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

Primary Purpose

Non Muscle Invasive Bladder Cancer

Status
Terminated
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Nanoxel®M
Mitomycin-C
Sponsored by
Samyang Biopharmaceuticals Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non Muscle Invasive Bladder Cancer focused on measuring Nanoxel M, Docetaxel PM, Docetaxel, Mitomycin C, BCG, BCG refractory, Non muscle invasive bladder cancer, intravesical, superficial bladder cancer, Urothelial carcinoma, Transitional cell carcinoma

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Nanoxel®M

Mitomycin

Arm Description

75 mg in 100mL normal saline

40 mg in 100mL normal saline

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Overall survival
Time from random assignment to death resulting from any cause.
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.

Full Information

First Posted
November 24, 2016
Last Updated
August 28, 2019
Sponsor
Samyang Biopharmaceuticals Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT02982395
Brief Title
Study to Evaluate the Efficacy and Safety Of Intravesical Nanoxel®M In BCG Refractory NMIBC
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Terminated
Study Start Date
January 2017 (Actual)
Primary Completion Date
August 2018 (Actual)
Study Completion Date
August 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Samyang Biopharmaceuticals Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nanoxel®M
Arm Type
Experimental
Arm Description
75 mg in 100mL normal saline
Arm Title
Mitomycin
Arm Type
Active Comparator
Arm Description
40 mg in 100mL normal saline
Intervention Type
Drug
Intervention Name(s)
Nanoxel®M
Other Intervention Name(s)
Polysorbate 80, ethanol free Docetaxel
Intervention Description
Intravesical
Intervention Type
Drug
Intervention Name(s)
Mitomycin-C
Intervention Description
Intravesical
Primary Outcome Measure Information:
Title
Recurrence free rate
Description
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Recurrence free rate
Description
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.
Time Frame
6 months, 2 years
Title
Overall survival
Description
Time from random assignment to death resulting from any cause.
Time Frame
2 years
Title
Number of participants with adverse events as assessed by CTCAE v4.0
Description
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.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ja Hyeon Ku
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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