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Trial of NanoPac Focal Therapy for Prostate Cancer

NCT04221828 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2022-03-29

Study results available
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Summary

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

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • US Biotest, Inc.

    collaborator INDUSTRY

  • NanOlogy, LLC

    lead INDUSTRY

Principal Investigators

  • Shelagh Verco, PhD · US Biotest, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-20
Primary Completion
2021-01-27
Completion
2021-02-08
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04221828 on ClinicalTrials.gov