A Prospective Registry to Assess the Effectiveness and Local Tolerability of Intravesical Valrubicin in Subjects With Non-muscle Invasive Bladder Cancer (NMIBC)

NCT ID: NCT01314664

Last Updated: 2015-06-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-05-31

Study Completion Date

2012-01-31

Brief Summary

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The purpose of this study is to observe and describe the effectiveness and local tolerability of intravesical treatment with valrubicin for non-muscle invasive bladder cancer (NMIBC) in a cohort of subjects treated under routine practice conditions.

Detailed Description

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Conditions

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Bladder Cancer CIS

Study Design

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Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Males and females 18 years of age and older
* Diagnosed with NMIBC
* Prescribed intravesical valrubicin to treat NMIBC
* Understood and signed Informed Consent to participate

Exclusion Criteria

* None
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Endo Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Todd Kirby, PhD

Role: STUDY_DIRECTOR

Endo

Locations

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BCG Oncology

Phoenix, Arizona, United States

Site Status

Urology Research Network

Hialeah, Florida, United States

Site Status

Advanced Urology Association of Florida

Vero Beach, Florida, United States

Site Status

Kansas City Urology Care

Overland Park, Kansas, United States

Site Status

Delaware Valley Urology

Sewell, New Jersey, United States

Site Status

Delaware Valley Urology

Voorhees Township, New Jersey, United States

Site Status

Long Island Urological Associates

Bethpage, New York, United States

Site Status

Urologic Consultants of SE PA

Bala-Cynwyd, Pennsylvania, United States

Site Status

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status

Urology Associates of North Texas

Arlington, Texas, United States

Site Status

Urology Clinics of North Texas

Dallas, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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EN3329-402

Identifier Type: -

Identifier Source: org_study_id

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