This study evaluates the use of NanoPac injected directly into tumors in the lung of people with lung cancer.
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, the submicron particle paclitaxel will be injected directly into tumors in the lungs of people with small cell or non-small cell lung cancer. All subjects in this study will receive NanoPac and will be evaluated to see if NanoPac is safe and has an effect on the tumor within the lung.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
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.
University of Florida Health
Gainesville, Florida, United States
Parkview Research Institute
Fort Wayne, Indiana, United States
Johns Hopkins
Baltimore, Maryland, United States
University of North Carolina Chapel Hill
Chapel Hill, North Carolina, United States
Number of Participants With Treatment Emergent Adverse Events
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Time frame: Day 1 to Week 24 (6 Months)
Concentration of Paclitaxel in the Systemic Circulation Post-injection
To characterize the pharmacokinetics of intratumoral NanoPac, plasma samples were taken on days of NanoPac injection prior to injection and at 1, 2, and 4 hours after NanoPac injection, as well as at all other study visits up through Week 24. Plasma paclitaxel concentrations are reported in pg/mL.
Time frame: Day 1, Weeks 1, 2, 4, 5, 6, 8, 9, 10, 12, 18, and 24
Progression Free Survival (PFS)
Progression free survival (PFS) as assessed using RECIST v1.1
Time frame: Weeks 24, 38, and 52
Overall Survival
Overall survival (OS) as determined by survival time following first NanoPac injection
Time frame: Weeks 24, 38, and 52
Change in Tumor Dimensions (Longest Diameter)
Change in longest dimension (cm) as determined by CT imaging compared to baseline (Screening)
Time frame: Weeks 12, 24, 38, and 52
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