Evidence map›Paper›PMID 33909097›Full record

ArticleCancer chemotherapy and pharmacology2021

Pharmacokinetics and safety of rucaparib in patients with advanced solid tumors and hepatic impairment.

Nikolay Grechko, Viera Skarbova, Monika Tomaszewska-Kiecana, Rodryg Ramlau, Piotr Centkowski, Yvette Drew, Rafal Dziadziuszko, Milada Zemanova, Jeri Beltman, Eileen Nash and 3 more

Open access · hybridAbstract readClinical Trial, Phase I
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. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 1 pooled it
1.3field-weighted citation impact, top 18% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 1 synthesis or guideline pooled it, 17 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
  4. Article
  5. Review
  6. Review
  7. Article
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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 7 institutions in 4 countries.

Nikolay GrechkoClinical Science, Clovis Oncology UK Ltd., Cambridge, UK.
Viera SkarbovaDepartment of Internal Medicine and Clinical Pharmacology, Summit Clinical Research, Bratislava, Slovakia.
Monika Tomaszewska-KiecanaBioVirtus Centrum Medyczne, Jozefow, Poland.ORCID 0000-0001-5271-9998
Rodryg RamlauDepartment of Oncology and Pulmonology, Poznan University of Medical Sciences, Poznan, Poland.ORCID 0000-0002-3199-2298
Piotr CentkowskiDepartment of Oncology, Provincial Specialist Hospital in Biała Podlaska, Biała Podlaska, Poland.
Yvette DrewClinical and Translational Institute, Newcastle University, Newcastle Upon Tyne, UK.ORCID 0000-0001-6676-9224
Rafal DziadziuszkoDepartment of Oncology and Radiotherapy and Early Clinical Trials Unit, Medical University of Gdańsk, Gdańsk, Poland.ORCID 0000-0001-8080-9843
Milada ZemanovaDepartment of Oncology, First Faculty of Medicine, Charles University, Prague, Czech Republic.ORCID 0000-0002-1904-1035
Jeri BeltmanRegulatory Affairs, Clovis Oncology, Inc., Boulder, CO, USA.
Eileen NashClinical Operations, Clovis Oncology, Inc., Boulder, CO, USA.
Jenn HabeckBiostatistics, Clovis Oncology, Inc., Boulder, CO, USA.
Mingxiang LiaoClinical Pharmacology, Clovis Oncology, Inc., 5500 Flatiron Pkwy, Boulder, CO, 80301, USA.ORCID 0000-0003-1853-1419
Jim XiaoClinical Pharmacology, Clovis Oncology, Inc., 5500 Flatiron Pkwy, Boulder, CO, 80301, USA. jxiao@clovisoncology.com.ORCID 0000-0003-3632-2012
Clovis Oncology (United States) · USBioVirtus (Poland) · PLCharles University · CZClovis Oncology (United Kingdom) · GBGdańsk Medical University · PLNewcastle University · GBPoznan University of Medical Sciences · PL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThe 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.

methodsPatients 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.

resultsSixteen patients were enrolled (n = 8 per group). Rucaparib maximum concentration (C

conclusionPatients with moderate hepatic impairment showed mildly increased AUC

Indexed as

AdultAgedAntineoplastic AgentsArea Under CurveFemaleHumansIndolesLiverLiver DiseasesLiver Function TestsMaleMiddle AgedNeoplasmsPoly(ADP-ribose) Polymerase InhibitorsAntineoplastic AgentsIndolesPoly(ADP-ribose) Polymerase InhibitorsrucaparibHepatic impairmentPharmacokineticsPoly(ADP-ribose) polymerase inhibitorsRucaparibSafety

Identifiers

PMID33909097
PMCPMC8236452
OpenAlexW3158906188

What OpenQuestion holds

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Registered trials

None linked

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 OpenQuestion graph.