Evidence map›Paper›PMID 28143428›Full record

ArticleBMC cancer2017

BK-UM in patients with recurrent ovarian cancer or peritoneal cancer: a first-in-human phase-I study.

Shingo Miyamoto, Fusanori Yotsumoto, Taeko Ueda, Tatsuya Fukami, Ayako Sanui, Kohei Miyata, Sung Ouk Nam, Satoshi Fukagawa, Takahiro Katsuta, Miyako Maehara and 24 more

Open access · goldAbstract readClinical Trial, Phase I
PubMed Full text at PMC Publisher
In one paragraph

Article in BMC cancer, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
2.4field-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

4 citing papers in PubMed, 12 citations in OpenAlex.

  1. Review
  2. Review
  3. Review
  4. 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

34 authors at 5 institutions in 1 country.

Shingo MiyamotoDepartment of Obstetrics and Gynecology, Faculty of Medicine, Fukuoka University, 7-45-1 Nanakuma, Jonan-ku, Fukuoka, 814-0180, Japan. smiya@cis.fukuoka-u.ac.jp.
Fusanori YotsumotoDepartment of Obstetrics and Gynecology, Faculty of Medicine, Fukuoka University, 7-45-1 Nanakuma, Jonan-ku, Fukuoka, 814-0180, Japan.
Taeko UedaDepartment of Obstetrics and Gynecology, University of Occupational and Environmental Health School of Medicine, 1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu, 807-8555, Japan.
Tatsuya FukamiDepartment of Obstetrics and Gynecology, Faculty of Medicine, Fukuoka University, 7-45-1 Nanakuma, Jonan-ku, Fukuoka, 814-0180, Japan.
Ayako SanuiDepartment of Obstetrics and Gynecology, Faculty of Medicine, Fukuoka University, 7-45-1 Nanakuma, Jonan-ku, Fukuoka, 814-0180, Japan.
Kohei MiyataDepartment of Obstetrics and Gynecology, Faculty of Medicine, Fukuoka University, 7-45-1 Nanakuma, Jonan-ku, Fukuoka, 814-0180, Japan.
Sung Ouk NamDepartment of Obstetrics and Gynecology, Faculty of Medicine, Fukuoka University, 7-45-1 Nanakuma, Jonan-ku, Fukuoka, 814-0180, Japan.
Satoshi FukagawaDepartment of Obstetrics and Gynecology, Faculty of Medicine, Fukuoka University, 7-45-1 Nanakuma, Jonan-ku, Fukuoka, 814-0180, Japan.
Takahiro KatsutaDepartment of Obstetrics and Gynecology, Faculty of Medicine, Fukuoka University, 7-45-1 Nanakuma, Jonan-ku, Fukuoka, 814-0180, Japan.
Miyako MaeharaDepartment of Obstetrics and Gynecology, Faculty of Medicine, Fukuoka University, 7-45-1 Nanakuma, Jonan-ku, Fukuoka, 814-0180, Japan.
Haruhiko KondoDepartment of Obstetrics and Gynecology, Faculty of Medicine, Fukuoka University, 7-45-1 Nanakuma, Jonan-ku, Fukuoka, 814-0180, Japan.
Daisuke MiyaharaDepartment of Obstetrics and Gynecology, Faculty of Medicine, Fukuoka University, 7-45-1 Nanakuma, Jonan-ku, Fukuoka, 814-0180, Japan.
Kyoko ShirotaDepartment of Obstetrics and Gynecology, Faculty of Medicine, Fukuoka University, 7-45-1 Nanakuma, Jonan-ku, Fukuoka, 814-0180, Japan.
Toshiyuki YoshizatoDepartment of Obstetrics and Gynecology, School of Medicine, Kurume University, 67 Asahi-machi, Kurume, Fukuoka, 830-0011, Japan.
Masahide KurokiCenter for Advanced Molecular Medicine, 7-45-1 Nanakuma, Jonan-ku, Fukuoka, 814-0180, Japan.
Hiroaki NishikawaDepartment of Cardiology, Faculty of Medicine, Fukuoka University, 7-45-1 Nanakuma, Jonan-ku, Fukuoka, 814-0180, Japan.
Keijiro SakuDepartment of Cardiology, Faculty of Medicine, Fukuoka University, 7-45-1 Nanakuma, Jonan-ku, Fukuoka, 814-0180, Japan.
Yoshio TsuboiDepartment of Neurology, Faculty of Medicine, Fukuoka University, 7-45-1 Nanakuma, Jonan-ku, Fukuoka, 814-0180, Japan.
Kenji IshitsukaDepartment of Hematology and Immunology, Kagoshima University Medical and Dental Hospital, 8-35-1 Sakuragaoka, Kagoshima, 890-8544, Japan.
Yasushi TakamatsuDepartment of Internal Medicine, Division of Medical Oncology, Hematology and Infectious Disease, Faculty of Medicine, Fukuoka University, 7-45-1 Nanakuma, Jonan-ku, Fukuoka, 814-0180, Japan.
Kazuo TamuraDepartment of Internal Medicine, Division of Medical Oncology, Hematology and Infectious Disease, Faculty of Medicine, Fukuoka University, 7-45-1 Nanakuma, Jonan-ku, Fukuoka, 814-0180, Japan.
Akira MatsunagaDepartment of Laboratory Medicine, Faculty of Medicine, Fukuoka University, 7-45-1 Nanakuma, Jonan-ku, Fukuoka, 814-0180, Japan.
Toru HachisugaDepartment of Obstetrics and Gynecology, University of Occupational and Environmental Health School of Medicine, 1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu, 807-8555, Japan.
Shinsuke NishinoKanonji Institute, Research Foundation for Microbial Diseases of Osaka University, 2-9-41 Yahata-Cho, Kanonji, Kagawa, 768-0061, Japan.
Takashi OdawaraKanonji Institute, Research Foundation for Microbial Diseases of Osaka University, 2-9-41 Yahata-Cho, Kanonji, Kagawa, 768-0061, Japan.
Kazuhiro MaedaKanonji Institute, Research Foundation for Microbial Diseases of Osaka University, 2-9-41 Yahata-Cho, Kanonji, Kagawa, 768-0061, Japan.
Sadao ManabeKanonji Institute, Research Foundation for Microbial Diseases of Osaka University, 2-9-41 Yahata-Cho, Kanonji, Kagawa, 768-0061, Japan.
Toyokazu IshikawaKanonji Institute, Research Foundation for Microbial Diseases of Osaka University, 2-9-41 Yahata-Cho, Kanonji, Kagawa, 768-0061, Japan.
Yoshinobu OkunoKanonji Institute, Research Foundation for Microbial Diseases of Osaka University, 2-9-41 Yahata-Cho, Kanonji, Kagawa, 768-0061, Japan.
Minako OhishiDepartment of Cell Biology, Research Institute for Microbial Disease, Osaka University, 3-1 Yamadaoka, Suita, Osaka, 565-0871, Japan.
Tomoya HikitaDepartment of Cell Biology, Research Institute for Microbial Disease, Osaka University, 3-1 Yamadaoka, Suita, Osaka, 565-0871, Japan.
Hiroto MizushimaDepartment of Cell Biology, Research Institute for Microbial Disease, Osaka University, 3-1 Yamadaoka, Suita, Osaka, 565-0871, Japan.
Ryo IwamotoDepartment of Cell Biology, Research Institute for Microbial Disease, Osaka University, 3-1 Yamadaoka, Suita, Osaka, 565-0871, Japan.
Eisuke MekadaDepartment of Cell Biology, Research Institute for Microbial Disease, Osaka University, 3-1 Yamadaoka, Suita, Osaka, 565-0871, Japan.
Fukuoka University · JPOsaka University · JPUniversity of Occupational and Environmental Health Japan · JPKagoshima University · JPKurume University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundBK-UM (CRM197) is a mutant form of diphtheria toxin and a specific inhibitor of heparin-binding epidermal growth factor-like growth factor (HB-EGF). We assessed the safety, pharmacokinetics, recommended dose, and efficacy of BK-UM in patients with recurrent ovarian cancer (OC) or peritoneal cancer (PC), and measured HB-EGF levels in serum and abdominal fluid after BK-UM administration.

