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Brief Title: Evaluation of NanoDoce® in Participants With Urothelial Carcinoma

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Phase 1/2 Trial Evaluating the Safety and Tolerability of NanoDoce® Injection and Intravesical Instillation in Subjects With Urothelial Carcinoma

INTRODUCTION

  • Org Study ID: NANODOCE-2017-02
  • Secondary ID: N/A
  • NCT ID: NCT03636256
  • Sponsor: NanOlogy, LLC

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 or Maintenance intravesical instillations.

  • Overall Status
    Completed
  • Start Date
    April 2, 2019
  • Phase
    PHASE1, PHASE2
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Incidence of Treatment Emergent Adverse Events (Safety and Tolerability)

Primary Outcome 1 - Timeframe: Up to End of Treatment (Month 6 for Group 1 and Group 2 Subset

CONDITION

  • 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

ELIGIBILITY

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

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Donald Lamm, MD, FACS

Role: Principal Investigator

Affiliation: BCG Oncology, PC

Overall Contact

Name: N/A

Phone: N/A

Email: N/A

LOCATION

Facility Status Contact

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