Trial Details

Study Phase: Phase 1/2a

Investigational Product: TSD-001

Sponsor: LIPAC Oncology, LLC

About this Trial

The purpose of this study is to look at an investigational treatment, TSD-001 (paclitaxel), for Non-Muscle Invasive Bladder Cancer. This is an investigational product, which means that it is not yet approved for bladder injection by the Food and Drug Administration (FDA). Other formulations of paclitaxel are approved by the FDA for intravenous administration.

This research is being done because paclitaxel instilled directly into a bladder (intravesical therapy) may provide a more effective method to reduce bladder cancer recurrence and progression.

Participants in the study will undergo a Transurethral Resection of Bladder Tumor (TURBT) procedure. Participants will either have one solitary tumor that will not be resected or have all but one bladder tumor removed from the bladder during endoscopic surgical resection. Each participant will receive six doses of the investigational product.

Six to eight weeks after completion of the weekly intravesical therapy (TSD-001), a biopsy of the marker lesion tumor area (and removal of any visible tumor) will also be performed at the time of the cystoscopy to ensure that no residual tumor exists.

Participants will be in the study for over two years; including screening, a 13-week study period, and an additional 21 months of follow-up (surveillance). Participation requires approximately 14 visits to the clinic during the study treatment portion of the study; no overnight stays are required. The follow-up portion of the study will consist of another seven clinical visits. Most procedures that are study-related are performed solely for the study and will be done at no charge to you or your insurance company.

How to Qualify

For more information on eligibility for this study, please contact the site nearest you as listed in the Trial Site Locations section.
 
Some major criteria for study eligibility are listed here:
  • Have a diagnosis of low-grade, papillary-appearing bladder tumor, stage Ta. You may meet this criteria if you have a small solitary papillary tumor.
  • If you have 2-5 tumors you should be a surgical candidate for a TURBT.
NOT ELIGIBLE IF:
  • You have an active concurrent malignancy besides bladder cancer now. You will not be excluded for recurrent NMIBC, basal or squamous cell skin cancers, or noninvasive cancer of the cervix.
  • You have a life-threatening disease.
  • You have carcinoma in situ or T1 Transitional Cell Carcinoma.
  • You have had previous intravesical therapy in the last 6 months or current treatment of any chemotherapeutic.

Trial Site Locations

United States, Arizona
Urological Associates of Southern Arizona, PC
Tucson, Arizona, United States, 85741
Contact: Suzan Swanson
(520) 351-5573
suzans@uasapc.com
Contact: Lorrie Mills
(520) 351-5573
lorriem@uasapc.com
Principal Investigator: Curtis J. Dunshee, MD, FACS

United States, California
Trovare Clinical Research
Bakersfield, California, United States, 93301
Contact: Laurie Nakayama, RN
(661) 663-3096 ext 112
Inakayama@trovarecr.com
Principal Investigator: Danny Huynh, MD

Tower Urology
Los Angeles, California, United States, 90048
Contact: Shiblee Nomanee
(310) 854-9898 ext 168
nomanees@towerurology.com
Principal Investigator: David Josephson, MD
United States, Maryland
Chesapeake Urology Associates
Hanover, Maryland, United States, 21076
Contact: Wendy Paxton
(443) 471-5763
wpaxton@chesuro.com
Principal Investigator: Rian Dickstein, MD

United States, Pennsylvania
UPMC Urology
Pittsburgh, Pennsylvania, United States, 15232
Contact: Dawn McBride, RN
(412) 623-2764
mcbridedl@upmc.edu
Principal Investigator: Jodi Maranchie, MD

United States, South Carolina
Carolina Urologic Research Clinic
Myrtle Beach, South Carolina, United States, 29572
Contact: Stacy Rust
(843) 449-1010 ext 261
srust@curcmb.com
Principal Investigator: Neal Shore, MD