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

Non Muscle Invasive Bladder Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02982395
• Other study ID #: DPMBLC301
• Status: Terminated
• Phase: Phase 3
• Start date: January 2017
• Est. completion date: August 2018

Study information

• Verified date: August 2019
• Source: Samyang Biopharmaceuticals Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 36
• Est. completion date: August 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Non Muscle Invasive Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

Drug:
• Nanoxel®M
Intravesical
• Mitomycin-C
Intravesical

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samyang Biopharmaceuticals Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 year
Secondary	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.	6 months, 2 years
Secondary	Overall survival	Time from random assignment to death resulting from any cause.	2 years
Secondary	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.	2 years