This study evaluates the use of NanoDoce injected directly into tumors in the kidney of people with renal cell carcinoma.
NanoDoce is very small (submicron) particles of the chemotherapy drug, docetaxel, 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 docetaxel will be injected directly into tumors in the kidney of people with renal cell carcinoma that is localized to (has not spread beyond) the kidney. All subjects in this study will receive NanoDoce and will be evaluated to see if NanoDoce is safe.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
NanoDoce is manufactured using a Precipitation with Compressed Antisolvent (PCA) technique that employs supercritical carbon dioxide and acetone to generate docetaxel nanoparticles within a well-characterized particle-size distribution. Prior to administration, the NanoDoce powder in vial is suspended with a sterile solution of Polysorbate 80 (0.0075% - 0.0375% (w/w))/Ethanol (0.06% - 0.3% (w/w)) in 0.9% Sodium Chloride for injection.
Number of participants with treatment emergent adverse events
Treatment emergent adverse events (including changes in laboratory assessments, physical examination findings, and vital signs)
Time frame: Day 1 to 180 days post-last NanoDoce injection
Concentration of docetaxel in the systemic circulation post-injection
Pharmacokinetic samples will be obtained on the days of NanoDoce injection and other clinic visits
Time frame: Screening, Day 1, Day 2, Day 15, Day 27, Day 30, Day 31, Day 45, Month 2, Month 3, Month 4, Month 5, and 180 days post-last NanoDoce injection
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.