Evaluation of NanoDoce® in Participants With Urothelial Carcinoma

July 20, 2023 updated by: NanOlogy, LLC

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 2
  • Phase 1

Expanded Access

Available outside the clinical trial. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85032
        • BCG Oncology, PC
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • James Buchanan Brady Urological Institute, Johns Hopkins Medical Institutions
    • New York
      • New York, New York, United States, 10032
        • Columbia University Herbert Irving Comprehensive Cancer Center
    • South Carolina
      • Myrtle Beach, South Carolina, United States, 29572
        • Carolina Urologic Research Center
    • Texas
      • San Antonio, Texas, United States, 78229
        • UT Health San Antonio

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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)
Other Names:
  • docetaxel; large surface area microparticle docetaxel
Drug: NanoDoce (intravesical instillation) - Visit 2 Instillation
All subjects will receive an initial intravesical instillation within 2 hours of direct injection.
Other Names:
  • docetaxel; large surface area microparticle docetaxel
Drug: NanoDoce (intravesical instillation) - Induction and Maintenance Instillations
Group 1 (NMIBC) will receive intravesical instillations in an Induction Period and a Maintenance Period.
Other Names:
  • docetaxel; large surface area microparticle docetaxel
Experimental: 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.
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)
Other Names:
  • docetaxel; large surface area microparticle docetaxel
Drug: NanoDoce (intravesical instillation) - Visit 2 Instillation
All subjects will receive an initial intravesical instillation within 2 hours of direct injection.
Other Names:
  • docetaxel; large surface area microparticle docetaxel
Other: Institutional Standard of Care
Group 2 (MIBC) will receive institutional standard of care treatments after the Visit 2 intravesical instillation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Treatment Emergent Adverse Events (Safety and Tolerability)
Time Frame: Up to End of Treatment (Month 6 for Group 1 and Group 2 Subset, and Day 45 for Group 2)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence Free Survival (RFS)
Time Frame: At Months 6, 9, and 12
No evidence of tumor recurrence or disease progression
At Months 6, 9, and 12
Disease Progression
Time Frame: Day 45
Disease progression at Day 45 derived from cytology and biopsy assessments
Day 45

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NanOlogy, LLC

Collaborators

US Biotest, Inc.

Investigators

  • Principal Investigator: Donald Lamm, MD, FACS, BCG Oncology, PC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 2, 2019

Primary Completion (Actual)

November 2, 2021

Study Completion (Actual)

November 2, 2021

Study Registration Dates

First Submitted

August 14, 2018

First Submitted That Met QC Criteria

August 14, 2018

First Posted (Actual)

August 17, 2018

Study Record Updates

Last Update Posted (Actual)

August 14, 2023

Last Update Submitted That Met QC Criteria

July 20, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NANODOCE-2017-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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