Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Sequential Assignment
Intervention Model Description
Open-label, dose rising trial consisting of a dose escalation phase and a dose confirmation phase for direct injection doses. In the dose escalation phase, subjects will be enrolled in sequential cohorts of three subjects starting at the lowest concentration. The dose determined to be most suitable for further evaluation will enroll additional subjects to total up to 12 subjects at that dose level. The study will also dose escalate Groups 1 and 2 for the intravesical instillation of NanoDoce concentrations (2.0 and 3.0 mg/mL).
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • 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)
    Other names:
    • docetaxel
  • Drug: NanoDoce (intravesical instillation) - Visit 2 Instillation
    All subjects will receive an initial intravesical instillation within 2 hours of direct injection.
    Other names:
    • docetaxel
  • Drug: NanoDoce (intravesical instillation) - Induction and Maintenance Instillations
    Group 1 (NMIBC) will receive intravesical instillations in an Induction Period and a Maintenance Period.
    Other names:
    • docetaxel
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.
  • 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)
    Other names:
    • docetaxel
  • Drug: NanoDoce (intravesical instillation) - Visit 2 Instillation
    All subjects will receive an initial intravesical instillation within 2 hours of direct injection.
    Other names:
    • docetaxel
  • 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.
    Other names:
    • docetaxel

Recruiting Locations

UT Health San Antonio
San Antonio, Texas 78229
Contact:
Karen Nijland
210-567-8554
NijlandK@uthscsa.edu

More Details

NCT ID
NCT03636256
Status
Recruiting
Sponsor
NanOlogy, LLC

Study Contact

Rose Marie Cavanna-Mast
805-595-1300
NANODOCE-2017-02@usbiotest.com

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.