Evidence map›Paper›PMID 38878209›Full record

ArticleCancer chemotherapy and pharmacology2024

Evaluation of the effect of modafinil on the pharmacokinetics of encorafenib and binimetinib in patients with BRAF V600-mutant advanced solid tumors.

Joseph Piscitelli, Micaela B Reddy, Lance Wollenberg, Laurence Del Frari, Jason Gong, Kyle Matschke, Jason H Williams

Registry-linked trialAbstract readClinical Trial, Phase I
In one paragraph

Article in Cancer chemotherapy and pharmacology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03864042 (An Open-label Phase 1 Study to Evaluate Drug-Drug Interactions of Agents Co-Administered With Encorafenib and Binimetinib in Patients With BRAF V600-mutant Unresectable or Metastatic Melanoma or Other Advanced Solid Tumors), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
–field-weighted citation impact
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.

NCT03864042 phase1completednot on this map

An Open-label Phase 1 Study to Evaluate Drug-Drug Interactions of Agents Co-Administered With Encorafenib and Binimetinib in Patients With BRAF V600-mutant Unresectable or Metastatic Melanoma or Other Advanced Solid Tumors

TypeinterventionalSponsorPfizerRan2018 to 2023Enrolled56ConditionsAdvanced Solid Tumors, Metastatic MelanomaArmslosartan, dextromethorphan, caffeine, omeprazole, midazolam
3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

  1. Review
  2. Article
  3. Article
  4. Article
  5. 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

7 authors.

Joseph PiscitelliPfizer Inc, 10555 Science Center Dr, San Diego, CA, 92121, USA. joseph.piscitelli@pfizer.com.
Micaela B ReddyPfizer Inc, Boulder, CO, USA.
Lance WollenbergPfizer Inc, Boulder, CO, USA.
Laurence Del FrariPierre Fabre Medicament, Toulouse, France.
Jason GongPfizer Inc, New York, NY, USA.
Kyle MatschkePfizer Inc, Collegeville, PA, USA.
Jason H WilliamsPfizer Inc, 10555 Science Center Dr, San Diego, CA, 92121, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundA clinical drug-drug interaction (DDI) study was designed to evaluate the effect of multiple doses of modafinil, a moderate CYP3A4 inducer at a 400 mg QD dose, on the multiple oral dose pharmacokinetics (PK) of encorafenib and its metabolite, LHY746 and binimetinib and its metabolite, AR00426032.

methodsThis study was conducted in patients with BRAF V600-mutant advanced solid tumors. Treatment of 400 mg QD modafinil was given on Day 15 through Day 21. Encorafenib 450 mg QD and binimetinib 45 mg BID were administered starting on Day 1. PK sampling was conducted from 0 to 8 h on Day 14 and Day 21. Exposure parameters were calculated for each patient by noncompartmental analysis and geometric least-squares mean ratio. Corresponding 90% confidence intervals were calculated to estimate the magnitude of effects.

resultsAmong 11 PK evaluable patients, encorafenib C

conclusionThe results from this clinical study indicate modafinil 400 mg QD had a weak effect on encorafenib PK. Based on these results, encorafenib can be coadministered with a moderate CYP3A4 inducer without dosing adjustment. CLINICAL

trial registrationClinicalTrials.gov NCT03864042, registered 6 March 2019.

Indexed as

BenzimidazolesCarbamatesDrug InteractionsModafinilNeoplasmsProto-Oncogene Proteins B-rafSulfonamidesAdultAgedAntineoplastic Combined Chemotherapy ProtocolsArea Under CurveCytochrome P-450 CYP3A InducersFemaleHumansMaleMiddle AgedBenzimidazolesbinimetinibBRAF protein, humanCarbamatesCytochrome P-450 CYP3A InducersencorafenibModafinilProto-Oncogene Proteins B-rafSulfonamidesDrug-drug interactionModafinilOncology

Identifiers

PMID38878209
PMCPMC11420244

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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.