Phase-I dose finding and pharmacokinetic study of the novel hydrophilic camptothecin ST-1968 (namitecan) in patients with solid tumors

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• 作者：M. Joerger (1) (2)
  D. Hess (1) (2)
  A. Delmonte (3)
  E. Gallerani (3)
  P. Barbieri (4)
  S. Pace (5)
  C. Sessa (3)
  
  1. Department of Medical Oncology & Hematology ; Cantonal Hospital ; St.Gallen ; Switzerland
  2. Clinical Research Facility ; Department of Medical Oncology & Hematology ; Cantonal Hospital ; Rorschacherstr. 95 ; 9007 ; St. Gallen ; Switzerland
  3. IOSI Oncology Insitute of Southern Switzerland ; Bellinzona ; Switzerland
  4. Sigma-Tau Research Switzerland S.A. ; Mendrisio ; Switzerland
  5. Sigma-Tau Industrie Farmaceutiche Riunite SpA ; Pomezia ; Italy
  
• 关键词：Antineoplastic agens ; Namitecan ; Camptothecan ; Maximum tolerated dose ; Neutropenia ; Phase 1 clinical trial
• 刊名：Investigational New Drugs
• 出版年：2015
• 出版时间：April 2015
• 年：2015
• 卷：33
• 期：2
• 页码：472-479
• 全文大小：1,262 KB
• 参考文献：1. Fiorani, P, Amatruda, JF, Silvestri, A, Butler, RH, Bjornsti, MA, Benedetti, P (1999) Domain interactions affecting human DNA topoisomerase I catalysis and camptothecin sensitivity. Mol Pharmacol 56: pp. 1105-1115
  2. McNeil, C (1996) Topotecan: after FDA and ASCO, what鈥檚 next?. J Natl Cancer Inst 88: pp. 788-789 CrossRef
  3. FDA approves irinotecan as first-line therapy for colorectal cancer (2000). Oncology (Williston Park) 14 (5):652鈥?54
  4. Pecorelli, S, Ray-Coquard, I, Tredan, O, Colombo, N, Parma, G, Tisi, G, Katsaros, D, Lhomme, C, Lissoni, AA, Vermorken, JB, Bois, A, Poveda, A, Frigerio, L, Barbieri, P, Carminati, P, Brienza, S, Guastalla, JP (2010) Phase II of oral gimatecan in patients with recurrent epithelial ovarian, fallopian tube or peritoneal cancer, previously treated with platinum and taxanes. Ann Oncol 21: pp. 759-765 CrossRef
  5. Cesare, M, Pratesi, G, Perego, P, Carenini, N, Tinelli, S, Merlini, L, Penco, S, Pisano, C, Bucci, F, Vesci, L, Pace, S, Capocasa, F, Carminati, P, Zunino, F (2001) Potent antitumor activity and improved pharmacological profile of ST1481, a novel 7-substituted camptothecin. Cancer Res 61: pp. 7189-7195
  6. Cesare, M, Beretta, GL, Tinelli, S, Benedetti, V, Pratesi, G, Penco, S, Dallavalle, S, Merlini, L, Pisano, C, Carminati, P, Zunino, F (2007) Preclinical efficacy of ST1976, a novel camptothecin analog of the 7-oxyiminomethyl series. Biochem Pharmacol 73: pp. 656-664 CrossRef
  7. Beretta, GL, Zuco, V, Cesare, M, Perego, P, Zaffaroni, N (2012) Namitecan: a hydrophilic camptothecin with a promising preclinical profile. Curr Med Chem 19: pp. 3488-3501 CrossRef
  8. Pisano, C, Zuco, V, Cesare, M, Benedetti, V, Vesci, L, Fodera, R, Bucci, F, Aulicino, C, Penco, S, Carminati, P, Zunino, F (2008) Intracellular accumulation and DNA damage persistence as determinants of human squamous cell carcinoma hypersensitivity to the novel camptothecin ST1968. Eur J Cancer 44: pp. 1332-1340 CrossRef
  9. Zuco, V, Supino, R, Favini, E, Tortoreto, M, Cincinelli, R, Croce, AC, Bucci, F, Pisano, C, Zunino, F (2010) Efficacy of ST1968 (namitecan) on a topotecan-resistant squamous cell carcinoma. Biochem Pharmacol 79: pp. 535-541 CrossRef
  10. Pisano, C, Cesare, M, Beretta, GL, Zuco, V, Pratesi, G, Penco, S, Vesci, L, Fodera, R, Ferrara, FF, Guglielmi, MB, Carminati, P, Dallavalle, S, Morini, G, Merlini, L, Orlandi, A, Zunino, F (2008) Preclinical profile of antitumor activity of a novel hydrophilic camptothecin, ST1968. Mol Cancer Ther 7: pp. 2051-2059 CrossRef
  11. Meco, D, Francesco, AM, Cusano, G, Bucci, F, Pierri, F, Patriarca, V, Torella, AR, Pisano, C, Riccardi, R (2012) Preclinical evaluation of the novel 7-substituted camptothecin Namitecan (ST1968) in paediatric tumour models. Cancer Chemother Pharmacol 70: pp. 811-822 CrossRef
  12. Cassinelli, G, Zuco, V, Petrangolini, G, Cesare, M, Tortoreto, M, Lanzi, C, Cominetti, D, Zaffaroni, N, Orlandi, A, Passeri, D, Meco, D, Francesco, AM, Riccardi, R, Bucci, F, Pisano, C, Zunino, F (2012) The curative efficacy of namitecan (ST1968) in preclinical models of pediatric sarcoma is associated with antiangiogenic effects. Biochem Pharmacol 84: pp. 163-171 CrossRef
  13. Zuco, V, Benedetti, V, Zunino, F (2010) ATM- and ATR-mediated response to DNA damage induced by a novel camptothecin, ST1968. Cancer Lett 292: pp. 186-196 CrossRef
  14. Administration USFaD (2005) Guidance for Industry - Estimating the Maximum Safe Starting Dose in Initial Clinical Trials for Therapeutics in Adult Healthy Volunteers. http://www.fdagov/downloads/Drugs/Guidance/UCM078932pdf
  15. Michielin, O, Udry, E, Periard, D, Matzinger, O, Lobrinus, JA, Stupp, R (2004) Irinotecan-induced interstitial pneumonia. Lancet Oncol 5: pp. 322-324 CrossRef
  16. Shinoda, T, Kawahara, H, Yoshinaga, K, Shioya, H, Kobayashi, S, Yanaga, K, Komine, K (2006) Refractory Irinotecan-induced interstitial pneumonitis after treatment of metastatic lung cancer from the rectum: a case report. Jikeikai Med J 53: pp. 159-162
  17. Bol, JM, Mathijssen, RH, Creemers, GJ, Planting, AS, Loos, WJ, Wiemer, EA, Friberg, LE, Verweij, J, Sparreboom, A, Jong, FA (2010) A CYP3A4 phenotype-based dosing algorithm for individualized treatment of irinotecan. Clin Cancer Res 16: pp. 736-742 CrossRef
  
• 刊物类别：Medicine
• 刊物主题：Medicine & Public Health
  Oncology
  Pharmacology and Toxicology
  
• 出版者：Springer Netherlands
• ISSN：1573-0646

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