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Clinical trialNCT01310803TerminatedPhase 3Interventional

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

SponsorEndo USA Inc., a Keenova Therapeutics CompanyEnrollment1Carcinoma in SituNon-muscle Invasive Bladder CancerTransitional Cell Carcinoma
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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).
clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

  • Philippe E Spiess, MD, MS, FACS, FRCS(C)

    H. Lee Moffitt Cancer Center and Research Institute

    Principal Investigator
    clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

6 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • Bcg Oncology

    Phoenix, Arizona, United States

  • the Urology Center of Colorado

    Denver, Colorado, United States

  • Urology Associates

    Cumberland, Maryland, United States

  • Delaware Valley Urology

    Sewell, New Jersey, United States

  • Associated Medical Professionals of New York

    Syracuse, New York, United States

  • Urologic Consultants of Se Pa

    Bala-Cynwyd, Pennsylvania, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

VALSTAR - Maintenance Therapy
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
31 May 2011
Primary completion
31 Jan 2012
Completion
31 Jan 2012
Last update posted
5 Oct 2017
Registered enrollment
1
Registry id
NCT01310803
clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.