Evidence map›Paper›PMID 25715767›Full record

ArticleCancer research and treatment2016

Phase I Study of CKD-516, a Novel Vascular Disrupting Agent, in Patients with Advanced Solid Tumors.

Do-Youn Oh, Tae-Min Kim, Sae-Won Han, Dong-Yeop Shin, Yun Gyoo Lee, Keun-Wook Lee, Jee Hyun Kim, Tae-You Kim, In-Jin Jang, Jong-Seok Lee and 1 more

Abstract readClinical Trial, Phase I
In one paragraph

Article in Cancer research and treatment, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
–field-weighted citation impact
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

10 citing papers in PubMed.

  1. Article
  2. Thiazole, Isatin and Phthalimide Derivatives TestedCurrent medicinal chemistry · 2024
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  3. 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

11 authors.

Do-Youn OhDepartment of Internal Medicine, Seoul National University Hospital, Seoul, Korea ; Cancer Research Institute, Seoul National University College of Medicine, Seoul, Korea.
Tae-Min KimDepartment of Internal Medicine, Seoul National University Hospital, Seoul, Korea ; Cancer Research Institute, Seoul National University College of Medicine, Seoul, Korea.
Sae-Won HanDepartment of Internal Medicine, Seoul National University Hospital, Seoul, Korea ; Cancer Research Institute, Seoul National University College of Medicine, Seoul, Korea.
Dong-Yeop ShinDepartment of Internal Medicine, Seoul National University Hospital, Seoul, Korea ; Department of Internal Medicine, Korea Cancer Center Hospital, Korea Institute of Radiological and Medical Sciences, Seoul, Korea.
Yun Gyoo LeeDepartment of Internal Medicine, Seoul National University Hospital, Seoul, Korea ; Department of Internal Medicine, Kangbuk Samsung Medical Center, Seoul, Korea.
Keun-Wook LeeDepartment of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Korea.
Jee Hyun KimDepartment of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Korea.
Tae-You KimDepartment of Internal Medicine, Seoul National University Hospital, Seoul, Korea ; Cancer Research Institute, Seoul National University College of Medicine, Seoul, Korea.
In-Jin JangDepartment of Clinical Pharmacology and Therapeutics, Seoul National University Hospital, Seoul, Korea.
Jong-Seok LeeDepartment of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Korea.
Yung-Jue BangDepartment of Internal Medicine, Seoul National University Hospital, Seoul, Korea ; Cancer Research Institute, Seoul National University College of Medicine, Seoul, Korea.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeCKD-516 is a newly developed vascular disrupting agent. This phase I dose-escalation study of CKD-516 was conducted to determine maximum-tolerated dose (MTD), safety, pharmacokinetics, and preliminary antitumor efficacy in patients with advanced solid tumors. MATERIALS AND

methodsPatients received CKD-516 intravenously on D1 and D8 every 3 weeks, in a standard 3+3 design. Safety was evaluated by National Cancer Institute Common Terminology Criteria for Adverse Events ver. 4.02 and response was assessed by Response Evaluation Criteria in Solid Tumor ver. 1.1.

resultsTwenty-three patients were treated with CKD-516 at seven dosing levels: 1 mg/m(2)/day (n=3), 2 mg/m(2)/day (n=3), 3.3 mg/m(2)/day (n=3), 5 mg/m(2)/day (n=3), 7 mg/m(2)/day (n=3), 9 mg/m(2)/day (n=6), and 12 mg/m(2)/day (n=2). Mean age was 54 and 56.5% of patients were male. Two dose-limiting toxicities, which were both grade 3 hypertension, were observed in two patients at 12 mg/m(2)/day. The MTD was determined as 12 mg/m(2)/day. Most common adverse events were gastrointestinal adverse events (diarrhea, 34.8% [30.4% grade 1/2, 13.0% grade 3]; nausea, 21.7% [all grade 1/2]; vomiting, 21.7% [all grade 1/2]), myalgia (17.4%, all grade 1/2), and abdominal pain (21.7% [21.7% grade 1/2, 4.3% grade 3]). The pharmacokinetic study showed the dose-linearity of all dosing levels. Among 23 patients, six patients (26.1%) showed stable disease. Median progression-free survival was 39 days (95% confidence interval, 37 to 41 days).

conclusionThis study demonstrates feasibility of CKD-516, novel vascular disrupting agent, in patients with advanced solid tumor. MTD of CKD-516 was defined as 12 mg/m(2)/day on D1 and D8 every 3 weeks.

Indexed as

AdultAgedAntineoplastic AgentsBenzophenonesBlood VesselsDose-Response Relationship, DrugFemaleHumansMaleMaximum Tolerated DoseMiddle AgedNeoplasmsValineAntineoplastic AgentsBenzophenonesN-(4-(3-(1H-1,2,4-triazol-1-yl)-4-(3,4,5-trimethoxybenzoyl)phenyl)thiazol-2-yl)-2-amino-3-methylbutanamideValineCKD-516Phase I clinical trialSolid tumorVascular disrupting agent

Identifiers

PMID25715767
PMCPMC4720091

What OpenQuestion holds

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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.