# 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

Source: https://onco.cc/trials/nct01310803/  
OnCo record `nct01310803` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A phase 3 trial of Valrubicin in Non-muscle-invasive bladder cancer, run by Endo USA Inc., a Keenova Therapeutics Company, recorded as terminated on the registry.

## Summary

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 is a phase 3 interventional study registered as NCT01310803 by Endo USA Inc., a Keenova Therapeutics Company, with 1 participants recorded, started 2011-05 and due to reach its primary completion in 2012-01. Interventions recorded: VALSTAR - Maintenance Therapy, No Maintenance treatment ( Standard of Care). Conditions recorded: Carcinoma in Situ, Transitional Cell Carcinoma, Non-muscle Invasive Bladder Cancer.

Linked to the drug Valrubicin because the registry names it among its interventions and Non-muscle-invasive bladder cancer among its conditions. Registry record only: no result has been read by an editor.

## Fields

- Kind: Trial
- Last checked: 2026-09-22
- Tags: pipeline; ctgov-ingest
- Registry id: NCT01310803
- Phase: 3
- Setting: 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
- Sponsor: Endo USA Inc., a Keenova Therapeutics Company
- Enrolled: 1

## Sources

- ClinicalTrials.gov NCT01310803: https://clinicaltrials.gov/study/NCT01310803

## Connected records

- cancers: [Non-muscle-invasive bladder cancer](https://onco.cc/cancers/non-muscle-invasive-bladder-cancer/)
- drugs: [Valrubicin](https://onco.cc/drugs/valrubicin/)
- companies: [Endo (now Keenova Therapeutics and Par Health)](https://onco.cc/companies/endo/)

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JSON: https://onco.cc/api/v1/entities/nct01310803.json