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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

Tracking Information
First Submitted Date  ICMJE August 14, 2018
First Posted Date  ICMJE August 17, 2018
Last Update Posted Date September 12, 2019
Actual Study Start Date  ICMJE April 2, 2019
Estimated Primary Completion Date November 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 22, 2019)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 14, 2018)
Incidence of Treatment Emergent Adverse Events (safety and tolerability) [ Time Frame: Up to final safety visit (Visit 13, scheduled for 7 months after start of Induction) ]
Treatment Emergent Adverse Events will include laboratory assessments, physical examination findings, and vital signs.
Change History Complete list of historical versions of study NCT03636256 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 22, 2019)
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 14, 2018)
  • Pharmacokinetics: Area under the plasma concentration versus time curve (AUC) of NanoDoce [ Time Frame: Up to end of treatment (Visit 12, scheduled for 6 months after start of Induction) ]
    Plasma samples will be collected on Visit 2 (prior to NanoDoce injection and at 1, 2, 4, 6, and 24 hours post-injection), on Visit 3 (prior to NanoDoce intravesical instillation and at 1, 2, 4, 6, and 24 hours post- intravesical instillation), on Visits 4-11 prior to the NanoDoce intravesical instillation, and on Visit 12.
  • Pharmacokinetics: Peak plasma concentration (Cmax) of NanoDoce [ Time Frame: Up to end of treatment (Visit 12, scheduled for 6 months after start of Induction) ]
    Plasma samples will be collected on Visit 2 (prior to NanoDoce injection and at 1, 2, 4, 6, and 24 hours post-injection), on Visit 3 (prior to NanoDoce intravesical instillation and at 1, 2, 4, 6, and 24 hours post- intravesical instillation), on Visits 4-11 prior to the NanoDoce intravesical instillation, and on Visit 12.
  • Pharmacokinetics: Time at which peak plasma concentration is observed (Tmax) of NanoDoce. [ Time Frame: Up to end of treatment (Visit 12, scheduled for 6 months after start of Induction) ]
    Plasma samples will be collected on Visit 2 (prior to NanoDoce injection and at 1, 2, 4, 6, and 24 hours post-injection), on Visit 3 (prior to NanoDoce intravesical instillation and at 1, 2, 4, 6, and 24 hours post- intravesical instillation), on Visits 4-11 prior to the NanoDoce intravesical instillation, and on Visit 12.
  • Tumor Recurrence [ Time Frame: At Visit 9 (3 months after start of Induction) and at Visit 12 (6 months after start of Induction) ]
    No evidence of disease as defined by cystoscopy, cytology, and if indicated, biopsy.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of NanoDoce® in Participants With Urothelial Carcinoma
Official Title  ICMJE Phase 1/2 Trial Evaluating the Safety and Tolerability of NanoDoce® Injection and Intravesical Instillation in Subjects With Urothelial Carcinoma
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE 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
Condition  ICMJE
  • 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
Intervention  ICMJE
  • 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.
  • 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
Study Arms  ICMJE
  • 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.
    Interventions:
    • Drug: NanoDoce (direct injection)
    • Drug: NanoDoce (intravesical instillation) - Visit 2 Instillation
    • Drug: NanoDoce (intravesical instillation) - Induction and Maintenance Instillations
  • 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.
    Interventions:
    • Drug: NanoDoce (direct injection)
    • Drug: NanoDoce (intravesical instillation) - Visit 2 Instillation
    • Other: Institutional Standard of Care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 3, 2019)
75
Original Estimated Enrollment  ICMJE
 (submitted: August 14, 2018)
48
Estimated Study Completion Date  ICMJE November 2020
Estimated Primary Completion Date November 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Rose Marie Cavanna-Mast 805-595-1300 NANODOCE-2017-02@usbiotest.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03636256
Other Study ID Numbers  ICMJE NANODOCE-2017-02
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party NanOlogy, LLC
Study Sponsor  ICMJE NanOlogy, LLC
Collaborators  ICMJE US Biotest, Inc.
Investigators  ICMJE
Principal Investigator: Donald Lamm, MD, FACS BCG Oncology, PC
PRS Account NanOlogy, LLC
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP