Retrospective Chart Review of Valstar

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01304173
• Date of registration: 23/02/2011
• Prospective Registration: Yes
• Primary sponsor: Endo Pharmaceuticals
• Public title: Retrospective Chart Review of Valstar
• Scientific title: A Retrospective Analysis to Evaluate the Effectiveness, Safety and Tolerability of Intravesical Valrubicin for the Treatment of Bladder Carcinoma in Situ in Clinical Practice
• Date of first enrolment: March 2011
• Target sample size: 113
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01304173
• Study type: Observational
• Study design: Observational Model: Case-Only, Time Perspective: Retrospective
• Phase: N/A

Countries of recruitment

United States

Contacts

• Name: Michael Cookson, MD
• Affiliation: Vanderbilt University

Key inclusion & exclusion criteria

Inclusion Criteria:

- age 18 years old or greater

- diagnosis of CIS (physician defined in the medical record)

- treated with at least one IVe dose of valrubicin since 10/2009 and completed
prescribed therapy or no longer receiving therapy at time of study enrollment

- willing and able to provide informed consent (unless waiver of informed consent is
applicable and in place at that clinical site per Chapter 45 CFR part 46 Subpart A
46.117

Exclusion Criteria:

- route of administration of valrubicin other than intravesical



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Carcinoma in Situ of Bladder

Primary Outcome(s)

Event-free survival [Time Frame: 12 months]

Secondary Outcome(s)

Worsening-free Survival [Time Frame: 12 months]

Secondary ID(s)

EN3329-401

Source(s) of Monetary Support

Please refer to primary and secondary sponsors