Efficacy and Safety of Multi-Instillations of Apaziquone in Patients With Non-Muscle Invasive Bladder Cancer
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|ClinicalTrials.gov Identifier: NCT01410565|
Recruitment Status : Terminated (Business reason)
First Posted : August 5, 2011
Results First Posted : December 13, 2016
Last Update Posted : December 13, 2016
|Condition or disease||Intervention/treatment||Phase|
|Bladder Cancer||Drug: Apaziquone Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||66 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Phase 3 International, Multicenter, Double-Blind, Placebo-Controlled, Randomized Trial Evaluating the Efficacy and Safety of Multiple Instillations of Intravesical Apaziquone vs. Placebo in Patients With Low-Intermediate Risk Non-Muscle Invasive Bladder Cancer (NMIBC)|
|Study Start Date :||July 2011|
|Actual Primary Completion Date :||March 2014|
|Actual Study Completion Date :||March 2014|
|Active Comparator: Apaziquone||
Apaziquone 4 mg in 40 mL diluent
Placebo Comparator: Placebo
Placebo for Double Blind Phase
- Time to Recurrence [ Time Frame: Recurrence of cancer in the bladder during 24 months of follow-up ]Time to recurrence is the time from randomization to the date of first histologically confirmed recurrence of bladder cancer (for eligible patients with Low- intermediate risk NMIBC, who had undergone TURBT followed by, a single instillation of apaziquone immediately post TURBT and multiple instillations of apaziquone or placebo).
- Recurrence Rate at 24 Months [ Time Frame: 24 months ]Measurement the number of participants with the recurrence at 24 months.
- Participants With Treatment Emergent Adverse Events (TEAEs) [ Time Frame: 24 Months from Randomization ]TEAEs will be mainly characterized by the number of treatment emergent adverse events and treatment related AEs that occur or worsen after the first dose of study treatment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01410565
|Study Director:||Show-Li Sun, MD||Spectrum Pharmaceuticals, Inc|