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

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


  • Org Study ID: NANODOCE-2017-02
  • Secondary ID:
  • NCT ID: NCT03636256
  • NCT Alias:
  • Sponsor: NanOlogy, LLC - Industry
  • Source: 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 of Maintenance
intravesical instillations.

Overal Status Start Date Phase Study Type
Recruiting April 2, 2019 Phase 1/Phase 2 Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Incidence of Treatment Emergent Adverse Events (safety and tolerability)

Primary Outcome 1 - Time Frame: Up to End of Treatment (Month 6 for Group 1 and Day 45 for Group 2)

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

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.
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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: Rose Marie Cavanna-Mast

Phone: 805-595-1300

Email: NANODOCE-2017-02@usbiotest.com

Locations

Facility Status Contact
BCG Oncology, PC
Phoenix, Arizona 85032
United States
Recruiting
James Buchanan Brady Urological Institute, Johns Hopkins Medical Institutions
Baltimore, Maryland 21287
United States
Recruiting
Carolina Urologic Research Center
Myrtle Beach, South Carolina 29572
United States
Recruiting