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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
FKD Therapies Oy
ClinicalTrials.gov Identifier:
NCT01687244
First received: September 6, 2012
Last updated: June 23, 2017
Last verified: June 2017
Results First Received: January 9, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition: Superficial Bladder Cancer
Intervention: Drug: INSTILADRIN

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
rAd-IFN Dose 1x10^11vps/ml

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.

rAd-IFN Dose 3x10^11 Vps/ml

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.


Participant Flow:   Overall Study
    rAd-IFN Dose 1x10^11vps/ml   rAd-IFN Dose 3x10^11 Vps/ml
STARTED   21   19 
COMPLETED   21   19 
NOT COMPLETED   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
rAd-IFN Dose 1x10^11vps/ml Patients were randomly assigned to the 1x10^11vps/ml of rAd-IFN/Syn3 arm.
rAd-IFN Dose 3x10^11 Vps/ml Patients were randomly assigned to the 3x10^11vps/ml of rAd-IFN/Syn3 arm.
Total Total of all reporting groups

Baseline Measures
   rAd-IFN Dose 1x10^11vps/ml   rAd-IFN Dose 3x10^11 Vps/ml   Total 
Overall Participants Analyzed 
[Units: Participants]
 21   19   40 
Age 
[Units: Participants]
Count of 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 
[Units: Years]
Mean (Standard Deviation)
 71.6  (8.07)   71.1  (9.42)   71.1  (9.42) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      2   9.5%      5  26.3%      7  17.5% 
Male      19  90.5%      14  73.7%      33  82.5% 
Region of Enrollment 
[Units: Participants]
Count of Participants
     
United States   21   19   40 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Incidence of High Grade-Recurrence Free Survival at 360 Days   [ Time Frame: 360 Days ]

2.  Secondary:   Safety of rAd-IFN/Syn3   [ Time Frame: 360 Days ]

3.  Secondary:   Incidence of High Grade Recurrence-Free Survival at 3 Months (90 Days).   [ Time Frame: 90 Days ]

4.  Secondary:   Incidence of High Grade-Recurrence-Free Survival at 6 Months (180 Days).   [ Time Frame: 180 Days ]

5.  Secondary:   Incidence of High Grade-Recurrence-Free Survival at 9 Months (270 Days).   [ Time Frame: 270 Days ]

6.  Secondary:   Incidence of Cystectomy in All Patients   [ Time Frame: 360 Days ]

7.  Secondary:   Overall Survival in All Patients.   [ Time Frame: 360 Days ]

8.  Secondary:   Number of Patients With Elevated Levels of Viral Vector in Blood   [ Time Frame: 103 Days ]

9.  Secondary:   Number of Patients With Elevated Levels of Viral Vector in Urine   [ Time Frame: 103 Days ]

10.  Secondary:   Number of Patients With Elevated IFN alpha2b Protein Levels in Serum   [ Time Frame: 360 Days ]

11.  Secondary:   Number of Patients With Elevated IFN alpha2b Protein Levels in Urine   [ Time Frame: 103 Days ]

12.  Secondary:   Number of Patients With Elevated Levels of Anti-IFN alpha2b Antibodies in Serum   [ Time Frame: 360 Days ]

13.  Secondary:   Number of Patients With Elevated Levels of Anti-Adenovirus Type 5 Antibodies in Serum.   [ Time Frame: 360 Days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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 agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: David Sawutz, PhD
Organization: FKD Therapies Oy
phone: 416-607-9515
e-mail: david.sawutz@fkdtherapies.com



Responsible Party: FKD Therapies Oy
ClinicalTrials.gov Identifier: NCT01687244     History of Changes
Other Study ID Numbers: rAd-IFN-CS-002
Study First Received: September 6, 2012
Results First Received: January 9, 2017
Last Updated: June 23, 2017