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

June 10, 2015 updated by: Endo Pharmaceuticals

A PROSPECTIVE REGISTRY TO ASSESS THE EFFECTIVENESS AND LOCAL TOLERABILITY OF INTRAVESICAL VALRUBICIN IN SUBJECTS WITH NON-MUSCLE INVASIVE BLADDER CANCER (NMIBC)

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.

Study Overview

Status

Terminated

Conditions

Study Type

Observational

Enrollment (Actual)

15

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85032
        • BCG Oncology
    • Florida
      • Hialeah, Florida, United States, 33149
        • Urology Research Network
      • Vero Beach, Florida, United States, 32960
        • Advanced Urology Association of Florida
    • Kansas
      • Overland Park, Kansas, United States, 66211
        • Kansas City Urology Care
    • New Jersey
      • Sewell, New Jersey, United States, 08080
        • Delaware Valley Urology
      • Voorhees, New Jersey, United States, 08043
        • Delaware Valley Urology
    • New York
      • Bethpage, New York, United States, 11714
        • Long Island Urological Associates
    • Pennsylvania
      • Bala-Cynwyd, Pennsylvania, United States, 19004
        • Urologic Consultants of SE PA
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center
    • Texas
      • Arlington, Texas, United States, 76017
        • Urology Associates of North Texas
      • Dallas, Texas, United States, 75231
        • Urology Clinics of North Texas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

subjects who will be receiving intravesical valrubicin treatment for NMIBC

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Endo Pharmaceuticals

Investigators

  • Study Director: Todd Kirby, PhD, Endo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (ACTUAL)

January 1, 2012

Study Completion (ACTUAL)

January 1, 2012

Study Registration Dates

First Submitted

March 11, 2011

First Submitted That Met QC Criteria

March 11, 2011

First Posted (ESTIMATE)

March 14, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

June 12, 2015

Last Update Submitted That Met QC Criteria

June 10, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EN3329-402

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Bladder Cancer

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Lebanon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe