Evidence map›Paper›PMID 32449142›Full record

ArticleCancer chemotherapy and pharmacology2020

Pharmacokinetics and tolerability of fedratinib, an oral, selective Janus kinase 2 inhibitor, in subjects with renal or hepatic impairment.

Ken Ogasawara, William B Smith, Christine Xu, Jian Yin, Maria Palmisano, Gopal Krishna

Abstract readClinical Trial, Phase IMulticenter Study
PubMed Publisher
In one paragraph

Article in Cancer chemotherapy and pharmacology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
0.6field-weighted citation impact, top 31% 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

6 citing papers in PubMed, 11 citations in OpenAlex.

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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

6 authors at 4 institutions in 2 countries.

Ken OgasawaraBristol Myers Squibb, 556 Morris Ave, Summit, NJ, 07901, USA.ORCID http://orcid.org/0000-0002-4264-8927
William B SmithAlliance for Multispecialty Research, University of Tennessee, Knoxville, TN, USA.
Christine XuSanofi, Bridgewater, NJ, USA.
Jian YinSanofi, Bridgewater, NJ, USA.
Maria PalmisanoBristol Myers Squibb, 556 Morris Ave, Summit, NJ, 07901, USA.
Gopal KrishnaBristol Myers Squibb, 556 Morris Ave, Summit, NJ, 07901, USA. gopal.krishna@bms.com.ORCID http://orcid.org/0000-0002-3163-3009
Bristol-Myers Squibb (United States) · USSanofi (United States) · USAlliance for Multispecialty Research (United States) · USBristol-Myers Squibb (Germany) · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeFedratinib is an oral, selective Janus kinase 2 inhibitor that is approved in the United States for the treatment of patients with intermediate-2 or high-risk myelofibrosis. Pharmacokinetics and tolerability of fedratinib in subjects with renal impairment (RI) and hepatic impairment (HI) were evaluated in two separate studies.

methodsIn the renal study, male and female subjects with stable, chronic mild, moderate, and severe RI, as well as those with end-stage renal disease, were included. The hepatic study included subjects with stable, chronic mild HI. Both were phase 1, multicenter, open-label, single-dose studies, and included matched healthy subjects. Subjects received a single oral dose of fedratinib 300 mg on day 1, were discharged on day 4, returned for clinical visits on days 5-12, and had their end-of-study visit between days 14 and 16.

resultsThirty-six and 17 subjects were included in the renal and hepatic studies, respectively. In the renal study, fedratinib area under the plasma concentration-time curve from time 0 to infinity (AUC

conclusionMild RI and HI do not necessitate fedratinib dosage adjustments. Subjects with moderate RI should be monitored (with dosage adjustments made as necessary), whereas those with severe RI should receive a daily dose of 200 mg, reduced from the indicated dose of 400 mg.

Indexed as

AdolescentAdultAgedArea Under CurveBenzenesulfonamidesCase-Control StudiesFemaleFollow-Up StudiesHumansJanus Kinase 2Kidney Failure, ChronicLiver DiseasesMaleMaximum Tolerated DoseMiddle AgedPrognosisBenzenesulfonamidesfedratinibJAK2 protein, humanJanus Kinase 2PyrrolidinesSulfonamidesFedratinibHepatic impairmentPharmacokineticsRenal impairmentTolerability

Identifiers

PMID32449142
OpenAlexW3026082810

What Socratic holds

Textmetadata
Read underepoch 390

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 Socratic graph.