Evidence map›Paper›PMID 33772633›Full record

ArticleCancer chemotherapy and pharmacology2021

The pharmacokinetics of pamiparib in the presence of a strong CYP3A inhibitor (itraconazole) and strong CYP3A inducer (rifampin) in patients with solid tumors: an open-label, parallel-group phase 1 study.

Song Mu, Chester Lin, Anna Skrzypczyk-Ostaszewicz, Iurie Bulat, Marina Maglakelidze, Viera Skarbova, Claudia Andreu-Vieyra, Srikumar Sahasranaman

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase I
PubMed Full text at PMC Publisher
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 NCT03994211 (A Phase 1, Open-label, Parallel-group, Fixed-sequence Study to Investigate the Effect of the CYP3A Inducer Rifampin and the CYP3A Inhibitor Itraconazole on the Pharmacokinetics of Pamiparib), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
0.5field-weighted citation impact, top 32% 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.

NCT03994211 phase1completednot on this map

A Phase 1, Open-label, Parallel-group, Fixed-sequence Study to Investigate the Effect of the CYP3A Inducer Rifampin and the CYP3A Inhibitor Itraconazole on the Pharmacokinetics of Pamiparib (BGB-290) in Cancer Patients

TypeinterventionalSponsorBeiGeneRan2019 to 2021Enrolled25ConditionsSolid TumorArmspamiparib 60 mg, pamiparib 20 mg, itraconazole, rifampin, pamiparib
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 7 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Review
  4. Guidance on the management of adverse reactions induced by poly(ADP-ribose) polymerase inhibitors.Zhejiang da xue xue bao. Yi xue ban = Journal of Zhejiang University. Medical sciences · 2022
    Article
  5. Article
  6. 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

8 authors at 2 institutions in 2 countries.

Song MuBeiGene USA, Inc., 2955 Campus Drive, San Mateo, CA, 94403, USA.
Chester LinBeiGene USA, Inc., 2955 Campus Drive, San Mateo, CA, 94403, USA.
Anna Skrzypczyk-OstaszewiczSzpital LuxMed, Warszawa, Poland.
Iurie BulatARENSIA Oncology Unit, Institute of Oncology of Moldova, Chisinau, Moldova.
Marina MaglakelidzeLLC ARENSIA Exploratory Medicine SRL, Research Institute of Clinical Medicine, Tbilisi, Georgia.
Viera SkarbovaSummit Clinical Research, Bratislava, Slovakia.
Claudia Andreu-VieyraBeiGene USA, Inc., 2955 Campus Drive, San Mateo, CA, 94403, USA.
Srikumar SahasranamanBeiGene USA, Inc., 2955 Campus Drive, San Mateo, CA, 94403, USA. sri.sahasranaman@beigene.com.ORCID 0000-0002-0762-2967
BeiGene (China) · CNInstitutul Oncologic din Republica Moldova · MD

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposePamiparib is an investigational, selective, oral poly(ADP-ribose) polymerase 1/2 (PARP1/2) inhibitor that has demonstrated PARP-DNA complex trapping and CNS penetration in preclinical models, as well as preliminary anti-tumor activity in early-phase clinical studies. We investigated whether the single-dose pharmacokinetic (PK) profile of pamiparib is altered by coadministration of a strong CYP3A inducer (rifampin) or a strong CYP3A inhibitor (itraconazole) in patients with solid tumors.

methodsIn this open-label, phase 1 study, adults with advanced solid tumors received either oral pamiparib 60 mg (days 1 and 10) and once-daily oral rifampin 600 mg (days 3-11) or oral pamiparib 20 mg (days 1 and 7) and once-daily oral itraconazole 200 mg (days 3-8). Primary endpoints included pamiparib maximum observed concentration (C

resultsRifampin coadministration did not affect pamiparib C

conclusionsPamiparib plasma exposure was reduced 38-43% with rifampin coadministration but was unaffected by itraconazole coadministration. Pamiparib dose modifications are not considered necessary when coadministered with CYP3A inhibitors. Clinical safety and efficacy data will be used with these results to recommend dose modifications when pamiparib is coadministered with CYP3A inducers.

Indexed as

AdultAgedArea Under CurveCytochrome P-450 CYP3ACytochrome P-450 CYP3A InducersCytochrome P-450 CYP3A InhibitorsDrug InteractionsFemaleFluorenesHumansItraconazoleMaleMiddle AgedNeoplasmsPoly(ADP-ribose) Polymerase InhibitorsRifampinCytochrome P-450 CYP3ACytochrome P-450 CYP3A InducersCytochrome P-450 CYP3A InhibitorsFluorenesItraconazolepamiparibPoly(ADP-ribose) Polymerase InhibitorsRifampinAnticancer agentsAnticancer drugsClinical pharmacokineticsCYP3APhase I, II and III trialsSolid tumors

Identifiers

PMID33772633
PMCPMC8149352
OpenAlexW3150665659

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.