Marshall Edwards Extends Accrual Time for Phase III Ovarian Cancer Trial
Posted on: Monday, 12 May 2008, 09:01 CDT
Marshall Edwards has extended the accrual time for the Ovature clinical study, a Phase III study of the investigational chemosensitizing drug, phenoxodiol, to facilitate complete patient enrollment in the US, Europe, and Australia.
Increasing the accrual period allowed decreasing the total number of patients in the study, without changing the required statistical analyses. As a result, the Ovature study will enroll 340 patients at 60 to 80 clinical sites throughout the US, Europe, and Australia. Initially, this study was announced to enroll 470 patients.
The Ovature trial is recruiting ovarian cancer patients whose cancer initially responded to chemotherapy, but has since become resistant or refractory to traditional platinum treatments. Patients are being recruited at clinical sites across USA, UK, Europe and Australia. Currently, more than 25 sites in the US, 20 sites in Europe and UK, and five sites in Australia are participating in this clinical study.
The primary outcome of the Ovature trial is the assessment of the relative time it takes for the ovarian cancer to progress.
Source: Datamonitor
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