NCT04221828

Trial of NanoPac Focal Therapy for Prostate Cancer

Phase 2 Trial of NanoPac Focal Therapy for Prostate Cancer in Subjects Undergoing Radical Prostatectomy

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: NanOlogy, LLC · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study evaluates the use of NanoPac injected directly into the prostate lesion in men with prostate cancer.

Detailed description

NanoPac is very small (submicron) particles of the chemotherapy drug, paclitaxel, 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, this submicron particle paclitaxel will be injected directly into the prostate lesion in men with prostate cancer scheduled for prostatectomy on up to three different occasions. All subjects in the study will receive NanoPac and will be evaluated to see if NanoPac is safe, well-tolerated, and has an impact on prostate cancer.

Conditions

• Prostate Cancer
• Prostate Adenocarcinoma
• Prostate Cancer Adenocarcinoma
• Prostatic Neoplasm
• Urogenital Neoplasms
• Genital Neoplasms, Male
• Localized Cancer

Interventions

Type	Name	Description
DRUG	NanoPac (sterile nanoparticulate paclitaxel) Powder for Suspension	NanoPac is manufactured using a Precipitation with Compressed Antisolvent (PCA) technique that employs supercritical carbon dioxide and acetone to generate paclitaxel nanoparticles. For clinical administration, the NanoPac powder in vial is suspended with Sterile Reconstitution Solution (1% Polysorbate 80, NF in 0.9% Sodium Chloride for Injection, USP) and then further diluted with 0.9% Sodium Chloride for Injection, USP, to achieve the final clinical formulation.

Timeline

• Start date: 2020-10-20
• Primary completion: 2021-01-27
• Completion: 2021-02-08
• First posted: 2020-01-09
• Last updated: 2022-03-29
• Results posted: 2022-03-29

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study