Pharmacologic Interaction Between Ifosfamide and Aprepitant in Treated Patients With Soft Tissue Sarcoma

Summary

This trial is a multicentric study aiming to assess the evolution of the serum ifosfamide concentrations and its serum metabolites in patients treated for an Soft Tissue Sarcoma and co-exposed to Aprepitant. The study will be conducted on a population of patients treated with Doxorubicin and Ifosfamide. The Aprepitant can be prescribed to patients from cycle 2, according to the current recommendations. Doxorubicin, Ifosfamide and Aprepitant will be administered in the context of routine care. The follow-up during the treatment period and the clinical, biological and radiological assessments will be performed according to the standard of each centre. Patients will be followed during the two first cycles of treatment. For the pharmacokinetic study, blood samples will be collected at different time points during the 2 treatment cycles.

Timeline

Start

2018-05-18

Primary completion

2020-11-23

Completion

2020-11-23

Publications

• Results Valentin T, Lambert M, Chaltiel L, Allal B, Mseddi M, Yakoubi M, Chevreau C, Toulmonde M, Firmin N, Filleron T, Chatelut E. Population pharmacokinetic analysis reveals no impact of aprepitant on the pharmacokinetics of ifosfamide, 2-dechloroifosfamide, and 3-dechloroifosfamide. Eur J Pharm Sci. 2023 Jun 1;185:106420. doi: 10.1016/j.ejps.2023.106420. Epub 2023 Mar 5.

Drugs

Indications