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Phase I study of CKD-516, a novel vascular disrupting agent, in patients with advanced solid tumors
DC Field | Value | Language |
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dc.contributor.author | Oh, Do-Youn | - |
dc.contributor.author | Kim, Tae-Min | - |
dc.contributor.author | Han, Sae-Won | - |
dc.contributor.author | Shin, Dong-Yeop | - |
dc.contributor.author | Lee, Yun Gyoo | - |
dc.contributor.author | Lee, Keun-Wook | - |
dc.contributor.author | Kim, Jee Hyun | - |
dc.contributor.author | Kim, Tae-You | - |
dc.contributor.author | Jang, In-Jin | - |
dc.contributor.author | Lee, Jong-Seok | - |
dc.contributor.author | Bang, Yung-Jue | - |
dc.date.accessioned | 2021-01-31T12:03:09Z | - |
dc.date.available | 2021-01-31T12:03:09Z | - |
dc.date.created | 2018-08-03 | - |
dc.date.issued | 2016-01 | - |
dc.identifier.citation | Cancer Research and Treatment, Vol.48 No.1, pp.28-36 | - |
dc.identifier.issn | 1598-2998 | - |
dc.identifier.other | 41859 | - |
dc.identifier.uri | https://hdl.handle.net/10371/173236 | - |
dc.description.abstract | Purpose CKD-516 i 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 Methods Patients 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. Results Twenty-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). Conclusion This study demonstrates feasibility of CKD-516, novel vascular disrupting agent, in patients with advanced solid tumor. MID of CKD-516 was defined as 12 mg/m(2)/day on D1 and D8 every 3 weeks. | - |
dc.language | 영어 | - |
dc.publisher | 대한암학회 | - |
dc.title | Phase I study of CKD-516, a novel vascular disrupting agent, in patients with advanced solid tumors | - |
dc.type | Article | - |
dc.contributor.AlternativeAuthor | 방영주 | - |
dc.identifier.doi | 10.4143/crt.2014.258 | - |
dc.citation.journaltitle | Cancer Research and Treatment | - |
dc.identifier.wosid | 000368215200004 | - |
dc.identifier.scopusid | 2-s2.0-84957541113 | - |
dc.citation.endpage | 36 | - |
dc.citation.number | 1 | - |
dc.citation.startpage | 28 | - |
dc.citation.volume | 48 | - |
dc.identifier.sci | 000368215200004 | - |
dc.identifier.kciid | ART002073969 | - |
dc.description.isOpenAccess | N | - |
dc.contributor.affiliatedAuthor | Oh, Do-Youn | - |
dc.contributor.affiliatedAuthor | Lee, Keun-Wook | - |
dc.contributor.affiliatedAuthor | Kim, Jee Hyun | - |
dc.contributor.affiliatedAuthor | Kim, Tae-You | - |
dc.contributor.affiliatedAuthor | Jang, In-Jin | - |
dc.contributor.affiliatedAuthor | Lee, Jong-Seok | - |
dc.contributor.affiliatedAuthor | Bang, Yung-Jue | - |
dc.type.docType | Article | - |
dc.description.journalClass | 1 | - |
dc.subject.keywordPlus | TUBULIN POLYMERIZATION INHIBITOR | - |
dc.subject.keywordPlus | COMBRETASTATIN A4 PHOSPHATE | - |
dc.subject.keywordPlus | ANTITUMOR-ACTIVITY | - |
dc.subject.keywordPlus | TARGETING AGENT | - |
dc.subject.keywordPlus | CANCER | - |
dc.subject.keywordPlus | EFFICACY | - |
dc.subject.keywordPlus | TRIAL | - |
dc.subject.keywordPlus | COMBINATION | - |
dc.subject.keywordPlus | SCHEDULE | - |
dc.subject.keywordPlus | MURINE | - |
dc.subject.keywordAuthor | CKD-516 | - |
dc.subject.keywordAuthor | Vascular disrupting agent | - |
dc.subject.keywordAuthor | Phase I clinical trial | - |
dc.subject.keywordAuthor | Solid tumor | - |
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