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Efficacy and Safety of Multi-Instillations of Apaziquone in Patients With Non-Muscle Invasive Bladder Cancer

This study has been terminated.
(Business reason)
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
Spectrum Pharmaceuticals, Inc
ClinicalTrials.gov Identifier:
NCT01410565
First received: August 1, 2011
Last updated: December 12, 2016
Last verified: December 2016
Results First Received: October 10, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Bladder Cancer
Interventions: Drug: Apaziquone
Drug: Placebo

  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
Apaziquone

Apaziquone: Apaziquone 4 mg in 40 mL diluent

Apaziquone: Apaziquone in the Double Blind Phase

Placebo

Placebo

Placebo: Placebo in the Double Blind Phase

Open Label-Apaziquone No text entered.

Participant Flow for 2 periods

Period 1:   Open Label Phase Apaziquone
    Apaziquone   Placebo   Open Label-Apaziquone
STARTED   0   0   66 
COMPLETED   0   0   58 
NOT COMPLETED   0   0   8 

Period 2:   Double Blind Phase
    Apaziquone   Placebo   Open Label-Apaziquone
STARTED   13 [1]   15   0 
COMPLETED   0   0   0 
NOT COMPLETED   13   15   0 
[1] All 66 patients received one dose of Apaziquone in the open label phase.



  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 Analysis Population included all randomized patients in the double blind phase.

Reporting Groups
  Description
Apaziquone

Apaziquone 4 mg in 40 mL diluent

Apaziquone in the Double Blind Phase

Placebo

Placebo

Placebo in the Double Blind Phase

Total Total of all reporting groups

Baseline Measures
   Apaziquone   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 13   15   28 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      7  53.8%      6  40.0%      13  46.4% 
>=65 years      6  46.2%      9  60.0%      15  53.6% 
Age 
[Units: Years]
Mean (Standard Deviation)
 65.5  (11.77)   70.5  (12.66)   68.2  (12.30) 
Gender 
[Units: Participants]
Count of Participants
     
Female      2  15.4%      2  13.3%      4  14.3% 
Male      11  84.6%      13  86.7%      24  85.7% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      0   0.0%      2  13.3%      2   7.1% 
Not Hispanic or Latino      13 100.0%      13  86.7%      26  92.9% 
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      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      0   0.0%      0   0.0%      0   0.0% 
White      13 100.0%      15 100.0%      28 100.0% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Time to Recurrence   [ Time Frame: Recurrence of cancer in the bladder during 24 months of follow-up ]

2.  Secondary:   Recurrence Rate at 24 Months   [ Time Frame: 24 months ]

3.  Secondary:   Participants With Treatment Emergent Adverse Events (TEAEs)   [ Time Frame: 24 Months from Randomization ]


  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 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: Gajanan Bhat
Organization: Spectrum Pharmaceutical Inc.
phone: 949-743-9219
e-mail: gajanan.bhat@sppirx.com


Publications:

Responsible Party: Spectrum Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT01410565     History of Changes
Other Study ID Numbers: SPI-1011
Study First Received: August 1, 2011
Results First Received: October 10, 2016
Last Updated: December 12, 2016