Characterization of exposure-response relationships of ipatasertib in patients with metastatic castration-resistant prostate cancer in the IPATential150 study.

ABSTRACT:

Purpose

The exposure-response relationships for efficacy and safety of ipatasertib, a selective AKT kinase inhibitor, were characterized using data collected from 1101 patients with metastatic castration-resistant prostate cancer in the IPATential150 study (NCT03072238).

Methods

External validation of a previously developed population pharmacokinetic model was performed using the observed pharmacokinetic data from the IPATential150 study. Exposure metrics of ipatasertib for subjects who received ipatasertib 400 mg once-daily orally in this study were generated as model-predicted area under the concentration-time curve at steady state (AUC_SS). The exposure-response relationship with radiographic progression-free survival (rPFS) was evaluated using Cox regression an

SUBMITTER: Kotani N 

PROVIDER: S-EPMC9637074 | biostudies-literature | 2022 Dec

REPOSITORIES: biostudies-literature