Clinical trial
Phase 1/2 Trial Evaluating the Safety and Tolerability of NanoDoce® Injection and Intravesical Instillation in Subjects With Urothelial Carcinoma
Name
NANODOCE-2017-02
Description
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.
Trial arms
Trial start
2019-04-02
Estimated PCD
2021-11-02
Trial end
2021-11-02
Status
Completed
Phase
Early phase I
Treatment
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)
Arms:
Muscle Invasive Bladder Cancer, Non-Muscle Invasive Bladder Cancer
Other names:
docetaxel; large surface area microparticle docetaxel
NanoDoce (intravesical instillation) - Visit 2 Instillation
All subjects will receive an initial intravesical instillation within 2 hours of direct injection.
Arms:
Muscle Invasive Bladder Cancer, Non-Muscle Invasive Bladder Cancer
Other names:
docetaxel; large surface area microparticle docetaxel
Institutional Standard of Care
Group 2 (MIBC) will receive institutional standard of care treatments after the Visit 2 intravesical instillation.
Arms:
Muscle Invasive Bladder Cancer
NanoDoce (intravesical instillation) - Induction and Maintenance Instillations
Group 1 (NMIBC) will receive intravesical instillations in an Induction Period and a Maintenance Period.
Arms:
Non-Muscle Invasive Bladder Cancer
Other names:
docetaxel; large surface area microparticle docetaxel
Size
36
Primary endpoint
Incidence of Treatment Emergent Adverse Events (Safety and Tolerability)
Up to End of Treatment (Month 6 for Group 1 and Group 2 Subset, and Day 45 for Group 2)
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': '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.\n\nThe study will also dose escalate Groups 1 and 2 for the intravesical instillation of NanoDoce concentrations (2.0 and 3.0 mg/mL).', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 36, 'type': 'ACTUAL'}}
Updated at
2023-08-14
1 organization
1 product
5 indications
Organization
NanOlogyProduct
NanoDoceIndication
Bladder CancerIndication
Urogenital NeoplasmsIndication
Urologic NeoplasmsIndication
Urologic CancerIndication
Bladder cancer