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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Endo Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01314664
First received: March 11, 2011
Last updated: February 14, 2012
Last verified: February 2012
  Purpose

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
Bladder Cancer
CIS

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: A PROSPECTIVE REGISTRY TO ASSESS THE EFFECTIVENESS AND LOCAL TOLERABILITY OF INTRAVESICAL VALRUBICIN IN SUBJECTS WITH NON-MUSCLE INVASIVE BLADDER CANCER (NMIBC)

Resource links provided by NLM:


Further study details as provided by Endo Pharmaceuticals:

Estimated Enrollment: 200
Study Start Date: May 2011
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

subjects who will be receiving intravesical valrubicin treatment for NMIBC

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01314664

Locations
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
  More Information

No publications provided

Responsible Party: Endo Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01314664     History of Changes
Other Study ID Numbers: EN3329-402
Study First Received: March 11, 2011
Last Updated: February 14, 2012
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on September 29, 2014