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Spots Global Cancer Trial Database for Efficacy and Safety of Multi-Instillations of Apaziquone in Patients With Non-Muscle Invasive Bladder Cancer

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Trial Identification

Brief Title: Efficacy and Safety of Multi-Instillations of Apaziquone in Patients With Non-Muscle Invasive Bladder Cancer

Official Title: A Phase 3 International, Multicenter, Double-Blind, Placebo-Controlled, Randomized Trial Evaluating the Efficacy and Safety of Multiple Instillations of Intravesical Apaziquone vs. Placebo in Patients With Low-Intermediate Risk Non-Muscle Invasive Bladder Cancer (NMIBC)

Study ID: NCT01410565

Conditions

Bladder Cancer

Interventions

Apaziquone
Placebo

Study Description

Brief Summary: This is an international, multicenter, double-blind, placebo-controlled, randomized study. All eligible patients entering the open label phase of the study will receive a single immediate instillation of apaziquone (4 mg in 40 mL diluent), post transurethral resection-bladder tumor (TURBT). Following Central Pathology review of histology and Double Blind Phase qualification, patients with confirmed eligibility will be randomized to receive either 6 weekly intravesical instillations of apaziquone or matching placebo and undergo cystoscopic and safety assessments every 3 months for 24 months from randomization. Patients with histologic evidence of recurrent disease during the study will be treated according to current treatment guidelines or local standard of care. Safety and efficacy assessments will be performed at 3 month intervals for all randomized patients throughout the study. Patients who receive single dose of apaziquone immediately following TURBT and are not eligible for randomization will be followed for 3 months by cystoscopic exam and safety assessments.

Detailed Description:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Valley Urologic Associates, Glendale, Arizona, United States

Precision Trials, LLC, Phoenix, Arizona, United States

South Orange County Medical Research Center, Laguna Woods, California, United States

The Urology Center of Colorado, Denver, Colorado, United States

Connecticut Clinical Research Center, Middlebury, Connecticut, United States

Urology Enterprises, Marietta, Georgia, United States

North Idaho Urology, Coeur d'Alene, Idaho, United States

Idaho Urologic Institute, P.A., Meridian, Idaho, United States

Northeast Indiana Research, LLC, Ft. Wayne, Indiana, United States

First Urology, PSC, Jeffersonville, Indiana, United States

Regional Urology, LLC, Shreveport, Louisiana, United States

Anne Arundel Urology, Annapolis, Maryland, United States

Spectrum Health Medical Group, Grand Rapids, Michigan, United States

University of Minnesota, Minneapolis, Minnesota, United States

Five Valleys Urology, Missoula, Montana, United States

Delaware Valley Urology, LLC - Voorhees, Voorhees, New Jersey, United States

Delaware Valley Urology, LLC-Westampton, Westampton, New Jersey, United States

University Urology Associates, New York, New York, United States

Urology Associates of Rochester, LLC, Rochester, New York, United States

TriState Urologic Services PSC, Inc., Cincinnati, Ohio, United States

Urologic Consultants of Southeastern Pennsylvania, LLP, Bala Cynwyd, Pennsylvania, United States

Urology Health Specialists, Bryn Mawr, Pennsylvania, United States

Urological Associates of Lancaster, Lancaster, Pennsylvania, United States

Carolina Urologic Research Center, Myrtle Beach, South Carolina, United States

Urology Associates of South Texas, McAllen, Texas, United States

Urology of Virginia, PC, Virginia Beach, Virginia, United States

Urology of Virginia, PLLC, Virginia Beach, Virginia, United States

Integrity Medical Research, LLC, Mountlake Terrace, Washington, United States

G. Steinhoff Clinical Research Pacific Urologic Research, Victoria, British Columbia, Canada

Queen Elizabeth II Health Science Center, Halifax, Nova Scotia, Canada

The Male/Female Health and Research Centre - Royal Court Medical Centre, Barrie, Ontario, Canada

Brantford Urology Research, Brantford, Ontario, Canada

G. Kenneth Jansz Medicine Professional Corporation, Burlington, Ontario, Canada

Urology Resource Centre, Burlington, Ontario, Canada

Kingston General Hospital / Queen's University, Kingston, Ontario, Canada

Urology Associates, Urologic Medical Research, Kitchener, Ontario, Canada

Mor Urology, Inc., Newmarket, Ontario, Canada

Office of Bernard Goldfarb, North Bay, Ontario, Canada

Stanley Flax Medical Professional Corporation, North York, Ontario, Canada

The Fe/Male Health Centre, Oakville, Ontario, Canada

Urotec, Oshawa, Ontario, Canada

Urology/Male Infertility, Scarborough, Ontario, Canada

Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada

University Health Network Princess Margaret Hospital, Toronto, Ontario, Canada

Centre universitaire de sante McGill, Montreal, Quebec, Canada

Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke, Quebec, Canada

Centre Hospitalier Universitaire de Quebec, Quebec, , Canada

Contact Details

Name: Show-Li Sun, MD

Affiliation: Spectrum Pharmaceuticals, Inc

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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