NCT01310803View on ClinicalTrials.gov

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

PHASE3TerminatedINTERVENTIONAL
Enrollment

1

Participants

Timeline

Start Date

May 31, 2011

Primary Completion Date

January 31, 2012

Study Completion Date

January 31, 2012

Conditions
Carcinoma in SituTransitional Cell CarcinomaNon-muscle Invasive Bladder Cancer
Interventions
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

Trial Locations (6)

13210

Associated Medical Professionals of New York, Syracuse

19004

Urologic Consultants of SE PA, Bala-Cynwyd

21502

Urology Associates, Cumberland

80211

The Urology Center of Colorado, Denver

85032

BCG Oncology, Phoenix

08080

Delaware Valley Urology, Sewell

Sponsors
All Listed Sponsors
lead

Endo Pharmaceuticals

INDUSTRY