Trial of NanoDoce Intratumoral Injection in Renal Cell Carcinoma

Renal Cell Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04260360
• Other study ID #: NANODOCE-2018-01
• Status: Withdrawn
• Phase: Phase 1
• Start date: April 2020
• Est. completion date: October 2022

Study information

• Verified date: July 2020
• Source: NanOlogy, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2022
• Est. primary completion date: June 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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;

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma of Kidney
• Adenocarcinoma, Renal
• Carcinoma
• Carcinoma, Renal Cell
• Kidney Cancer
• Kidney Neoplasms
• Renal Cell Cancer
• Renal Cell Carcinoma

Intervention

Drug:
• NanoDoce (sterile nanoparticulate docetaxel) Powder for Suspension
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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
NanOlogy, LLC	US Biotest, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with treatment emergent adverse events	Treatment emergent adverse events (including changes in laboratory assessments, physical examination findings, and vital signs)	Day 1 to 180 days post-last NanoDoce injection
Secondary	Concentration of docetaxel in the systemic circulation post-injection	Pharmacokinetic samples will be obtained on the days of NanoDoce injection and other clinic visits	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