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

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ClinicalTrials.gov Identifier: NCT01314664
Recruitment Status : Terminated (Business decision, not safety related)
First Posted : March 14, 2011
Last Update Posted : June 12, 2015
Information provided by (Responsible Party):
Endo Pharmaceuticals

Brief Summary:
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.

Condition or disease
Bladder Cancer CIS

Study Type : Observational
Actual Enrollment : 15 participants
Time Perspective: Prospective
Study Start Date : May 2011
Primary Completion Date : January 2012
Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer
Drug Information available for: Valrubicin
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
subjects who will be receiving intravesical valrubicin treatment for NMIBC

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:

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): NCT01314664

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

Responsible Party: Endo Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01314664     History of Changes
Other Study ID Numbers: EN3329-402
First Posted: March 14, 2011    Key Record Dates
Last Update Posted: June 12, 2015
Last Verified: June 2015

Keywords provided by Endo Pharmaceuticals:
Non-Muscle Invasive Bladder Cancer
BCG Refractory

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Urinary Bladder Diseases
Urologic Diseases
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action