Evidence map›Paper›PMID 40515475›Full record

Trial reportThe oncologist2025

A phase II, multicenter, single-arm study of pemigatinib in patients with metastatic or unresectable colorectal cancer harboring FGFR alterations.

Margaret C Wheless, Tyler J Zemla, Joleen M Hubbard, John H Strickler, Olumide B Gbolahan, Luke Wilson, Blake Waechter, Fang-Shu Ou, Andrew B Nixon, Tanios S Bekaii-Saab and 1 more

Registry-linked trialAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in The oncologist, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04096417 (A Phase II, Multicenter, Single-Arm Study of Pemigatinib in Patients With Metastatic or Unresectable Colorectal Cancer Harboring FGFR Alterations), which is not on this map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
–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.

NCT04096417 phase2unknown statusnot on this map

A Phase II, Multicenter, Single-Arm Study of Pemigatinib in Patients With Metastatic or Unresectable Colorectal Cancer Harboring FGFR Alterations

TypeinterventionalSponsorAcademic and Community Cancer Research UnitedRan2020 to 2025Enrolled14ConditionsFGFR1 Gene Amplification, FGFR1 Gene Mutation, FGFR1 Gene Translocation, FGFR2 Gene AmplificationArmsPemigatinib, Quality-of-Life Assessment
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 1 synthesis or guideline pooled it.

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

11 authors.

Margaret C WhelessDepartment of Internal Medicine, Division of Hematology/Oncology, Vanderbilt University Medical Center, Nashville, TN, United States.
Tyler J ZemlaDepartment of Quantitative Health Sciences, Mayo Clinic, Rochester, MN, United States.
Joleen M HubbardAllina Health Cancer Institute, Rochester, MN, United States.
John H StricklerDepartment of Medicine, Division of Medical Oncology, Duke University Medical Center Durham, NC, United States.
Olumide B GbolahanDepartment of Hematology and Medical Oncology, Emory University School of Medicine, Atlanta, GA, United States.
Luke WilsonDepartment of Quantitative Health Sciences, Mayo Clinic, Rochester, MN, United States.
Blake WaechterDepartment of Quantitative Health Sciences, Mayo Clinic, Rochester, MN, United States.
Fang-Shu OuDepartment of Quantitative Health Sciences, Mayo Clinic, Rochester, MN, United States.ORCID 0000-0003-1267-8735
Andrew B NixonDepartment of Medicine, Division of Medical Oncology, Duke University Medical Center Durham, NC, United States.
Tanios S Bekaii-SaabDivision of Medical Oncology and Hematology, Mayo Clinic, Scottsdale, AZ, United States.
Kristen K CiomborDepartment of Internal Medicine, Division of Hematology/Oncology, Vanderbilt University Medical Center, Nashville, TN, United States.

Funding

VOLT (Vanderbilt Oncology Training Program)T32CA217834 · NCI · VANDERBILT UNIVERSITY MEDICAL CENTER · PI Debra L. Friedman, Douglas B Johnson · 2018 to 2026
$2.7M
NCI NIH HHS T32 CA217834NIH HHS 2T32CA217834-07
6 · The paper itself

Abstract

backgroundFGFR alterations are known to be driver alterations in several tumor types. We aimed to assess the efficacy of pemigatinib, an oral FGFR1-3 inhibitor, in patients with metastatic or unresectable colorectal cancer whose tumors harbored FGF/FGFR alterations. PATIENTS AND

methodsThe ACCRU-GI-1701 is a single-arm phase II trial which enrolled patients with previously treated FGF/FGFR-altered metastatic colorectal cancer to receive oral pemigatinib daily in 21-day cycles. The primary endpoint is objective response. Secondary endpoints include clinical benefit, progression-free survival, overall survival, quality of life, and adverse events (AEs). This trial was registered with ClinicalTrials.gov (NCT04096417).

resultsOf the 14 patients included in the interim analysis, the objective response rate as well as clinical benefit rate were 0%. Given these results, the trial closed to enrollment after stage one due to futility. A total of 42.9% of patients had at least one grade 3 or higher AE, the most common being anemia and fatigue.

conclusionPemigatinib monotherapy did not lead to objective responses in patients with chemorefractory metastatic colorectal cancer harboring FGF/FGFR alterations, although it was overall relatively well tolerated with no new safety signals. Notably, 93% (n = 13) of patients had only FGF/FGFR mutations and amplifications; one patient had an FGFR3-WHSC1 fusion at a low cfDNA percentage (0.02%).

Indexed as

Colorectal NeoplasmsMorpholinesPyrimidinesPyrrolesReceptors, Fibroblast Growth FactorAdultAgedAged, 80 and overFemaleHumansMaleMiddle AgedNeoplasm MetastasisMorpholinespemigatinibPyrimidinesPyrrolesReceptors, Fibroblast Growth Factorcolorectal cancerFGFFGFRpemigatinib

Identifiers

PMID40515475
PMCPMC12166116

What Socratic 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 Socratic graph.