Evidence map›Paper›PMID 34370076›Full record

ArticleCancer chemotherapy and pharmacology2021

A phase 1, open-label, drug-drug interaction study of rucaparib with rosuvastatin and oral contraceptives in patients with advanced solid tumors.

Mingxiang Liao, Krzysztof G Jeziorski, Monika Tomaszewska-Kiecana, István Láng, Marek Jasiówka, Viera Skarbová, Piotr Centkowski, Rodryg Ramlau, Maria Górnaś, John Lee and 5 more

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

Article in Cancer chemotherapy and pharmacology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03954366 (A Phase 1, Open-label, Drug-drug-interaction Study to Determine the Effect of Rucaparib on the Pharmacokinetics of Oral Rosuvastatin), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing 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.

NCT03954366 phase1completednot on this map

A Phase 1, Open-label, Drug-drug-interaction Study to Determine the Effect of Rucaparib on the Pharmacokinetics of Oral Rosuvastatin (Arm A) and Oral Contraceptives (Ethinylestradiol and Levonorgestrel) (Arm B) in Patients With Advanced Solid Tumors

TypeinterventionalSponsorpharmaand GmbHRan2019 to 2021Enrolled36ConditionsNeoplasmsArmsRucaparib, Rosuvastatin, Oral Contraceptives
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 10 citations in OpenAlex.

  1. Combined Oral Contraceptives As Victims of Drug Interactions.Drug metabolism and disposition: the biological fate of chemicals · 2023
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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

15 authors at 6 institutions in 3 countries.

Mingxiang LiaoClinical Pharmacology, Clovis Oncology, Inc 5500 Flatrion Pkwy, Boulder, CO, 80301, USA.
Krzysztof G JeziorskiDepartment of Gerontology, Public Health and Didactics, National Institute of Geriatrics, Rheumatology and Rehabilitation, Warsaw, Poland.
Monika Tomaszewska-KiecanaBioVirtus Research Site Sp. Z.O.O., BioVirtus Medical Centre, Józefów, Poland.
István LángOncology Unit, Istenhegy Private Health Center, Budapest, Hungary.
Marek JasiówkaGynecological Oncology Clinic, Centre of Oncology, Maria Skłodowska-Curie Memorial Institute, Krakow, Poland.
Viera SkarbováDepartment of Internal Medicine and Clinical Pharmacology, Summit Clinical Research, Bratislava, Slovakia.
Piotr CentkowskiDepartment of Oncology and Hematology, Provincial Specialist Hospital, Biala Podlaska, Poland.
Rodryg RamlauDepartment of Oncology, Poznan University of Medical Sciences, Poznań, Poland.
Maria GórnaśDepartment of Chemotherapy, ATTIS Centre, Warsaw, Poland.
John LeeRegulatory Affairs, Clovis Oncology UK, Ltd., Cambridge, UK.
Sarah EdwardsMedical Affairs, Clovis Oncology UK, Ltd., Cambridge, UK.
Jenn HabeckBiostatistics, Clovis Oncology, Inc., Boulder, CO, USA.
Eileen NashClinical Operations, Clovis Oncology, Inc., Boulder, CO, USA.
Nikolay GrechkoClinical Science, Clovis Oncology UK, Ltd., Cambridge, UK.
Jim J XiaoClinical Pharmacology, Clovis Oncology, Inc 5500 Flatrion Pkwy, Boulder, CO, 80301, USA. jxiao@clovisoncology.com.ORCID 0000-0003-3632-2012
Clovis Oncology (United States) · USClovis Oncology (United Kingdom) · GBBioVirtus (Poland) · PLKrakow Cardiovascular Research Institute · PLPoznan University of Medical Sciences · PLUniversity Clinical Hospital In Bialystok · PL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThis study aimed at evaluating the effect of rucaparib on the pharmacokinetics of rosuvastatin and oral contraceptives in patients with advanced solid tumors and the safety of rucaparib with and without coadministration of rosuvastatin or oral contraceptives.

methodsPatients received single doses of oral rosuvastatin 20 mg (Arm A) or oral contraceptives ethinylestradiol 30 µg + levonorgestrel 150 µg (Arm B) on days 1 and 19 and continuous doses of rucaparib 600 mg BID from day 5 to 23. Serial blood samples were collected with and without rucaparib for pharmacokinetic analysis.

resultsThirty-six patients (n = 18 each arm) were enrolled and received at least 1 dose of study drug. In the drug-drug interaction analysis (n = 15 each arm), the geometric mean ratio (GMR) of maximum concentration (C

conclusionRucaparib 600 mg BID weakly increased the plasma exposure to rosuvastatin or oral contraceptives. Rucaparib safety profile when coadministered with rosuvastatin or oral contraceptives was consistent with that of rucaparib monotherapy. Dose adjustments of rosuvastatin and oral contraceptives are not necessary when coadministered with rucaparib. ClinicalTrials.gov NCT03954366; Date of registration May 17, 2019.

Indexed as

Administration, OralAdultAgedAntineoplastic Combined Chemotherapy ProtocolsATP Binding Cassette Transporter, Subfamily G, Member 2Contraceptives, OralDrug InteractionsEthinyl EstradiolFemaleHumansIndolesLevonorgestrelLiver-Specific Organic Anion Transporter 1MaleMiddle AgedNeoplasm ProteinsABCG2 protein, humanATP Binding Cassette Transporter, Subfamily G, Member 2Contraceptives, OralEthinyl EstradiolIndolesLevonorgestrelLiver-Specific Organic Anion Transporter 1Neoplasm ProteinsRosuvastatin CalciumrucaparibSLCO1B1 protein, humanBCRPDrug–drug interactionOncologyOral contraceptivesRucaparib

Identifiers

PMID34370076
PMCPMC8484168
OpenAlexW3192151430

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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.