Pazopanib with low fat meal (PALM) in advanced renal cell carcinoma View Full Text


Ontology type: schema:ScholarlyArticle     


Article Info

DATE

2019-04

AUTHORS

Melissa A. Reimers, Maryann M. Shango, Stephanie Daignault-Newton, Rachel Dedinsky, Danielle Karsies, Shawna Kraft, Liam Riddle, Jeremy A. Felton, Bo Wen, Christina Gersch, James M. Rae, Bruce G. Redman, Ajjai S. Alva

ABSTRACT

Background Pazopanib is approved for metastatic renal cell carcinoma (RCC). We assessed the safety and efficacy of pazopanib with a low fat meal (LFM): <400 cal and < 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. More... »

PAGES

323-330

Identifiers

URI

http://scigraph.springernature.com/pub.10.1007/s10637-018-0692-8

DOI

http://dx.doi.org/10.1007/s10637-018-0692-8

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1108025799

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/30393825


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