (0.00%)  0 1/19 (5.26%)  1
Nausea * 1  3/21 (14.29%)  3 3/19 (15.79%)  3
Oesophageal Dilatation * 1  1/21 (4.76%)  1 0/19 (0.00%)  0
Vomiting * 1  2/21 (9.52%)  2 2/19 (10.53%)  2
General disorders     
Asthenia * 1  1/21 (4.76%)  1 2/19 (10.53%)  2
Chest pain * 1  1/21 (4.76%)  1 0/19 (0.00%)  0
Chills * 1  0/21 (0.00%)  0 7/19 (36.84%)  7
Facial Pain * 1  0/21 (0.00%)  0 1/19 (5.26%)  1
Fatique * 1  6/21 (28.57%)  6 7/19 (36.84%)  7
Feeling Cold * 1  0/21 (0.00%)  0 1/19 (5.26%)  1
Influenza Like Illness * 1  2/21 (9.52%)  2 0/19 (0.00%)  0
Infusion Site Reactions * 1  0/21 (0.00%)  0 1/19 (5.26%)  1
Malaise * 1  1/21 (4.76%)  1 0/19 (0.00%)  0
Pain * 1  1/21 (4.76%)  1 1/19 (5.26%)  1
Pyrexia * 1  1/21 (4.76%)  1 6/19 (31.58%)  6
Facial Pain * 1  1/21 (4.76%)  1 0/19 (0.00%)  0
Infections and infestations     
Bronchitis * 1  2/21 (9.52%)  2 0/19 (0.00%)  0
Cystitis * 1  0/21 (0.00%)  0 1/19 (5.26%)  1
Gasteroenteritis * 1  1/21 (4.76%)  1 0/19 (0.00%)  0
Influenza * 1  0/21 (0.00%)  0 2/19 (10.53%)  2
Nasophanryngitis * 1  1/21 (4.76%)  1 1/19 (5.26%)  1
Pneumonia * 1  1/21 (4.76%)  1 0/19 (0.00%)  0
Sepsis * 1  1/21 (4.76%)  1 0/19 (0.00%)  0
Skin Infection * 1  1/21 (4.76%)  1 0/19 (0.00%)  0
Tooth Abscess * 1  0/21 (0.00%)  0 1/19 (5.26%)  1
Urinary Tract Infection * 1  3/21 (14.29%)  3 5/19 (26.32%)  5
Injury, poisoning and procedural complications     
Clavicle Fracture * 1  1/21 (4.76%)  1 0/19 (0.00%)  0
Contusion * 1  1/21 (4.76%)  1 0/19 (0.00%)  0
Fracture * 1  0/21 (0.00%)  0 1/19 (5.26%)  1
Laceration * 1  1/21 (4.76%)  1 0/19 (0.00%)  0
Investigations     
Blood Creatinine Increase * 1  0/21 (0.00%)  0 1/19 (5.26%)  1
Glycosylated Hemoglobin Increase * 1  1/21 (4.76%)  1 0/19 (0.00%)  0
pH Urine Decreased * 1  0/21 (0.00%)  0 1/19 (5.26%)  1
Urine Output DeEcreased * 1  1/21 (4.76%)  1 0/19 (0.00%)  0
Metabolism and nutrition disorders     
Decreased Appetite * 1  0/21 (0.00%)  0 1/19 (5.26%)  1
Fluid Retention * 1  1/21 (4.76%)  1 1/19 (5.26%)  1
Hyperglycemia * 1  2/21 (9.52%)  2 0/19 (0.00%)  0
Hyperkalemia * 1  0/21 (0.00%)  0 1/19 (5.26%)  1
Hypokalemia * 1  1/21 (4.76%)  1 0/19 (0.00%)  0
Hypomagnesemia * 1  1/21 (4.76%)  1 0/19 (0.00%)  0
Oedemia Peripheral * 1  1/21 (4.76%)  1 0/19 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  2/21 (9.52%)  2 2/19 (10.53%)  2
Back pain * 1  0/21 (0.00%)  0 2/19 (10.53%)  2
Flank Pain * 1  1/21 (4.76%)  1 0/19 (0.00%)  0
Intervertrebral Disc Degeneration * 1  1/21 (4.76%)  1 0/19 (0.00%)  0
Joint Range of Motion Decreased * 1  1/21 (4.76%)  1 0/19 (0.00%)  0
Myalgia * 1  0/21 (0.00%)  0 1/19 (5.26%)  1
Pain in Extremity * 1  0/21 (0.00%)  0 1/19 (5.26%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Basal Cell Carcinoma * 1  1/21 (4.76%)  1 0/19 (0.00%)  0
Cancer Pain * 1  0/21 (0.00%)  0 1/19 (5.26%)  1
Lentigo Maligno Stage Unspecified * 1  1/21 (4.76%)  1 0/19 (0.00%)  0
Malignant Melanoma * 1  1/21 (4.76%)  1 0/19 (0.00%)  0
Renal Neoplasm * 1  1/21 (4.76%)  1 0/19 (0.00%)  0
Seborrhoeic Keratosis * 1  1/21 (4.76%)  1 0/19 (0.00%)  0
Transitional Cell Carcinoma * 1  1/21 (4.76%)  1 0/19 (0.00%)  0
Nervous system disorders     
Carotid Artery Occlusion * 1  1/21 (4.76%)  1 0/19 (0.00%)  0
Carotid Artery Stenosis * 1  1/21 (4.76%)  1 0/19 (0.00%)  0
Dizziness * 1  2/21 (9.52%)  2 4/19 (21.05%)  4
Encephalopathy * 1  1/21 (4.76%)  1 0/19 (0.00%)  0
Headache * 1  0/21 (0.00%)  0 1/19 (5.26%)  1
Lethargy * 1  1/21 (4.76%)  1 0/19 (0.00%)  0
