Bladder CancerPhase 1/2NCT03636256

Evaluation of NanoDoce® in Participants With Urothelial Carcinoma

A Phase 1/2 study testing NanoDoce (direct injection), NanoDoce (intravesical instillation) - Visit 2 Instillation and NanoDoce (intravesical instillation) - Induction and Maintenance Instillations in people with Bladder Cancer and Urothelial Carcinoma, run by NanOlogy, LLC at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Bladder Cancer, Urothelial Carcinoma, Urinary Bladder Neoplasm
What is being tested?: NanoDoce (direct injection), NanoDoce (intravesical instillation) - Visit 2 Instillation and NanoDoce (intravesical instillation) - Induction and Maintenance Instillations
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 36 participants
Where: 5 sitesUnited States
Study dates: 2 Apr 2019to 2 Nov 2021
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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;

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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.

Who cannot join

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;

Show all 10Show fewer

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.

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

United States5 sites

James Buchanan Brady Urological Institute, Johns Hopkins Medical Institutions
Baltimore, Maryland, 21287
Carolina Urologic Research Center
Myrtle Beach, South Carolina, 29572
Columbia University Herbert Irving Comprehensive Cancer Center
New York, New York, 10032
BCG Oncology, PC
Phoenix, Arizona, 85032
UT Health San Antonio
San Antonio, Texas, 78229

Other trials in United States

About this study

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

Read the 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.

Conditions: Bladder Cancer, Urothelial Carcinoma, Urinary Bladder Neoplasm, Urinary Bladder Cancer, Urogenital Neoplasms, Urologic Neoplasms
Being tested: NanoDoce (direct injection), NanoDoce (intravesical instillation) - Visit 2 Instillation, Institutional Standard of Care, NanoDoce (intravesical instillation) - Induction and Maintenance Instillations
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
Medical subject headings: Urinary Bladder Neoplasms, Carcinoma, Transitional Cell, Urogenital Neoplasms, Urologic Neoplasms, Non-Muscle Invasive Bladder Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

NanoDoce (direct injection)Drug
Also called docetaxel; large surface area microparticle docetaxel
Subjects will receive NanoDoce injected into the index tumor resection site on the bladder wall, immediately following transurethral resection of the bladder tumor (TURBT)
NanoDoce (intravesical instillation) - Visit 2 InstillationDrug
Also called docetaxel; large surface area microparticle docetaxel
All subjects will receive an initial intravesical instillation within 2 hours of direct injection.
Institutional Standard of CareOther
Group 2 (MIBC) will receive institutional standard of care treatments after the Visit 2 intravesical instillation.
NanoDoce (intravesical instillation) - Induction and Maintenance InstillationsDrug
Also called docetaxel; large surface area microparticle docetaxel
Group 1 (NMIBC) will receive intravesical instillations in an Induction Period and a Maintenance Period.

Study groups in NCT03636256
Study group	Role	What they receive
Non-Muscle Invasive Bladder Cancer	Experimental	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. Receives: Drug: NanoDoce (direct injection); Drug: NanoDoce (intravesical instillation) - Visit 2 Instillation; Drug: NanoDoce (intravesical instillation) - Induction and Maintenance Instillations
Muscle Invasive Bladder Cancer	Experimental	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. Receives: Drug: NanoDoce (direct injection); Drug: NanoDoce (intravesical instillation) - Visit 2 Instillation; Other: Institutional Standard of Care

What is being measured

The primary outcome is the main question the study is designed to answer.

