Pazopanib with low fat meal (PALM) in advanced renal cell carcinoma.
Investigational new drugs
Advanced disease; Fat meal; Pazopanib; Renal cell carcinoma; Tyrosine kinase inhibitor therapy
Background Pazopanib is approved for metastatic renal cell carcinoma (RCC). We assessed the safety and efficacy of pazopanib with a low fat meal (LFM):< 20% fat or 10 g per meal. Methods A single arm study of pazopanib with a LFM in 16 adult patients with metastatic RCC with a clear cell component, RECIST 1.1 measurable disease, ECOG PS ≤ 2, and ≤ 3 prior therapies. Pazopanib at 400 mg daily given with LFM for 12 weeks. Incremental dose increases up to 800 mg, or irreversible decreases to 200 mg, allowed every 2 weeks. Primary study endpoint was safety; adverse events (AE) measured per CTCAE version 4.0. Secondary endpoints of RECIST 1.1 response with assessment as 12 weeks; pharmacokinetic (PK) analysis at nine time points, and CYP3A4 polymorphism evaluation. Results Pazopanib with a LFM was well tolerated; 13 of 16 subjects completed all 12 weeks. Three patients withdrew due to adverse events (AEs), with five occurrences of grade 3 AEs. Conclusions Pazopanib with a LFM has acceptable safety and comparable efficacy to fasting administration. Total median pazopanib dose per subject for the study duration was 63.5% of maximum possible conventional dose. A larger study is warranted. Clinical Trial Registration Number: NCT02729194.
Kidney & Diabetes
Reimers, Melissa A; Shango, Maryann M; Daignault-Newton, Stephanie; Dedinsky, Rachel; Karsies, Danielle; Kraft, Shawna; Riddle, Liam; Felton, Jeremy A; Wen, Bo; Gersch, Christina; Rae, James M; Redman, Bruce G; and Alva, Ajjai S, "Pazopanib with low fat meal (PALM) in advanced renal cell carcinoma." (2018). Articles, Abstracts, and Reports. 936.