Characterization of exposure-response relationships of ipatasertib in patients with metastatic castration-resistant prostate cancer in the IPATential150 study.
AKT inhibitor
Exposure–response
IPATential150
Ipatasertib
Metastatic castration-resistant prostate cancer
Journal
Cancer chemotherapy and pharmacology
ISSN: 1432-0843
Titre abrégé: Cancer Chemother Pharmacol
Pays: Germany
ID NLM: 7806519
Informations de publication
Date de publication:
Dec 2022
Dec 2022
Historique:
received:
14
07
2022
accepted:
19
10
2022
pubmed:
29
10
2022
medline:
9
11
2022
entrez:
28
10
2022
Statut:
ppublish
Résumé
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). 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 A statistically significant correlation between ipatasertib AUC The exposure-efficacy results indicated that patients receiving ipatasertib may continue benefiting from this treatment at the administered dose, despite some variability in exposures, while the exposure-safety results suggested increased risks of AEs with ipatasertib treatment and/or increased ipatasertib exposures.
Identifiants
pubmed: 36305957
doi: 10.1007/s00280-022-04488-2
pii: 10.1007/s00280-022-04488-2
pmc: PMC9637074
doi:
Substances chimiques
ipatasertib
524Y3IB4HQ
Piperazines
0
Pyrimidines
0
Banques de données
ClinicalTrials.gov
['NCT03072238']
Types de publication
Clinical Study
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
511-521Informations de copyright
© 2022. The Author(s).
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