Conditions: Carcinoma in Situ Transitional Cell Carcinoma Non-muscle Invasive Bladder Cancer
Keywords: Urinary Bladder Neoplasms Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Urinary Bladder Diseases Urologic Diseases TURBT Valstar
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1
Healthy volunteers: no

Brief 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).

Detailed description:

Arms:
arm 1: Chemotherapeutic: EN3329-301 (VALSTAR) arm 2: Subjects randomized to No Maintenance (Standard of Care) will not receive any additional intravesical therapy

Interventions: intervention 1: VALSTAR - Maintenance Therapy intervention 2: No Maintenance treatment ( Standard of Care)
Intervention descriptions: intervention 1: Treatment phase - 10 monthly intravesical installations starting 10 to 12 weeks after the beginning of induction. Follow-up phase intervention 2: Subjects randomized to No Maintenance (Standard of Care) will not receive any additional intravesical therapy

Protocol document: