Evidence map›Paper›PMID 34098895›Full record

ArticleBMC cancer2021

A phase I study of the safety and activity of K-001 in patients with advanced pancreatic ductal adenocarcinoma.

Jiujie Cui, Haiyan Yang, Jue Liu, Donghui Chen, Jiong Hu, Haiyan Zhang, Yu Wang, Ting Han, Tiebo Mao, Feng Jiao and 4 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase I
PubMed Full text at PMC Publisher
In one paragraph

Article in BMC cancer, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02720666 (K-001 Treatment of Advanced Pancreatic Cancer), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
0.1field-weighted citation impact, top 55% 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.

NCT02720666 phase1completednot on this map

K-001 Treatment of Advanced Pancreatic Cancer: Phase I Clinical Trial of Monotherapy's Tolerability

TypeinterventionalSponsorShanghai General Hospital, Shanghai Jiao Tong University School of MedicineRan2016 to 2016Enrolled12ConditionsPancreatic CancerArmsK-001
3 · Its place in the literature

Who cites it

0 citing papers in PubMed, 1 citations in OpenAlex.

No citing paper in PubMed yet.

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

14 authors at 5 institutions in 1 country.

Jiujie Cui *Department of Medical Oncology, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.
Haiyan Yang *Department of Medical Oncology, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.
Jue Liu *Department of Epidemiology and Biostatistics, School of Public Health, Peking University, Beijing, China.
Donghui ChenDepartment of Oncology, First People's Hospital, Shanghai Jiaotong University, Shanghai, China.
Jiong HuDepartment of Medical Oncology, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.
Haiyan ZhangDepartment of Oncology, First People's Hospital, Shanghai Jiaotong University, Shanghai, China.
Yu WangDepartment of Medical Oncology, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.
Ting HanDepartment of Medical Oncology, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.
Tiebo MaoDepartment of Medical Oncology, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.
Feng JiaoDepartment of Medical Oncology, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.
Ewelina BiskupCollege of Fundamental Medicine, Shanghai University of Medicine and Health Sciences, Shanghai, China.
Yaotian PanInstitute of Psychology Chinese Academy of Sciences, Beijing, China. panyt@psych.ac.cn.
Min LiuDepartment of Epidemiology and Biostatistics, School of Public Health, Peking University, Beijing, China. liumin@bjmu.edu.cn.
Liwei WangDepartment of Medical Oncology, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China. liweiwang@shsmu.edu.cn.ORCID http://orcid.org/0000-0002-0031-4363
Shanghai Jiao Tong University · CNPeking University · CNShanghai First People's Hospital · CNInstitute of Psychology, Chinese Academy of Sciences · CNShanghai University of Medicine and Health Sciences · CN

Funding

Development Center for Medical Science & Technology National Health Commission of the People's Republic of China 2018ZX09711001-007-010
6 · The paper itself

Abstract

backgroundPancreatic ductal adenocarcinoma (PDAC) is a deadly disease that lack of effective therapeutic drugs. K-001 is an oral antitumor drug made from active ingredients of marine microorganisms. The current study aimed to evaluate safety and antitumor activity of K-001 in patients with advanced PDAC.

methodsIn this phase I, open-label trial, patients with advanced PDAC were recruited to a dose-escalation study in a standard 3 + 3 design. K-001 was administered twice daily in four-week cycles, and dose escalation from 1350 mg to 2160 mg was evaluated twice daily. Physical examination and laboratory tests were done at screening and then weekly. The safety, dose-limiting toxicity (DLT), and maximum tolerated dose (MTD) of K-001 were assessed while tumor response was estimated by Response Evaluation Criteria in Solid Tumor (RECIST).

resultsEighteen patients with advanced PDAC were screened, and twelve eligible patients were analyzed in the study. No DLT was observed. Totally, 47 adverse events (AEs) presented, and 14 drug-related AEs were reported in 7 patients, including 8 grade 1 events (57.1%) and 6 grade 2 events (42.9%). There was no grade 3 or 4 drug-related AE. In these 14 drug-related AEs, the most frequent ones were dyspepsia (21.4%), followed by flatulence, constipation, and hemorrhoid bleeding (above 10% of each). Among all 12 patients, 10 patients (83.3%) maintained stable disease (SD), and 2 patients (16.7%) had progressive disease (PD). The objective response rate (ORR) was 0% and the disease control rate (DCR) was 83.3%.

conclusionsK-001 manifests satisfactory safety and tolerability, as well as meaningful antitumor activity in advanced PDAC patients. Further evaluation of K-001 in phase II/III appears warranted.

trial registrationNCT02720666 . Registered 28 Match 2016 - Retrospectively registered.

Indexed as

AgedAquatic OrganismsBiological ProductsCarcinoma, Pancreatic DuctalDose-Response Relationship, DrugFemaleHumansMaleMaximum Tolerated DoseMiddle AgedPancreatic NeoplasmsPeptidoglycanResponse Evaluation Criteria in Solid TumorsTreatment OutcomeBiological ProductsPeptidoglycanClinical trialK-001Pancreatic ductal adenocarcinomaPhase I studySafety

Identifiers

PMID34098895
PMCPMC8183060
OpenAlexW3172333823

What OpenQuestion holds

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LicenceCC BY
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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.