Clinical trial · Interventional

Evaluation of NanoDoce® in Participants With Urothelial Carcinoma

Phase 1/2 Trial Evaluating the Safety and Tolerability of NanoDoce® Injection and Intravesical Instillation in Subjects With Urothelial Carcinoma

NCT03636256CI-TRIAL-00068779completedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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.

Conditions

Conditions (9)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Bladder Cancer	Malignant Bladder Neoplasm	CURATED_EXACT	0.92
Cancer of the Bladder	Malignant Bladder Neoplasm	ALIAS	0.90
Malignant Tumor of the Urinary Bladder	Malignant Bladder Neoplasm	ALIAS	0.90
Urinary Bladder Cancer	Malignant Bladder Neoplasm	ALIAS	0.90
Urinary Bladder Neoplasm	Bladder Neoplasm	ALIAS	0.90
Urogenital Neoplasms	—	UNRESOLVED	—
Urologic Cancer	—	UNRESOLVED	—
Urologic Neoplasms	Urinary Tract Neoplasm	ALIAS	0.90
Urothelial Carcinoma	Urothelial Carcinoma	ONTOLOGY_EXACT	0.98

Interventions

Interventions (4)

Intervention	Type	Mapped drug	Match
Institutional Standard of Care	Other	—	UNRESOLVED
NanoDoce (direct injection)	Drug	—	UNRESOLVED
NanoDoce (intravesical instillation) - Induction and Maintenance Instillations	Drug	—	UNRESOLVED
NanoDoce (intravesical instillation) - Visit 2 Instillation	Drug	—	UNRESOLVED

Design

Arms and outcomes

Arms (2)

type
EXPERIMENTAL
label
Non-Muscle Invasive Bladder Cancer
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.
interventionNames
1. Drug: NanoDoce (direct injection)
2. Drug: NanoDoce (intravesical instillation) - Visit 2 Instillation
3. Drug: NanoDoce (intravesical instillation) - Induction and Maintenance Instillations
type
EXPERIMENTAL
label
Muscle Invasive Bladder Cancer
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.
interventionNames

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

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.

References

Publications (0)

Data not yet available

No reference posted for this study.

Registry

Dates and enrollment

Start: Apr 2, 2019
Primary completion: Nov 2, 2021
Completion: Nov 2, 2021
First posted: Aug 17, 2018
Last update posted: Aug 14, 2023
Results first posted: Aug 14, 2023
Enrollment: 36 (actual)
Lead sponsor: NanOlogy, LLC INDUSTRY
Collaborators: US Biotest, Inc.
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

Data updated 22 days agoSource updated Aug 14, 2023source: clinicaltrials

Locations

Locations by country (5)

Country	Sites	Recruiting
United States	5	0

Trial listing is informational. Eligibility is decided by the study team; contact information is on ClinicalTrials.gov.