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

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02982395

Enrollment

Registered

2016-12-05

Start date

2017-01-31

Completion date

2018-08-31

Last updated

2019-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non Muscle Invasive Bladder Cancer

Keywords

Nanoxel M, Docetaxel PM, Docetaxel, Mitomycin C, BCG, BCG refractory, Non muscle invasive bladder cancer, intravesical, superficial bladder cancer, Urothelial carcinoma, Transitional cell carcinoma

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.

Interventions

DRUGNanoxel®M

Intravesical

DRUGMitomycin-C

Intravesical

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026