Evidence map›Paper›PMID 28865153›Full record

ArticleBritish journal of clinical pharmacology2018

Evaluation of the pharmacokinetic drug interaction potential of tivantinib (ARQ 197) using cocktail probes in patients with advanced solid tumours.

Masaya Tachibana, Kyriakos P Papadopoulos, John H Strickler, Igor Puzanov, Roohi Gajee, Yibin Wang, Hamim Zahir

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

Article in British journal of clinical pharmacology, 2018. 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
0.7field-weighted citation impact, top 27% 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, 8 citations in OpenAlex.

  1. Article
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  4. Evidence-based complementary and alternative medicine : eCAM · 2019
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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

7 authors at 5 institutions in 2 countries.

Masaya TachibanaDaiichi Sankyo Co., Ltd., Tokyo, Japan.
Kyriakos P PapadopoulosSouth Texas Accelerated Research Therapeutics, San Antonio, Texas, USA.
John H StricklerDuke University Medical Center, Durham, North Carolina, USA.
Igor PuzanovRoswell Park Cancer Institute, Buffalo, New York, USA.
Roohi GajeeDaiichi Sankyo, Inc., Edison, New Jersey, USA.
Yibin WangDaiichi Sankyo, Inc., Edison, New Jersey, USA.
Hamim ZahirDaiichi Sankyo, Inc., Edison, New Jersey, USA.ORCID http://orcid.org/0000-0002-2501-5669
Daiichi Sankyo (United States) · USDaiichi-Sankyo (Japan) · JPDuke Medical Center · USRoswell Park Comprehensive Cancer Center · USSouth Texas Accelerated Research Therapeutics · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsThis phase 1, open-label, crossover study sought to evaluate drug-drug interactions between tivantinib and cytochrome P450 (CYP) substrates and tivantinib and P-glycoprotein.

methodsThe effect of tivantinib doses on the pharmacokinetics of the probe drugs for CYP1A2 (caffeine), CYP2C9 (S-warfarin), CYP2C19 (omeprazole), and CYP3A4 (midazolam), and for P-glycoprotein (digoxin) was investigated in 28 patients with advanced cancer using a cocktail probe approach. Patients received single doses of probe drugs alone and, after 5 days of treatment, with tivantinib 360 mg twice daily.

resultsThe ratios of geometric least squares mean (90% confidence interval) for the area under the concentration-time curve from time zero to the last quantifiable concentration in the presence/absence of tivantinib were 0.97 (0.89-1.05) for caffeine, 0.88 (0.76-1.02) for S-warfarin, 0.89 (0.60-1.31) for omeprazole, 0.83 (0.67-1.02) for midazolam, and 0.69 (0.51-0.94) for digoxin. Similar effects were observed for maximum plasma concentrations; the ratio for digoxin in the presence/absence of tivantinib was 0.75 (0.60-0.95).

conclusionsThe data suggest that tivantinib 360 mg twice daily has either a minimal or no effect on the pharmacokinetics of probe drugs for CYP1A2, CYP2C9, CYP2C19 and CYP3A4 substrates, and decreases the systemic exposure of P-glycoprotein substrates when administered with tivantinib.

Indexed as

Drug InteractionsAdultAgedAged, 80 and overAntineoplastic AgentsATP Binding Cassette Transporter, Subfamily BCaffeineChromatography, High Pressure LiquidCross-Over StudiesCytochrome P-450 Enzyme SystemDrug Therapy, CombinationFemaleHumansMaleMidazolamMiddle AgedABCB1 protein, humanAntineoplastic AgentsARQ 197ATP Binding Cassette Transporter, Subfamily BCaffeineCytochrome P-450 Enzyme SystemMidazolamOmeprazoleProto-Oncogene Proteins c-metPyrrolidinonesQuinolinesWarfarincancercytochrome P450drug interactionP-glycoproteinpharmacokineticstivantinib

Identifiers

PMID28865153
PMCPMC5736844
OpenAlexW2752435257

What OpenQuestion 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 OpenQuestion graph.