An exposure-safety analysis to support the dosage of the novel AKT inhibitor capivasertib.

ABSTRACT:

Purpose

This study aimed to evaluate capivasertib exposure-response relationships for clinical safety events to support dosage selection.

Methods

Data from 277 patients with solid tumors participating in three phase 1 studies were analyzed. Capivasertib 80-800 mg was administered as monotherapy orally twice daily (BID) on continuous or intermittent (4 days on, 3 days off [4/3] or 2 days on, 5 days off [2/5]) schedules. Relationships between exposure related metrics (dose, weekly dose, AUC, AUC_PWD, C_max, and C_min) and probability of safety endpoints (adverse event [AE] leading to dose discontinuation, AE leading to dose modification, serious AE [SAE], AE grade ≥ 3, AE grade ≥ 1, diarrhea AE grade ≥ 2, rash AE grade ≥ 2, hyperglycemia AE grade 

SUBMITTER: Teruel CF 

PROVIDER: S-EPMC11953117 | biostudies-literature | 2025 Mar

REPOSITORIES: biostudies-literature