Evidence map›Paper›PMID 33114652›Full record

ArticleCancers2020

Safety, Efficacy and Pharcacokinetics of Targeted Therapy with The Liposomal RNA Interference Therapeutic Atu027 Combined with Gemcitabine in Patients with Pancreatic Adenocarcinoma. A Randomized Phase Ib/IIa Study.

Beate Schultheis, Dirk Strumberg, Jan Kuhlmann, Martin Wolf, Karin Link, Thomas Seufferlein, Joerg Kaufmann, Mathilde Feist, Frank Gebhardt, Mike Khan and 2 more

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Cancers, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01808638 (A PHASE Ib/IIa STUDY OF COMBINATION THERAPY WITH GEMCITABINE AND ATU027 IN SUBJECTS WITH LOCALLY ADVANCED OR METASTATIC PANCREATIC ADENOCARCINOMA), which is not on this map. Cited by 44 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
44citing papers in PubMed, 1 pooled it
2.8field-weighted citation impact, top 7% 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.

NCT01808638 phase1 / phase2completednot on this map

A PHASE Ib/IIa STUDY OF COMBINATION THERAPY WITH GEMCITABINE AND ATU027 IN SUBJECTS WITH LOCALLY ADVANCED OR METASTATIC PANCREATIC ADENOCARCINOMA

TypeinterventionalSponsorSilence Therapeutics GmbHRan2013 to 2016Enrolled29ConditionsCarcinoma, Pancreatic DuctalArmsAtu027 & gemcitabine in lead in safety period, Atu027 & gemcitabine in treatment arm 1, Atu027 & gemcitabine in treatment arm 2
3 · Its place in the literature

Who cites it

44 citing papers in PubMed, 1 synthesis or guideline pooled it, 60 citations in OpenAlex.

  1. Pooled it
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  3. Advances in applications of siRNA in cancer therapy: challenges and opportunities.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026
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  11. Article
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  13. Small interfering RNA: From designing to therapeutic in cancer.Journal, genetic engineering & biotechnology · 2025
    Review
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  18. Article
  19. Targeting and monitoring ovarian cancer invasion with an RNAi and peptide delivery system.Proceedings of the National Academy of Sciences of the United States of America · 2024
    Article
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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

12 authors at 8 institutions in 2 countries.

Beate SchultheisDepartment of Hematology and Oncology, Marien Hospital Herne, University of Bochum, 44627 Herne, Germany.
Dirk StrumbergDepartment of Hematology and Oncology, Marien Hospital Herne, University of Bochum, 44627 Herne, Germany.
Jan KuhlmannDepartment of Medicine II, University Hospital Freiburg, 79106 Freiburg, Germany.
Martin WolfDepartment of Medicine, Hospital Kassel, 34125 Kassel, Germany.
Karin LinkDepartment of Medicine V, Hospital Nuernberg Nord, 90419 Nuernberg, Germany.
Thomas SeufferleinDepartment of Medicine I, Universitätsklinikum Ulm, 89081 Ulm, Germany.
Joerg KaufmannSilence Therapeutics GmbH, 13125 Berlin, Germany.
Mathilde FeistDepartment of Surgery, Charité-Universitätsmedizin Berlin, 13353 Berlin, Germany.
Frank GebhardtSilence Therapeutics GmbH, 13125 Berlin, Germany.
Mike KhanDepartment of Biological Sciences, University of Warwick, Coventry CV4 7AL, UK.
Sebastian StintzingMedical faculty, Humboldt-Universität zu Berlin, 10099 Berlin, Germany.ORCID 0000-0002-3297-5801
Uwe PelzerMedical faculty, Humboldt-Universität zu Berlin, 10099 Berlin, Germany.ORCID 0000-0001-9213-2737
Humboldt-Universität zu Berlin · DESilence Therapeutics (Germany) · DEUniversitätsklinik Marien Hospital Herne · DEKlinikum Arnsberg · DEKlinikum Kassel · DEUniversity Hospital Ulm · DEUniversity Medical Center Freiburg · DEUniversity of Warwick · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAtu027 is a liposomally formulated short interfering RNA with anti-metastatic activity, which silences the expression of protein kinase N3 (PKN3) in the vascular endothelium. This trial was designed to assess the safety, pharmacokinetics and efficacy of Atu027 in combination with gemcitabine in advanced pancreatic carcinoma (APC).

methodsIn total, 23 patients (pts) with inoperable APC were randomly assigned to gemcitabine combined with two different Atu027 schedules (0.235 mg/kg once weekly vs. 0.235 mg/kg twice weekly). ClinicalTrials.gov Identifier: NCT01808638.

resultsThe treatment was well-tolerated. There were Grade 3 adverse events (AEs) in 9/11 pts (arm 1) and 11/12 pts (arm 2), while Grade 4 AEs were reported for two pts in each arm. The AEs were mainly laboratory abnormalities without clinical significance. The median progression-free survival reached statistical significance in patients who had metastatic disease (1.6 vs. 2.9 months,

conclusionsCombining Atu027 with gemcitabine is safe and well tolerated. In pts with metastatic APC, twice-weekly Atu027 is associated with significantly improved outcomes. Our clinical results support the significant involvement of the vascular endothelium in the spread of cancer, and thus the further investigation of its target role.

Indexed as

pancreatic cancerrandomized trialRNA interferingtargeted therapy

Identifiers

PMID33114652
PMCPMC7693593
OpenAlexW3096548793

What OpenQuestion holds

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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.