Renal Cell CarcinomaPhase 1NCT04260360

Trial of NanoDoce Intratumoral Injection in Renal Cell Carcinoma

A Phase 1 study testing NanoDoce (sterile nanoparticulate docetaxel) Powder for Suspension in people with Renal Cell Carcinoma and Kidney Cancer, run by NanOlogy, LLC.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

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Trial summary

This study evaluates the use of NanoDoce injected directly into tumors in the kidney of people with renal cell carcinoma. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Renal Cell Carcinoma, Kidney Cancer, Adenocarcinoma of Kidney
What is being tested?: NanoDoce (sterile nanoparticulate docetaxel) Powder for Suspension
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 0 participants
Where: No sites listed yet
Study dates: Apr 2020to Oct 2022
Phase: Phase 1
Are there results?: None posted in the registry

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;
Localized T1a renal cell carcinoma;
Maximum tumor volume of 25.0 mL;
Performance Status (ECOG) 0-2;
Life expectancy of at least 6 months;

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Adequate marrow, liver, and renal function;
ANC ≥ 1.5 x 109/L
Hemoglobin ≥ 9.5 grams/dL
Platelets ≥ 75 x 109/L
Total bilirubin ≤ 1.5x institutional ULN
AST/ ALT ≤ 2.5x institutional ULN
Creatinine ≤ 1.5x institutional ULN
eGFR < 60 mL/min/1.73m2
Adequate method of birth control.

Who cannot join

Renal cyst;
Multifocal or bilateral renal mass;
Known hypersensitivity to any of the study drug or reconstitution components;
Pregnant or breastfeeding female;
Administration of an investigational product in a 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;
Known drug or alcohol abuse.

About this study

Official title: Phase 1 Trial Evaluating the Safety and Tolerability of NanoDoce® Intratumoral Injection in Subjects With Localized Renal Cell Carcinoma

This study evaluates the use of NanoDoce injected directly into tumors in the kidney of people with renal cell carcinoma.

Read the detailed description

NanoDoce is very small (submicron) particles of the chemotherapy drug, docetaxel, which is administered intravenously in a number of types of cancer. These submicron particles are injected directly into solid tumors to target cancer at the site of disease with less systemic exposure than intravenously administered chemotherapy. In this study, the submicron particle docetaxel will be injected directly into tumors in the kidney of people with renal cell carcinoma that is localized to (has not spread beyond) the kidney. All subjects in this study will receive NanoDoce and will be evaluated to see if NanoDoce is safe.

Conditions: Renal Cell Carcinoma, Kidney Cancer, Adenocarcinoma of Kidney, Adenocarcinoma, Renal, Renal Cell Cancer
Being tested: NanoDoce (sterile nanoparticulate docetaxel) Powder for Suspension
Keywords: docetaxel
Medical subject headings: Carcinoma, Renal Cell, Kidney Neoplasms

What participants receive

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

NanoDoce (sterile nanoparticulate docetaxel) Powder for SuspensionDrug
Also called docetaxel
NanoDoce is manufactured using a Precipitation with Compressed Antisolvent (PCA) technique that employs supercritical carbon dioxide and acetone to generate docetaxel nanoparticles within a well-characterized particle-size distribution. Prior to administration, the NanoDoce powder in vial is suspended with a sterile solution of Polysorbate 80 (0.0075% - 0.0375% (w/w))/Ethanol (0.06% - 0.3% (w/w)) in 0.9% Sodium Chloride for injection.

Study groups in NCT04260360
Study group	Role	What they receive
NanoDoce	Experimental	Intratumoral injection of NanoDoce (2.0 to 6.0 mg/mL) at a volume not to exceed 5.0 mL. NanoDoce will be administered on up to two occasions with at least 4 weeks between doses. Receives: Drug: NanoDoce (sterile nanoparticulate docetaxel) Powder for Suspension

What is being measured

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

Number of participants with treatment emergent adverse events
Treatment emergent adverse events (including changes in laboratory assessments, physical examination findings, and vital signs)
Measured: Day 1 to 180 days post-last NanoDoce injection

Secondary outcomes (1)

Concentration of docetaxel in the systemic circulation post-injection
Pharmacokinetic samples will be obtained on the days of NanoDoce injection and other clinic visits
Measured: Screening, Day 1, Day 2, Day 15, Day 27, Day 30, Day 31, Day 45, Month 2, Month 3, Month 4, Month 5, and 180 days post-last NanoDoce injection

Timeline

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

Apr 2020Oct 2022

First posted7 Feb 2020
Study startApr 2020 (estimated)
Primary completionJun 2022 (estimated)
Study completionOct 2022 (estimated)

Why it stopped: Not initiated

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Renal Cell CarcinomaStudies 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
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04260360
Sponsor's protocol ID: NANODOCE-2018-01
Status last verified: Jul 2020
First submitted: 5 Feb 2020
Last updated: 4 Aug 2020
Results posted: No
Data monitoring committee: No
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?

