Evidence map›Paper›PMID 39088774›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2024

Devimistat (CPI-613) With Modified Fluorouarcil, Oxaliplatin, Irinotecan, and Leucovorin (FFX) Versus FFX for Patients With Metastatic Adenocarcinoma of the Pancreas: The Phase III AVENGER 500 Study.

Philip A Philip, Vaibhav Sahai, Nathan Bahary, Amit Mahipal, Anup Kasi, Caio Max S Rocha Lima, Angela T Alistar, Paul E Oberstein, Talia Golan, Jean-Philippe Metges and 11 more

Registry-linked trialAbstract readClinical Trial, Phase IIIRandomized Controlled TrialMulticenter Study
PubMed Publisher
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03504423 (A Phase III Multicenter Open-label Randomized Trial to Evaluate Efficacy and Safety of Folfirinox), which is not on this map. Cited by 35 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
35citing 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.

NCT03504423 phase3completednot on this map

A Phase III Multicenter Open-label Randomized Trial to Evaluate Efficacy and Safety of Folfirinox (FFX) Versus Combination of CPI-613 With Modified Folfirinox (mFFX) in Patients With Metastatic Adenocarcinoma of the Pancreas

TypeinterventionalSponsorCornerstone PharmaceuticalsRan2018 to 2022Enrolled528ConditionsPancreatic Cancer MetastaticArmsCPI 613, mFolfirinox, Folfirinox
3 · Its place in the literature

Who cites it

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

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

21 authors.

Philip A PhilipDepartment of Oncology and Department of Pharmacology, Henry Ford Cancer Institute, Wayne State University School of Medicine, Detroit, MI.ORCID 0000-0002-6513-3491
Vaibhav SahaiUniversity of Michigan Rogel Cancer Center, Ann Arbor, MI.ORCID 0000-0003-1892-1548
Nathan BaharyAllegheny Health Network Cancer Institute, Pittsburgh, PA.ORCID 0000-0001-7317-9118
Amit MahipalUniversity Hospitals Seidman Cancer Center, Case Western Reserve University, Cleveland, OH.ORCID 0000-0002-1111-8333
Anup KasiDivision of Medical Oncology, University of Kansas Medical Center, Kansas City, KS.ORCID 0000-0002-4305-5701
Caio Max S Rocha LimaDivision of Hematology and Oncology, Atrium Wake Forest Baptist Medical Center, Winston-Salem, NC.
Angela T AlistarAtlantic Health System, Morristown, NJ.ORCID 0009-0009-0473-7513
Paul E ObersteinPerlmutter Cancer Center, NYU Langone Health, New York, NY.ORCID 0000-0001-5918-6004
Talia GolanInstitute of Oncology, Sheba Medical Center, Faculty of Medicine Tel Avi University, Ramat Gan, Israel.ORCID 0000-0001-5939-7012
Jean-Philippe MetgesInstitut de Cancérologie et d'Hématologie, ARPEGO Network CHU Morvan, Brest, France.ORCID 0000-0003-0728-0861
Jill LacyDepartment of Medical Oncology, Yale University School of Medicine, New Haven, CT.ORCID 0000-0002-2297-8435
Christos FountzilasDepartment of Medicine, Roswell Park Comprehensive Cancer Center, Buffalo, NY.ORCID 0000-0003-3837-5644
Charles D LopezOregon Health and Science University, Portland, OR.
Michel DucreuxGustave Roussy, University Paris Saclay, Inserm, U1279, Villejuif, France.ORCID 0000-0001-8649-7449
Pascal HammelDepartment of Digestive and Medical Oncology, University Paris-Saclay, Paul Brousse Hospital (AP-HP), Villejuif, France.
Mohamed SalemDepartment of Medical Oncology, Levine Cancer Institute, Atrium Health, Charlotte, NC.ORCID 0000-0002-3661-6785
David BajorUniversity Hospitals Seidman Cancer Center, Case Western Reserve University, Cleveland, OH.
Al B BensonDivision of Hematology & Oncology, Robert H. Lurie Comprehensive Cancer Center, Feinberg School of Medicine, Northwestern University, Chicago, IL.ORCID 0000-0001-5485-7227
Sanjeev LutherCornerstone Pharmaceuticals, Newark, NJ.
Timothy PardeeDivision of Hematology and Oncology, Atrium Wake Forest Baptist Medical Center, Winston-Salem, NC.
Eric Van CutsemUniversity Hospitals Gasthuisberg Leuven and KU Leuven, Leuven, Belgium.ORCID 0000-0002-6372-1230

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeMetastatic pancreatic adenocarcinoma (mPC) remains a difficult-to-treat disease. Fluorouarcil, oxaliplatin, irinotecan, and leucovorin (FFX) is a standard first-line therapy for mPC for patients with a favorable performance status and good organ function. In a phase I study, devimistat (CPI-613) in combination with modified FFX (mFFX) was deemed safe and exhibited promising efficacy in mPC.

methodsThe AVENGER 500 trial (ClinicalTrials.gov identifier: NCT03504423) is a global, randomized phase III trial conducted at 74 sites across six countries to investigate the efficacy and safety of devimistat in combination with mFFX (experimental arm) compared with standard-dose FFX (control arm) in treatment-naïve patients with mPC. Treatment, administered in once-every-2-weeks cycles until disease progression or intolerable toxicity, included intravenous devimistat at 500 mg/m

resultsFive hundred and twenty-eight patients were randomly assigned (266 in the experimental arm and 262 in the control arm). The median OS was 11.10 months for devimistat plus mFFX versus 11.73 months for FFX (hazard ratio [HR], 0.95 [95% CI, 0.77 to 1.18];

conclusionDevimistat in combination with mFFX did not improve long- and short-term mPC patient outcomes compared with standard FFX. There were no new toxicity signals with the addition of devimistat.

Indexed as

AdenocarcinomaAntineoplastic Combined Chemotherapy ProtocolsIrinotecanLeucovorinOxaliplatinPancreatic NeoplasmsAdultAgedFemaleFluorouracilGemcitabineHumansMaleMiddle AgedProgression-Free SurvivalFluorouracilGemcitabineIrinotecanLeucovorinOxaliplatin

Identifiers

PMID39088774

What Socratic holds

Textmetadata
Read underepoch 390

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.