Evidence map›Paper›PMID 40100120›Full record

ArticleClinical cancer research : an official journal of the American Association for Cancer Research2025

Phase I Study of the Mutant IDH1 Inhibitor Ivosidenib: Long-term Safety and Clinical Activity in Patients with Conventional Chondrosarcoma.

William D Tap, Gregory M Cote, Howard Burris, Lia Gore, Anthony Elias, Murali Beeram, Anthony P Conley, Diego A Gianolio, Zhe Qu, Susan Pandya and 1 more

2 registry-linked trialsAbstract readClinical Trial, Phase IMulticenter Study
In one paragraph

Article in Clinical cancer research : an official journal of the American Association for Cancer Research, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing 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.

NCT02073994 phase1completednot on this map

A Phase 1, Multicenter, Open-Label, Dose-Escalation and Expansion, Safety, Pharmacokinetic, Pharmacodynamic, and Clinical Activity Study of Orally Administered AG-120 in Subjects With Advanced Solid Tumors, Including Glioma, With an IDH1 Mutation

TypeinterventionalSponsorInstitut de Recherches Internationales ServierRan2014 to 2024Enrolled174ConditionsCholangiocarcinoma, Chondrosarcoma, Glioma, Other Advanced Solid TumorsArmsAG-120
NCT06127407 phase3recruitingnot on this map

A Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled Study of Ivosidenib in Participants ≥18 Years of Age With Locally Advanced or Metastatic Conventional Chondrosarcoma With an IDH1 Mutation, Untreated or Previously Treated With 1 Systemic Treatment Regimen

TypeinterventionalSponsorServier Bio-Innovation LLCRan2024 to 2030Enrolled136ConditionsLocally Advanced or Metastatic Conventional Chondrosarcoma With an IDH1 Mutation, Untreated or Previously Treated With 1 Systemic Treatment RegimenArmsIvosidenib 500mg, Placebo
3 · Its place in the literature

Who cites it

8 citing papers in PubMed.

  1. Review
  2. Review
  3. Article
  4. Clinical advancement in the management of mutant isocitrate dehydrogenase (EJC supplements : EJC : official journal of EORTC, European Organization for Research and Treatment of Cancer ... [et al.] · 2026
    Article
  5. Article
  6. Article
  7. Review
  8. 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.

William D TapMemorial Sloan Kettering Cancer Center, New York, New York.ORCID 0000-0001-7779-2796
Gregory M CoteMass General Cancer Center, Boston, Massachusetts.ORCID 0000-0003-0181-886X
Howard BurrisSarah Cannon Research Institute, Nashville, Tennessee.ORCID 0000-0002-1501-2931
Lia GoreUniversity of Colorado School of Medicine and University of Colorado Cancer Center, Aurora, Colorado.ORCID 0000-0002-2546-4616
Anthony EliasUniversity of Colorado School of Medicine and University of Colorado Cancer Center, Aurora, Colorado.ORCID 0000-0002-6509-9211
Murali BeeramSTART Center for Cancer Care, San Antonio, Texas.ORCID 0009-0002-6603-3780
Anthony P ConleyMD Anderson Cancer Center, Houston, Texas.ORCID 0000-0002-6232-1163
Diego A GianolioServier Bio-Innovation, Boston, Massachusetts.ORCID 0009-0005-9540-8870
Zhe QuServier Bio-Innovation, Boston, Massachusetts.ORCID 0009-0006-1231-4420
Susan PandyaServier Bio-Innovation, Boston, Massachusetts.ORCID 0009-0006-7669-0652
Jonathan C TrentSylvester Comprehensive Cancer Center, Miami, Florida.ORCID 0000-0001-6169-5238

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI SELWYN M VICKERS · 1985 to 2026
$347.4M
Agios Pharmaceuticals (Agios)NCI NIH HHS P30 CA008748Servier (Servier Laboratories)
6 · The paper itself

Abstract

purposeA phase I study demonstrated that ivosidenib, a mutant isocitrate dehydrogenase 1 (mIDH1) inhibitor, showed manageable toxicity and durable disease control in patients with mIDH1 conventional chondrosarcoma (CS). In this study, we present long-term follow-up data on the safety and clinical activity of ivosidenib in patients with mIDH1 conventional CS from this phase I study. PATIENTS AND

methodsThis phase I, open-label, dose-escalation, and expansion study assessed ivosidenib monotherapy in patients with advanced mIDH1 solid tumors, including CS. An ivosidenib dose of 500 mg/day was identified in the dose-escalation phase and used for the expansion phase. The primary outcome was safety and tolerability. Secondary outcomes included objective response rate and progression-free survival. The database lock date for this analysis was March 18, 2024.

resultsOf 168 patients with advanced mIDH1 solid tumors receiving ivosidenib in this study, 21 patients had CS, of which 13 had conventional histology. Six (46.2%), 4 (30.8%), and 3 (23.1%) patients with conventional CS continued ivosidenib treatment for >1 year, >6 years, and >7 years, respectively. Of the 21 patients with CS, 71.4% and 28.6% had treatment-related and serious adverse events, respectively, but no serious adverse events were considered related to ivosidenib. The objective response rate for patients with conventional CS was 23.1%, and the median duration of response was 53.5 months. The median progression-free survival of patients with conventional CS treated with ivosidenib was 7.4 months.

conclusionsIvosidenib demonstrated long-term disease control and manageable toxicity for some patients with mIDH1 conventional CS and is under further investigation (NCT06127407).

Indexed as

Bone NeoplasmsChondrosarcomaGlycineIsocitrate DehydrogenaseMutationPyridinesAdolescentAdultAgedFemaleFollow-Up StudiesHumansMaleMiddle AgedYoung AdultGlycineIDH1 protein, humanIsocitrate DehydrogenaseivosidenibPyridines

Identifiers

PMID40100120
PMCPMC12130799

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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.