Evidence map›Paper›PMID 30724423›Full record

ArticleCancer science2019

Phase I dose-escalation study of capmatinib (INC280) in Japanese patients with advanced solid tumors.

Taito Esaki, Fumihiko Hirai, Akitaka Makiyama, Takashi Seto, Hideaki Bando, Yoichi Naito, Kiyotaka Yoh, Kae Ishihara, Tomoyuki Kakizume, Kazuto Natsume and 2 more

Abstract readClinical Trial, Phase IMulticenter Study
In one paragraph

Article in Cancer science, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers.

0numbers the graph read from it
0cells of the map it votes in
22citing 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

22 citing papers in PubMed.

  1. Trial
  2. Review
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  5. AberrantCells · 2024
    Review
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  8. Review
  9. Article
  10. Review
  11. Article
  12. Article
  13. Article
  14. Review
  15. Current and future treatment options forTherapeutic advances in medical oncology · 2021
    Review
  16. Article
  17. Review
  18. Article
  19. Article
  20. 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

12 authors.

Taito EsakiNational Hospital Organization Kyushu Cancer Center, Fukuoka, Japan.ORCID https://orcid.org/0000-0002-9169-8453
Fumihiko HiraiNational Hospital Organization Kyushu Cancer Center, Fukuoka, Japan.
Akitaka MakiyamaNational Hospital Organization Kyushu Cancer Center, Fukuoka, Japan.
Takashi SetoNational Hospital Organization Kyushu Cancer Center, Fukuoka, Japan.ORCID https://orcid.org/0000-0002-2960-4364
Hideaki BandoNational Cancer Center Hospital East, Kashiwa, Japan.ORCID https://orcid.org/0000-0001-5041-2765
Yoichi NaitoNational Cancer Center Hospital East, Kashiwa, Japan.ORCID https://orcid.org/0000-0002-8490-9064
Kiyotaka YohNational Cancer Center Hospital East, Kashiwa, Japan.
Kae IshiharaNovartis Pharma K.K., Tokyo, Japan.
Tomoyuki KakizumeNovartis Pharma K.K., Tokyo, Japan.
Kazuto NatsumeNovartis Pharma K.K., Tokyo, Japan.
Andrea MyersNovartis Institute for Biomedical Research, Shanghai, China.
Toshihiko DoiNational Cancer Center Hospital East, Kashiwa, Japan.

Funding

Novartis Pharmaceuticals Corporation
6 · The paper itself

Abstract

Capmatinib is a highly specific, potent and selective MET inhibitor. This was an open-label, multicenter, dose-escalation, phase I study conducted in Japanese patients with advanced solid tumors (not selected based on their MET status). The primary objective was to determine the maximum tolerated dose (MTD) and/or highest studied dose being safe. Secondary objectives included safety, pharmacokinetics and preliminary antitumor activity. Dose escalation was guided by a Bayesian Logistic Regression Model dependent on dose-limiting toxicities (DLT) in cycle 1. Of 44 adult Japanese patients with confirmed advanced solid tumors enrolled, 29 received capmatinib capsules (doses ranging from 100 mg once daily [q.d.] to 600 mg twice daily [b.i.d.]) and 15 received tablets (200 mg b.i.d. and 400 mg b.i.d.). DLT occurred in two patients: grade 2 suicidal ideation (600 mg b.i.d. capsule) and grade 3 depression (400 mg b.i.d. tablet). MTD was not reached. The highest studied dose determined to be safe as tablet was 400 mg b.i.d., whereas it is not yet determined for capsules. Most common adverse events suspected to be drug-related were increased blood creatinine, nausea, decreased appetite, vomiting and diarrhea. Following repeated daily dosing up to day 15 by q.d. or b.i.d. regimen using capsules, median time to reach maximum plasma drug concentration (T

Indexed as

AgedAged, 80 and overAntineoplastic AgentsBenzamidesBiomarkersFemaleHumansImidazolesMaleMiddle AgedNeoplasm MetastasisNeoplasmsNeoplasm StagingProtein Kinase InhibitorsSurvival AnalysisTreatment OutcomeAntineoplastic AgentsBenzamidesBiomarkerscapmatinibImidazolesProtein Kinase InhibitorsTriazinescapmatinibINC280JapanMETphase 1

Identifiers

PMID30724423
PMCPMC6447844

What OpenQuestion holds

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Registered trials

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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.