Spots Global Cancer Trial Database for Efficacy and Safety of Multi-Instillations of Apaziquone in Patients With Non-Muscle Invasive Bladder Cancer
The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
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
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
Take Control of Your Skin and Body Changes Today.
Try out Spots for free, set up only takes 2 mins.
Join others from around the world:
