Evaluation of NanoDoce® in Participants With Urothelial Carcinoma
Completed · Phase 1/Phase 2
Conditions studied: Bladder Cancer, Urothelial Carcinoma, Urinary Bladder Neoplasm, Urinary Bladder Cancer, Urogenital Neoplasms, Urologic Neoplasms, Urologic Cancer, Malignant Tumor of the Urinary Bladder, Cancer of the Bladder
In brief
This is a clinical trial studying the administration of NanoDoce as a direct injection to the bladder wall immediately after tumor resection and as an intravesical instillation. All participants will receive NanoDoce, and will be evaluated for safety and tolerability, as well as the potential effects of NanoDoce on urothelial carcinoma.
Key facts
- Study ID
- NCT03636256
- Run by
- NanOlogy, LLC
- People needed
- 36
- Starts
- 2019-04-02
- Expected to finish
- 2021-11-02
- Last updated by the study team
- 2023-08-14
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Signed informed consent;
- Age ≥18 years;
- Patients with either:
- High-risk Non-Muscle Invasive Bladder Cancer (NMIBC);
- Muscle Invasive Bladder Cancer (MIBC);
- Urothelial carcinoma confirmed by biopsy, urine cytology, computed tomography scan (CT) or other institution-approved diagnostic methodology;
- All visible tumors removed during bladder resection (TURBT);
- Performance Status (ECOG) 0-2 at study entry;
- Life expectancy of at least 6 months;
- Adequate marrow, liver, and renal function;
- ANC ≥ 1.5 x 10\^9/L;
- Hemoglobin ≥ 9.5 grams/dL;
- Platelets ≥ 75 x 10\^9/L;
- Total bilirubin ≤ 1.5x institutional ULN;
- AST/ ALT ≤ 2.5x institutional ULN;
- Creatinine ≤ 1.5x institutional ULN;
- Adequate method of birth control.
You may not qualify if…
- Metastatic disease;
- Previous (within 12 months) or concurrent history of non-bladder malignancy, except for non-melanoma skin cancer;
- Intravesical therapy within 6 weeks prior to consent (chemotherapy or immunotherapy including BCG administered directly into the bladder);
- Resection surface area greater than 8 cm2;
- Upper tract and urethral disease within 18 months;
- Known hypersensitivity to any of the study drug components or reconstitution components;
- Pregnant or breastfeeding;
- Participation in the treatment phase of another clinical trial within 3 months prior to consent;
- Investigator's opinion of subject's probable noncompliance or inability to understand the trial and/or give adequate informed consent;
- Ongoing drug or alcohol abuse.
Where it is running
- BCG Oncology, PC — Phoenix, Arizona, United States
- James Buchanan Brady Urological Institute, Johns Hopkins Medical Institutions — Baltimore, Maryland, United States
- Columbia University Herbert Irving Comprehensive Cancer Center — New York, New York, United States
- Carolina Urologic Research Center — Myrtle Beach, South Carolina, United States
- UT Health San Antonio — San Antonio, Texas, United States
Full record on ClinicalTrials.gov
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