Evaluation of NanoDoce® in Participants With Urothelial Carcinoma

• Status: Active, not recruiting
• Trial end date: 2022-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NanOlogy, LLC
• Collaborator: US Biotest, Inc.
• Treatments: Docetaxel

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.