Study to Evaluate the Efficacy and Safety Of Intravesical Nanoxel®M In BCG Refractory NMIBC
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|ClinicalTrials.gov Identifier: NCT02982395|
Recruitment Status : Terminated
First Posted : December 5, 2016
Last Update Posted : August 30, 2019
|Condition or disease||Intervention/treatment||Phase|
|Non Muscle Invasive Bladder Cancer||Drug: Nanoxel®M Drug: Mitomycin-C||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||36 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase Ⅲ Study to Evaluate the Efficacy and Safety Of Intravesical Nanoxel®M (Docetaxel-PM) In Bacillius Calmette-Guerin Refractory Non-Muscle Invasive Bladder Cancer|
|Actual Study Start Date :||January 2017|
|Actual Primary Completion Date :||August 2018|
|Actual Study Completion Date :||August 2018|
75 mg in 100mL normal saline
Other Name: Polysorbate 80, ethanol free Docetaxel
Active Comparator: Mitomycin
40 mg in 100mL normal saline
- Recurrence free rate [ Time Frame: 1 year ]Recurrence free rate will be summarized as the percentage of participants who achieved a confirmed recurrence free as assessed by urine cytology and cystoscopy. Recurrence means reappearance of high-risk disease (high grade, T1 or CIS) after the start of therapy.
- Recurrence free rate [ Time Frame: 6 months, 2 years ]Recurrence free rate will be summarized as the percentage of participants who achieved a confirmed recurrence free as assessed by urine cytology and cystoscopy.Recurrence means reappearance of high-risk disease (high grade, T1 or CIS) after the start of therapy.
- Overall survival [ Time Frame: 2 years ]Time from random assignment to death resulting from any cause.
- Number of participants with adverse events as assessed by CTCAE v4.0 [ Time Frame: 2 years ]Adverse event (AE) is as any AE occurring or worsening from the first treatment of any study drug to the last dose of the last study drug. Severity grades according to NCI CTCAE version 4.0.
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): NCT02982395
|Korea, Republic of|
|Seoul National University Hospital|
|Seoul, Korea, Republic of|
|Principal Investigator:||Ja Hyeon Ku||Seoul National University Hospital|