Evaluation of NanoDoce® in Participants With Urothelial Carcinoma

NanOlogy

Status and phase: Completed; Phase 2; Phase 1

Conditions: Urinary Bladder Cancer; Urinary Bladder Neoplasm; Bladder Cancer; Urologic Cancer; Malignant Tumor of the Urinary Bladder; Urogenital Neoplasms; Urothelial Carcinoma; Cancer of the Bladder; Urologic Neoplasms

Treatments: Other: Institutional Standard of Care; Drug: NanoDoce (intravesical instillation) - Visit 2 Instillation; Drug: NanoDoce (direct injection); Drug: NanoDoce (intravesical instillation) - Induction and Maintenance Instillations

Study type: Interventional

Funder types: Industry

Identifiers

NCT03636256

NANODOCE-2017-02

Details and patient eligibility

About

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 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 or Maintenance intravesical instillations.

Enrollment: 36 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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36 participants in 2 patient groups

Non-Muscle Invasive Bladder Cancer

Experimental group

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.

Treatment:

Drug: NanoDoce (intravesical instillation) - Induction and Maintenance Instillations

Drug: NanoDoce (direct injection)

Drug: NanoDoce (intravesical instillation) - Visit 2 Instillation

Muscle Invasive Bladder Cancer

Experimental group

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. Subjects will then go on to receive institutional standard of care.

Treatment:

Drug: NanoDoce (direct injection)

Drug: NanoDoce (intravesical instillation) - Visit 2 Instillation

Other: Institutional Standard of Care