Evidence map›Paper›PMID 30427584›Full record

ArticleClinical and translational science2019

Evaluation of Drug-Drug Interactions of Rucaparib and CYP1A2, CYP2C9, CYP2C19, CYP3A, and P-gp Substrates in Patients With an Advanced Solid Tumor.

Jim J Xiao, Dorota Nowak, Rodryg Ramlau, Monika Tomaszewska-Kiecana, Piotr J Wysocki, Jeff Isaacson, Jeri Beltman, Eileen Nash, Robert Kaczanowski, Gerhard Arold and 1 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase I
In one paragraph

Article in Clinical and translational science, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02740712 (A Phase 1, Open-label, Multiple-probe Drug-drug Interaction Study to Determine the Effect of Rucaparib on Pharmacokinetics of Caffeine, S-Warfarin, Omeprazole, Midazolam, and Digoxin in Patients With Advanced Solid Tumors), which is not on this map. Cited by 16 papers.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed
0.8field-weighted citation impact, top 24% 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.

NCT02740712 phase1completednot on this map

A Phase 1, Open-label, Multiple-probe Drug-drug Interaction Study to Determine the Effect of Rucaparib on Pharmacokinetics of Caffeine, S-Warfarin, Omeprazole, Midazolam, and Digoxin in Patients With Advanced Solid Tumors

TypeinterventionalSponsorpharmaand GmbHRan2016 to 2019Enrolled17ConditionsNeoplasmsArmsCaffeine, Warfarin, Omeprazole, Midazolam, digoxin
3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 20 citations in OpenAlex.

  1. Article
  2. Review
  3. Review
  4. Article
  5. Research progress regardingZhong nan da xue xue bao. Yi xue ban = Journal of Central South University. Medical sciences · 2023
    Article
  6. Combined Oral Contraceptives As Victims of Drug Interactions.Drug metabolism and disposition: the biological fate of chemicals · 2023
    Review
  7. Review
  8. Review
  9. Review
  10. Appropriate Selection of PARP Inhibitors in Ovarian Cancer.Current treatment options in oncology · 2022
    Review
  11. Article
  12. Manage wisely: poly (ADP-ribose) polymerase inhibitor (PARPi) treatment and adverse events.International journal of gynecological cancer : official journal of the International Gynecological Cancer Society · 2020
    Review
  13. Article
  14. Article
  15. Review
  16. Review
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

11 authors at 6 institutions in 2 countries.

Jim J XiaoClinical Pharmacology and DMPK, Clovis Oncology, Inc., Boulder, Colorado, USA.
Dorota NowakDepartment of Oncology, West Pomeranian Center of Oncology, Szczecin, Poland.
Rodryg RamlauDepartment of Oncology, Poznan University of Medical Sciences, Poznan, Poland.
Monika Tomaszewska-KiecanaMedical Department, BioVirtus Research Site, Warsaw, Poland.
Piotr J WysockiDepartment of Oncology, Jagiellonian University - Medical College, Cracow, Poland.
Jeff IsaacsonBiostatistics and Data Management, Clovis Oncology, Inc., Boulder, Colorado, USA.
Jeri BeltmanRegulatory Affairs, Clovis Oncology, Inc., Boulder, Colorado, USA.
Eileen NashClinical Operations, Clovis Oncology, Inc., Boulder, Colorado, USA.
Robert KaczanowskiMedical Affairs, PRA Health Sciences, Berlin, Germany.
Gerhard AroldMedical Affairs, PRA Health Sciences, Berlin, Germany.
Simon WatkinsClinical Science, Clovis Oncology, Inc., Boulder, Colorado, USA.
Clovis Oncology (United States) · USPRA Health Sciences · USBioVirtus (Poland) · PLJagiellonian University · PLPomeranian Medical University · PLPoznan University of Medical Sciences · PL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

This phase I study (CO-338-044; NCT02740712), conducted in patients with advanced solid tumors, evaluated the effect of the poly(ADP-ribose) polymerase (PARP) inhibitor rucaparib on the pharmacokinetics (PK) of caffeine 200 mg, warfarin 10 mg, omeprazole 40 mg, and midazolam 2 mg (cytochrome P450 (CYP) 1A2, CYP2C9, CYP2C19, and CYP3A substrates; dosed as a cocktail) and digoxin 0.25 mg (P-glycoprotein (P-gp) substrate; dosed separately) without rucaparib and following oral rucaparib 600 mg b.i.d. Geometric mean (GM) ratios (90% confidence interval (CI)) of area under the concentration-time curve (AUC) from time zero to last quantifiable measurement with and without rucaparib were: caffeine, 2.26 (1.93-2.65); S-warfarin, 1.49 (1.40-1.58); omeprazole, 1.55 (1.32-1.83); midazolam, 1.39 (1.14-1.68); and digoxin, 1.20 (1.12-1.29). There was limited effect on peak concentration of the substrates (GM ratios, 0.99-1.13). At steady state, rucaparib 600 mg b.i.d. moderately inhibited CYP1A2, weakly inhibited CYP2C9, CYP2C19, and CYP3A, and marginally increased digoxin exposure.

Indexed as

AdultAgedATP Binding Cassette Transporter, Subfamily BCytochrome P-450 Enzyme SystemDose-Response Relationship, DrugDrug Administration ScheduleDrug InteractionsFemaleGenotyping TechniquesHumansIndolesMaleMiddle AgedNeoplasmsNeoplasm StagingPoly(ADP-ribose) Polymerase InhibitorsABCB1 protein, humanATP Binding Cassette Transporter, Subfamily BCytochrome P-450 Enzyme SystemIndolesPoly(ADP-ribose) Polymerase Inhibitorsrucaparib

Identifiers

PMID30427584
PMCPMC6342242
OpenAlexW2900890182

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

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.