NCT02982395TerminatedPhase 3
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
Samyang Biopharmaceuticals Corporation1 site in 1 country36 target enrollmentStarted: January 2017Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Terminated
- Sponsor
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- Recurrence free rate
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Histologically confirmed diagnosis of superficial transitional cell carcinoma of the bladder (Ta, T1)
- •Recurrent superficial bladder cancer refractory to Bacillus Calmette-Guerin (BCG)
- •No previous intravesical therapy for 6 weeks
- •No history of prior radiation to the pelvis
- •Peripheral neuropathy ≤ grade 1
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 t0 2
- •Adequate hematopoietic and hepatic parameters
Exclusion Criteria
- •Muscle invasive disease (T2-T4)
- •Any other malignancy diagnosed within 2 years of study entry (Except basal or squamous cell skin cancers or noninvasive cancer of the cervix)
- •Participation in any other research protocol involving administration of an investigational agent within 3 months before study entry
- •History of sensitivity reaction to docetaxel
- •Prescribed immunosuppressive medications because of a confounding medical condition
- •Female patients who were pregnant or lactating
Arms & Interventions
Nanoxel®M
Experimental
75 mg in 100mL normal saline
Intervention: Nanoxel®M (Drug)
Mitomycin
Active Comparator
40 mg in 100mL normal saline
Intervention: Mitomycin-C (Drug)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Recurrence free rate(6 months, 2 years)
- Overall survival(2 years)
- Number of participants with adverse events as assessed by CTCAE v4.0(2 years)
Investigators
Study Sites (1)
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