Pharmacokinetics and safety of niraparib in patients with moderate hepatic impairment.
Dosing
Hepatic impairment
Niraparib
Pharmacokinetics
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:
11 2021
11 2021
Historique:
received:
25
03
2021
accepted:
24
06
2021
pubmed:
30
7
2021
medline:
4
1
2022
entrez:
29
7
2021
Statut:
ppublish
Résumé
The purpose of this study is to characterize niraparib pharmacokinetics (PK) and safety in patients with normal hepatic function (NHF) versus moderate hepatic impairment (MHI). Patients with advanced solid tumors were stratified by NHF or MHI (National Cancer Institute-Organ Dysfunction Working Group criteria [bilirubin > 1.5-3 × upper limit of normal and any aspartate aminotransferase elevation]). In the PK phase, all patients received one 300 mg dose of niraparib. In the extension phase, patients with MHI received niraparib 200 mg daily; patients with NHF received 200 or 300 mg based on weight (< 77 kg, ≥ 77 kg)/platelets (< 150,000/µL, ≥ 150,000/µL). PK parameters included maximum concentration (C In the PK phase (NHF, n = 9; MHI, n = 8), mean niraparib C These findings support adjusting the 300 mg niraparib starting dose to 200 mg QD in patients with MHI. NCT03359850; registered December 2, 2017.
Identifiants
pubmed: 34324028
doi: 10.1007/s00280-021-04329-8
pii: 10.1007/s00280-021-04329-8
pmc: PMC8484145
doi:
Substances chimiques
Indazoles
0
Piperidines
0
niraparib
HMC2H89N35
Banques de données
ClinicalTrials.gov
['NCT03359850']
Types de publication
Clinical Trial, Phase I
Journal Article
Multicenter Study
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
825-836Subventions
Organisme : NCATS NIH HHS
ID : UL1 TR003167
Pays : United States
Organisme : NCI NIH HHS
ID : P30 CA016672
Pays : United States
Informations de copyright
© 2021. The Author(s).
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