Evaluation of NanoDoce® in Participants With Urothelial Carcinoma

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-02

Study Completion Date

2021-11-02

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

NanoDoce (direct injection)

Intervention Type DRUG

Subjects will receive NanoDoce injected into the index tumor resection site on the bladder wall, immediately following transurethral resection of the bladder tumor (TURBT)

NanoDoce (intravesical instillation) - Visit 2 Instillation

Intervention Type DRUG

All subjects will receive an initial intravesical instillation within 2 hours of direct injection.

NanoDoce (intravesical instillation) - Induction and Maintenance Instillations

Intervention Type DRUG

Group 1 (NMIBC) will receive intravesical instillations in an Induction Period and a Maintenance Period.

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.

Group Type EXPERIMENTAL

NanoDoce (direct injection)

Intervention Type DRUG

Subjects will receive NanoDoce injected into the index tumor resection site on the bladder wall, immediately following transurethral resection of the bladder tumor (TURBT)

NanoDoce (intravesical instillation) - Visit 2 Instillation

Intervention Type DRUG

All subjects will receive an initial intravesical instillation within 2 hours of direct injection.

Institutional Standard of Care

Intervention Type OTHER

Group 2 (MIBC) will receive institutional standard of care treatments after the Visit 2 intravesical instillation.

Interventions

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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)

Intervention Type DRUG

NanoDoce (intravesical instillation) - Visit 2 Instillation

All subjects will receive an initial intravesical instillation within 2 hours of direct injection.

Intervention Type DRUG

Institutional Standard of Care

Group 2 (MIBC) will receive institutional standard of care treatments after the Visit 2 intravesical instillation.

Intervention Type OTHER

NanoDoce (intravesical instillation) - Induction and Maintenance Instillations

Group 1 (NMIBC) will receive intravesical instillations in an Induction Period and a Maintenance Period.

Intervention Type DRUG

Other Intervention Names

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docetaxel; large surface area microparticle docetaxel docetaxel; large surface area microparticle docetaxel docetaxel; large surface area microparticle docetaxel

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No