Preliminary phase 2 results of ABT-751 in subjects with advanced renal cell carcinoma (RCC)

Autor: Anne E. Hagey, K. A. Meek, K. N. Chi, Gary Gordon, N. Moldawer, P. Cernohous, D. M. Medina, Jeffrey A. Sosman, Robert A. Figlin
Rok vydání: 2005
Předmět:
Zdroj: Journal of Clinical Oncology. 23:4603-4603
ISSN: 1527-7755
0732-183X
DOI: 10.1200/jco.2005.23.16_suppl.4603
Popis: 4603 Background: There is currently no effective adjuvant therapy available for subjects with advanced RCC. ABT-751, an oral antimitotic agent that binds to the colchicine site of β-tubulin and prevents microtubule polymerization, has shown antitumor activity in various human xenograft models. In addition, signs of antitumor activity, consisting mainly of stable disease, were seen in subjects with RCC during phase 1 ABT-751 studies. Methods: This phase 2, open label, multi-center study evaluated safety and efficacy of ABT-751 in subjects with advanced RCC [N = 97: 43 subjects with no prior therapy (NPT), 54 subjects with prior therapy (PT)]. For each cycle, subjects received 200 mg ABT-751 orally once daily for 21 consecutive days followed by a 7-day break. Cycles were repeated until the subject met discontinuation criteria. Safety was assessed by adverse events (AEs) and laboratory evaluations. Time to progression (TTP) was analyzed using Kaplan-Meier methodology. Tumor response was assessed radiographic...
Databáze: OpenAIRE