Population exposure-efficacy and exposure-safety analyses for rucaparib in patients with recurrent ovarian carcinoma from Study 10 and ARIEL2.

ABSTRACT:

Objective

To evaluate correlations between rucaparib exposure and selected efficacy and safety endpoints in patients with recurrent ovarian carcinoma using pooled data from Study 10 and ARIEL2.

Methods

Efficacy analyses were limited to patients with carcinomas harboring a deleterious BRCA1 or BRCA2 mutation who had received ≥2 prior lines of chemotherapy. Safety was evaluated in all patients who received ≥1 rucaparib dose. Steady-state daily area under the concentration-time curve (AUC_ss) and maximum concentration (C_max,ss) for rucaparib were calculated for each patient and averaged by actual dose received over time (AUC_avg,ss and C_max,avg,ss) using a previously developed population pharmacokinetic model.

Results

Rucaparib e

SUBMITTER: Konecny GE 

PROVIDER: S-EPMC9535637 | biostudies-literature | 2021 Jun

REPOSITORIES: biostudies-literature