NCT04260360

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

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: NanOlogy, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-04-01
• Primary completion: 2022-06-01
• Completion: 2022-10-01
• First posted: 2020-02-07
• Last updated: 2020-08-04

Regulatory

• FDA-regulated drug study