Evidence map›Paper›PMID 30844808›Full record

Trial reportOncology2019

A Phase 2 Study of PCI-27483, a Factor VIIa Inhibitor in Combination with Gemcitabine for Advanced Pancreatic Cancer.

Ramesh K Ramanathan, Gary W Thomas, Alok A Khorana, Satish Shah, Cathy Zhou, Sofia Wong, George Cole, Danelle James, Nashat Y Gabrail

Open access · hybridAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Oncology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed
2.0field-weighted citation impact, top 13% 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

12 citing papers in PubMed, 18 citations in OpenAlex.

  1. Article
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  12. Rivaroxaban does not affect growth of human pancreatic tumors in mice.Journal of thrombosis and haemostasis : JTH · 2019
    Article
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

9 authors at 6 institutions in 1 country.

Ramesh K RamanathanHonor Health Research Institute/Translational Genomics Research Institute, Scottsdale, Arizona, USA.
Gary W ThomasSouth Carolina Cancer Specialists, Hilton Head Island, South Carolina, USA.
Alok A KhoranaUniversity of Rochester, Rochester, New York, USA.
Satish ShahGettysburg Cancer Center, Gettysburg, Pennsylvania, USA.
Cathy ZhouPharmacyclics LLC, an AbbVie Company, Sunnyvale, California, USA.
Sofia WongPharmacyclics LLC, an AbbVie Company, Sunnyvale, California, USA.
George ColePharmacyclics LLC, an AbbVie Company, Sunnyvale, California, USA, gecole@pcyc.com.
Danelle JamesPharmacyclics LLC, an AbbVie Company, Sunnyvale, California, USA.
Nashat Y GabrailGabrail Cancer Center, Canton, Ohio, USA.
AbbVie (United States) · USGabrail Cancer Center · USGettysburg College · USPharmacyclics (United States) · USTranslational Genomics Research Institute · USUniversity of Rochester · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTissue factor overexpression is associated with tumor progression, venous thromboembolism, and worsened survival in patients with cancer. Tissue factor and activated factor VII (FVIIa) complex may contribute to tumor invasiveness by promoting cell migration and angiogenesis. The study objective was to evaluate safety, pharmacokinetics, and efficacy of PCI-27483, a selective FVIIa inhibitor.

methodsThis was an open-label, multicenter phase 2 trial of patients with advanced pancreatic cancer. Part A of the study was an intrapatient dose escalation lead-in portion in patients concurrently receiving gemcitabine, and in part B, patients were randomized 1: 1 to the recommended phase 2 dose combination PCI-27483-gemcitabine versus gemcitabine alone.

resultsTarget international normalized ratio (between 2.0-3.0) was achieved following PCI-27483 treatment. Overall safety of PCI-27483-gemcitabine (n = 26) was similar to gemcitabine alone (n = 16), with a higher incidence of mostly low-grade bleeding events (65% vs. 19%). Progression-free survival (PFS) and overall survival (OS) were not significantly different between patients treated with PCI-27483-gemcitabine (PFS: 3.7 months, OS: 5.7 months) and those treated with gemcitabine alone (PFS: 1.9 months, OS: 5.6 months).

conclusionsTargeted inhibition of the coagulation cascade was achieved by administering PCI-27483. PCI-27483-gemcitabine was well tolerated, but superiority to single agent gemcitabine was not demonstrated.

Indexed as

AgedAged, 80 and overAnticoagulantsAntineoplastic Combined Chemotherapy ProtocolsAspartic AcidBenzamidinesBenzimidazolesBlood CoagulationCarcinoma, Pancreatic DuctalDeoxycytidineDrug MonitoringFactor VIIaFemaleGemcitabineHemorrhageHumansAnticoagulantsAspartic AcidBenzamidinesBenzimidazolesDeoxycytidineFactor VIIaGemcitabinePCI-27483PhenolsSulfonamidesAnti-tumorCancer antigen 19-9GemcitabinePancreatic cancerPancreatic carcinomaPhase II studySurvival

Identifiers

PMID30844808
PMCPMC6492608
OpenAlexW2921328916

What OpenQuestion holds

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Read underepoch 390

Registered trials

None linked

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.