Evidence map›Paper›PMID 32598495›Full record

ArticleJournal of clinical pharmacology2020

Population Pharmacokinetic Analysis of Quizartinib in Healthy Volunteers and Patients With Relapsed/Refractory Acute Myeloid Leukemia.

Dongwoo Kang, Elizabeth Ludwig, David Jaworowicz, Hannah Huang, Jill Fiedler-Kelly, Jorge Cortes, Siddhartha Ganguly, Samer Khaled, Alwin Krämer, Mark Levis and 7 more

Open access · hybridAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Journal of clinical pharmacology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.1field-weighted citation impact, top 53% 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

3 citing papers in PubMed, 4 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Article
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

17 authors at 10 institutions in 4 countries.

Dongwoo KangDaiichi Sankyo, Inc., Basking Ridge, New Jersey, USA.
Elizabeth LudwigCognigen Corporation, a Simulations Plus company, Buffalo, New York, USA.
David JaworowiczCognigen Corporation, a Simulations Plus company, Buffalo, New York, USA.
Hannah HuangCognigen Corporation, a Simulations Plus company, Buffalo, New York, USA.
Jill Fiedler-KellyCognigen Corporation, a Simulations Plus company, Buffalo, New York, USA.
Jorge CortesThe University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Siddhartha GangulyThe University of Kansas Cancer Center, Fairway, Kansas, USA.
Samer KhaledCity of Hope, Arcadia, California, USA.
Alwin KrämerClinical Cooperation Unit Molecular Hematology/Oncology, Department of Internal Medicine V, University of Heidelberg, Heidelberg, Germany.
Mark LevisSidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, Baltimore, Maryland, USA.
Giovanni MartinelliIstituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy.
Alexander PerlDivision of Hematology and Oncology, Abramson Cancer Center of the University of Pennsylvania, Philadelphia, Pennsylvania, USA.
Nigel RussellCentre for Clinical Haematology, Nottingham University Hospitals NHS Trust, Nottingham, UK.
Malaz AbutarifDaiichi Sankyo, Inc., Basking Ridge, New Jersey, USA.
Youngsook ChoiDaiichi Sankyo, Inc., Basking Ridge, New Jersey, USA.
Jeanne MendellDaiichi Sankyo, Inc., Basking Ridge, New Jersey, USA.
Ophelia YinDaiichi Sankyo, Inc., Basking Ridge, New Jersey, USA.
Daiichi Sankyo (United States) · USSimulations Plus (United States) · USCity of Hope · USHeidelberg University · DEIstituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori · ITJohns Hopkins University · USNottingham University Hospitals NHS Trust · GBThe University of Kansas Cancer Center · USThe University of Texas MD Anderson Cancer Center · USUniversity of Pennsylvania · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Quizartinib is an FMS-like tyrosine kinase 3 (FLT3) inhibitor that has shown robust clinical activity in patients with FLT3-internal tandem duplication-mutated relapsed/refractory acute myeloid leukemia (AML). This analysis evaluated the population pharmacokinetics (PK) of quizartinib and its active metabolite, AC886, in a pooled analysis of data from 649 healthy volunteers or patients with AML from 8 clinical trials including the phase 3 QuANTUM-R study. Quizartinib was given as a single dose or multiple once-daily doses of 20, 30, 60, or 90 mg. Nonlinear mixed-effects modeling was performed using observed concentrations of quizartinib and AC886. Strong CYP3A inhibitor use resulted in an 82% increase in the area under the curve (AUC) and a 72% increase in the maximum concentration (C

Indexed as

Administration, OralAdolescentAdultAgedAged, 80 and overArea Under CurveBenzothiazolesBody Surface AreaClinical Trials as TopicCytochrome P-450 CYP3A InhibitorsDrug InteractionsFemalefms-Like Tyrosine Kinase 3Healthy VolunteersHumansLeukemia, Myeloid, AcuteBenzothiazolesCytochrome P-450 CYP3A InhibitorsFLT3 protein, humanfms-Like Tyrosine Kinase 3Phenylurea CompoundsProtein Kinase InhibitorsquizartinibAC886acute myeloid leukemiapopulation pharmacokineticsquizartinibrelapsed/refractory

Identifiers

PMID32598495
PMCPMC7689835
OpenAlexW3037099654

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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 OpenQuestion graph.