clinical trials
Following the successful conclusion of its CYT997 Phase I clinical study programme, Cytopia has commenced a series of Phase II studies, primarily in solid tumours.
Phase Ib/II study of CYT997 in combination with carboplatin in relapsed glioblastoma multiforme
Cytopia has opened a Phase II single-arm study for patients with relapsed glioblastoma multiforme (GBM; glioma).
Patients will receive CYT997 as a 24-hour intravenous infusion every three weeks. The standard chemotherapeutic agent-carboplatin is also administered with CYT997. The study aims to determine whether CYT997's ability to disrupt tumour blood vessels will positively affect glioma tumours. The tolerability of the combination of CYT997 with carboplatin will also be determined.
This study is being conducted at centres in Melbourne, Adelaide and Sydney. Other sites in Australia will open to enrolment in 2009.
For more information go to http://www.anzctr.org.au/trial_view.aspx?ID=82702
Phase II study of CYT997 in relapsed or refractory multiple myeloma
Cytopia has commenced a Phase II study in patients with multiple myeloma (a cancer of the plasma cells found in bone marrow) who have failed to respond to other available drug therapies.
Patients receive CYT997 as a 24-hour intravenous infusion on two occasions in a 21-day cycle. The study aims to determine whether this CYT997 treatment can favorably affect patients’ myeloma disease.
The study is being conducted at The Alfred Hospital in Melbourne. For more information go to http://www.anzctr.org.au/trial_view.aspx?ID=82405
STUDIES CONCLUDED
Phase I dose-escalation study of CYT997 given as a 24-hour intravenous infusion every three weeks in patients with advanced solid tumours.
This study successfully concluded in late 2007. The programme was led by Drs Jason Lickliter and Paul Vasey.
In total, 31 patients with advanced cancer were treated at the Royal Brisbane Hospital in Queensland. Of those patients, 17 experienced stabilization of their cancer as a best response during the study. Seven of the patients were stabilized for a period in excess of four months and two patients with advancing disease continued therapy beyond their participation in the clinical trial.
In addition, analysis of data from the patient group indicated that CYT997 appeared to be affecting the function of tumour blood vessels, suggesting that the drug may be able to disturb the necessary supply of nutrients and oxygen to growing tumours.
Data from this study will be used to assist the design of future clinical trials.
For more information go to http://www.anzctr.org.au/trial_view.aspx?ID=945
Phase I accelerated dose-escalation study of CYT997 given as an oral capsule every three weeks in patients with advanced solid tumours.
This study successfully concluded in early 2008. The programme was led by Dr Jason Lickliter.
In total, 21 patients with advanced cancer were treated at centres in Melbourne, Brisbane, Adelaide and Townsville.
Data from this study confirmed that CYT997 is well absorbed following oral capsule administration to cancer patients. As in the company’s Phase I IV programme, significant changes in tumour blood vessels were detected in this study indicating that CYT997 perturbs tumour vasculature.
For more information go to http://www.anzctr.org.au/trial_view.aspx?ID=81754
Patients interested in learning more about the company’s various clinical studies should contact:
Dr Gregg Smith
Director, Drug Development & Operations
gregg.smith@cytopia.com.au
Ph: +61 3 9926 0406
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