Brief Title
Evaluation of NanoDoce® in Participants With Urothelial Carcinoma
Official Title
Phase 1/2 Trial Evaluating the Safety and Tolerability of NanoDoce® Injection and Intravesical Instillation in Subjects With Urothelial Carcinoma
Brief 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.
Detailed Description
In this clinical trial, subjects with high-risk non-muscle invasive bladder cancer (NMIBC) or muscle invasive bladder cancer (MIBC), will receive NanoDoce. Subjects will be stratified into two treatment groups, Group 1 (NMIBC) and Group 2 (MIBC). All subjects will receive NanoDoce injected into the index tumor resection site on the bladder wall, immediately following transurethral resection of the bladder tumor (TURBT), followed by an initial NanoDoce intravesical instillation. Once the TURBT resection site is healed (approximately 1 month), Group 1 (NMIBC) subjects will proceed to a 3-month Induction period (6 weekly NanoDoce intravesical instillations, followed by 6 weeks of rest). After the Induction period, following confirmation of non-recurrence, Group 1 subjects will proceed to a 3-month Maintenance period (3 weekly NanoDoce intravesical instillations, followed by 9 weeks of rest). After NanoDoce direct injection and the initial intravesical instillation, Group 2 subjects will proceed to institutional standard of care and will not receive Induction of Maintenance intravesical instillations.
Study Phase
Phase 1/Phase 2
Study Type
Interventional
Primary Outcome
Incidence of Treatment Emergent Adverse Events (safety and tolerability)
Secondary Outcome
Pharmacokinetics: Area under the plasma concentration versus time curve (AUC) of NanoDoce
Condition
Bladder Cancer
Intervention
NanoDoce (direct injection)
Study Arms / Comparison Groups
Non-Muscle Invasive Bladder Cancer
Description: Subjects will be enrolled in sequential, dose escalating cohorts of NanoDoce direct injection (0.75 1.5, 2.5, or 3.75 mg/mL). Subjects will also receive an initial NanoDoce intravesical instillation at 2.0 or 3.0 mg/mL and additional Induction (6 weekly NanoDoce intravesical instillations, followed by 6 weeks of rest) and Maintenance (3 weekly NanoDoce intravesical instillations, followed by 9 weeks of rest) instillations at 2.0 or 3.0 mg/mL.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
36
Start Date
April 2, 2019
Completion Date
November 2, 2021
Primary Completion Date
November 2, 2021
Eligibility 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.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Donald Lamm, MD, FACS, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT03636256
Organization ID
NANODOCE-2017-02
Responsible Party
Sponsor
Study Sponsor
NanOlogy, LLC
Collaborators
US Biotest, Inc.
Study Sponsor
Donald Lamm, MD, FACS, Principal Investigator, BCG Oncology, PC
Verification Date
November 2021