Evidence map›Paper›PMID 34324028›Full record

ArticleCancer chemotherapy and pharmacology2021

Pharmacokinetics and safety of niraparib in patients with moderate hepatic impairment.

Mehmet Akce, Anthony El-Khoueiry, Sarina A Piha-Paul, Emeline Bacque, Peng Pan, Zhi-Yi Zhang, Reginald Ewesuedo, Divya Gupta, Yongqiang Tang, Ashley Milton and 3 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Article in Cancer chemotherapy and pharmacology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03359850 (An Open-Label, Non-Randomized, Multicenter Study to Determine the Pharmacokinetics and Safety of Niraparib Following a Single Oral Dose in Patients With Advanced Solid Tumors and Either Normal Hepatic Function or Moderate Hepatic Impairment), which is not on this map. Cited by 13 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 1 pooled it
0.9field-weighted citation impact, top 23% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03359850 phase1completednot on this map

An Open-Label, Non-Randomized, Multicenter Study to Determine the Pharmacokinetics and Safety of Niraparib Following a Single Oral Dose in Patients With Advanced Solid Tumors and Either Normal Hepatic Function or Moderate Hepatic Impairment

TypeinterventionalSponsorTesaro, Inc.Ran2018 to 2020Enrolled17ConditionsOvarian Neoplasms, Neoplasms, Solid Tumor, Hepatic ImpairmentArmsNiraparib
3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 1 synthesis or guideline pooled it, 12 citations in OpenAlex.

  1. Pooled it
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors at 6 institutions in 1 country.

Mehmet AkceWinship Cancer Institute of Emory University, Atlanta, GA, USA.
Anthony El-KhoueiryUniversity of Southern California Norris Comprehensive Cancer Center, Los Angeles, CA, USA.
Sarina A Piha-PaulUniversity of Texas MD Anderson Cancer Center, Houston, TX, USA.
Emeline BacqueGlaxoSmithKline, Waltham, MA, USA.
Peng PanGlaxoSmithKline, Waltham, MA, USA.
Zhi-Yi ZhangGlaxoSmithKline, Waltham, MA, USA.
Reginald EwesuedoGlaxoSmithKline, Waltham, MA, USA.
Divya GuptaGlaxoSmithKline, Waltham, MA, USA.
Yongqiang TangGlaxoSmithKline, Waltham, MA, USA.
Ashley MiltonGlaxoSmithKline, Waltham, MA, USA.
Stefan ZajicGlaxoSmithKline, Upper Providence, PA, USA.
Patricia L JudsonGlaxoSmithKline, Waltham, MA, USA.
Cindy L O'BryantUniversity of Colorado Cancer Center, Mail Stop C238, 12850 East Montview Blvd., V20-1223, Aurora, CO, 80045, USA. cindy.obryant@cuanschutz.edu.ORCID 0000-0001-6337-2221
GlaxoSmithKline (United States) · USEmory University · USProvidence College · USThe University of Texas MD Anderson Cancer Center · USUniversity of Colorado Cancer Center · USUniversity of Southern California · US

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI DIANE BODURKA · 1985 to 2026
$290.8M
Convalescent Plasma to Limit Coronavirus Associated ComplicationsUL1TR003167 · NCATS · UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON · PI KARP, DANIEL D, MCPHERSON, DAVID D · 2019 to 2023
$45.3M
NCATS NIH HHS UL1 TR003167NCI NIH HHS P30 CA016672
6 · The paper itself

Abstract

purposeThe purpose of this study is to characterize niraparib pharmacokinetics (PK) and safety in patients with normal hepatic function (NHF) versus moderate hepatic impairment (MHI).

methodsPatients 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

resultsIn the PK phase (NHF, n = 9; MHI, n = 8), mean niraparib C

conclusionThese findings support adjusting the 300 mg niraparib starting dose to 200 mg QD in patients with MHI.

trial registrationNCT03359850; registered December 2, 2017.

Indexed as

AgedArea Under CurveDose-Response Relationship, DrugFemaleHumansIndazolesLiverMaleMiddle AgedPiperidinesIndazolesniraparibPiperidinesDosingHepatic impairmentNiraparibPharmacokineticsSafety

Identifiers

PMID34324028
PMCPMC8484145
OpenAlexW3184289098

What Socratic holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.