methodsEleven patients with advanced or recurrent OC or PC were enrolled and treated with BK-UM via the intraperitoneal route. The dose was escalated (1.0, 2.0, 3.3, and 5.0 mg/m

resultsEight of 11 patients completed treatment. No dose-limiting toxicity (DLT) was experienced at dose levels 1 (1.0 mg/m

conclusionsBK-UM was well tolerated at doses of 1.0 and 2.0 mg/m

trial registrationThis trial was prospectively performed as an investigator-initiated clinical trial. The trial numbers are UMIN000001002 and UMIN000001001, with registration dates of 1/30/2008 and 2/4/2008, respectively. UMIN000001001 was registered as a trial for the continuous administration of BK-UM after UMIN000001002 .

Indexed as

AgedBacterial ProteinsDose-Response Relationship, DrugFemaleHeparin-binding EGF-like Growth FactorHumansMiddle AgedNeoplasm Recurrence, LocalOvarian NeoplasmsPeritoneal NeoplasmsBacterial ProteinsCRM197 (non-toxic variant of diphtheria toxin)Heparin-binding EGF-like Growth FactorBK-UMHB-EGFOvarian cancerPhase-I studyTargeted therapy

Identifiers

PMID28143428
PMCPMC5286856
OpenAlexW2585943634

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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.