Evidence map›Paper›PMID 30318515›Full record

Trial reportBritish journal of cancer2018

Galunisertib plus gemcitabine vs. gemcitabine for first-line treatment of patients with unresectable pancreatic cancer.

Davide Melisi, Rocio Garcia-Carbonero, Teresa Macarulla, Denis Pezet, Gael Deplanque, Martin Fuchs, Jorg Trojan, Helmut Oettle, Mark Kozloff, Ann Cleverly and 7 more

Open access · hybridAbstract readClinical Trial, Phase IClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in British journal of cancer, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 201 papers.

0numbers the graph read from it
0cells of the map it votes in
201citing papers in PubMed
10.1field-weighted citation impact, top 1% of its field
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

201 citing papers in PubMed, 267 citations in OpenAlex.

  1. Trial
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  6. Niches in cancer: from primary tumors to metastatic disease.Journal of hematology & oncology · 2026
    Review
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  9. SNX3 exacerbates hepatic fibrosis by amplifying TGF-Acta pharmaceutica Sinica. B · 2026
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  15. Aging and cancer: current understandings and future perspectives.Signal transduction and targeted therapy · 2026
    Review
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  18. Review
  19. Article
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141 more citing papers are in PubMed but not listed here.

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

17 authors at 12 institutions in 7 countries.

Davide MelisiUniversity of Verona, Piazzale Ludovico Antonio Scuro, 10, 37134, Verona, Italy. davide.melisi@univr.it.
Rocio Garcia-CarboneroOncology Department, Hospital Universitario 12 de Octubre, Instituto de Investigación Sanitaria Hospital 12 de Octubre (imas12), UCM, CNIO, CIBERONC, Madrid, Spain.
Teresa MacarullaVall d'Hebron University Hospital Institute of Oncology (VHIO), CIBERONC, C/ Natzaret, 115-117, 08035, Barcelona, Spain.
Denis PezetCentre Hospitalier Universitaire, 1 Place Lucie Aubrac, 63003, Clermont-Ferrand, France.
Gael DeplanqueHôpital Riviera-Chablais, Avenue de la Prairie 3, 1800, Vevey, Switzerland.
Martin FuchsKlinikum Bogenhausen, Städtisches Klinikum München GmbH, Englschalkinger Road 77, 81925, Munich, Germany.
Jorg TrojanGoethe University Medical Center, Theodor-Stern-Kai 7, 60590, Frankfurt, Germany.
Helmut OettleOnkologische und Hämatologische Schwerpunktpraxis, Friedrichshafen, Germany.
Mark KozloffIngalls Memorial Hospital, 71W. 156th St., Harvey, IL, 60426, USA.
Ann CleverlyEli Lilly and Company, Erl Wood Manor, Windlesham, Surrey, GU20 6PH, UK.
Claire Smithformerly of Eli Lilly and Company, Indianapolis, IN, 46285, USA.
Shawn T EstremEli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, 46285, USA.
Ivelina GueorguievaEli Lilly and Company, Erl Wood Manor, Windlesham, Surrey, GU20 6PH, UK.
Michael M F Lahn6820 Wisconsin Ave., #8008, Bethesda, MD, 20815, USA.
Al BluntAdvaxis, Inc., 305 College Road East, Princeton, NJ, 08540, USA.
Karim A BenhadjiEli Lilly and Company, 440 Route 22 East, Bridgewater, NJ, 08807, USA.
Josep TaberneroVall d'Hebron University Hospital and Institute of Oncology (VHIO), CIBERONC, Universitat Autònoma de Barcelona, P. Vall d'Hebron 119-129, 08035, Barcelona, Spain.
Eli Lilly (United States) · USCentro de Investigación Biomédica en Red de Cáncer · ESEli Lilly (United Kingdom) · GBAdvaxis (United States) · USCentre Hospitalier Universitaire de Clermont-Ferrand · FRGoethe University Frankfurt · DEHôpital Riviera-Chablais · CHIngalls Memorial Hospital · USMünchen Klinik Bogenhausen · DEPraxis für Hämatologie und Onkologie · DEUniversity of Verona · ITVall d'Hebron Hospital Universitari · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundGalunisertib is the first-in-class, first-in-human, oral small-molecule type I transforming growth factor-beta receptor (ALK5) serine/threonine kinase inhibitor to enter clinical development. The effect of galunisertib vs. placebo in patients with unresectable pancreatic cancer was determined.

methodsThis was a two-part, multinational study: phase 1b was a non-randomised, open-label, multicentre, and dose-escalation study; phase 2 was a randomised, placebo- and Bayesian-augmented controlled, double-blind study in patients with locally advanced or metastatic pancreatic adenocarcinoma considered candidates for first-line chemotherapy with gemcitabine. Patients were randomised 2:1 to galunisertib-gemcitabine (N = 104) or placebo-gemcitabine (N = 52). Gemcitabine dose was 1000 mg/m

resultsDose-escalation suggested a 300-mg/day dose. Primary objective was met: median survival times were 8.9 and 7.1 months for galunisertib and placebo, respectively (hazard ratio [HR] = 0.79 [95% credible interval: 0.59-1.09] and posterior probability HR < 1 = 0.93). Lower baseline biomarkers macrophage inflammatory protein-1-alpha and interferon-gamma-induced protein 10 were associated with galunisertib benefit.

conclusionsGalunisertib-gemcitabine combination improved overall survival vs. gemcitabine in patients with unresectable pancreatic cancer, with minimal added toxicity. Future exploration of galunisertib in pancreatic cancer is ongoing in combination with durvalumab.

Indexed as

AdultAgedAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorDeoxycytidineDose-Response Relationship, DrugFemaleGemcitabineHumansMaleMiddle AgedPancreatic NeoplasmsPlacebosPyrazolesQuinolinesSignal TransductionBiomarkers, TumorDeoxycytidineGemcitabineLY-2157299PlacebosPyrazolesQuinolinesTransforming Growth Factor beta

Identifiers

PMID30318515
PMCPMC6251034
OpenAlexW2896652675

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Registered trials

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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.