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Clinical Trial Summary

This is a Phase 3b open-label, randomized, parallel-arm, multicenter study to evaluate the efficacy and safety of 10 monthly intravesical administrations of maintenance therapy with valrubicin following induction with valrubicin as compared to induction with valrubicin only in subjects with CIS of the bladder. The randomization will be 1:1 and subjects will be stratified by tumor type (CIS plus papillary disease vs. CIS only) and time from last bacillus Calmette-Guerin (BCG) failure (>1 year vs. <1 year).


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT01310803
Study type Interventional
Source Endo Pharmaceuticals
Contact
Status Terminated
Phase Phase 3
Start date May 2011
Completion date January 2012

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