At a glance
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Phase 2 Trial Evaluating the Safety and Tolerability of Intratumoral Injections of NanoPac® With Standard of Care Therapy in Subjects With Lung Cancer
In Brief
A Phase 2 clinical trial evaluating NanoPac (sterile nanoparticulate paclitaxel) Powder for Suspension for Lung Cancer, Nonsmall Cell and 3 related conditions. Completed, enrolled 18 participants across 4 sites.
Detailed Summary
This study evaluates the use of NanoPac injected directly into tumors in the lung of people with lung cancer.
Study Details
Timeline
Interventions
NanoPac is manufactured using a Precipitation with Compressed Antisolvent (PCA) technique that employs supercritical carbon dioxide and acetone to generate paclitaxel nanoparticles within a well-characterized particle-size distribution. Following PCA, NanoPac is filled into a clear 60mL Type 1, USP, clear-glass vial (306 mg/vial) as a powder fill of nanoparticulate paclitaxel, closed with a bromobutyl rubber stopper and aluminum crimp seal, and sterilized by gamma irradiation. Prior to administration at the hospital/clinic, NanoPac will be reconstituted with 1% Polysorbate 80, NF in 0.9% Sodium Chloride for Injection, USP, to form a suspension. The suspension will be further diluted with 0.9% Sodium Chloride for Injection, USP to achieve the final clinical formulation.