Pharmacokinetics and safety of rucaparib in patients with advanced solid tumors and hepatic impairment.
Hepatic impairment
Pharmacokinetics
Poly(ADP-ribose) polymerase inhibitors
Rucaparib
Safety
Journal
Cancer chemotherapy and pharmacology
ISSN: 1432-0843
Titre abrégé: Cancer Chemother Pharmacol
Pays: Germany
ID NLM: 7806519
Informations de publication
Date de publication:
08 2021
08 2021
Historique:
received:
03
12
2020
accepted:
14
04
2021
pubmed:
29
4
2021
medline:
18
9
2021
entrez:
28
4
2021
Statut:
ppublish
Résumé
The poly(ADP-ribose) polymerase inhibitor rucaparib is approved for the treatment of patients with recurrent ovarian and metastatic castration-resistant prostate cancer; however, limited data are available on its use in patients with hepatic dysfunction. This study investigated whether hepatic impairment affects the pharmacokinetics, safety, and tolerability of rucaparib in patients with advanced solid tumors. Patients with normal hepatic function or moderate hepatic impairment according to the National Cancer Institute Organ Dysfunction Working Group (NCI-ODWG) criteria were enrolled and received a single oral dose of rucaparib 600 mg. Concentrations of rucaparib and its metabolite M324 in plasma and urine were measured. Pharmacokinetic parameters were compared between hepatic function groups, and safety and tolerability were assessed. Sixteen patients were enrolled (n = 8 per group). Rucaparib maximum concentration (C Patients with moderate hepatic impairment showed mildly increased AUC
Identifiants
pubmed: 33909097
doi: 10.1007/s00280-021-04278-2
pii: 10.1007/s00280-021-04278-2
pmc: PMC8236452
doi:
Substances chimiques
Antineoplastic Agents
0
Indoles
0
Poly(ADP-ribose) Polymerase Inhibitors
0
rucaparib
8237F3U7EH
Types de publication
Clinical Trial, Phase I
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
259-270Références
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