French drugmaker Ipsen (Euronext: IPN) has announced that the Phase III clinical trial evaluating Decapeptyl (triptorelin pamoate) in patients with prostate cancer has met its primary endpoints.
The single arm, open label, Phase III study evaluated the efficacy, safety and local tolerability of a three-month triptorelin pamoate administered subcutaneously in patients with locally advanced or metastatic prostate cancer. The study co-primary end points were: the proportion of patients castrated at Day 29, and the proportion of patients with castration maintained at Day 183. The study was performed in five European countries (Latvia, Bulgaria, Romania, Poland and France) with a target recruitment of 120 patients. The full study results will be presented this year during a medical congress.
Based on these results, Ipsen intends to apply for the addition of the subcutaneous route, alongside the intramuscular route, to the label of triptorelin pamoate 11.25 mg.
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