search
Back to results

Evaluation of NanoDoce® in Participants With Urothelial Carcinoma

Primary Purpose

Bladder Cancer, Urothelial Carcinoma, Urinary Bladder Neoplasm

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
NanoDoce (direct injection)
NanoDoce (intravesical instillation) - Visit 2 Instillation
Institutional Standard of Care
NanoDoce (intravesical instillation) - Induction and Maintenance Instillations
Sponsored by
NanOlogy, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bladder Cancer focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • BCG Oncology, PC
  • James Buchanan Brady Urological Institute, Johns Hopkins Medical Institutions
  • Columbia University Herbert Irving Comprehensive Cancer Center
  • Carolina Urologic Research Center
  • UT Health San Antonio

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Non-Muscle Invasive Bladder Cancer

Muscle Invasive Bladder Cancer

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Incidence of Treatment Emergent Adverse Events (Safety and Tolerability)
Treatment Emergent Adverse Events included laboratory assessments, physical examination findings, and vital signs.

Secondary Outcome Measures

Recurrence Free Survival (RFS)
No evidence of tumor recurrence or disease progression
Disease Progression
Disease progression at Day 45 derived from cytology and biopsy assessments

Full Information

First Posted
August 14, 2018
Last Updated
July 20, 2023
Sponsor
NanOlogy, LLC
Collaborators
US Biotest, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT03636256
Brief Title
Evaluation of NanoDoce® in Participants With Urothelial Carcinoma
Official Title
Phase 1/2 Trial Evaluating the Safety and Tolerability of NanoDoce® Injection and Intravesical Instillation in Subjects With Urothelial Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
April 2, 2019 (Actual)
Primary Completion Date
November 2, 2021 (Actual)
Study Completion Date
November 2, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NanOlogy, LLC
Collaborators
US Biotest, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 or Maintenance intravesical instillations.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
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)
Allocation
Non-Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Non-Muscle Invasive Bladder Cancer
Arm Type
Experimental
Arm Description
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.
Arm Title
Muscle Invasive Bladder Cancer
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
NanoDoce (direct injection)
Other Intervention Name(s)
docetaxel; large surface area microparticle docetaxel
Intervention Description
Subjects will receive NanoDoce injected into the index tumor resection site on the bladder wall, immediately following transurethral resection of the bladder tumor (TURBT)
Intervention Type
Drug
Intervention Name(s)
NanoDoce (intravesical instillation) - Visit 2 Instillation
Other Intervention Name(s)
docetaxel; large surface area microparticle docetaxel
Intervention Description
All subjects will receive an initial intravesical instillation within 2 hours of direct injection.
Intervention Type
Other
Intervention Name(s)
Institutional Standard of Care
Intervention Description
Group 2 (MIBC) will receive institutional standard of care treatments after the Visit 2 intravesical instillation.
Intervention Type
Drug
Intervention Name(s)
NanoDoce (intravesical instillation) - Induction and Maintenance Instillations
Other Intervention Name(s)
docetaxel; large surface area microparticle docetaxel
Intervention Description
Group 1 (NMIBC) will receive intravesical instillations in an Induction Period and a Maintenance Period.
Primary Outcome Measure Information:
Title
Incidence of Treatment Emergent Adverse Events (Safety and Tolerability)
Description
Treatment Emergent Adverse Events included laboratory assessments, physical examination findings, and vital signs.
Time Frame
Up to End of Treatment (Month 6 for Group 1 and Group 2 Subset, and Day 45 for Group 2)
Secondary Outcome Measure Information:
Title
Recurrence Free Survival (RFS)
Description
No evidence of tumor recurrence or disease progression
Time Frame
At Months 6, 9, and 12
Title
Disease Progression
Description
Disease progression at Day 45 derived from cytology and biopsy assessments
Time Frame
Day 45

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Donald Lamm, MD, FACS
Organizational Affiliation
BCG Oncology, PC
Official's Role
Principal Investigator
Facility Information:
Facility Name
BCG Oncology, PC
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
James Buchanan Brady Urological Institute, Johns Hopkins Medical Institutions
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Columbia University Herbert Irving Comprehensive Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Carolina Urologic Research Center
City
Myrtle Beach
State/Province
South Carolina
ZIP/Postal Code
29572
Country
United States
Facility Name
UT Health San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Evaluation of NanoDoce® in Participants With Urothelial Carcinoma

We'll reach out to this number within 24 hrs