Pilot Study of Pazopanib With Low Fat Meal (PALM) in Advanced Renal Cell Carcinoma
Status:
Completed
Trial end date:
2017-09-01
Target enrollment:
Participant gender:
Summary
Pazopanib is an orally administered multi-kinase inhibitor targeting VEGFR (vascular
endothelial growth factor receptor), PDGFR (platelet derived growth factor) and c-kit, which
are critical to growth and proliferation of neoplastic cells. Pazopanib has been FDA approved
for advanced renal cell carcinoma (RCC) with a clear cell component. Conventional Pazopanib
dosing WITHOUT FOOD is with an initial dose of 800 mg by mouth daily. Investigators
hypothesize that administration of pazopanib with low fat meal would be safe and feasible
with secondary implications of higher pazopanib levels; potentially translating into greater
anti-tumor efficacy in advanced renal cell cancer, with significant cost savings. In the
proposed pilot study, investigators seek to test the feasibility and practicality of this
approach and gather preliminary data on adverse effects and the safety profile. Investigators
hope to ameliorate any potential for greater toxicities with a dynamic dosing design that
incorporates adverse events from each cycle into dosing for the next cycle and a structured
symptom specific plan.
Phase:
Early Phase 1
Details
Lead Sponsor:
University of Michigan Cancer Center University of Michigan Rogel Cancer Center