Incidence of Treatment Emergent Adverse Events (Safety and Tolerability)
Treatment Emergent Adverse Events included laboratory assessments, physical examination findings, and vital signs.
Measured: Up to End of Treatment (Month 6 for Group 1 and Group 2 Subset, and Day 45 for Group 2)

Secondary outcomes (2)

Recurrence Free Survival (RFS)
No evidence of tumor recurrence or disease progression
Measured: At Months 6, 9, and 12
Disease Progression
Disease progression at Day 45 derived from cytology and biopsy assessments
Measured: Day 45

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Apr 20192 Nov 2021

First posted17 Aug 2018
Study start2 Apr 2019
Primary completion2 Nov 2021
Study completion2 Nov 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Bladder CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
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)
Enrolment: 36 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03636256
Sponsor's protocol ID: NANODOCE-2017-02
Status last verified: Jul 2023
First submitted: 14 Aug 2018
Last updated: 14 Aug 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No
Expanded access: Available

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
RecruitingPhase 3
A Clinical Trial of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) and Pembrolizumab (MK-3475A) in Participants With Bladder Cancer (MK-2870-055)
Bladder Cancer
Active, not recruitingPhase 2/3
A Study of CTX-009 in Combination With Paclitaxel in Adult Patients With Unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers (COMPANION-002)
Biliary Tract Cancer, Cholangiocarcinoma
Recruiting
Effect of Cyclic Sighing Breathing Exercise on CRBD, Pain, and Sleep Quality in Patients Undergoing TUR
Transurethral Resection of Bladder Tumor, Transurethral Resection of the Prostate (TURP)
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma

All Bladder Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase 1/2 Trial Evaluating the Safety and Tolerability of NanoDoce® Injection and Intravesical Instillation in Subjects With Urothelial Carcinoma
ClinicalTrials.gov ID: NCT03636256
Acronym / sponsor ID: NANODOCE-2017-02
Conditions: Bladder Cancer, Urothelial Carcinoma, Urinary Bladder Neoplasm, Urinary Bladder Cancer, Urogenital Neoplasms, Urologic Neoplasms
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
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 36 participants (actual)
Lead sponsor: NanOlogy, LLCIndustry (pharma, biotech, devices)
Collaborators: US Biotest, Inc.
Study start: 2 Apr 2019 (actual)
Primary completion: 2 Nov 2021 (actual)
Study completion: 2 Nov 2021 (actual)
First posted: 17 Aug 2018 (actual)
Results: Posted 14 Aug 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 2
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).

Arm	Type	Receives
Non-Muscle Invasive Bladder Cancer	Experimental	Drug: NanoDoce (direct injection), Drug: NanoDoce (intravesical instillation) - Visit 2 Instillation, Drug: NanoDoce (intravesical instillation) - Induction and Maintenance InstillationsSubjects 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.
Muscle Invasive Bladder Cancer	Experimental	Drug: NanoDoce (direct injection), Drug: NanoDoce (intravesical instillation) - Visit 2 Instillation, Other: Institutional Standard of CareSubjects 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (17 listed)

Signed informed consent;
Age ≥18 years;
Patients with either:
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);

Key exclusion criteria (10 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
NanoDoce (direct injection)Also: docetaxel; large surface area microparticle docetaxelSubjects will receive NanoDoce injected into the index tumor resection site on the bladder wall, immediately following transurethral resection of the bladder tumor (TURBT)	Drug	Muscle Invasive Bladder Cancer, Non-Muscle Invasive Bladder Cancer
NanoDoce (intravesical instillation) - Visit 2 InstillationAlso: docetaxel; large surface area microparticle docetaxelAll subjects will receive an initial intravesical instillation within 2 hours of direct injection.	Drug	Muscle Invasive Bladder Cancer, Non-Muscle Invasive Bladder Cancer
Institutional Standard of CareGroup 2 (MIBC) will receive institutional standard of care treatments after the Visit 2 intravesical instillation.	Other	Muscle Invasive Bladder Cancer
NanoDoce (intravesical instillation) - Induction and Maintenance InstillationsAlso: docetaxel; large surface area microparticle docetaxelGroup 1 (NMIBC) will receive intravesical instillations in an Induction Period and a Maintenance Period.	Drug	Non-Muscle Invasive Bladder Cancer

Primary outcome

Incidence of Treatment Emergent Adverse Events (Safety and Tolerability)
Time frame: Up to End of Treatment (Month 6 for Group 1 and Group 2 Subset, and Day 45 for Group 2)
Treatment Emergent Adverse Events included laboratory assessments, physical examination findings, and vital signs.

