Successful Planned Independent Analysis of Pivotal Phase III Trial of YONDELIS(R) in Ovarian Cancer.
PR Newswire Europe, October, 2006
MADRID, October 5 /PRNewswire/ -- PharmaMar today announced the successful planned review by the Independent Data Monitoring Committee (IDMC) of the YONDELIS(R) (trabectedin) Phase III pivotal clinical trial in ovarian cancer, known as OVA-301. The IDMC recommended that the present study should continue without modification.
The IDMC can recommend that the study protocol be stopped, temporarily suspended or amended if it determines that a trial is not meeting the necessary safety and efficacy requirements. In the case of OVA-301, this recommendation means that the trial is progressing positively as expected.
The OVA-301 pivotal Phase III multi-national study will enrol a total of 650 patients. The accrual halfway point in the study (325 patients)...
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