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Single Dose Intravesical Apaziquone Postoperative in Patients Undergoing TURBT for Noninvasive Bladder Cancer (SPI-612)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00598806
First Posted: January 23, 2008
Last Update Posted: November 13, 2017
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.
Information provided by (Responsible Party):
Spectrum Pharmaceuticals, Inc
Results First Submitted: July 14, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Bladder Cancer
Interventions: Drug: Apaziquone
Drug: Placebo
Procedure: TURBT

  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
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Reporting Groups
  Description
Apaziquone Apaziquone: TURBT + a single intravesical dose of Apaziquone 4mg in 40ml instilled into the bladder post-TURBT
Placebo Placebo: TURBT + a single intravesical dose of placebo instilled into the bladder post-TURBT

Participant Flow:   Overall Study
    Apaziquone   Placebo
STARTED   402   410 
COMPLETED   329   346 
NOT COMPLETED   73   64 



  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.
Safety Population

Reporting Groups
  Description
Apaziquone Apaziquone: TURBT + a single intravesical dose of Apaziquone 4mg in 40ml instilled into the bladder post-TURBT
Placebo Placebo: TURBT + a single intravesical dose of placebo instilled into the bladder post-TURBT
Total Total of all reporting groups

Baseline Measures
   Apaziquone   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 402   410   812 
Age 
[Units: Years]
Mean (Standard Deviation)
 66.9  (11.60)   66.5  (11.83)   66.7  (11.71) 
Age, Customized 
[Units: Participants]
Count of Participants
     
<65   157   164   321 
65-75   144   146   290 
>75   101   100   201 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      105  26.1%      108  26.3%      213  26.2% 
Male      297  73.9%      302  73.7%      599  73.8% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      13   3.2%      12   2.9%      25   3.1% 
Not Hispanic or Latino      389  96.8%      398  97.1%      787  96.9% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      5   1.2%      7   1.7%      12   1.5% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      5   1.2%      2   0.5%      7   0.9% 
White      392  97.5%      400  97.6%      792  97.5% 
More than one race      0   0.0%      1   0.2%      1   0.1% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
     
Canada   215   223   438 
United States   82   85   167 
Poland   105   102   207 


  Outcome Measures
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1.  Primary:   Recurrence Rate at 2 Years   [ Time Frame: 2 years ]

2.  Secondary:   Time to Recurrence   [ Time Frame: 2 years ]

3.  Secondary:   Progression Rate at 2 Years   [ Time Frame: 2 years ]

4.  Secondary:   Time to Progression   [ Time Frame: 2 years ]

5.  Secondary:   Number of Recurrences Per Patient   [ Time Frame: 2 years ]

6.  Secondary:   Disease-Free Interval   [ Time Frame: 2 years ]

7.  Secondary:   Disease-Free Survival   [ Time Frame: 2 years ]

8.  Secondary:   Overall Survival   [ Time Frame: 2 years ]


  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: Gajanan Bhat, PhD
Organization: Spectrum Pharmaceuticals
phone: 949-743-9219
e-mail: Gajanan.Bhat@sppirx.com



Responsible Party: Spectrum Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT00598806     History of Changes
Other Study ID Numbers: SPI-612
First Submitted: January 11, 2008
First Posted: January 23, 2008
Results First Submitted: July 14, 2017
Results First Posted: August 15, 2017
Last Update Posted: November 13, 2017