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Phase Ib/II study of the pan-cyclin-dependent kinase inhibitor roniciclib in combination with chemotherapy in patients with extensive-disease small-cell lung cancer
DC Field | Value | Language |
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dc.contributor.author | Cho, Byoung Chul | - |
dc.contributor.author | Dy, Grace K. | - |
dc.contributor.author | Govindan, Ramaswamy | - |
dc.contributor.author | Kim, Dong-Wan | - |
dc.contributor.author | Pennell, Nathan A. | - |
dc.contributor.author | Zalcman, Gerard | - |
dc.contributor.author | Besse, Benjamin | - |
dc.contributor.author | Kim, Joo-Hang | - |
dc.contributor.author | Koca, Goekben | - |
dc.contributor.author | Rajagopalan, Prabhu | - |
dc.contributor.author | Langer, Simon | - |
dc.contributor.author | Ocker, Matthias | - |
dc.contributor.author | Nogai, Hendrik | - |
dc.contributor.author | Barlesi, Fabrice | - |
dc.date.accessioned | 2020-04-27T11:02:22Z | - |
dc.date.available | 2020-04-27T11:02:22Z | - |
dc.date.created | 2019-06-12 | - |
dc.date.issued | 2018-09 | - |
dc.identifier.citation | Lung Cancer, Vol.123, pp.14-21 | - |
dc.identifier.issn | 0169-5002 | - |
dc.identifier.other | 75285 | - |
dc.identifier.uri | https://hdl.handle.net/10371/165230 | - |
dc.description.abstract | Objectives: This phase Ib/II study evaluated safety, pharmacokinetics, maximum tolerated dose (MTD), and efficacy of the pan-cyclin-dependent kinase inhibitor roniciclib with cisplatin-etoposide (CIS-ETOP) or carboplatin-etoposide (CARBO-ETOP) in patients with extensive-disease small-cell lung cancer (ED-SCLC). Patients and methods: In this open-label, non-randomized study, patients with previously untreated ED-SCLC received roniciclib twice daily (BID) in a 3 days on/4 days off schedule. Cisplatin 75 mg/m(2) or carboplatin (AUC5) dose was administered on day 1, and etoposide 100 mg/m(2) on days 1-3, of 21-day cycles. Phase Ib used a dose-escalation design to define the MTD for phase II. Pharmacokinetics were assessed. Results: Forty-three patients received treatment (roniciclib 2.5 mg BID [+ CARBO-ETOP, n = 4; + CIS-ETOP, n = 3] and roniciclib 5 mg BID [+ CARBO-ETOP, n = 24; + CIS-ETOP, n = 12]). The MTD of roniciclib was 5 mg BID with CARBO-ETOP or CIS-ETOP. Common adverse events were nausea (90.7%) and vomiting (69.8%). Roniciclib was readily absorbed following oral administration at the MTD (median t,,, 0.5-1 h), with a 30-40% reduction in exposure when co-administered with CARBO-ETOP or CIS-ETOP; administration of roniciclib had no effect on etoposide or platinum pharmacokinetics. The response rate was 81.4% (35/43) overall and 86.1% (31/36) in the pooled roniciclib 5 mg BID population (all partial responses). Conclusion: Roniciclib co-administered with chemotherapy in patients with ED-SCLC demonstrated tolerability, acceptable pharmacokinetics, and promising efficacy. An observed safety signal in a related phase II study resulted in discontinuation of the present study and termination of further roniciclib development. | - |
dc.language | 영어 | - |
dc.publisher | Elsevier BV | - |
dc.title | Phase Ib/II study of the pan-cyclin-dependent kinase inhibitor roniciclib in combination with chemotherapy in patients with extensive-disease small-cell lung cancer | - |
dc.type | Article | - |
dc.contributor.AlternativeAuthor | 김동완 | - |
dc.identifier.doi | 10.1016/j.lungcan.2018.04.022 | - |
dc.citation.journaltitle | Lung Cancer | - |
dc.identifier.wosid | 000443788200003 | - |
dc.identifier.scopusid | 2-s2.0-85049104249 | - |
dc.citation.endpage | 21 | - |
dc.citation.startpage | 14 | - |
dc.citation.volume | 123 | - |
dc.identifier.sci | 000443788200003 | - |
dc.description.isOpenAccess | Y | - |
dc.contributor.affiliatedAuthor | Kim, Dong-Wan | - |
dc.type.docType | Article | - |
dc.description.journalClass | 1 | - |
dc.subject.keywordPlus | III TRIAL | - |
dc.subject.keywordPlus | CISPLATIN | - |
dc.subject.keywordPlus | ETOPOSIDE | - |
dc.subject.keywordPlus | PROGRESS | - |
dc.subject.keywordPlus | CARBOPLATIN | - |
dc.subject.keywordAuthor | Extensive-disease small-cell lung cancer | - |
dc.subject.keywordAuthor | Roniciclib | - |
dc.subject.keywordAuthor | Platinum chemotherapy | - |
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