Evaluation of NanoDoce® in Participants With Urothelial Carcinoma

Bladder Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03636256
• Other study ID #: NANODOCE-2017-02
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: April 2, 2019
• Est. completion date: November 2, 2021

Study information

• Verified date: July 2023
• Source: NanOlogy, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: November 2, 2021
• Est. primary completion date: November 2, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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.

Related Conditions & MeSH terms

• Bladder Cancer
• Cancer of the Bladder
• Carcinoma
• Carcinoma, Transitional Cell
• Malignant Tumor of the Urinary Bladder
• Neoplasms
• Urinary Bladder Cancer
• Urinary Bladder Neoplasm
• Urinary Bladder Neoplasms
• Urogenital Neoplasms
• Urologic Cancer
• Urologic Neoplasms
• Urothelial Carcinoma

Intervention

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)
• NanoDoce (intravesical instillation) - Visit 2 Instillation
All subjects will receive an initial intravesical instillation within 2 hours of direct injection.

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.

Locations

Country	Name	City	State
United States	James Buchanan Brady Urological Institute, Johns Hopkins Medical Institutions	Baltimore	Maryland
United States	Carolina Urologic Research Center	Myrtle Beach	South Carolina
United States	Columbia University Herbert Irving Comprehensive Cancer Center	New York	New York
United States	BCG Oncology, PC	Phoenix	Arizona
United States	UT Health San Antonio	San Antonio	Texas

Sponsors (2)

Lead Sponsor	Collaborator
NanOlogy, LLC	US Biotest, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Treatment Emergent Adverse Events (Safety and Tolerability)	Treatment Emergent Adverse Events included laboratory assessments, physical examination findings, and vital signs.	Up to End of Treatment (Month 6 for Group 1 and Group 2 Subset, and Day 45 for Group 2)
Secondary	Recurrence Free Survival (RFS)	No evidence of tumor recurrence or disease progression	At Months 6, 9, and 12
Secondary	Disease Progression	Disease progression at Day 45 derived from cytology and biopsy assessments	Day 45