Evidence map›Paper›PMID 37000035›Full record

ArticleCancer medicine2023

FIGHT-102: A phase 1 study of pemigatinib in Japanese patients with advanced malignancies.

Yutaka Fujiwara, Yasutoshi Kuboki, Masayuki Furukawa, Nobumasa Mizuno, Hiroki Hara, Tatsuya Ioka, Makoto Ueno, Yasuo Takahashi, Shunji Takahashi, Shinji Takeuchi and 4 more

Open access · goldAbstract readClinical Trial, Phase I
PubMed Full text at PMC Publisher
In one paragraph

Article in Cancer medicine, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 1 pooled it
2.6field-weighted citation impact, top 10% 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.

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

9 citing papers in PubMed, 1 synthesis or guideline pooled it, 13 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Review
  4. Review
  5. Article
  6. Article
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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

14 authors at 11 institutions in 2 countries.

Yutaka FujiwaraNational Cancer Center Hospital, Tokyo, Japan.
Yasutoshi KubokiNational Cancer Central Hospital East, Chiba, Japan.
Masayuki FurukawaKyushu Cancer Center, Fukuoka, Japan.
Nobumasa MizunoAichi Cancer Center, Nagoya, Japan.
Hiroki HaraSaitama Cancer Center, Saitama, Japan.
Tatsuya IokaDepartment of Oncology Center, Yamaguchi University Hospital, Ube, Japan.
Makoto UenoKanagawa Cancer Center, Yokohama, Japan.
Yasuo TakahashiHokkaido Cancer Center, Sapporo, Japan.
Shunji TakahashiCancer Institute Hospital of JFCR, Tokyo, Japan.
Shinji TakeuchiKanazawa University Hospital, Kanazawa, Japan.
Christine LihouIncyte Corporation, Wilmington, Delaware, USA.
Tao JiIncyte Corporation, Wilmington, Delaware, USA.
Chenwei TianIncyte Corporation, Wilmington, Delaware, USA.
Toshio ShimizuNational Cancer Center Hospital, Tokyo, Japan.
Incyte (United States) · USAichi Cancer Center · JPJapan Cancer Society · JPKanagawa Prefectural Hospital Organization · JPKanazawa University Hospital · JPNational Cancer Center Hospital East · JPNational Hospital Organization Kyushu Cancer Center · JPSaitama Cancer Center · JPThe Cancer Institute Hospital · JPTokyo National Hospital · JPYamaguchi University Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundFIGHT-102 was a phase 1, dose-escalation, dose-expansion study of pemigatinib in Japanese patients with advanced solid tumors. Here, we report safety, tolerability, and preliminary efficacy of pemigatinib from FIGHT-102.

methodsPatients (≥20 years old) self-administered oral pemigatinib 9, 13.5, or 18 mg QD on intermittent dosing (Part 1) or 13.5 mg QD intermittent or continuous dosing (Part 2). A dosing cycle was 21 days (2 weeks on/1 week off or 21 continuous days). Primary endpoint was safety. Secondary endpoints were pharmacokinetics, pharmacodynamics, and preliminary efficacy.

resultsForty-four patients (Part 1, n = 14; Part 2, n = 30) were enrolled; most common tumors, cholangiocarcinoma, n = 8; esophageal, n = 6; 26 patients had confirmed FGF/FGFR alterations (Part 1, n = 3; Part 2, n = 23); 70.5% had ≥3 prior systemic therapies. Maximum tolerated dose was not identified. The recommended phase 2 dosage was determined to be 13.5 mg QD. Most common treatment-emergent adverse events (TEAEs) were hyperphosphatemia (81.8%), dysgeusia (45.5%), stomatitis (43.2%), and alopecia (38.6%); most frequent Grade ≥3 TEAEs were anemia and decreased appetite (9.1% each). In Part 1, no patient achieved partial response (PR) or complete response, and 7 (50.0%) patients had stable disease (SD). In Part 2, 5 (16.7%) patients achieved PR (one each with cholangiocarcinoma, gall bladder cancer, breast cancer, urothelial tract/bladder cancer, and sweat gland carcinoma) and 6 (20%) had SD. Median duration of response was 9.56 months (95% CI: 4.17, 14.95).

conclusionsPemigatinib demonstrated manageable adverse events, consistent pharmacokinetics and pharmacodynamics profiles, and preliminary efficacy in Japanese patients with advanced solid tumors.

Indexed as

MorpholinesNeoplasmsPyrimidinesPyrrolesAdultEast Asian PeopleHumansYoung AdultMorpholinespemigatinibPyrimidinesPyrrolesadvanced solid tumorsFGFRJapanese patientspemigatinibphase 1 clinical trial

Identifiers

PMID37000035
PMCPMC10225205
OpenAlexW4362460401

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LicenceCC BY
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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.