Intravesical AD 32 (Valrubicin) in Patients With Carcinoma in Situ (CIS) of the Bladder Who Have Failed or Have Recurrence Following Treatment With Bacillus Calmette-guerin (BCG)
- Conditions
- Bladder CancerCarcinoma in Situ
- Interventions
- Drug: Valrubicin, 800 mg
- Registration Number
- NCT01316874
- Lead Sponsor
- Endo Pharmaceuticals
- Brief Summary
This is a Phase II/Phase III study of intravesical AD 32 (valrubicin) in patients with carcinoma in situ (CIS) who have been previously treated with intravesical Bacillus Calmette-Guerin (BCG) for CIS and in whom recurrence or failure has occurred after multiple courses of intravesical treatment.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 90
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description AD32 (valrubicin) Valrubicin, 800 mg 800mg, once weekly for 6 weeks
- Primary Outcome Measures
Name Time Method Assess the efficacy of AD 32 (valrubicin) in patients with CIS of the bladder who previously have been treated with BCG for CIS and in whom recurrence or failure had occurred after multiple courses of intravesical treatment. 12 weeks
- Secondary Outcome Measures
Name Time Method To determine the concentration of anthracyclines in the voided urine of patients who chose to participate in a urine recovery study. 6 weeks To evaluate the qualitative toxicities associated with intravesical therapy using AD 32 (valrubicin). 6 weeks
Trial Locations
- Locations (39)
Myron Murdock, MD
🇺🇸Greenbelt, Maryland, United States
Stacy Childs, MD
🇺🇸Alabaster, Alabama, United States
Scott Swanson, MD
🇺🇸Scottsdale, Arizona, United States
Bruce Dalkin, MD
🇺🇸Tucson, Arizona, United States
Donald Gleason, MD
🇺🇸Tucson, Arizona, United States
William Friedel, MD
🇺🇸La Mesa, California, United States
Stephen Auerbach, MD
🇺🇸Newport Beach, California, United States
Standley Brosman, MD
🇺🇸Santa Monica, California, United States
B. Thomas Brown, MD
🇺🇸Daytona Beach, Florida, United States
Eugene Dula, MD
🇺🇸Van Nuys, California, United States
Charles Jackson, MD
🇺🇸Ft. Lauderdale, Florida, United States
Charles Brendler, MD
🇺🇸Chicago, Illinois, United States
Jeffrey Ignatoff, MD
🇺🇸Evanston, Illinois, United States
John Tuttle, MD
🇺🇸Lexington, Kentucky, United States
Patrick Guinan, MD
🇺🇸Chicago, Illinois, United States
David Wood, MD
🇺🇸Lexington, Kentucky, United States
Harold Frazier, MD
🇺🇸Bethasda, Maryland, United States
Dennis Venable, MD
🇺🇸Shreveport, Louisiana, United States
John Libertino
🇺🇸Burlington, Massachusetts, United States
W. Lamar Weems, MD
🇺🇸Jackson, Mississippi, United States
Hugh Fisher, MD
🇺🇸Albany, New York, United States
Michael Blute, MD
🇺🇸Rochester, New York, United States
Michael Wolff, MD
🇺🇸Burlington, North Carolina, United States
Eric Klein, MD
🇺🇸Cleveland, Ohio, United States
Jeffrey Cohen, MD
🇺🇸Pittsburgh, Pennsylvania, United States
Jacques Susset, MD
🇺🇸Providence, Rhode Island, United States
Ian Thompson, MD
🇺🇸Ft. San Houston, Texas, United States
William Moseley, MD
🇺🇸San Diego, California, United States
Marc Soloway, MD
🇺🇸Miami, Florida, United States
L. Dean Knoll, MD
🇺🇸Nashville, Tennessee, United States
Seth Lemer, MD
🇺🇸Houston, Texas, United States
Steohen Hardeman, MD
🇺🇸Austin, Texas, United States
Williams Ellis, MD
🇺🇸Seattle, Washington, United States
Richard Boxer, MD
🇺🇸Milwaukee, Wisconsin, United States
William Bohnert, MD
🇺🇸Phoenix, Arizona, United States
Cary Robertson, MD
🇺🇸Durham, North Carolina, United States
Bruce Lowe, MD
🇺🇸Portland, Oregon, United States
Aaron Katz, MD
🇺🇸Richmond, Virginia, United States
Gary Katz, MD
🇺🇸Richmond, Virginia, United States