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

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

Research output: Contribution to journalArticle

1 Scopus citations

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.

Original languageEnglish
Pages (from-to)323-330
Number of pages8
JournalInvestigational New Drugs
Volume37
Issue number2
DOIs
StatePublished - Apr 15 2019

Keywords

  • Advanced disease
  • Fat meal
  • Pazopanib
  • Renal cell carcinoma
  • Tyrosine kinase inhibitor therapy

Fingerprint Dive into the research topics of 'Pazopanib with low fat meal (PALM) in advanced renal cell carcinoma'. Together they form a unique fingerprint.

  • Cite this

    Reimers, M. A., Shango, M. M., Daignault-Newton, S., Dedinsky, R., Karsies, D., Kraft, S., Riddle, L., Felton, J. A., Wen, B., Gersch, C., Rae, J. M., Redman, B. G., & Alva, A. S. (2019). Pazopanib with low fat meal (PALM) in advanced renal cell carcinoma. Investigational New Drugs, 37(2), 323-330. https://doi.org/10.1007/s10637-018-0692-8