Evidence map›Paper›PMID 28852909›Full record

ArticleInvestigational new drugs2018

Effects of rifampin, itraconazole and esomeprazole on the pharmacokinetics of alisertib, an investigational aurora a kinase inhibitor in patients with advanced malignancies.

Xiaofei Zhou, Shubham Pant, John Nemunaitis, A Craig Lockhart, Gerald Falchook, Todd M Bauer, Manish Patel, John Sarantopoulos, Michael Bargfrede, Andreas Muehler and 3 more

Open access · hybridAbstract readClinical Trial, Phase I
In one paragraph

Article in Investigational new drugs, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
0.9field-weighted citation impact, top 28% 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

11 citing papers in PubMed, 19 citations in OpenAlex.

  1. Trial
  2. Review
  3. Article
  4. Article
  5. Review
  6. Article
  7. Article
  8. Biotransformation Pathways and Metabolite Profiles of Oral [Drug metabolism and disposition: the biological fate of chemicals · 2020
    Article
  9. The role of Aurora-A in human cancers and future therapeutics.American journal of cancer research · 2020
    Review
  10. Article
  11. Validation of in vitro methods for human cytochrome P450 enzyme induction: Outcome of a multi-laboratory study.Toxicology in vitro : an international journal published in association with BIBRA · 2019
    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

13 authors at 9 institutions in 2 countries.

Xiaofei ZhouMillennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA, USA. xiaofei.zhou@takeda.com.ORCID 0000-0003-0319-1327
Shubham PantOklahoma University Medical Center, Oklahoma City, OK, USA.
John NemunaitisMary Crowley Cancer Research Centers, Dallas, TX, USA.
A Craig LockhartWashington University, St. Louis, MO, USA.
Gerald FalchookSarah Cannon Research Institute at HealthONE, Denver, CO, USA.
Todd M BauerSarah Cannon Research Institute, Nashville, TN, USA.
Manish PatelFlorida Cancer Specialists, Sarasota, FL, USA.
John SarantopoulosInstitute for Drug Development, Cancer Therapy and Research Center, University of Texas Health Science Center San Antonio, San Antonio, TX, USA.
Michael BargfredeMJB Pharma Consulting, Inc, Cambridge, MA, USA.
Andreas MuehlerMillennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA, USA.
Lakshmi RangachariMillennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA, USA.
Bin ZhangSeqirus Pharmaceuticals, Cambridge, MA, USA.
Karthik VenkatakrishnanMillennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA, USA.
Takeda (United States) · USSarah Cannon · USBridge Pharma (United States) · USFlorida Cancer Specialists & Research Institute · USMary Crowley Cancer Research Center · USSeqirus (United States) · USThe University of Texas Health Science Center at San Antonio · USUniversity Medical Center · USWashington University in St. Louis · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Aim Two studies investigated the effect of gastric acid reducing agents and strong inducers/inhibitors of CYP3A4 on the pharmacokinetics of alisertib, an investigational Aurora A kinase inhibitor, in patients with advanced malignancies. Methods In Study 1, patients received single doses of alisertib (50 mg) in the presence and absence of either esomeprazole (40 mg once daily [QD]) or rifampin (600 mg QD). In Study 2, patients received single doses of alisertib (30 mg) in the presence and absence of itraconazole (200 mg QD). Blood samples for alisertib and 2 major metabolites were collected up to 72 h (Study 1) and 96 h (Study 2) postdose. Area under the curve from time zero extrapolated to infinity (AUC

Indexed as

Area Under CurveAurora Kinase AAzepinesDose-Response Relationship, DrugDrugs, InvestigationalEsomeprazoleFemaleHumansItraconazoleMaleProtein Kinase InhibitorsPyrimidinesRifampinAurora Kinase AAzepinesDrugs, InvestigationalEsomeprazoleItraconazoleMLN 8237Protein Kinase InhibitorsPyrimidinesRifampinAlisertibAurora A kinaseCYP3A4Drug-drug interactionsInductionInhibition

Identifiers

PMID28852909
PMCPMC5869871
OpenAlexW2752203183

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Registered trials

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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.