NCT02982395

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 24, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 5, 2016

Completed
27 days until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

August 30, 2019

Status Verified

August 1, 2019

Enrollment Period

1.6 years

First QC Date

November 24, 2016

Last Update Submit

August 28, 2019

Conditions

Non Muscle Invasive Bladder Cancer

Keywords

Nanoxel MDocetaxel PMDocetaxelMitomycin CBCGBCG refractoryNon muscle invasive bladder cancerintravesicalsuperficial bladder cancerUrothelial carcinomaTransitional cell carcinoma

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Recurrence free rate

    6 months, 2 years

  • Overall survival

    2 years

  • Number of participants with adverse events as assessed by CTCAE v4.0

    2 years

Study Arms (2)

Nanoxel®M

EXPERIMENTAL

75 mg in 100mL normal saline

Drug: Nanoxel®M

Mitomycin

ACTIVE COMPARATOR

40 mg in 100mL normal saline

Drug: Mitomycin-C

Interventions

Nanoxel®MDRUG

Intravesical

Also known as: Polysorbate 80, ethanol free Docetaxel
Nanoxel®M
Mitomycin-CDRUG

Intravesical

Mitomycin

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Non-Muscle Invasive Bladder NeoplasmsCarcinoma, Transitional Cell

Interventions

PolysorbatesMitomycin

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsUrinary Bladder NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Polyethylene GlycolsEthylene GlycolsGlycolsAlcoholsOrganic ChemicalsPolymersMacromolecular SubstancesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and AgricultureMitomycinsIndolequinonesQuinonesAzirinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Ja Hyeon Ku

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 24, 2016

First Posted

December 5, 2016

Study Start

January 1, 2017

Primary Completion

August 1, 2018

Study Completion

August 1, 2018

Last Updated

August 30, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)