Clinical and pharmacological phase I study with accelerated titration design of a daily times five schedule of BBR3464, a novel cationic triplatinum complex

Annals of Oncology - Tập 11 - Trang 977-984 - 2000
C. Sessa1,2, G. Capri3,2, L. Gianni3,2, F. Peccatori4, G. Grasselli3,2, J. Bauer5, M. Zucchetti6,2, L. Viganò2, A. Gatti7, C. Minoia7, P. Liati2, S. Van den Bosch1, A. Bernareggi8, G. Camboni8, S. Marsoni2
1Istituto Oncologico della Svizzera Italiana, Bellinzona, Switzerland
2South European New Drug Development Orgamzation (SENDO) Milan, Italy
3Division of Oncology, Istituto Nazionale dei Tumori Milan
4Division of Medical Oncology A. Istituto Europeo di Oncologia Milan
5Centre Pluridisciplinaire d'Oncologie, CHUV, Lausanne, Switzerland
6Department of Oncology, Istituto di Ricerche Farmacologiche Mario Negri Milan
7Fondazione Maugeri Pavia
8Novuspharma Monza

Tài liệu tham khảo

BBR 3464 Information Package, in Vivo Studies. Boehringer Mannheim Italia 1997. Farrell, 1997, Chemical studies and DNA binding of charged polynuclear platinum complexes, Proc Am Ass Cancer Res, 38, 310 Pratesi, 1999, A novel charged trinuclear platinum complex effective against cisplatin-resistant xenografts, Br J Cancer, 80, 1912, 10.1038/sj.bjc.6690620 Simon, 1997, Accelerated titration designs for phase I clinical trials in oncology J Natl Cancer Inst, 89, 1138 Miller, 1981, Reporting results of cancer treatment, Cancer, 47, 207, 10.1002/1097-0142(19810101)47:1<207::AID-CNCR2820470134>3.0.CO;2-6 Shah, 1992, Analytical methods validation: Bioavailability, bioequivalence and pharmacokinetic studies, Pharmaceut Res, 9, 588, 10.1023/A:1015829422034 Sacchi Landriani, 1983, Ni-FITa microcomputer program for non-linear fitting, Comput Programs Biomed, 16, 35, 10.1016/0010-468X(83)90006-5 Calvert, 1999, A phase I study of a novel trinuclear, platinum analogue, BBR3464, in patients with advanced solid tumors, Proc AACR-NCI-EORTC Int Conf Clin Cancer Res, 5, 3796S Clark, 1999, Predictive value of preclinical toxicology studies for platinum anticancer drugs, Clin Cancer Res, 5, 1161