Trial of NanoDoce Intratumoral Injection in Renal Cell Carcinoma

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.

Study Overview

• Status: Withdrawn
• Conditions: Kidney Cancer; Renal Cell Carcinoma; Renal Cell Cancer; Adenocarcinoma of Kidney; Adenocarcinoma, Renal
• Intervention / Treatment: Drug: NanoDoce (sterile nanoparticulate docetaxel) Powder for Suspension

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.

• Study Type: Interventional
• Phase: Phase 1

Expanded Access

Available outside the clinical trial. See expanded access record.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: NanoDoce; 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.

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.; Other Names: docetaxel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: NanOlogy, LLC
• Collaborators: US Biotest, Inc.
• Investigators: Study Director: Rose Marie Cavanna-Mast, RT, CCRA, US Biotest, Inc.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): April 1, 2020
• Primary Completion (ANTICIPATED): June 1, 2022
• Study Completion (ANTICIPATED): October 1, 2022

Study Registration Dates

• First Submitted: February 5, 2020
• First Submitted That Met QC Criteria: February 5, 2020
• First Posted (ACTUAL): February 7, 2020

Study Record Updates

• Last Update Posted (ACTUAL): August 4, 2020
• Last Update Submitted That Met QC Criteria: July 31, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: docetaxel
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases; Neoplasms, Glandular and Epithelial; Kidney Neoplasms; Carcinoma, Renal Cell; Carcinoma; Adenocarcinoma; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Docetaxel
• Other Study ID Numbers: NANODOCE-2018-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No