Evidence map›Paper›PMID 39652198›Full record

Trial reportJournal of gastrointestinal cancer2024

A Phase 2 study of Savolitinib in Patients with MET Amplified Metastatic Colorectal Cancer.

Jingquan Jia, Ashley Moyer, Melissa Lowe, Emily Bolch, Jeremy Kortmansky, May Cho, Heinz-Josef Lenz, Aparna Kalyan, Donna Niedzwiecki, John H Strickler

Registry-linked trialAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Journal of gastrointestinal cancer, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03592641 (A Phase 2 Study of Savolitinib in Subjects With MET Amplified Metastatic Colorectal Cancer), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing 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.

NCT03592641 phase2terminatednot on this map

A Phase 2 Study of Savolitinib in Subjects With MET Amplified Metastatic Colorectal Cancer

TypeinterventionalSponsorNational Cancer Institute (NCI)Ran2019 to 2021Enrolled5ConditionsColorectal Carcinoma, Metastatic Colon Adenocarcinoma, Metastatic Rectal Adenocarcinoma, Stage III Colon Cancer AJCC v8ArmsSavolitinib
3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Review
  2. Article
  3. Article
  4. 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

10 authors.

Jingquan JiaDivision of Oncology, Department of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
Ashley MoyerDepartment of Pathology, Duke University, Durham, NC, USA.
Melissa LoweDuke Cancer Institute, Duke University, Durham, NC, USA.
Emily BolchDuke Cancer Institute, Duke University, Durham, NC, USA.
Jeremy KortmanskySection of Medical Oncology, Yale Cancer Center, New Haven, CT, USA.
May ChoDivision of Hematology/Oncology, Department of Medicine, University of California, Irvine, Irvine, CA, USA.
Heinz-Josef LenzNorris Comprehensive Cancer Center, University of Southern California, Los Angeles, CA, USA.
Aparna KalyanFeinberg School of Medicine, Northwestern University, Chicago, IL, USA.
Donna NiedzwieckiDuke Cancer Institute, Duke University, Durham, NC, USA.
John H StricklerDuke Cancer Institute, Duke University, Durham, NC, USA. john.strickler@duke.edu.ORCID http://orcid.org/0000-0001-7579-1175

Funding

USC/NORRIS COMPREHENSIVE CANCER CENTER (CORE) SUPPORTP30CA014089 · NCI · UNIVERSITY OF SOUTHERN CALIFORNIA · PI MYLES G COCKBURN · 1985 to 2026
$181.4M
Phase I Molecular and Clinical Pharmacodynamic Trials ETCTNUM1CA186717 · NCI · BECKMAN RESEARCH INSTITUTE/CITY OF HOPE · PI A. Dimitrios Colevas, Alexey V. Danilov · 2014 to 2026
$19.8M
Duke-UNC-Wash U Partnership for Early Phase Clinical Trials in CancerUM1CA186704 · NCI · DUKE UNIVERSITY · PI ABBRUZZESE, JAMES L., DEES, ELIZABETH CLAIRE · 2014 to 2019
$6.8M
NCI NIH HHS P30 CA014089NCI NIH HHS UM1 CA186704NCI NIH HHS UM1 CA186717NIH HHS 1UM1-CA186704-01
6 · The paper itself

Abstract

purposeMET amplification (amp) is a driver of acquired resistance to epidermal growth factor receptor (EGFR) antibodies in patients with RAS wild-type (WT) metastatic colorectal cancer (mCRC). Savolitinib is an oral small molecule tyrosine kinase inhibitor that has demonstrated anti-tumor activity in MET-driven advanced solid tumors. We report the results of a phase 2 study of savolitinib in patients with mCRC with MET amp detected by circulating cell free (cf)DNA.

methodsPatients with chemotherapy refractory mCRC and MET amp detected by cfDNA were treated with savolitinib until unacceptable toxicity or disease progression. The primary endpoint was objective response rate. Secondary endpoints were clinical activity and safety.

resultsFive patients were enrolled and treated. Best overall response was stable disease (SD) in two patients, progressive disease (PD) in two patients, and one patient unevaluable for response. The majority of treatment-emergent adverse events (TEAEs) were grade 1 or 2. The most common TEAEs included fatigue (n = 3) and nausea (n = 3). There were no grade 4 or 5 TEAEs.

conclusionSavolitinib was well tolerated; however, in this small group of biomarker-selected patients, we observed no evidence of anti-tumor activity.

trial registrationClinicaltrials.gov Identifier: NCT03592641. Registered on July 17, 2018.

Indexed as

Colorectal NeoplasmsProto-Oncogene Proteins c-metAgedFemaleGene AmplificationHumansMaleMiddle AgedProtein Kinase InhibitorsTriazinesMET protein, humanProtein Kinase InhibitorsProto-Oncogene Proteins c-metTriazinesEGFR antibody resistanceMET amplificationMetastatic colon cancerSavolitinib

Identifiers

PMID39652198
PMCPMC11993306

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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.