Trial of NanoDoce Intratumoral Injection in Renal Cell Carcinoma

Phase 1

Withdrawn

• Conditions: Kidney Cancer; Adenocarcinoma of Kidney; Adenocarcinoma, Renal; Renal Cell Carcinoma; Renal Cell Cancer
• Interventions: Drug: NanoDoce (sterile nanoparticulate docetaxel) Powder for Suspension

• Registration Number: NCT04260360
• Lead Sponsor: NanOlogy, LLC

Brief Summary

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

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 Timeline

• Study First Submitted: 2020-02-05
• Study First Submitted QC: 2020-02-05
• Study First Posted: 2020-02-07
• Study Start: 2020-04
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-31
• Last Update Posted: 2020-08-04
• Primary Completion: 2022-06
• Study Completion: 2022-10

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
NanoDoce	NanoDoce (sterile nanoparticulate docetaxel) Powder for Suspension	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Concentration of docetaxel in the systemic circulation post-injection	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	Pharmacokinetic samples will be obtained on the days of NanoDoce injection and other clinic visits