Evidence map›Paper›PMID 41264161›Full record

Trial reportInternational journal of clinical oncology2026

Pooled safety analysis of pimitespib for the treatment of patients with advanced gastrointestinal stromal tumors.

Yukinori Kurokawa, Noboru Yamamoto, Yuko Hirano, Naoki Arimura, Chunlan Sun, Toshihiko Doi

Registry-linked trialAbstract readClinical Trial, Phase IClinical Trial, Phase IIClinical Trial, Phase III
In one paragraph

Trial report in International journal of clinical oncology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02965885 (A Phase IA/IB Study Evaluating TAS-116 in Patients With Advanced Solid Tumors), which is not on this map. Not yet cited in PubMed.

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

NCT02965885 phase1completednot on this map

A Phase IA/IB Study Evaluating TAS-116 in Patients With Advanced Solid Tumors

TypeinterventionalSponsorTaiho Oncology, Inc.Ran2017 to 2019Enrolled31ConditionsAdvanced Solid TumorsArmsTAS-116
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

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.

Yukinori KurokawaDepartment of Gastroenterological Surgery, The University of Osaka Graduate School of Medicine, Osaka, Japan.ORCID http://orcid.org/0000-0002-2883-0132
Noboru YamamotoDepartment of Experimental Therapeutics, National Cancer Center Hospital, Tokyo, Japan.ORCID http://orcid.org/0000-0002-0787-2851
Yuko HiranoTaiho Pharmaceutical Co., Ltd., Tokyo, Japan.
Naoki ArimuraTaiho Pharmaceutical Co., Ltd., Tokyo, Japan.
Chunlan SunTaiho Pharmaceutical Co., Ltd., Tokyo, Japan.
Toshihiko DoiDepartment of Experimental Therapeutics, National Cancer Center Hospital East, 6-5-1 Kashiwanoha, Kashiwa-Shi, Chiba, 277-8577, Japan. tdoi@east.ncc.go.jp.ORCID http://orcid.org/0000-0003-2042-6829

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPimitespib is a first-in-class heat shock protein 90 (HSP90) inhibitor, approved in Japan for the treatment of advanced gastrointestinal stromal tumors (GIST). This study aimed to characterize the incidence and time course of adverse drug reactions (ADRs) associated with pimitespib.

methodsThis was a post hoc analysis of pooled safety data from a phase 1 (NCT02965885), phase 2 (jRCT2080223127), and phase 3 (jRCT2080224033) study of pimitespib in patients with advanced GIST. The present analysis included Japanese study participants who received oral pimitespib 160 mg once daily for 5 days followed by 2 days' rest per week in 21-day cycles. Pooled safety outcomes included the incidence and severity of ADRs; ADRs leading to treatment modifications or discontinuation; and the time to ADR onset and resolution.

resultsIn total, 119 patients were included. ADRs were reported in 114 patients (95.8%); gastrointestinal ADRs were most common (99 patients [83.2%]; most often diarrhea [75.6%]) and ocular ADRs occurred in 26 patients (21.8%; most often night blindness [11.8%]). Median time to first onset of any gastrointestinal ADR was 3.0 days; the outcome of gastrointestinal ADRs was recovered/recovering in 61 patients (61.6%), with a median time to resolution of 44.0 days. Median time to first onset of any ocular ADR was 19.0 days; ocular ADRs were recovered/recovering in 20 patients (76.9%), with a median time to resolution of 21.0 days.

conclusionsThis analysis suggests that most ADRs associated with pimitespib are manageable and reversible, thus supporting its use in patients with advanced GIST.

Indexed as

Aniline CompoundsAntineoplastic AgentsGastrointestinal NeoplasmsGastrointestinal Stromal TumorsAdultAgedAged, 80 and overFemaleHumansJapanMaleMiddle AgedAniline CompoundsAntineoplastic AgentsGastrointestinal stromal tumorsGastrointestinal toxicityHeat shock protein 90 (HSP90) inhibitorOcular toxicityPimitespibSafety

Identifiers

PMID41264161
PMCPMC12769986

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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.