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

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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

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.

Condition or disease Intervention/treatment Phase
Non Muscle Invasive Bladder Cancer Drug: Nanoxel®M Drug: Mitomycin-C Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : January 2017
Actual Primary Completion Date : August 2018
Actual Study Completion Date : August 2018


Arm Intervention/treatment
Experimental: Nanoxel®M
75 mg in 100mL normal saline
Drug: Nanoxel®M
Intravesical
Other Name: Polysorbate 80, ethanol free Docetaxel

Active Comparator: Mitomycin
40 mg in 100mL normal saline
Drug: Mitomycin-C
Intravesical




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. Overall survival [ Time Frame: 2 years ]
    Time from random assignment to death resulting from any cause.

  3. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02982395


Locations
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Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Samyang Biopharmaceuticals Corporation
Investigators
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Principal Investigator: Ja Hyeon Ku Seoul National University Hospital

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Responsible Party: Samyang Biopharmaceuticals Corporation
ClinicalTrials.gov Identifier: NCT02982395     History of Changes
Other Study ID Numbers: DPMBLC301
First Posted: December 5, 2016    Key Record Dates
Last Update Posted: August 30, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Samyang Biopharmaceuticals Corporation:
Nanoxel M
Docetaxel PM
Docetaxel
Mitomycin C
BCG
BCG refractory
Non muscle invasive bladder cancer
intravesical
superficial bladder cancer
Urothelial carcinoma
Transitional cell carcinoma
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Docetaxel
Mitomycins
Mitomycin
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antibiotics, Antineoplastic
Alkylating Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors