A Phase 3 interventional study of Nanoxel®M and Mitomycin-C in Non Muscle Invasive Bladder Cancer, sponsored by Samyang Biopharmaceuticals Corporation. Terminated at 1 site in Korea, Republic of. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2019-08-30.
Sponsored by Samyang Biopharmaceuticals Corporation · Phase 3, Interventional, and Treatment
The purpose of this study is to determine whether Nanoxel®M is effective in the treatment of patients with recurrent Ta and T1 who experienced treatment failure with at least one prior BCG intravesical treatment.
1,616 studies on the registry are indexed under Urinary Bladder Neoplasms; 421 are open to participants now.
This study's enrollment of 36 is below the median of 60 across 1,163 interventional studies indexed under Urinary Bladder Neoplasms.
Browse Urinary Bladder Neoplasms studies →Samyang Biopharmaceuticals Corporation is the lead sponsor of 29 studies on the registry; 6 are open to participants now.
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Exclusion Criteria:
75 mg in 100mL normal saline
Drug: Nanoxel®M
40 mg in 100mL normal saline
Drug: Mitomycin-C
Intravesical
Also known as: Polysorbate 80, ethanol free Docetaxel
Intravesical
Recurrence free rate
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.
Time frame: 1 year
Recurrence free rate
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.
Time frame: 6 months, 2 years
Overall survival
Time from random assignment to death resulting from any cause.
Time frame: 2 years
Number of participants with adverse events as assessed by CTCAE v4.0
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.
Time frame: 2 years
Plan to share: No
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This study is terminated, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
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Samyang Biopharmaceuticals Corporation