Condition: Non-Muscle Invasive Bladder Cancer ("NMIBC") Unresponsive/Intolerant to BCG · Sponsor: Theralase® Technologies Inc.
This is a phase II, open-label, single-arm, multi-center Study conducted in Canada and the United States. Patients with Non-Muscle Invasive Bladder Cancer ("NMIBC") Carcinoma In-Situ ("CIS") (with or without resected papillary disease (Ta, T1)) that are considered Bacillus Calmette-Guerin ("BCG")-Unresponsive or who are intolerant to BCG therapy. BCG-Unresponsive is at least one of the following: At least five of six doses of an initial induction course plus at least two of three doses of maintenance therapy; or, at least five of six doses of an initial induction course plus at least two of six doses of a second induction course. Patients experiencing disease relapse within 12 months after finishing the second course of BCG therapy are considered BCG-Unresponsive. The Study will consist of 90 patients who will undergo one (1) Study Procedure, with up to two (2) additional re-induction Study Procedures based on patient response.
This description comes directly from the study's public registry record.
Arkady Mandel, MD, PhD, DSc · 416-699-5273 · amandel@theralase.com
Always discuss trial participation with your own doctor first.
| Site 02-012 - University of Chicago | Chicago, Illinois, United States | Recruiting |
| Site 02-016 - Urology of Indiana | Greenwood, Indiana, United States | Recruiting |
| Site 02-015 - Associated Medical Professionals of New York | Syracuse, New York, United States | Recruiting |
| Site 02-017 - Central Ohio Urology Group | Gahanna, Ohio, United States | Recruiting |
| Site 02-008 - MidLantic Urology | Bala-Cynwyd, Pennsylvania, United States | Terminated |
| Site 02-006 - Carolina Urologic Research Center | Myrtle Beach, South Carolina, United States | Recruiting |
| Site 02-007 - Urology Associates, P. C | Nashville, Tennessee, United States | Recruiting |
| Site 02-010 - Urology San Antonio P. A | San Antonio, Texas, United States | Terminated |
| Site 02-009 - Virginia Urology | Richmond, Virginia, United States | Terminated |
| Site 02-011 - University of Wisconsin Health University Hospital | Madison, Wisconsin, United States | Recruiting |
| Site 01-005 - The Vancouver Prostate Centre - Diamond Health Care Centre - Vancouver General Hospital | Vancouver, British Columbia, Canada | Recruiting |
| Site 01-004 - Nova Scotia Health Authority - Centre for Applied Urology Research | Halifax, Nova Scotia, Canada | Recruiting |
+ 4 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT03945162