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

August 28, 2019 updated by: Samyang Biopharmaceuticals Corporation

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

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 Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nanoxel®M
75 mg in 100mL normal saline
Drug: Nanoxel®M
Intravesical
Other Names:
  • Polysorbate 80, ethanol free Docetaxel
Active Comparator: Mitomycin
40 mg in 100mL normal saline
Drug: Mitomycin-C
Intravesical

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence free rate
Time Frame: 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.
6 months, 2 years
Overall survival
Time Frame: 2 years
Time from random assignment to death resulting from any cause.
2 years
Number of participants with adverse events as assessed by CTCAE v4.0
Time Frame: 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.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samyang Biopharmaceuticals Corporation

Investigators

  • Principal Investigator: Ja Hyeon Ku, Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

August 1, 2018

Study Completion (Actual)

August 1, 2018

Study Registration Dates

First Submitted

November 24, 2016

First Submitted That Met QC Criteria

December 2, 2016

First Posted (Estimate)

December 5, 2016

Study Record Updates

Last Update Posted (Actual)

August 30, 2019

Last Update Submitted That Met QC Criteria

August 28, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DPMBLC301

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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