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. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03636256 |
Recruitment Status :
Active, not recruiting
First Posted : August 17, 2018
Last Update Posted : March 4, 2021
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 |
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 : | 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 : | March 2021 |
Estimated Study Completion Date : | January 2022 |

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. |
- 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.
- 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.
- Progression free survival (PFS) [ Time Frame: At Months 6, 9, and 12 ]No evidence of tumor recurrence or disease progression

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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
United States, Arizona | |
BCG Oncology, PC | |
Phoenix, Arizona, United States, 85032 | |
United States, Maryland | |
James Buchanan Brady Urological Institute, Johns Hopkins Medical Institutions | |
Baltimore, Maryland, United States, 21287 | |
United States, New York | |
Columbia University Herbert Irving Comprehensive Cancer Center | |
New York, New York, United States, 10032 | |
United States, South Carolina | |
Carolina Urologic Research Center | |
Myrtle Beach, South Carolina, United States, 29572 | |
United States, Texas | |
UT Health San Antonio | |
San Antonio, Texas, United States, 78229 |
Principal Investigator: | Donald Lamm, MD, FACS | BCG Oncology, PC |
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: | March 4, 2021 |
Last Verified: | March 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
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 |
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 |