Evaluation of NanoDoce® in Participants With Urothelial Carcinoma

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

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