Evaluation of NanoDoce® in Participants With Urothelial Carcinoma

Overview

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.

Full Title of Study: “Phase 1/2 Trial Evaluating the Safety and Tolerability of NanoDoce® Injection and Intravesical Instillation in Subjects With Urothelial Carcinoma”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Sequential Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 2021

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.

Interventions

  • Drug: NanoDoce (direct injection)
    • Subjects will receive NanoDoce injected into the index tumor resection site on the bladder wall, immediately following transurethral resection of the bladder tumor (TURBT)
  • Drug: NanoDoce (intravesical instillation) – Visit 2 Instillation
    • All subjects will receive an initial intravesical instillation within 2 hours of direct injection.
  • Other: Institutional Standard of Care
    • Group 2 (MIBC) will receive institutional standard of care treatments after the Visit 2 intravesical instillation.
  • Drug: NanoDoce (intravesical instillation) – Induction and Maintenance Instillations
    • Group 1 (NMIBC) will receive intravesical instillations in an Induction Period and a Maintenance Period.

Arms, Groups and Cohorts

  • Experimental: Non-Muscle Invasive Bladder Cancer
    • 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.
  • Experimental: Muscle Invasive Bladder Cancer
    • 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. Subjects will then go on to receive institutional standard of care.

Clinical Trial Outcome Measures

Primary Measures

  • Incidence of Treatment Emergent Adverse Events (safety and tolerability)
    • Time Frame: Up to End of Treatment (Month 6 for Group 1 and Day 45 for Group 2)
    • Treatment Emergent Adverse Events will include laboratory assessments, physical examination findings, and vital signs.

Secondary Measures

  • Pharmacokinetics: Area under the plasma concentration versus time curve (AUC) of NanoDoce
    • Time Frame: Up to End of Treatment (Month 6 for Group 1 and Day 45 for Group 2)
    • Plasma samples will be collected to characterize the pharmacokinetics of NanoDoce.
  • Pharmacokinetics: Peak plasma concentration (Cmax) of NanoDoce
    • Time Frame: Up to End of Treatment (Month 6 for Group 1 and Day 45 for Group 2)
    • Plasma samples will be collected to characterize the pharmacokinetics of NanoDoce.
  • Pharmacokinetics: Time at which peak plasma concentration is observed (Tmax) of NanoDoce.
    • Time Frame: Up to End of Treatment (Month 6 for Group 1 and Day 45 for Group 2)
    • Plasma samples will be collected to characterize the pharmacokinetics of NanoDoce.
  • Progression free survival (PFS)
    • Time Frame: At Months 6, 9, and 12
    • No evidence of tumor recurrence or disease progression

Participating in This Clinical Trial

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 Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • NanOlogy, LLC
  • Collaborator
    • US Biotest, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Donald Lamm, MD, FACS, Principal Investigator, BCG Oncology, PC

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