1
Participants
Start Date
October 20, 2020
Primary Completion Date
January 27, 2021
Study Completion Date
February 8, 2021
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.
Moffitt Cancer Center, Tampa
Henry Ford Health System, Detroit
University of Missouri, Columbia
University of Kansas Medical Center, Kansas City
Lead Sponsor
US Biotest, Inc.
INDUSTRY
NanOlogy, LLC
INDUSTRY