A phase I trial of the novel oral taxane BMS-275183 in patients with advanced solid tumors

Autor:	Maurizio Voi, F.Y.F.L. de Vos, Linda E. Bröker, E.G.E. de Vries, Giuseppe Giaccone, J. A. Gietema, MB Cohen, H.E. Gall
Rok vydání:	2004
Předmět:	Cancer Research medicine.medical_specialty Taxane Dose limiting toxicity business.industry Pharmacology medicine.disease Gastroenterology Discontinuation Peripheral neuropathy Oncology Pharmacokinetics Tolerability Refractory Internal medicine medicine In patient business
Zdroj:	Journal of Clinical Oncology. 22:2029-2029
ISSN:	1527-7755 0732-183X
DOI:	10.1200/jco.2004.22.90140.2029
Popis:	2029 Background: BMS-275183, a novel orally administered taxane, has been studied in this phase I trial to assess its safety, tolerability, pharmacokinetics (PK) and possible anti-tumor activity. Methods: BMS-275183 was given in a continuous, weekly schedule to adult patients (pts) with advanced solid tumors refractory to standard therapy. Plasma samples were collected on weeks 1 and 3 for 48 h after drug administration and analyzed using a LC/MS/MS assay. Results: To date, 31 pts have been treated at escalating dose levels of 5 mg (n=1) and 5 (n=2), 10 (n=1), 20 (n=1), 40 (n=1), 80 (n=1), 160 (n=1) and 320 mg/m2 (n=6), and at subsequent intermediate dose levels of 240 (n=2) and 200 mg/m2(n=15). Most common and dose limiting toxicity (DLT) consists of peripheral neuropathy, which was severe (CTC grade 3) in 1/6 pts at 320 and 2/2 pts at 240 mg/m2, and developed rapidly after the first dose but generally recovered to gr 1 after dose reduction or discontinuation. Severe hematological toxicity was infrequent...
Databáze:	OpenAIRE
Externí odkaz:	https://explore.openaire.eu/search/publication?articleId=doi_________::e4c2dff2349b08c89e23120ff0fb7043 https://doi.org/10.1200/jco.2004.22.90140.2029 Zobrazit plný text záznamu