Marshall Edwards, an oncology company engaged in the clinical development of novel anti-cancer therapeutics, has announced that the independent data monitoring committee constituted to oversee the conduct of the Phase III Ovature trial has recommended continuation of the study.
The Ovature trial is a major multi-center international Phase III clinical trial of orally-administered investigational drug phenoxodiol in combination with carboplatin in women with advanced ovarian cancer resistant or refractory to platinum-based drugs, to determine its safety and effectiveness when used in combination with carboplatin.
The independent data monitoring committee is responsible to ensure that patients recruited to the study are not exposed to unnecessary safety risks, that the study continues to meet its clinical objectives, that it is run according to the required standards of Good Clinical Practice, and that recruitment progress is satisfactory.
Following the review of recruitment progress, as well as safety and efficacy data, the committee has recommended that the study remain open and continue as planned towards its accrual target of 340 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 the US, UK, Europe and Australia.