Neuropathy Peripheral * 1  0/21 (0.00%)  0 1/19 (5.26%)  1
Restless Leg Syndrome * 1  1/21 (4.76%)  1 0/19 (0.00%)  0
Sinus Headache * 1  0/21 (0.00%)  0 2/19 (10.53%)  2
Syncope * 1  1/21 (4.76%)  1 1/19 (5.26%)  1
Psychiatric disorders     
Anxiety * 1  0/21 (0.00%)  0 1/19 (5.26%)  1
Depression * 1  1/21 (4.76%)  1 0/19 (0.00%)  0
Mental Status Change * 1  0/21 (0.00%)  0 1/19 (5.26%)  1
Depression * 1  0/21 (0.00%)  0 1/19 (5.26%)  1
Renal and urinary disorders     
Bladder Discomfort * 1  1/21 (4.76%)  1 0/19 (0.00%)  0
Bladder Pain * 1  0/21 (0.00%)  0 3/19 (15.79%)  3
Bladder Perforation * 1  0/21 (0.00%)  0 1/19 (5.26%)  1
Dysuria * 1  9/21 (42.86%)  9 7/19 (36.84%)  7
Hematuria * 1  5/21 (23.81%)  5 5/19 (26.32%)  5
Incontinence * 1  0/21 (0.00%)  0 1/19 (5.26%)  1
Micturition Urgency * 1  10/21 (47.62%)  10 6/19 (31.58%)  6
Nocturia * 1  5/21 (23.81%)  5 5/19 (26.32%)  5
Pollakiuria * 1  6/21 (28.57%)  6 5/19 (26.32%)  5
Polyuria * 1  1/21 (4.76%)  1 0/19 (0.00%)  0
Renal Failure * 1  1/21 (4.76%)  1 0/19 (0.00%)  0
Renal Failure Acute * 1  0/21 (0.00%)  0 1/19 (5.26%)  1
Renal Pain * 1  1/21 (4.76%)  1 1/19 (5.26%)  1
Urethral Stenosis * 1  1/21 (4.76%)  1 0/19 (0.00%)  0
Urinary Incontinence * 1  3/21 (14.29%)  3 1/19 (5.26%)  1
Urinary Retention * 1  1/21 (4.76%)  1 0/19 (0.00%)  0
Urinary Tract Disorder * 1  1/21 (4.76%)  1 0/19 (0.00%)  0
Urine Flow Decreased * 1  1/21 (4.76%)  1 0/19 (0.00%)  0
Reproductive system and breast disorders     
Prostatic Hemorrhage * 1  0/21 (0.00%)  0 1/19 (5.26%)  1
Respiratory, thoracic and mediastinal disorders     
Chronic Obstructive Pulmonary Disease * 1  2/21 (9.52%)  2 0/19 (0.00%)  0
Cough * 1  0/21 (0.00%)  0 1/19 (5.26%)  1
Hypoxia * 1  1/21 (4.76%)  1 0/19 (0.00%)  0
Oropharyngeal Pain * 1  1/21 (4.76%)  1 0/19 (0.00%)  0
Rhinorrhea * 1  1/21 (4.76%)  1 0/19 (0.00%)  0
Sinus Congestion * 1  2/21 (9.52%)  2 0/19 (0.00%)  0
Skin and subcutaneous tissue disorders     
Actinic Keratosis * 1  1/21 (4.76%)  1 0/19 (0.00%)  0
Alopecia * 1  0/21 (0.00%)  0 1/19 (5.26%)  1
Dermatitis Contact * 1  0/21 (0.00%)  0 1/19 (5.26%)  1
Erythemia * 1  1/21 (4.76%)  1 0/19 (0.00%)  0
Hyperhydrosis * 1  1/21 (4.76%)  1 1/19 (5.26%)  1
Rash * 1  1/21 (4.76%)  1 1/19 (5.26%)  1
Rash Maculo-Papular * 1  0/21 (0.00%)  0 1/19 (5.26%)  1
Swelling Face * 1  1/21 (4.76%)  1 0/19 (0.00%)  0
Surgical and medical procedures     
Nephroureterectomy * 1  1/21 (4.76%)  1 0/19 (0.00%)  0
Vascular disorders     
Aortic Stenosis * 1  1/21 (4.76%)  1 0/19 (0.00%)  0
Arterial Hemorrhage * 1  1/21 (4.76%)  1 0/19 (0.00%)  0
Hypertension * 1  2/21 (9.52%)  2 1/19 (5.26%)  1
Hypotension * 1  1/21 (4.76%)  1 0/19 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 15.0
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.
Sponsor will complete its review within the review period and will have authority to require that the Institution and/or Investigator delete from the disclosure of any reference to Confidential Information, other than results.
Results Point of Contact
Name/Title: David Sawutz, PhD
Organization: FKD Therapies Oy
Phone: 416-607-9515
Responsible Party: FKD Therapies Oy
ClinicalTrials.gov Identifier: NCT01687244     History of Changes
Other Study ID Numbers: rAd-IFN-CS-002
First Submitted: September 6, 2012
First Posted: September 18, 2012
Results First Submitted: January 9, 2017
Results First Posted: May 30, 2017
Last Update Posted: July 24, 2017