Effect of Weight on the Population Pharmacokinetic Analysis of Doxorubicin and Cyclophosphamide

Summary

To determine the effect of weight on doxorubicin and cyclophosphamide plasma clearance in participants who are normal weight (body mass index \[BMI\] \< 25 kg/m2, overweight or class I obese (BMI 25-34.9 kg/m2), or class II-III obese (BMI ≥ 35 kg/m2). The hypothesis is that participants who weigh more will have higher doxorubicin and cyclophosphamide clearances than participants who weigh less. Restated, the area under the drug-concentration time profile, also known as the AUC, in participants will decrease as participant weight increases.

Timeline

Start

2012-02

Primary completion

2016-12

Completion

2016-12

Publications

• Hall RG 2nd, Liu S, Pai MP, Putnam WC, Subramaniyan I, Kallem R, Haley B. Impact of obesity on doxorubicin pharmacokinetics in women with breast cancer. J Oncol Pharm Pract. 2026 Jul;32(5):901-907. doi: 10.1177/10781552251326045. Epub 2025 Mar 13.

Drugs

Indications