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Evaluation of NanoDoce® in Participants With Urothelial Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03636256
Recruitment Status : Recruiting
First Posted : August 17, 2018
Last Update Posted : September 12, 2019
Sponsor:
Collaborator:
US Biotest, Inc.
Information provided by (Responsible Party):
NanOlogy, LLC

Study Description
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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.

Condition or disease Intervention/treatment Phase
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 Drug: NanoDoce (direct injection) Drug: NanoDoce (intravesical instillation) - Visit 2 Instillation Other: Institutional Standard of Care Drug: NanoDoce (intravesical instillation) - Induction and Maintenance Instillations Phase 1 Phase 2

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description:

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).
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1/2 Trial Evaluating the Safety and Tolerability of NanoDoce® Injection and Intravesical Instillation in Subjects With Urothelial Carcinoma
Actual Study Start Date : April 2, 2019
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: docetaxel

Drug: NanoDoce (intravesical instillation) - Visit 2 Instillation
All subjects will receive an initial intravesical instillation within 2 hours of direct injection.
Other Name: 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 Name: 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 Name: docetaxel

Drug: NanoDoce (intravesical instillation) - Visit 2 Instillation
All subjects will receive an initial intravesical instillation within 2 hours of direct injection.
Other Name: docetaxel

Other: Institutional Standard of Care
Group 2 (MIBC) will receive institutional standard of care treatments after the Visit 2 intravesical instillation.


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of Treatment Emergent Adverse Events (safety and tolerability) [ Time Frame: Up to End of Treatment (Month 6 for Group 1 and Day 45 for Group 2) ]
    Treatment Emergent Adverse Events will include laboratory assessments, physical examination findings, and vital signs.


Secondary Outcome Measures :
  1. Pharmacokinetics: Area under the plasma concentration versus time curve (AUC) of NanoDoce [ Time Frame: Up to End of Treatment (Month 6 for Group 1 and Day 45 for Group 2) ]
    Plasma samples will be collected to characterize the pharmacokinetics of NanoDoce.

  2. Pharmacokinetics: Peak plasma concentration (Cmax) of NanoDoce [ Time Frame: Up to End of Treatment (Month 6 for Group 1 and Day 45 for Group 2) ]
    Plasma samples will be collected to characterize the pharmacokinetics of NanoDoce.

  3. Pharmacokinetics: Time at which peak plasma concentration is observed (Tmax) of NanoDoce. [ Time Frame: Up to End of Treatment (Month 6 for Group 1 and Day 45 for Group 2) ]
    Plasma samples will be collected to characterize the pharmacokinetics of NanoDoce.

  4. Tumor Recurrence [ Time Frame: Up to End of Treatment (Month 6 for Group 1 and Day 45 for Group 2) ]
    No evidence of disease as defined by cystoscopy, cytology, and if indicated, biopsy.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03636256


Contacts
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Contact: Rose Marie Cavanna-Mast 805-595-1300 NANODOCE-2017-02@usbiotest.com

Locations
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United States, Arizona
BCG Oncology, PC Recruiting
Phoenix, Arizona, United States, 85032
Contact: Debra Mobley    602-493-6626    debbi@bcgoncology.com   
Principal Investigator: Donald L Lamm, MD         
United States, Maryland
James Buchanan Brady Urological Institute, Johns Hopkins Medical Institutions Recruiting
Baltimore, Maryland, United States, 21287
Contact: Max Kates, MD    410-955-6100    mkates@jhmi.edu   
Principal Investigator: Max Kates, MD         
United States, New York
Columbia University Herbert Irving Comprehensive Cancer Center Recruiting
New York, New York, United States, 10032
Contact: Bridget James, M.A.    212-304-5543    bb2771@cumc.columbia.edu   
Principal Investigator: Guarionex Joel DeCastro, MD, MPH         
United States, South Carolina
Carolina Urologic Research Center Recruiting
Myrtle Beach, South Carolina, United States, 29572
Contact: Jennifer Baiden, RN, CCRC    843-449-1010    jbaiden@curcmb.com   
Principal Investigator: Neal Shore, MD, FACS         
United States, Texas
UT Health San Antonio Recruiting
San Antonio, Texas, United States, 78229
Contact: Karen Nijland    210-567-8554    NijlandK@uthscsa.edu   
Principal Investigator: Ahmed Mansour, MD         
Sponsors and Collaborators
NanOlogy, LLC
US Biotest, Inc.
Investigators
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Principal Investigator: Donald Lamm, MD, FACS BCG Oncology, PC
More Information
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Responsible Party: NanOlogy, LLC
ClinicalTrials.gov Identifier: NCT03636256    
Other Study ID Numbers: NANODOCE-2017-02
First Posted: August 17, 2018    Key Record Dates
Last Update Posted: September 12, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by NanOlogy, LLC:
non-muscle invasive bladder cancer
muscle invasive bladder cancer
high-risk bladder cancer
BCG-unresponsive bladder cancer
BCG failure
 BCG-refractory bladder cancer
BCG-resistant bladder cancer
NMIBC
MIBC
Additional relevant MeSH terms:
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Carcinoma
Neoplasms
Urinary Bladder Neoplasms
Carcinoma, Transitional Cell
Urogenital Neoplasms
Urologic Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms by Site
 Urinary Bladder Diseases
Urologic Diseases
Docetaxel
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action