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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02982395
Recruitment Status : Terminated
First Posted : December 5, 2016
Last Update Posted : August 30, 2019
Sponsor:
Information provided by (Responsible Party):
Samyang Biopharmaceuticals Corporation

Tracking Information
First Submitted Date  ICMJE November 24, 2016
First Posted Date  ICMJE December 5, 2016
Last Update Posted Date August 30, 2019
Actual Study Start Date  ICMJE January 2017
Actual Primary Completion Date August 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 2, 2016)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02982395 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 2, 2016)
  • 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.
  • Overall survival [ Time Frame: 2 years ]
    Time from random assignment to death resulting from any cause.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate the Efficacy and Safety Of Intravesical Nanoxel®M In BCG Refractory NMIBC
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Non Muscle Invasive Bladder Cancer
Intervention  ICMJE
  • Drug: Nanoxel®M
    Intravesical
    Other Name: Polysorbate 80, ethanol free Docetaxel
  • Drug: Mitomycin-C
    Intravesical
Study Arms  ICMJE
  • Experimental: Nanoxel®M
    75 mg in 100mL normal saline
    Intervention: Drug: Nanoxel®M
  • Active Comparator: Mitomycin
    40 mg in 100mL normal saline
    Intervention: Drug: Mitomycin-C
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: August 28, 2019)
36
Original Estimated Enrollment  ICMJE
 (submitted: December 2, 2016)
88
Actual Study Completion Date  ICMJE August 2018
Actual Primary Completion Date August 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02982395
Other Study ID Numbers  ICMJE DPMBLC301
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Samyang Biopharmaceuticals Corporation
Study Sponsor  ICMJE Samyang Biopharmaceuticals Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ja Hyeon Ku Seoul National University Hospital
PRS Account Samyang Biopharmaceuticals Corporation
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP