Evidence map›Paper›PMID 28965185›Full record

ArticleInvestigational new drugs2018

Safety, pharmacokinetic, and pharmacodynamics of erdafitinib, a pan-fibroblast growth factor receptor (FGFR) tyrosine kinase inhibitor, in patients with advanced or refractory solid tumors.

Tomohiro Nishina, Shunji Takahashi, Ryota Iwasawa, Hidehisa Noguchi, Masayuki Aoki, Toshihiko Doi

Registry-linked trialAbstract readClinical Trial, Phase IMulticenter Study
PubMed Publisher
In one paragraph

Article in Investigational new drugs, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01962532 (A Phase 1 Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of JNJ-42756493, a Pan-Fibroblast Growth Factor Receptor), which is not on this map. Cited by 44 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
44citing papers in PubMed, 2 pooled it
3.8field-weighted citation impact, top 6% 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.

NCT01962532 phase1completednot on this map

A Phase 1 Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of JNJ-42756493, a Pan-Fibroblast Growth Factor Receptor (FGFR) Tyrosine Kinase Inhibitor, in Subjects With Advanced or Refractory Solid Tumors or Lymphoma

TypeinterventionalSponsorJanssen Research & Development, LLCRan2013 to 2016Enrolled19ConditionsNeoplasms, Lymphoma, Adenocarcinoma, Esophagogastric JunctionArmsPart 1: JNJ-42756493, Part 2: JNJ-42756493
3 · Its place in the literature

Who cites it

44 citing papers in PubMed, 2 syntheses or guidelines pooled it, 80 citations in OpenAlex.

  1. Pooled it
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  10. Potential alternative drug treatment for bone giant cell tumor.Frontiers in cell and developmental biology · 2023
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  20. All Good Things Must End: Termination of Receptor Tyrosine Kinase Signal.International journal of molecular sciences · 2021
    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

6 authors at 3 institutions in 1 country.

Tomohiro NishinaNational Hospital Organization Shikoku Cancer Center, Matsuyama, Japan.
Shunji TakahashiThe Cancer Institute Hospital of Japanese Foundation of Cancer Research, Tokyo, Japan.
Ryota IwasawaJanssen Pharmaceutical K.K., Tokyo, Japan.
Hidehisa NoguchiJanssen Pharmaceutical K.K., Tokyo, Japan.
Masayuki AokiJanssen Pharmaceutical K.K., Tokyo, Japan.
Toshihiko DoiNational Cancer Center Hospital East, Kashiwa, Japan. tdoi@east.ncc.go.jp.
National Cancer Center Hospital East · JPShikoku Cancer Center · JPThe Cancer Institute Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Introduction This phase 1, open-label, multicenter, single-arm, dose-escalation study aimed to evaluate safety, pharmacokinetics (PK), and pharmacodynamics of erdafitinib (JNJ-42756493), an oral selective pan-fibroblast growth factor receptor (FGFR) tyrosine kinase inhibitor, and to determine the recommended phase 2 dose in Japanese patients with advanced or refractory solid tumors. Methods Three to 6 patients were enrolled into sequentially escalating dose cohorts (erdafitinib 2, 4, or 6 mg) with a daily dosing schedule of 21-day cycles or a 7 days-on/7 days-off intermittent schedule (erdafitinib 10 mg or 12 mg) of 28-day cycles. Results Nineteen patients received escalating doses of erdafitinib with a daily or intermittent schedule. The most common treatment-emergent adverse events (TEAEs) were hyperphosphatemia (73.7%), nausea (36.8%), stomatitis (26.3%), dysgeusia (26.3%) and dry mouth (21.1%). The maximum tolerated dose was not reached in this study. No Grade 3 or higher TEAEs, or serious TEAEs were noted and no clinically significant changes in vital signs, laboratory parameters, and electrocardiogram readings were observed. However, one case of dose-limiting toxicity in the 12 mg intermittent dosing group was observed: Grade 2 detachment of retinal pigment epithelium (bilateral) with treatment discontinuation. The maximum plasma concentrations of erdafitinib exhibited a dose-dependent increase. The median t

trial registrationNCT01962532.

Indexed as

AgedArea Under CurveFemaleHumansMaleMiddle AgedNeoplasmsNeoplasm StagingProtein Kinase InhibitorsPyrazolesQuinoxalinesReceptors, Fibroblast Growth FactorTreatment OutcomeerdafitinibProtein Kinase InhibitorsPyrazolesQuinoxalinesReceptors, Fibroblast Growth FactorErdafitinibPharmacodynamicsPharmacokineticsPhase 1Safety

Identifiers

PMID28965185
OpenAlexW2760207881

What OpenQuestion holds

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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.