Been re-reading a few old announcements etc. and came across this bit of info which may be of interest to some - particularly anyone interested in which companies are assisting in managing the trial.
"The Phase III protocol includes an 80-patient substudy being performed at selected study sites, to
investigate the pharmacokinetic and cardiotoxicity of HA-Irinotecan. This substudy is optional and
currently has 53 patients enrolled. To improve recruitment to this substudy, as well as to increase
the power of the overall study, the Company has determined that it will hold recruitment open to a
further 20 patients, bringing the total number of patients on the trial to 410. The addition of these
patients does not affect the timing of the clinical trial endpoint where the PFS will still be reported
in the first half of 2014.
Key vendors assisting the Alchemia team with the trial include CNF Pharma (USA), Practical
Clinical Inc. (Canada) and lead Clinical Research Organisation, PSI CRO AG (Switzerland).
Australian trial sites are managed by Novotech (Australia) Pty Ltd."
Taken from 3rd February 2013 announcement
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