This phase III study compares monotherapy liposomal doxorubicin, a Johnson & Johnson product known as Caelyx in Europe and Doxil in the US, to a combination of Yondelis (trabectedin) and Caelyx/Doxil in ovarian cancer patients who have relapsed after receiving standard first-line chemotherapy.
This randomized study will enroll 650 patients in 110 hospitals across 16 countries, including the US, Europe, Asia and South America. The primary objective is to test the hypothesis that combination therapy with Yondelis and Doxil/Caelyx improves progression-free and overall survival in women with relapsed ovarian cancer.
There will also be complementary pharmacogenomic studies to improve knowledge of ovarian cancer biology and help in the selection of patients who will benefit most from the drug combination.
The study protocol was reviewed by the FDA, through the special protocol assessment (SPA) process. The SPA procedure allows sponsors to obtain official written guidance from the FDA on pivotal phase III clinical trials. This study also was reviewed by the European Medicines Evaluation Agency (EMEA), through a similar process called protocol assistance (PA).
In previous phase II studies, Yondelis demonstrated activity in ovarian cancer patients who had relapsed after standard first-line treatment, demonstrating a response rate (a significant reduction in the tumor) of up to 43%. As the combination of Yondelis with Caelyx/Doxil also demonstrated activity and tolerability in a previous study , the study’s theoretical premise is that the combination of two active drugs may improve the survival rate of the target patient population.