|Full title:||A multi-center, open-label, dose-escalation study to assess the pharmacokinetics of ASA404 in adult cancer patients with impaired hepatic function and with normal hepatic function|
|ASA404 is a new anti tumour drug that was developed at Auckland Cancer Society Research Centre and Antisoma and is now licensed to Novartis Pharmaceuticals. It is a novel agent that disrupts the tumour’s blood supply. It has an acceptable safety profile in phase I and II clinical trials and a novel, but incompletely understood, mechanism of action. Results from previous research studies suggest that ASA404 may stop tumour growth by destroying tumour blood supply, preventing nutrients and oxygen reaching the centre of tumours, while normal blood vessels are unaffected. A phase III trial of ASA404 in combination with chemotherapy in NSCLC has recently begun recruiting.
Thus, it is hoped that ASA404 will likely be utilised in cancer patients. These patients often have co-existing morbidities, such as impaired liver function. Therefore it is important to understand the disposition and toxicity profile of ASA404 in this special population.
This study is designed to obtain pharmacokinetic data following a single IV dose of ASA404 in adult cancer patients with normal hepatic function (control group) and those with varying degrees of hepatic impairment. As well as examining the pharmacokinetic data the study will characterise the safety and tolerability of ASA404 in this specific population.
|Lead Investigator:||Professor Michael Findlay|
|Contact:||Sarah Benge (email@example.com)|
|Trial Registry reference:||NCT01278849 (click for more details)|