Study to Evaluate the Efficacy and Safety Of Intravesical Nanoxel®M In BCG Refractory NMIBC

Phase 3

Terminated

• Conditions: Non Muscle Invasive Bladder Cancer
• Interventions: Drug: Nanoxel®M; Drug: Mitomycin-C

• Registration Number: NCT02982395
• Lead Sponsor: Samyang Biopharmaceuticals Corporation

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-11-24
• Study First Submitted QC: 2016-12-02
• Study First Posted: 2016-12-05
• Study Start: 2017-01
• Primary Completion: 2018-08
• Study Completion: 2018-08
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-28
• Last Update Posted: 2019-08-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nanoxel®M	Nanoxel®M	75 mg in 100mL normal saline
Mitomycin	Mitomycin-C	40 mg in 100mL normal saline

Primary Outcome Measures

Name	Time	Method
Recurrence free rate	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 Outcome Measures

Name	Time	Method
Recurrence free rate	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	2 years	Time from random assignment to death resulting from any cause.
Number of participants with adverse events as assessed by CTCAE v4.0	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.

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of