Official record

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
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
Not yet recruitingPhase 2
Toripalimab and Lenvatinib With or Without SBRT Before Surgery for Non-Clear Cell Kidney Cancer
Nonmetastatic Locally Advanced Non-Clear Cell Renal Cell Carcinoma
Not yet recruitingPhase 2
Pucotenlimab, Lenvatinib, and SBRT Before Surgery for Localized Clear Cell Renal Cell Carcinoma
Localized Clear Cell Renal Cell Carcinoma

All Renal Cell Carcinoma trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase 1 Trial Evaluating the Safety and Tolerability of NanoDoce® Intratumoral Injection in Subjects With Localized Renal Cell Carcinoma
ClinicalTrials.gov ID: NCT04260360
Acronym / sponsor ID: NANODOCE-2018-01
Conditions: Renal Cell Carcinoma, Kidney Cancer, Adenocarcinoma of Kidney, Adenocarcinoma, Renal, Renal Cell Cancer
Keywords: docetaxel
Phase: Phase 1
Study type: Interventional
Recruitment status: WithdrawnReason stopped: Not initiated
Enrolment: 0 participants (actual)
Lead sponsor: NanOlogy, LLCIndustry (pharma, biotech, devices)
Collaborators: US Biotest, Inc.
Study start: Apr 2020 (estimated)
Primary completion: Jun 2022 (estimated)
Study completion: Oct 2022 (estimated)
First posted: 7 Feb 2020 (actual)
Results: Not posted in the source record

Clinical summary

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

This study evaluates the use of NanoDoce injected directly into tumors in the kidney of people with renal cell carcinoma.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
NanoDoce	Experimental	Drug: NanoDoce (sterile nanoparticulate docetaxel) Powder for SuspensionIntratumoral injection of NanoDoce (2.0 to 6.0 mg/mL) at a volume not to exceed 5.0 mL. NanoDoce will be administered on up to two occasions with at least 4 weeks between doses.

Who may qualify

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

Key inclusion criteria (15 listed)

Signed informed consent;
Age ≥18 years;
Localized T1a renal cell carcinoma;
Maximum tumor volume of 25.0 mL;
Performance Status (ECOG) 0-2;

Key exclusion criteria (7 listed)

Renal cyst;
Multifocal or bilateral renal mass;
Known hypersensitivity to any of the study drug or reconstitution components;
Pregnant or breastfeeding female;
Administration of an investigational product in a clinical trial within 3 months prior to consent;

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 (sterile nanoparticulate docetaxel) Powder for SuspensionAlso: docetaxelNanoDoce is manufactured using a Precipitation with Compressed Antisolvent (PCA) technique that employs supercritical carbon dioxide and acetone to generate docetaxel nanoparticles within a well-characterized particle-size distribution. Prior to administration, the NanoDoce powder in vial is suspended with a sterile solution of Polysorbate 80 (0.0075% - 0.0375% (w/w))/Ethanol (0.06% - 0.3% (w/w)) in 0.9% Sodium Chloride for injection.	Drug	NanoDoce

Primary outcome

Number of participants with treatment emergent adverse events
Time frame: Day 1 to 180 days post-last NanoDoce injection
Treatment emergent adverse events (including changes in laboratory assessments, physical examination findings, and vital signs)

1 secondary outcome

Concentration of docetaxel in the systemic circulation post-injection
Time frame: Screening, Day 1, Day 2, Day 15, Day 27, Day 30, Day 31, Day 45, Month 2, Month 3, Month 4, Month 5, and 180 days post-last NanoDoce injection

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2020.
Individual participant dataSharing planned: No

Related trials for Renal Cell Carcinoma

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
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
Not yet recruitingPhase 2
Toripalimab and Lenvatinib With or Without SBRT Before Surgery for Non-Clear Cell Kidney Cancer
Nonmetastatic Locally Advanced Non-Clear Cell Renal Cell Carcinoma
Not yet recruitingPhase 2
Pucotenlimab, Lenvatinib, and SBRT Before Surgery for Localized Clear Cell Renal Cell Carcinoma
Localized Clear Cell Renal Cell Carcinoma

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.

Rose Marie Cavanna-Mast, RT, CCRA study director

US Biotest, Inc.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing NanoDoce (sterile nanoparticulate docetaxel) Powder for Suspension in people with Renal Cell Carcinoma and Kidney Cancer, run by NanOlogy, LLC.

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 15 inclusion and 7 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: withdrawn, as of the sponsor's last update on 4 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

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 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.

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

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

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?

Number of participants with treatment emergent adverse events (time frame: Day 1 to 180 days post-last NanoDoce injection). 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 NCT04260360.

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 4 Aug 2020.