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A phase IA, open-label, dose-escalating study of PTK787/ZK 222584 administered orally on a continuous dosing schedule in patients with advanced cancer

Drevs, Joachim and Medinger, Michael and Mross, Klaus and Fuxius, Stefan and Hennig, Juergen and Buechert, Martin and Thomas, Anne and Unger, Clemens and Chen, Bee-Lian and Lebwohl, David and Laurent, Dirk. (2010) A phase IA, open-label, dose-escalating study of PTK787/ZK 222584 administered orally on a continuous dosing schedule in patients with advanced cancer. Anticancer Research, 30 (6). pp. 2335-2339.

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Official URL: http://edoc.unibas.ch/43922/

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Abstract

PTK787/ZK 222584 (PTK/ZK) offers a novel approach to inhibit tumour angiogenesis.; This study characterized the safety, tolerability, biological activity and pharmacokinetic profile of PTK/ZK, while determining the optimum dose. Seventy-one patients with advanced cancer were enrolled to receive once daily dosing. Pharmacokinetic, dynamic contrast enhanced magnetic resonance imaging and safety assessments were performed, along with measurement of soluble markers. Patients were treated until they had unacceptable toxicity and/or disease progression.; Twenty-nine patients were assessable for maximum tolerated dose (MTD) determination, but no MTD was established; only two patients experienced dose limiting toxicities. PTK/ZK was well tolerated with only nine patients experiencing serious adverse events suspected to be PTK/ZK related, but no objective tumour response was observed; 34% had stable disease and 48% had progressive disease. In addition, PTK/ZK was rapidly absorbed with a maximum concentration occurring 2 hours post-dosing. Vascular endothelial growth factor and basic fibroblastic growth factor were good predictors of best tumour response, as was the MRI bidirectional transfer constant on day 2 of treatment.; An MTD was not reached in this study but, based on these data and findings from other studies, 1200 mg was found to be the optimum dose of PTK/ZK for patients with advanced cancer.
Faculties and Departments:03 Faculty of Medicine
UniBasel Contributors:Medinger, Michael
Item Type:Article, refereed
Article Subtype:Research Article
Publisher:Stanford University Highwire Press
ISSN:0250-7005
e-ISSN:1791-7530
Note:Publication type according to Uni Basel Research Database: Journal article
Identification Number:
Last Modified:29 Nov 2017 09:29
Deposited On:29 Nov 2017 09:29

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