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
Registration number:
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TBC |
Ethics number:
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MEC/08/10/122
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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.
Progress
This trial is closed to recruitment.
Results
None to date
Centres involved
The New Zealand centres participating in this study are:
- Auckland (lead centre)
- Wellington
