NCT01310803

Multi-center Study to Evaluate the Efficacy and Safety of Maintenance Therapy With Valrubicin Versus no Maintenance, in Subjects Treated With Valrubicin Induction for Carcinoma in Situ (CIS) of the Bladder

A PHASE 3B, RANDOMIZED, OPEN-LABEL, MULTI-CENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF MAINTENANCE THERAPY WITH VALRUBICIN VERSUS NO MAINTENANCE, IN SUBJECTS TREATED WITH VALRUBICIN INDUCTION FOR CARCINOMA IN SITU (CIS) OF THE BLADDER

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Endo Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Carcinoma in Situ
• Transitional Cell Carcinoma
• Non-muscle Invasive Bladder Cancer

Interventions

Type	Name	Description
DRUG	VALSTAR - Maintenance Therapy	Treatment phase - 10 monthly intravesical installations starting 10 to 12 weeks after the beginning of induction. Follow-up phase
OTHER	No Maintenance treatment ( Standard of Care)	Subjects randomized to No Maintenance (Standard of Care) will not receive any additional intravesical therapy

Timeline

• Start date: 2011-05-01
• Primary completion: 2012-01-01
• Completion: 2012-01-01
• First posted: 2011-03-09
• Last updated: 2017-10-05
• Results posted: 2014-10-22

Locations

6 sites across 1 country: United States