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TERMINATEDPHASE3

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

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

NCT02982395•Samyang Biopharmaceuticals Corporation

View on ClinicalTrials.gov

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.

Eligibility

Age

20 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (1)

Seoul National University Hospital

Seoul, South Korea

Key Dates

Start Date

January 1, 2017

Primary Completion Date

August 1, 2018

Completion Date

August 1, 2018

Last Updated

August 30, 2019

Enrollment

ACTUAL participants

Conditions

Non Muscle Invasive Bladder Cancer

Interventions

Nanoxel®M

DRUG

Mitomycin-C

DRUG

Study of Cretostimogene Given in Patients With Non-Muscle Invasive Bladder Cancer ,Unresponsive to Bacillus-Calmette-Guerin

NCT04452591

Non Muscle Invasive Bladder CancerHigh-grade Ta/ T1 Papillary Disease Bladder Cancer

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ACTIVE_NOT_RECRUITINGPHASE1

A Phase 1/1b Study of ZH9 Treatment in Patients With Non-Muscle Invasive Bladder Cancer

NCT06181266

NMIBCHigh Risk NMIBC+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 30, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Study of Cretostimogene Given in Patients With Non-Muscle Invasive Bladder Cancer ,Unresponsive to Bacillus-Calmette-Guerin

A Phase 1/1b Study of ZH9 Treatment in Patients With Non-Muscle Invasive Bladder Cancer

Follow up of Intravesical N-803 Plus BCG in BCG-Naive Non-Muscle Invasive Bladder Cancer (NMIBC)

Predictors of Residual Tumor at Second Transurethral Resection for pT1 Non-muscle Invasive Bladder Cancer

Study With TMX-101 in Patients With Carcinoma In Situ (CIS) Bladder Cancer