2 secondary outcomes

Recurrence Free Survival (RFS)
Time frame: At Months 6, 9, and 12
Disease Progression
Time frame: Day 45

Results and safety

Results posted to the registry on 14 Aug 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Non-Muscle Invasive Bladder Cancer (Group 1) 0.75 mg/mL	4	1
Non-Muscle Invasive Bladder Cancer (Group 1) 1.5 mg/mL	3	3
Non-Muscle Invasive Bladder Cancer (Group 1) 2.5 mg/mL	3	1
Non-Muscle Invasive Bladder Cancer (Group 1) 3.75 mg/mL	9	8
Muscle Invasive Bladder Cancer (Group 2) Subset 3.75 mg/mL	1	1
Muscle Invasive Bladder Cancer (Group 2) 0.75 mg/mL	5	1
Muscle Invasive Bladder Cancer (Group 2) 1.5 mg/mL	2	0
Muscle Invasive Bladder Cancer (Group 2) 2.5 mg/mL	2	2
Muscle Invasive Bladder Cancer (Group 2) 3.75 mg/mL	7	2

Primary outcome: Incidence of Treatment Emergent Adverse Events (Safety and Tolerability)

Time frame: Up to End of Treatment (Month 6 for Group 1 and Group 2 Subset, and Day 45 for Group 2). Count of participants. Unit: Participants

Measure	Non-Muscle Invasive Bladder Cancer (Group 1) 0.75 mg/mL n = 4	Non-Muscle Invasive Bladder Cancer (Group 1) 1.5 mg/mL n = 3	Non-Muscle Invasive Bladder Cancer (Group 1) 2.5 mg/mL n = 3	Non-Muscle Invasive Bladder Cancer (Group 1) 3.75 mg/mL n = 9	Muscle Invasive Bladder Cancer (Group 2) Subset 3.75 mg/mL n = 1	Muscle Invasive Bladder Cancer (Group 2) 0.75 mg/mL n = 5	Muscle Invasive Bladder Cancer (Group 2) 1.5 mg/mL n = 2	Muscle Invasive Bladder Cancer (Group 2) 2.5 mg/mL n = 2	Muscle Invasive Bladder Cancer (Group 2) 3.75 mg/mL n = 7
Value	3	3	3	9	1	5	2	1	6

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Non-Muscle Invasive Bladder Cancer (Group 1) 0.75 mg/mL	0 of 4 (0%)	3 of 4 (75%)	0 of 4
Non-Muscle Invasive Bladder Cancer (Group 1) 1.5 mg/mL	0 of 3 (0%)	3 of 3 (100%)	0 of 3
Non-Muscle Invasive Bladder Cancer (Group 1) 2.5 mg/mL	0 of 3 (0%)	3 of 3 (100%)	0 of 3
Non-Muscle Invasive Bladder Cancer (Group 1) 3.75 mg/mL	1 of 9 (11.1%)	9 of 9 (100%)	0 of 9
Muscle Invasive Bladder Cancer (Group 2) Subset 3.75 mg/mL	0 of 1 (0%)	1 of 1 (100%)	0 of 1
Muscle Invasive Bladder Cancer (Group 2) 0.75 mg/mL	1 of 5 (20%)	4 of 5 (80%)	0 of 5
Muscle Invasive Bladder Cancer (Group 2) 1.5 mg/mL	0 of 2 (0%)	2 of 2 (100%)	0 of 2
Muscle Invasive Bladder Cancer (Group 2) 2.5 mg/mL	0 of 2 (0%)	2 of 2 (100%)	0 of 2
Muscle Invasive Bladder Cancer (Group 2) 3.75 mg/mL	1 of 7 (14.3%)	7 of 7 (100%)	0 of 7

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Donald Lamm, MD, FACS principal investigator

BCG Oncology, PC

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Treatment Emergent Adverse Events (Safety and Tolerability) (time frame: Up to End of Treatment (Month 6 for Group 1 and Group 2 Subset, and Day 45 for Group 2)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03636256.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2023.